Difference between revisions of "Peripheral T-cell lymphoma"
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=Guidelines= | =Guidelines= | ||
==[http://www.esmo.org/ ESMO]== | ==[http://www.esmo.org/ ESMO]== | ||
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*'''2015:''' d'Amore et al. [https://www.esmo.org/Guidelines/Haematological-Malignancies/Peripheral-T-Cell-Lymphomas Peripheral T-cell lymphomas: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up] | *'''2015:''' d'Amore et al. [https://www.esmo.org/Guidelines/Haematological-Malignancies/Peripheral-T-Cell-Lymphomas Peripheral T-cell lymphomas: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up] | ||
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===Older=== | ===Older=== | ||
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*'''2013:''' Dreyling et al. [http://annonc.oxfordjournals.org/content/24/4/857.full.pdf+html ESMO Consensus conferences: guidelines on malignant lymphoma. part 2: marginal zone lymphoma, mantle cell lymphoma, peripheral T-cell lymphoma.] [https://pubmed.ncbi.nlm.nih.gov/23425945 PubMed] | *'''2013:''' Dreyling et al. [http://annonc.oxfordjournals.org/content/24/4/857.full.pdf+html ESMO Consensus conferences: guidelines on malignant lymphoma. part 2: marginal zone lymphoma, mantle cell lymphoma, peripheral T-cell lymphoma.] [https://pubmed.ncbi.nlm.nih.gov/23425945 PubMed] | ||
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==[https://www.nccn.org/ NCCN]== | ==[https://www.nccn.org/ NCCN]== | ||
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*[https://www.nccn.org/professionals/physician_gls/pdf/t-cell.pdf NCCN Guidelines - T-cell Lymphomas] | *[https://www.nccn.org/professionals/physician_gls/pdf/t-cell.pdf NCCN Guidelines - T-cell Lymphomas] | ||
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=Untreated, randomized data= | =Untreated, randomized data= | ||
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==BV-CHP {{#subobject:6964de|Regimen=1}}== | ==BV-CHP {{#subobject:6964de|Regimen=1}}== | ||
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BV-CHP: '''<u>B</u>'''rentuximab '''<u>V</u>'''edotin, '''<u>C</u>'''yclophosphamide, '''<u>H</u>'''ydroxydaunorubicin (Doxorubicin), '''<u>P</u>'''rednisone | BV-CHP: '''<u>B</u>'''rentuximab '''<u>V</u>'''edotin, '''<u>C</u>'''yclophosphamide, '''<u>H</u>'''ydroxydaunorubicin (Doxorubicin), '''<u>P</u>'''rednisone | ||
<br>A+CHP: '''<u>A</u>'''dcetris (Brentuximab vedotin), '''<u>C</u>'''yclophosphamide, '''<u>H</u>'''ydroxydaunorubicin (Doxorubicin), '''<u>P</u>'''rednisone | <br>A+CHP: '''<u>A</u>'''dcetris (Brentuximab vedotin), '''<u>C</u>'''yclophosphamide, '''<u>H</u>'''ydroxydaunorubicin (Doxorubicin), '''<u>P</u>'''rednisone | ||
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
===Regimen {{#subobject:985a91|Variant=1}}=== | ===Regimen {{#subobject:985a91|Variant=1}}=== | ||
{| class="wikitable" style="color:white; background-color:#404040" | {| class="wikitable" style="color:white; background-color:#404040" | ||
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|} | |} | ||
''<sup>1</sup>Reported efficacy based on the 2021 update.'' | ''<sup>1</sup>Reported efficacy based on the 2021 update.'' | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Antibody-drug conjugate therapy==== | ====Antibody-drug conjugate therapy==== | ||
*[[Brentuximab vedotin (Adcetris)]] 1.8 mg/kg IV once on day 1, '''given fourth''' | *[[Brentuximab vedotin (Adcetris)]] 1.8 mg/kg IV once on day 1, '''given fourth''' | ||
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*[[Cyclophosphamide (Cytoxan)]] 750 mg/m<sup>2</sup> IV once on day 1 | *[[Cyclophosphamide (Cytoxan)]] 750 mg/m<sup>2</sup> IV once on day 1 | ||
*[[Doxorubicin (Adriamycin)]] 50 mg/m<sup>2</sup> IV once on day 1 | *[[Doxorubicin (Adriamycin)]] 50 mg/m<sup>2</sup> IV once on day 1 | ||
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====Glucocorticoid therapy==== | ====Glucocorticoid therapy==== | ||
*[[Prednisone (Sterapred)]] 100 mg PO once per day on days 1 to 5 | *[[Prednisone (Sterapred)]] 100 mg PO once per day on days 1 to 5 | ||
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'''21-day cycle for 6 to 8 cycles''' | '''21-day cycle for 6 to 8 cycles''' | ||
− | + | </div></div> | |
===References=== | ===References=== | ||
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#'''ECHELON-2:''' Horwitz S, O'Connor OA, Pro B, Illidge T, Fanale M, Advani R, Bartlett NL, Christensen JH, Morschhauser F, Domingo-Domenech E, Rossi G, Kim WS, Feldman T, Lennard A, Belada D, Illés Á, Tobinai K, Tsukasaki K, Yeh SP, Shustov A, Hüttmann A, Savage KJ, Yuen S, Iyer S, Zinzani PL, Hua Z, Little M, Rao S, Woolery J, Manley T, Trümper L; ECHELON-2 Study Group. Brentuximab vedotin with chemotherapy for CD30-positive peripheral T-cell lymphoma (ECHELON-2): a global, double-blind, randomised, phase 3 trial. Lancet. 2019 Jan 19;393(10168):229-240. Epub 2018 Dec 4. Erratum in: Lancet. 2019 Jan 19;393(10168):228. [https://doi.org/10.1016/S0140-6736(18)32984-2 link to original article] '''contains dosing details in abstract''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6436818/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/30522922 PubMed] NCT01777152 | #'''ECHELON-2:''' Horwitz S, O'Connor OA, Pro B, Illidge T, Fanale M, Advani R, Bartlett NL, Christensen JH, Morschhauser F, Domingo-Domenech E, Rossi G, Kim WS, Feldman T, Lennard A, Belada D, Illés Á, Tobinai K, Tsukasaki K, Yeh SP, Shustov A, Hüttmann A, Savage KJ, Yuen S, Iyer S, Zinzani PL, Hua Z, Little M, Rao S, Woolery J, Manley T, Trümper L; ECHELON-2 Study Group. Brentuximab vedotin with chemotherapy for CD30-positive peripheral T-cell lymphoma (ECHELON-2): a global, double-blind, randomised, phase 3 trial. Lancet. 2019 Jan 19;393(10168):229-240. Epub 2018 Dec 4. Erratum in: Lancet. 2019 Jan 19;393(10168):228. [https://doi.org/10.1016/S0140-6736(18)32984-2 link to original article] '''contains dosing details in abstract''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6436818/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/30522922 PubMed] NCT01777152 | ||
##'''Update:''' Horwitz S, O'Connor OA, Pro B, Trümper L, Iyer S, Advani R, Bartlett NL, Christensen JH, Morschhauser F, Domingo-Domenech E, Rossi G, Kim WS, Feldman T, Menne T, Belada D, Illés Á, Tobinai K, Tsukasaki K, Yeh SP, Shustov A, Hüttmann A, Savage KJ, Yuen S, Zinzani PL, Miao H, Bunn V, Fenton K, Fanale M, Puhlmann M, Illidge T. The ECHELON-2 Trial: 5-year results of a randomized, phase III study of brentuximab vedotin with chemotherapy for CD30-positive peripheral T-cell lymphoma. Ann Oncol. 2022 Mar;33(3):288-298. Epub 2021 Dec 16. [https://doi.org/10.1016/j.annonc.2021.12.002 link to original article] [https://pubmed.ncbi.nlm.nih.gov/34921960/ PubMed] | ##'''Update:''' Horwitz S, O'Connor OA, Pro B, Trümper L, Iyer S, Advani R, Bartlett NL, Christensen JH, Morschhauser F, Domingo-Domenech E, Rossi G, Kim WS, Feldman T, Menne T, Belada D, Illés Á, Tobinai K, Tsukasaki K, Yeh SP, Shustov A, Hüttmann A, Savage KJ, Yuen S, Zinzani PL, Miao H, Bunn V, Fenton K, Fanale M, Puhlmann M, Illidge T. The ECHELON-2 Trial: 5-year results of a randomized, phase III study of brentuximab vedotin with chemotherapy for CD30-positive peripheral T-cell lymphoma. Ann Oncol. 2022 Mar;33(3):288-298. Epub 2021 Dec 16. [https://doi.org/10.1016/j.annonc.2021.12.002 link to original article] [https://pubmed.ncbi.nlm.nih.gov/34921960/ PubMed] | ||
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==CHOP {{#subobject:38ee4a|Regimen=1}}== | ==CHOP {{#subobject:38ee4a|Regimen=1}}== | ||
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CHOP: '''<u>C</u>'''yclophosphamide, '''<u>H</u>'''ydroxydaunorubicin (Doxorubicin), '''<u>O</u>'''ncovin (Vincristine), '''<u>P</u>'''rednisone | CHOP: '''<u>C</u>'''yclophosphamide, '''<u>H</u>'''ydroxydaunorubicin (Doxorubicin), '''<u>O</u>'''ncovin (Vincristine), '''<u>P</u>'''rednisone | ||
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
===Regimen variant #1, 6 cycles, 40 mg/m<sup>2</sup> {{#subobject:d9nzc8|Variant=1}}=== | ===Regimen variant #1, 6 cycles, 40 mg/m<sup>2</sup> {{#subobject:d9nzc8|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
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|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | |||
*[[Cyclophosphamide (Cytoxan)]] 750 mg/m<sup>2</sup> IV once on day 1 | *[[Cyclophosphamide (Cytoxan)]] 750 mg/m<sup>2</sup> IV once on day 1 | ||
*[[Doxorubicin (Adriamycin)]] 50 mg/m<sup>2</sup> IV once on day 1 | *[[Doxorubicin (Adriamycin)]] 50 mg/m<sup>2</sup> IV once on day 1 | ||
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**Age 70 or younger: 1.4 mg/m<sup>2</sup> (maximum dose of 2 mg) IV once on day 1 | **Age 70 or younger: 1.4 mg/m<sup>2</sup> (maximum dose of 2 mg) IV once on day 1 | ||
**Age older than 70: 1.4 mg/m<sup>2</sup> (maximum dose of 1.5 mg) IV once on day 1 | **Age older than 70: 1.4 mg/m<sup>2</sup> (maximum dose of 1.5 mg) IV once on day 1 | ||
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====Glucocorticoid therapy==== | ====Glucocorticoid therapy==== | ||
*[[Prednisone (Sterapred)]] 40 mg/m<sup>2</sup> PO once per day on days 1 to 5 | *[[Prednisone (Sterapred)]] 40 mg/m<sup>2</sup> PO once per day on days 1 to 5 | ||
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'''21-day cycle for 6 cycles''' | '''21-day cycle for 6 cycles''' | ||
− | + | </div></div><br> | |
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
===Regimen variant #2, 6 cycles, prednisone 60 mg/m<sup>2</sup> {{#subobject:d9adc8|Variant=1}}=== | ===Regimen variant #2, 6 cycles, prednisone 60 mg/m<sup>2</sup> {{#subobject:d9adc8|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
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|} | |} | ||
''Note: the abstract of Reimer et al. 2004 does not have dosing details.'' | ''Note: the abstract of Reimer et al. 2004 does not have dosing details.'' | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | |||
*[[Cyclophosphamide (Cytoxan)]] 750 mg/m<sup>2</sup> IV once on day 1 | *[[Cyclophosphamide (Cytoxan)]] 750 mg/m<sup>2</sup> IV once on day 1 | ||
*[[Doxorubicin (Adriamycin)]] 50 mg/m<sup>2</sup> IV once on day 1 | *[[Doxorubicin (Adriamycin)]] 50 mg/m<sup>2</sup> IV once on day 1 | ||
*[[Vincristine (Oncovin)]] 1.4 mg/m<sup>2</sup> (maximum dose of 2 mg) IV once on day 1 | *[[Vincristine (Oncovin)]] 1.4 mg/m<sup>2</sup> (maximum dose of 2 mg) IV once on day 1 | ||
− | |||
====Glucocorticoid therapy==== | ====Glucocorticoid therapy==== | ||
*[[Prednisone (Sterapred)]] 60 mg/m<sup>2</sup> PO once per day on days 1 to 5 | *[[Prednisone (Sterapred)]] 60 mg/m<sup>2</sup> PO once per day on days 1 to 5 | ||
− | |||
'''21-day cycle for 6 cycles''' | '''21-day cycle for 6 cycles''' | ||
− | + | </div></div><br> | |
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
===Regimen variant #2, 8 cycles {{#subobject:f500e0|Variant=1}}=== | ===Regimen variant #2, 8 cycles {{#subobject:f500e0|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
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|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | |||
*[[Cyclophosphamide (Cytoxan)]] 750 mg/m<sup>2</sup> IV once on day 1 | *[[Cyclophosphamide (Cytoxan)]] 750 mg/m<sup>2</sup> IV once on day 1 | ||
*[[Doxorubicin (Adriamycin)]] 50 mg/m<sup>2</sup> IV once on day 1 | *[[Doxorubicin (Adriamycin)]] 50 mg/m<sup>2</sup> IV once on day 1 | ||
*[[Vincristine (Oncovin)]] 1.4 mg/m<sup>2</sup> (maximum dose of 2 mg) IV once on day 1 | *[[Vincristine (Oncovin)]] 1.4 mg/m<sup>2</sup> (maximum dose of 2 mg) IV once on day 1 | ||
− | |||
====Glucocorticoid therapy==== | ====Glucocorticoid therapy==== | ||
*[[Prednisone (Sterapred)]] 100 mg/m<sup>2</sup> PO once per day on days 1 to 5 | *[[Prednisone (Sterapred)]] 100 mg/m<sup>2</sup> PO once per day on days 1 to 5 | ||
− | |||
'''21-day cycle for 8 cycles''' | '''21-day cycle for 8 cycles''' | ||
− | + | </div> | |
+ | <div class="toccolours" style="background-color:#cbd5e7"> | ||
====Subsequent treatment==== | ====Subsequent treatment==== | ||
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*Patients with initial bulky disease (diameter at least 5 cm): [[#Radiation_therapy|IFRT]] x 40 Gy | *Patients with initial bulky disease (diameter at least 5 cm): [[#Radiation_therapy|IFRT]] x 40 Gy | ||
− | + | </div></div> | |
===References=== | ===References=== | ||
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#Reimer P, Schertlin T, Rüdiger T, Geissinger E, Roth S, Kunzmann V, Weissinger F, Nerl C, Schmitz N, Müller-Hermelink HK, Wilhelm M. Myeloablative radiochemotherapy followed by autologous peripheral blood stem cell transplantation as first-line therapy in peripheral T-cell lymphomas: first results of a prospective multicenter study. Hematol J. 2004;5(4):304-11. [https://doi.org/10.1038/sj.thj.6200359 link to original article] '''does not contain dosing details''' [https://pubmed.ncbi.nlm.nih.gov/15297846 PubMed] | #Reimer P, Schertlin T, Rüdiger T, Geissinger E, Roth S, Kunzmann V, Weissinger F, Nerl C, Schmitz N, Müller-Hermelink HK, Wilhelm M. Myeloablative radiochemotherapy followed by autologous peripheral blood stem cell transplantation as first-line therapy in peripheral T-cell lymphomas: first results of a prospective multicenter study. Hematol J. 2004;5(4):304-11. [https://doi.org/10.1038/sj.thj.6200359 link to original article] '''does not contain dosing details''' [https://pubmed.ncbi.nlm.nih.gov/15297846 PubMed] | ||
##'''Update:''' Reimer P, Rüdiger T, Geissinger E, Weissinger F, Nerl C, Schmitz N, Engert A, Einsele H, Müller-Hermelink HK, Wilhelm M. Autologous stem-cell transplantation as first-line therapy in peripheral T-cell lymphomas: results of a prospective multicenter study. J Clin Oncol. 2009 Jan 1;27(1):106-13. Epub 2008 Nov 24. [https://doi.org/10.1200/jco.2008.17.4870 link to original article] [https://pubmed.ncbi.nlm.nih.gov/19029417 PubMed] | ##'''Update:''' Reimer P, Rüdiger T, Geissinger E, Weissinger F, Nerl C, Schmitz N, Engert A, Einsele H, Müller-Hermelink HK, Wilhelm M. Autologous stem-cell transplantation as first-line therapy in peripheral T-cell lymphomas: results of a prospective multicenter study. J Clin Oncol. 2009 Jan 1;27(1):106-13. Epub 2008 Nov 24. [https://doi.org/10.1200/jco.2008.17.4870 link to original article] [https://pubmed.ncbi.nlm.nih.gov/19029417 PubMed] | ||
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##'''Update:''' Horwitz S, O'Connor OA, Pro B, Trümper L, Iyer S, Advani R, Bartlett NL, Christensen JH, Morschhauser F, Domingo-Domenech E, Rossi G, Kim WS, Feldman T, Menne T, Belada D, Illés Á, Tobinai K, Tsukasaki K, Yeh SP, Shustov A, Hüttmann A, Savage KJ, Yuen S, Zinzani PL, Miao H, Bunn V, Fenton K, Fanale M, Puhlmann M, Illidge T. The ECHELON-2 Trial: 5-year results of a randomized, phase III study of brentuximab vedotin with chemotherapy for CD30-positive peripheral T-cell lymphoma. Ann Oncol. 2022 Mar;33(3):288-298. Epub 2021 Dec 16. [https://doi.org/10.1016/j.annonc.2021.12.002 link to original article] [https://pubmed.ncbi.nlm.nih.gov/34921960/ PubMed] | ##'''Update:''' Horwitz S, O'Connor OA, Pro B, Trümper L, Iyer S, Advani R, Bartlett NL, Christensen JH, Morschhauser F, Domingo-Domenech E, Rossi G, Kim WS, Feldman T, Menne T, Belada D, Illés Á, Tobinai K, Tsukasaki K, Yeh SP, Shustov A, Hüttmann A, Savage KJ, Yuen S, Zinzani PL, Miao H, Bunn V, Fenton K, Fanale M, Puhlmann M, Illidge T. The ECHELON-2 Trial: 5-year results of a randomized, phase III study of brentuximab vedotin with chemotherapy for CD30-positive peripheral T-cell lymphoma. Ann Oncol. 2022 Mar;33(3):288-298. Epub 2021 Dec 16. [https://doi.org/10.1016/j.annonc.2021.12.002 link to original article] [https://pubmed.ncbi.nlm.nih.gov/34921960/ PubMed] | ||
#'''LYSA Ro-CHOP:''' Bachy E, Camus V, Thieblemont C, Sibon D, Casasnovas RO, Ysebaert L, Damaj G, Guidez S, Pica GM, Kim WS, Lim ST, André M, García-Sancho AM, Penarrubia MJ, Staber PB, Trotman J, Hüttmann A, Stefoni V, Re A, Gaulard P, Delfau-Larue MH, de Leval L, Meignan M, Li J, Morschhauser F, Delarue R. Romidepsin Plus CHOP Versus CHOP in Patients With Previously Untreated Peripheral T-Cell Lymphoma: Results of the Ro-CHOP Phase III Study (Conducted by LYSA). J Clin Oncol. 2022 Jan 20;40(3):242-251. Epub 2021 Nov 29. [https://doi.org/10.1200/jco.21.01815 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/34843406/ PubMed] NCT01796002 | #'''LYSA Ro-CHOP:''' Bachy E, Camus V, Thieblemont C, Sibon D, Casasnovas RO, Ysebaert L, Damaj G, Guidez S, Pica GM, Kim WS, Lim ST, André M, García-Sancho AM, Penarrubia MJ, Staber PB, Trotman J, Hüttmann A, Stefoni V, Re A, Gaulard P, Delfau-Larue MH, de Leval L, Meignan M, Li J, Morschhauser F, Delarue R. Romidepsin Plus CHOP Versus CHOP in Patients With Previously Untreated Peripheral T-Cell Lymphoma: Results of the Ro-CHOP Phase III Study (Conducted by LYSA). J Clin Oncol. 2022 Jan 20;40(3):242-251. Epub 2021 Nov 29. [https://doi.org/10.1200/jco.21.01815 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/34843406/ PubMed] NCT01796002 | ||
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==CHOP-14 (Prednisolone) {{#subobject:e35g92|Regimen=1}}== | ==CHOP-14 (Prednisolone) {{#subobject:e35g92|Regimen=1}}== | ||
− | |||
CHOP-14: '''<u>C</u>'''yclophosphamide, '''<u>H</u>'''ydroxydaunorubicin (Doxorubicin), '''<u>O</u>'''ncovin (Vincristine), '''<u>P</u>'''rednisolone every '''<u>14</u>''' days | CHOP-14: '''<u>C</u>'''yclophosphamide, '''<u>H</u>'''ydroxydaunorubicin (Doxorubicin), '''<u>O</u>'''ncovin (Vincristine), '''<u>P</u>'''rednisolone every '''<u>14</u>''' days | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen {{#subobject:b6yh3a|Variant=1}}=== | ===Regimen {{#subobject:b6yh3a|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
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|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#cbd5e8"> | ||
====Preceding treatment==== | ====Preceding treatment==== | ||
*ACT-2: [[#Vincristine_.26_Prednisolone_88|Vincristine & Prednisolone]] pre-phase | *ACT-2: [[#Vincristine_.26_Prednisolone_88|Vincristine & Prednisolone]] pre-phase | ||
+ | </div> | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | |||
*[[Cyclophosphamide (Cytoxan)]] 750 mg/m<sup>2</sup> IV once on day 1 | *[[Cyclophosphamide (Cytoxan)]] 750 mg/m<sup>2</sup> IV once on day 1 | ||
*[[Doxorubicin (Adriamycin)]] 50 mg/m<sup>2</sup> IV once on day 1 | *[[Doxorubicin (Adriamycin)]] 50 mg/m<sup>2</sup> IV once on day 1 | ||
*[[Vincristine (Oncovin)]] 1.4 mg/m<sup>2</sup> (maximum dose of 2 mg) IV once on day 1 | *[[Vincristine (Oncovin)]] 1.4 mg/m<sup>2</sup> (maximum dose of 2 mg) IV once on day 1 | ||
− | |||
====Glucocorticoid therapy==== | ====Glucocorticoid therapy==== | ||
*[[Prednisolone (Millipred)]] 100 mg PO once per day on days 1 to 5 | *[[Prednisolone (Millipred)]] 100 mg PO once per day on days 1 to 5 | ||
− | |||
====Supportive therapy==== | ====Supportive therapy==== | ||
*[[:Category:Granulocyte colony-stimulating factors|G-CSF]] support | *[[:Category:Granulocyte colony-stimulating factors|G-CSF]] support | ||
− | |||
'''14-day cycle for 6 cycles''' | '''14-day cycle for 6 cycles''' | ||
− | + | </div></div> | |
===References=== | ===References=== | ||
#'''ACT-2:''' Wulf GG, Altmann B, Ziepert M, D'Amore F, Held G, Greil R, Tournilhac O, Relander T, Viardot A, Wilhelm M, Wilhelm C, Pezzutto A, Zijlstra JM, van den Neste E, Lugtenburg PJ, Doorduijn JK, Gelder MV, van Imhoff GW, Zettl F, Braulke F, Nickelsen M, Glass B, Rosenwald A, Gaulard P, Loeffler M, Pfreundschuh M, Schmitz N, Trümper L; DSHNHL. Alemtuzumab plus CHOP versus CHOP in elderly patients with peripheral T-cell lymphoma: the DSHNHL2006-1B/ACT-2 trial. Leukemia. 2021 Jan;35(1):143-155. Epub 2020 May 7. [https://doi.org/10.1038/s41375-020-0838-5 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/32382083 PubMed] | #'''ACT-2:''' Wulf GG, Altmann B, Ziepert M, D'Amore F, Held G, Greil R, Tournilhac O, Relander T, Viardot A, Wilhelm M, Wilhelm C, Pezzutto A, Zijlstra JM, van den Neste E, Lugtenburg PJ, Doorduijn JK, Gelder MV, van Imhoff GW, Zettl F, Braulke F, Nickelsen M, Glass B, Rosenwald A, Gaulard P, Loeffler M, Pfreundschuh M, Schmitz N, Trümper L; DSHNHL. Alemtuzumab plus CHOP versus CHOP in elderly patients with peripheral T-cell lymphoma: the DSHNHL2006-1B/ACT-2 trial. Leukemia. 2021 Jan;35(1):143-155. Epub 2020 May 7. [https://doi.org/10.1038/s41375-020-0838-5 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/32382083 PubMed] | ||
− | |||
==CMED {{#subobject:1239e2|Regimen=1}}== | ==CMED {{#subobject:1239e2|Regimen=1}}== | ||
− | |||
CMED: '''<u>C</u>'''yclophosphamide, '''<u>M</u>'''ethotrexate, '''<u>E</u>'''toposide, '''<u>D</u>'''examethasone | CMED: '''<u>C</u>'''yclophosphamide, '''<u>M</u>'''ethotrexate, '''<u>E</u>'''toposide, '''<u>D</u>'''examethasone | ||
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
===Regimen {{#subobject:c4a84c|Variant=1}}=== | ===Regimen {{#subobject:c4a84c|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
Line 242: | Line 222: | ||
|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | |||
*[[Cyclophosphamide (Cytoxan)]] 2000 mg/m<sup>2</sup> IV once on day 1 | *[[Cyclophosphamide (Cytoxan)]] 2000 mg/m<sup>2</sup> IV once on day 1 | ||
*[[Methotrexate (MTX)]] 300 mg/m<sup>2</sup> IV once on day 1 | *[[Methotrexate (MTX)]] 300 mg/m<sup>2</sup> IV once on day 1 | ||
*[[Etoposide (Vepesid)]] 400 mg/m<sup>2</sup> IV once per day on days 1 & 2 | *[[Etoposide (Vepesid)]] 400 mg/m<sup>2</sup> IV once per day on days 1 & 2 | ||
− | |||
====Glucocorticoid therapy==== | ====Glucocorticoid therapy==== | ||
*[[Dexamethasone (Decadron)]] 20 mg/m<sup>2</sup> PO once per day on days 1 to 5 | *[[Dexamethasone (Decadron)]] 20 mg/m<sup>2</sup> PO once per day on days 1 to 5 | ||
− | |||
====Supportive therapy==== | ====Supportive therapy==== | ||
− | |||
*[[Folinic acid (Leucovorin)]] 15 mg IV every 6 hours for 12 doses, '''started 24 hours after MTX''' | *[[Folinic acid (Leucovorin)]] 15 mg IV every 6 hours for 12 doses, '''started 24 hours after MTX''' | ||
− | |||
'''14-day cycle for 6 cycles''' | '''14-day cycle for 6 cycles''' | ||
− | + | </div></div> | |
===References=== | ===References=== | ||
− | |||
#Avilés A, Castañeda C, Neri N, Cleto S, Talavera A, González M, Huerta-Guzmán J, Nambo MJ. Results of a phase III clinical trial: CHOP versus CMED in peripheral T-cell lymphoma unspecified. Med Oncol. 2008;25(3):360-4. Epub 2008 Feb 5. [https://doi.org/10.1007/s12032-008-9046-2 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/18247163 PubMed] | #Avilés A, Castañeda C, Neri N, Cleto S, Talavera A, González M, Huerta-Guzmán J, Nambo MJ. Results of a phase III clinical trial: CHOP versus CMED in peripheral T-cell lymphoma unspecified. Med Oncol. 2008;25(3):360-4. Epub 2008 Feb 5. [https://doi.org/10.1007/s12032-008-9046-2 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/18247163 PubMed] | ||
− | |||
==GDPT {{#subobject:e63a7d|Regimen=1}}== | ==GDPT {{#subobject:e63a7d|Regimen=1}}== | ||
− | |||
GDPT: '''<u>G</u>'''emcitabine, '''<u>D</u>'''DP (Cisplatin), '''<u>P</u>'''rednisone, '''<u>T</u>'''halidomide | GDPT: '''<u>G</u>'''emcitabine, '''<u>D</u>'''DP (Cisplatin), '''<u>P</u>'''rednisone, '''<u>T</u>'''halidomide | ||
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
===Regimen {{#subobject:5cd5b6|Variant=1}}=== | ===Regimen {{#subobject:5cd5b6|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
Line 279: | Line 253: | ||
|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | |||
*[[Gemcitabine (Gemzar)]] 800 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1 & 8 | *[[Gemcitabine (Gemzar)]] 800 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1 & 8 | ||
*[[Cisplatin (Platinol)]] 25 mg/m<sup>2</sup> IV once per day on days 1 to 3 | *[[Cisplatin (Platinol)]] 25 mg/m<sup>2</sup> IV once per day on days 1 to 3 | ||
− | |||
====Glucocorticoid therapy==== | ====Glucocorticoid therapy==== | ||
*[[Prednisone (Sterapred)]] 60 mg/m<sup>2</sup> PO once per day on days 1 to 5 | *[[Prednisone (Sterapred)]] 60 mg/m<sup>2</sup> PO once per day on days 1 to 5 | ||
− | |||
====Targeted therapy==== | ====Targeted therapy==== | ||
*[[Thalidomide (Thalomid)]] 50 mg PO once per day, increased by 50 mg per day until target dose of 200 mg PO once per day | *[[Thalidomide (Thalomid)]] 50 mg PO once per day, increased by 50 mg per day until target dose of 200 mg PO once per day | ||
− | |||
====Supportive therapy==== | ====Supportive therapy==== | ||
− | |||
*[[Aspirin]] 100 mg PO once per day | *[[Aspirin]] 100 mg PO once per day | ||
− | |||
'''21-day cycle for 6 cycles''' | '''21-day cycle for 6 cycles''' | ||
− | + | </div></div> | |
===References=== | ===References=== | ||
− | |||
#'''hnslblzlzx2011-3:''' Li L, Duan W, Zhang L, Li X, Fu X, Wang X, Wu J, Sun Z, Zhang X, Chang Y, Nan F, Yan J, Li Z, Young KH, Zhang M. The efficacy and safety of gemcitabine, cisplatin, prednisone, thalidomide versus CHOP in patients with newly diagnosed peripheral T-cell lymphoma with analysis of biomarkers. Br J Haematol. 2017 Sep;178(5):772-780. Epub 2017 Jun 9. [https://doi.org/10.1111/bjh.14763 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/28597542 PubMed] NCT01664975 | #'''hnslblzlzx2011-3:''' Li L, Duan W, Zhang L, Li X, Fu X, Wang X, Wu J, Sun Z, Zhang X, Chang Y, Nan F, Yan J, Li Z, Young KH, Zhang M. The efficacy and safety of gemcitabine, cisplatin, prednisone, thalidomide versus CHOP in patients with newly diagnosed peripheral T-cell lymphoma with analysis of biomarkers. Br J Haematol. 2017 Sep;178(5):772-780. Epub 2017 Jun 9. [https://doi.org/10.1111/bjh.14763 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/28597542 PubMed] NCT01664975 | ||
− | |||
=Untreated, non-randomized or retrospective data= | =Untreated, non-randomized or retrospective data= | ||
− | |||
==A-CHOP {{#subobject:75a3d2|Regimen=1}}== | ==A-CHOP {{#subobject:75a3d2|Regimen=1}}== | ||
− | |||
A-CHOP: '''<u>A</u>'''lemtuzumab, '''<u>C</u>'''yclophosphamide, '''<u>H</u>'''ydroxydaunorubicin (Doxorubicin), '''<u>O</u>'''ncovin (Vincristine), '''<u>P</u>'''redniso(lo)ne | A-CHOP: '''<u>A</u>'''lemtuzumab, '''<u>C</u>'''yclophosphamide, '''<u>H</u>'''ydroxydaunorubicin (Doxorubicin), '''<u>O</u>'''ncovin (Vincristine), '''<u>P</u>'''redniso(lo)ne | ||
<br>CHOP-AL: '''<u>C</u>'''yclophosphamide, '''<u>H</u>'''ydroxydaunorubicin (Doxorubicin), '''<u>O</u>'''ncovin (Vincristine), '''<u>P</u>'''redniso(lo)ne, '''<u>AL</u>'''emtuzumab | <br>CHOP-AL: '''<u>C</u>'''yclophosphamide, '''<u>H</u>'''ydroxydaunorubicin (Doxorubicin), '''<u>O</u>'''ncovin (Vincristine), '''<u>P</u>'''redniso(lo)ne, '''<u>AL</u>'''emtuzumab | ||
<br>CHOP-C: '''<u>C</u>'''yclophosphamide, '''<u>H</u>'''ydroxydaunorubicin (Doxorubicin), '''<u>O</u>'''ncovin (Vincristine), '''<u>P</u>'''redniso(lo)ne, '''<u>C</u>'''ampath (Alemtuzumab) | <br>CHOP-C: '''<u>C</u>'''yclophosphamide, '''<u>H</u>'''ydroxydaunorubicin (Doxorubicin), '''<u>O</u>'''ncovin (Vincristine), '''<u>P</u>'''redniso(lo)ne, '''<u>C</u>'''ampath (Alemtuzumab) | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen variant #1, 2 cycles {{#subobject:ab9c64|Variant=1}}=== | ===Regimen variant #1, 2 cycles {{#subobject:ab9c64|Variant=1}}=== | ||
{| class="wikitable" style="width: 60%; text-align:center;" | {| class="wikitable" style="width: 60%; text-align:center;" | ||
Line 319: | Line 284: | ||
|- | |- | ||
|} | |} | ||
− | ''These are the details for "Clin A" which was the regimen used for patients younger than 60. Note: this is a component of a sequential treatment protocol; to our knowledge there are no references to support using it as a stand-alone treatment.'' | + | ''Note: These are the details for "Clin A" which was the regimen used for patients younger than 60. Note: this is a component of a sequential treatment protocol; to our knowledge there are no references to support using it as a stand-alone treatment.'' |
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | |||
*[[Cyclophosphamide (Cytoxan)]] 750 mg/m<sup>2</sup> IV once on day 1 | *[[Cyclophosphamide (Cytoxan)]] 750 mg/m<sup>2</sup> IV once on day 1 | ||
*[[Doxorubicin (Adriamycin)]] 50 mg/m<sup>2</sup> IV once on day 1 | *[[Doxorubicin (Adriamycin)]] 50 mg/m<sup>2</sup> IV once on day 1 | ||
*[[Vincristine (Oncovin)]] 1.4 mg/m<sup>2</sup> (maximum dose of 2 mg) IV once on day 1 | *[[Vincristine (Oncovin)]] 1.4 mg/m<sup>2</sup> (maximum dose of 2 mg) IV once on day 1 | ||
− | |||
====Glucocorticoid therapy==== | ====Glucocorticoid therapy==== | ||
*[[Prednisone (Sterapred)]] 100 mg PO once per day on days 1 to 5 | *[[Prednisone (Sterapred)]] 100 mg PO once per day on days 1 to 5 | ||
Line 332: | Line 296: | ||
**Cycle 1: 3 mg IV once on day -2, then 10 mg IV once on day -1, then 20 mg IV once on day 0 | **Cycle 1: 3 mg IV once on day -2, then 10 mg IV once on day -1, then 20 mg IV once on day 0 | ||
**Cycle 2: 30 mg IV once on day 0 (= day 21 of cycle 1) | **Cycle 2: 30 mg IV once on day 0 (= day 21 of cycle 1) | ||
− | |||
'''21-day cycle for 2 cycles''' | '''21-day cycle for 2 cycles''' | ||
− | + | </div> | |
+ | <div class="toccolours" style="background-color:#cbd5e7"> | ||
====Subsequent treatment==== | ====Subsequent treatment==== | ||
− | |||
*[[#HyperCHidam|HyperCHidam]] x 2 | *[[#HyperCHidam|HyperCHidam]] x 2 | ||
− | + | </div></div><br> | |
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
===Regimen variant #2, 8 cycles {{#subobject:c8d06d|Variant=1}}=== | ===Regimen variant #2, 8 cycles {{#subobject:c8d06d|Variant=1}}=== | ||
{| class="wikitable" style="width: 40%; text-align:center;" | {| class="wikitable" style="width: 40%; text-align:center;" | ||
Line 349: | Line 313: | ||
|} | |} | ||
''Note: the paper reports using the CHOP dosing as specified by [https://doi.org/10.1056/NEJM199304083281404 Fisher et al. 1993]; however, note that the cycle length here is 28 days.'' | ''Note: the paper reports using the CHOP dosing as specified by [https://doi.org/10.1056/NEJM199304083281404 Fisher et al. 1993]; however, note that the cycle length here is 28 days.'' | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | |||
*[[Cyclophosphamide (Cytoxan)]] 750 mg/m<sup>2</sup> IV once on day 1 | *[[Cyclophosphamide (Cytoxan)]] 750 mg/m<sup>2</sup> IV once on day 1 | ||
*[[Doxorubicin (Adriamycin)]] 50 mg/m<sup>2</sup> IV once on day 1 | *[[Doxorubicin (Adriamycin)]] 50 mg/m<sup>2</sup> IV once on day 1 | ||
*[[Vincristine (Oncovin)]] 1.4 mg/m<sup>2</sup> (maximum dose of 2 mg) IV once on day 1 | *[[Vincristine (Oncovin)]] 1.4 mg/m<sup>2</sup> (maximum dose of 2 mg) IV once on day 1 | ||
− | |||
====Glucocorticoid therapy==== | ====Glucocorticoid therapy==== | ||
*[[Prednisone (Sterapred)]] 100 mg PO once per day on days 1 to 5 | *[[Prednisone (Sterapred)]] 100 mg PO once per day on days 1 to 5 | ||
Line 361: | Line 324: | ||
**Cycle 1: 3 mg IV once on day -2, then 10 mg IV once on day -1, then 20 mg IV once on day 0, then 30 mg IV once on day 1 | **Cycle 1: 3 mg IV once on day -2, then 10 mg IV once on day -1, then 20 mg IV once on day 0, then 30 mg IV once on day 1 | ||
**Cycles 2 to 8: 30 mg IV once on day 1 | **Cycles 2 to 8: 30 mg IV once on day 1 | ||
− | |||
====Supportive therapy==== | ====Supportive therapy==== | ||
− | |||
*[[Chlorpheniramine (Chlor-Trimeton)]] 10 mg IV once per infusion; 60 minutes prior to [[Alemtuzumab (Campath)]] | *[[Chlorpheniramine (Chlor-Trimeton)]] 10 mg IV once per infusion; 60 minutes prior to [[Alemtuzumab (Campath)]] | ||
*[[Acetaminophen (Tylenol)]] 500 mg PO once per infusion; 30 minutes prior to [[Alemtuzumab (Campath)]] | *[[Acetaminophen (Tylenol)]] 500 mg PO once per infusion; 30 minutes prior to [[Alemtuzumab (Campath)]] | ||
*[[Alizapride (Litican)]] 100 mg IV once per infusion; 30 minutes prior to [[Alemtuzumab (Campath)]] | *[[Alizapride (Litican)]] 100 mg IV once per infusion; 30 minutes prior to [[Alemtuzumab (Campath)]] | ||
− | |||
'''28-day cycle for 8 cycles''' | '''28-day cycle for 8 cycles''' | ||
+ | </div></div> | ||
===References=== | ===References=== | ||
#Gallamini A, Zaja F, Patti C, Billio A, Specchia MR, Tucci A, Levis A, Manna A, Secondo V, Rigacci L, Pinto A, Iannitto E, Zoli V, Torchio P, Pileri S, Tarella C. Alemtuzumab (Campath-1H) and CHOP chemotherapy as first-line treatment of peripheral T-cell lymphoma: results of a GITIL (Gruppo Italiano Terapie Innovative nei Linfomi) prospective multicenter trial. Blood. 2007 Oct 1;110(7):2316-23. Epub 2007 Jun 20. [http://www.bloodjournal.org/content/110/7/2316.long link to original article] '''contains partial protocol''' [https://pubmed.ncbi.nlm.nih.gov/17581918 PubMed] | #Gallamini A, Zaja F, Patti C, Billio A, Specchia MR, Tucci A, Levis A, Manna A, Secondo V, Rigacci L, Pinto A, Iannitto E, Zoli V, Torchio P, Pileri S, Tarella C. Alemtuzumab (Campath-1H) and CHOP chemotherapy as first-line treatment of peripheral T-cell lymphoma: results of a GITIL (Gruppo Italiano Terapie Innovative nei Linfomi) prospective multicenter trial. Blood. 2007 Oct 1;110(7):2316-23. Epub 2007 Jun 20. [http://www.bloodjournal.org/content/110/7/2316.long link to original article] '''contains partial protocol''' [https://pubmed.ncbi.nlm.nih.gov/17581918 PubMed] | ||
#'''PTCL-06:''' Corradini P, Vitolo U, Rambaldi A, Miceli R, Patriarca F, Gallamini A, Olivieri A, Benedetti F, Todeschini G, Rossi G, Salvi F, Bruno B, Baldini L, Ferreri A, Patti C, Tarella C, Pileri S, Dodero A. Intensified chemo-immunotherapy with or without stem cell transplantation in newly diagnosed patients with peripheral T-cell lymphoma. Leukemia. 2014 Sep;28(9):1885-91. Epub 2014 Feb 20. [https://doi.org/10.1038/leu.2014.79 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/24662801 PubMed] EudraCT 2006-004234-33 | #'''PTCL-06:''' Corradini P, Vitolo U, Rambaldi A, Miceli R, Patriarca F, Gallamini A, Olivieri A, Benedetti F, Todeschini G, Rossi G, Salvi F, Bruno B, Baldini L, Ferreri A, Patti C, Tarella C, Pileri S, Dodero A. Intensified chemo-immunotherapy with or without stem cell transplantation in newly diagnosed patients with peripheral T-cell lymphoma. Leukemia. 2014 Sep;28(9):1885-91. Epub 2014 Feb 20. [https://doi.org/10.1038/leu.2014.79 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/24662801 PubMed] EudraCT 2006-004234-33 | ||
− | |||
==CHOEP-14 {{#subobject:e84b92|Regimen=1}}== | ==CHOEP-14 {{#subobject:e84b92|Regimen=1}}== | ||
− | |||
CHOEP-14: '''<u>C</u>'''yclophosphamide, '''<u>H</u>'''ydroxydaunorubicin (Doxorubicin), '''<u>O</u>'''ncovin (Vincristine), '''<u>E</u>'''toposide, '''<u>P</u>'''rednisone every '''<u>14</u>''' days | CHOEP-14: '''<u>C</u>'''yclophosphamide, '''<u>H</u>'''ydroxydaunorubicin (Doxorubicin), '''<u>O</u>'''ncovin (Vincristine), '''<u>E</u>'''toposide, '''<u>P</u>'''rednisone every '''<u>14</u>''' days | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen {{#subobject:b15c3a|Variant=1}}=== | ===Regimen {{#subobject:b15c3a|Variant=1}}=== | ||
{| class="wikitable" style="width: 40%; text-align:center;" | {| class="wikitable" style="width: 40%; text-align:center;" | ||
Line 386: | Line 345: | ||
|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | |||
*[[Cyclophosphamide (Cytoxan)]] 750 mg/m<sup>2</sup> IV once on day 1 | *[[Cyclophosphamide (Cytoxan)]] 750 mg/m<sup>2</sup> IV once on day 1 | ||
*[[Doxorubicin (Adriamycin)]] 50 mg/m<sup>2</sup> IV once on day 1 | *[[Doxorubicin (Adriamycin)]] 50 mg/m<sup>2</sup> IV once on day 1 | ||
Line 393: | Line 352: | ||
*[[Etoposide (Vepesid)]] by the following age-based criteria: | *[[Etoposide (Vepesid)]] by the following age-based criteria: | ||
**Up to age 60: 100 mg/m<sup>2</sup> IV once per day on days 1 to 3 | **Up to age 60: 100 mg/m<sup>2</sup> IV once per day on days 1 to 3 | ||
− | |||
====Glucocorticoid therapy==== | ====Glucocorticoid therapy==== | ||
*[[Prednisone (Sterapred)]] 50 mg PO twice per day on days 1 to 5 | *[[Prednisone (Sterapred)]] 50 mg PO twice per day on days 1 to 5 | ||
− | |||
'''14-day cycle for 6 cycles''' | '''14-day cycle for 6 cycles''' | ||
+ | </div> | ||
+ | <div class="toccolours" style="background-color:#cbd5e7"> | ||
====Subsequent treatment==== | ====Subsequent treatment==== | ||
− | |||
*If patients in PR or CR after three cycles, stem cells are mobilized off of cycles 5 and 6, followed by BEAC or [[#BEAM.2C_then_auto_HSCT|BEAM]], then auto HSCT | *If patients in PR or CR after three cycles, stem cells are mobilized off of cycles 5 and 6, followed by BEAC or [[#BEAM.2C_then_auto_HSCT|BEAM]], then auto HSCT | ||
− | + | </div></div> | |
===References=== | ===References=== | ||
<!-- Presented orally in part at the 48th Annual Meeting of the American Society of Hematology, Orlando, FL, December 9-12, 2006; 14th Annual Meeting of the European Hematology Association, Berlin, Germany, June 4-7, 2009; 11th International Conference on Malignant Lymphoma, Lugano, Switzerland, June 15-18, 2011; and American Society of Hematology Annual Meeting, San Diego, CA, December 10-13, 2011. --> | <!-- Presented orally in part at the 48th Annual Meeting of the American Society of Hematology, Orlando, FL, December 9-12, 2006; 14th Annual Meeting of the European Hematology Association, Berlin, Germany, June 4-7, 2009; 11th International Conference on Malignant Lymphoma, Lugano, Switzerland, June 15-18, 2011; and American Society of Hematology Annual Meeting, San Diego, CA, December 10-13, 2011. --> | ||
− | |||
#'''NLG-T-01:''' d'Amore F, Relander T, Lauritzsen GF, Jantunen E, Hagberg H, Anderson H, Holte H, Österborg A, Merup M, Brown P, Kuittinen O, Erlanson M, Østenstad B, Fagerli UM, Gadeberg OV, Sundström C, Delabie J, Ralfkiaer E, Vornanen M, Toldbod HE. Up-front autologous stem-cell transplantation in peripheral T-cell lymphoma: NLG-T-01. J Clin Oncol. 2012 Sep 1;30(25):3093-9. Epub 2012 Jul 30. [https://doi.org/10.1200/jco.2011.40.2719 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/22851556 PubMed] NCT00791947 | #'''NLG-T-01:''' d'Amore F, Relander T, Lauritzsen GF, Jantunen E, Hagberg H, Anderson H, Holte H, Österborg A, Merup M, Brown P, Kuittinen O, Erlanson M, Østenstad B, Fagerli UM, Gadeberg OV, Sundström C, Delabie J, Ralfkiaer E, Vornanen M, Toldbod HE. Up-front autologous stem-cell transplantation in peripheral T-cell lymphoma: NLG-T-01. J Clin Oncol. 2012 Sep 1;30(25):3093-9. Epub 2012 Jul 30. [https://doi.org/10.1200/jco.2011.40.2719 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/22851556 PubMed] NCT00791947 | ||
− | |||
==CHOP & Everolimus {{#subobject:a3439a|Regimen=1}}== | ==CHOP & Everolimus {{#subobject:a3439a|Regimen=1}}== | ||
− | |||
CHOP & Everolimus: '''<u>C</u>'''yclophosphamide, '''<u>H</u>'''ydroxydaunorubicin (Doxorubicin), '''<u>O</u>'''ncovin (Vincristine), '''<u>P</u>'''redniso(lo)ne, Everolimus | CHOP & Everolimus: '''<u>C</u>'''yclophosphamide, '''<u>H</u>'''ydroxydaunorubicin (Doxorubicin), '''<u>O</u>'''ncovin (Vincristine), '''<u>P</u>'''redniso(lo)ne, Everolimus | ||
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
===Regimen {{#subobject:ccbdcf|Variant=1}}=== | ===Regimen {{#subobject:ccbdcf|Variant=1}}=== | ||
{| class="wikitable" style="width: 60%; text-align:center;" | {| class="wikitable" style="width: 60%; text-align:center;" | ||
Line 421: | Line 377: | ||
|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | |||
*[[Cyclophosphamide (Cytoxan)]] 750 mg/m<sup>2</sup> IV once on day 1 | *[[Cyclophosphamide (Cytoxan)]] 750 mg/m<sup>2</sup> IV once on day 1 | ||
*[[Doxorubicin (Adriamycin)]] 50 mg/m<sup>2</sup> IV once on day 1 | *[[Doxorubicin (Adriamycin)]] 50 mg/m<sup>2</sup> IV once on day 1 | ||
*[[Vincristine (Oncovin)]] 1.4 mg/m<sup>2</sup> (maximum dose of 2 mg) IV once on day 1 | *[[Vincristine (Oncovin)]] 1.4 mg/m<sup>2</sup> (maximum dose of 2 mg) IV once on day 1 | ||
− | |||
====Glucocorticoid therapy==== | ====Glucocorticoid therapy==== | ||
*[[Prednisone (Sterapred)]] 100 mg PO once per day on days 1 to 5 | *[[Prednisone (Sterapred)]] 100 mg PO once per day on days 1 to 5 | ||
====Targeted therapy==== | ====Targeted therapy==== | ||
*[[Everolimus (Afinitor)]] 5 mg PO once per day on days 1 to 14 | *[[Everolimus (Afinitor)]] 5 mg PO once per day on days 1 to 14 | ||
− | |||
'''21-day cycle for up to 6 cycles''' | '''21-day cycle for up to 6 cycles''' | ||
− | + | </div></div> | |
===References=== | ===References=== | ||
− | |||
#'''RADCHOP:''' Kim SJ, Shin DY, Kim JS, Yoon DH, Lee WS, Lee H, Do YR, Kang HJ, Eom HS, Ko YH, Lee SH, Yoo HY, Hong M, Suh C, Kim WS. A phase II study of everolimus (RAD001), an mTOR inhibitor plus CHOP for newly diagnosed peripheral T-cell lymphomas. Ann Oncol. 2016 Apr;27(4):712-8. [https://doi.org/10.1093/annonc/mdv624 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/26861608 PubMed] NCT01198665 | #'''RADCHOP:''' Kim SJ, Shin DY, Kim JS, Yoon DH, Lee WS, Lee H, Do YR, Kang HJ, Eom HS, Ko YH, Lee SH, Yoo HY, Hong M, Suh C, Kim WS. A phase II study of everolimus (RAD001), an mTOR inhibitor plus CHOP for newly diagnosed peripheral T-cell lymphomas. Ann Oncol. 2016 Apr;27(4):712-8. [https://doi.org/10.1093/annonc/mdv624 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/26861608 PubMed] NCT01198665 | ||
− | |||
==DA-EPOCH {{#subobject:9b4e41|Regimen=1}}== | ==DA-EPOCH {{#subobject:9b4e41|Regimen=1}}== | ||
− | |||
DA-EPOCH: '''<u>D</u>'''ose '''<u>A</u>'''djusted '''<u>E</u>'''toposide, '''<u>P</u>'''rednisone, '''<u>O</u>'''ncovin (Vincristine), '''<u>C</u>'''yclophosphamide, '''<u>H</u>'''ydroxydaunorubicin (Doxorubicin) | DA-EPOCH: '''<u>D</u>'''ose '''<u>A</u>'''djusted '''<u>E</u>'''toposide, '''<u>P</u>'''rednisone, '''<u>O</u>'''ncovin (Vincristine), '''<u>C</u>'''yclophosphamide, '''<u>H</u>'''ydroxydaunorubicin (Doxorubicin) | ||
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
===Regimen {{#subobject:263b57|Variant=1}}=== | ===Regimen {{#subobject:263b57|Variant=1}}=== | ||
{| class="wikitable" style="width: 60%; text-align:center;" | {| class="wikitable" style="width: 60%; text-align:center;" | ||
Line 453: | Line 405: | ||
|} | |} | ||
''Note: the authors state that they followed the Wilson et al. 2002 protocol, but there are some differences, in particular 1) it isn't clear whether prednisone is given once or twice per day; and 2) dose adjustments below level 1 are different based on age.'' | ''Note: the authors state that they followed the Wilson et al. 2002 protocol, but there are some differences, in particular 1) it isn't clear whether prednisone is given once or twice per day; and 2) dose adjustments below level 1 are different based on age.'' | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | |||
*[[Etoposide (Vepesid)]] 50 mg/m<sup>2</sup>/day IV continuous infusion over 96 hours, started on day 1 (total dose per cycle: 200 mg/m<sup>2</sup>) | *[[Etoposide (Vepesid)]] 50 mg/m<sup>2</sup>/day IV continuous infusion over 96 hours, started on day 1 (total dose per cycle: 200 mg/m<sup>2</sup>) | ||
*[[Vincristine (Oncovin)]] 0.4 mg/m<sup>2</sup>/day IV continuous infusion over 96 hours, started on day 1 (total dose per cycle: 1.6 mg/m<sup>2</sup>) | *[[Vincristine (Oncovin)]] 0.4 mg/m<sup>2</sup>/day IV continuous infusion over 96 hours, started on day 1 (total dose per cycle: 1.6 mg/m<sup>2</sup>) | ||
*[[Cyclophosphamide (Cytoxan)]] 750 mg/m<sup>2</sup> IV over 2 hours once on day 5 | *[[Cyclophosphamide (Cytoxan)]] 750 mg/m<sup>2</sup> IV over 2 hours once on day 5 | ||
*[[Doxorubicin (Adriamycin)]] 10 mg/m<sup>2</sup>/day IV continuous infusion over 96 hours, started on day 1 (total dose per cycle: 40 mg/m<sup>2</sup>) | *[[Doxorubicin (Adriamycin)]] 10 mg/m<sup>2</sup>/day IV continuous infusion over 96 hours, started on day 1 (total dose per cycle: 40 mg/m<sup>2</sup>) | ||
− | |||
====Glucocorticoid therapy==== | ====Glucocorticoid therapy==== | ||
*[[Prednisone (Sterapred)]] 60 mg/m<sup>2</sup>/day PO on days 1 to 5 | *[[Prednisone (Sterapred)]] 60 mg/m<sup>2</sup>/day PO on days 1 to 5 | ||
− | |||
====Supportive therapy==== | ====Supportive therapy==== | ||
− | |||
*[[:Category:Granulocyte colony-stimulating factors|G-CSF]] starting on day 6 and continuing until ANC greater than 5000/uL past nadir | *[[:Category:Granulocyte colony-stimulating factors|G-CSF]] starting on day 6 and continuing until ANC greater than 5000/uL past nadir | ||
*[[Trimethoprim-Sulfamethoxazole (Bactrim DS)]] (dose not specified) | *[[Trimethoprim-Sulfamethoxazole (Bactrim DS)]] (dose not specified) | ||
*[[Fluconazole (Diflucan)]] (dose not specified) | *[[Fluconazole (Diflucan)]] (dose not specified) | ||
− | |||
'''21-day cycle for 6 to 8 cycles''' | '''21-day cycle for 6 to 8 cycles''' | ||
− | |||
====Dose modifications==== | ====Dose modifications==== | ||
− | |||
*Start cycle 1 as described above. | *Start cycle 1 as described above. | ||
*Obtain CBCs twice per week for nadir measurements. | *Obtain CBCs twice per week for nadir measurements. | ||
Line 482: | Line 428: | ||
*'''Patients 70 and older:''' Dose adjustments below the cycle 1 starting dose apply to all drugs | *'''Patients 70 and older:''' Dose adjustments below the cycle 1 starting dose apply to all drugs | ||
*(Presumed, based on Wilson et al. 2002): Can start new cycle every 21 days if ANC greater than 1000/uL and platelets greater than 100 x 10<sup>9</sup>/L. If counts are below those levels, check daily CBC and continue growth factor support until counts are adequate and next cycle can start. | *(Presumed, based on Wilson et al. 2002): Can start new cycle every 21 days if ANC greater than 1000/uL and platelets greater than 100 x 10<sup>9</sup>/L. If counts are below those levels, check daily CBC and continue growth factor support until counts are adequate and next cycle can start. | ||
− | + | </div></div> | |
===References=== | ===References=== | ||
− | |||
#Maeda Y, Nishimori H, Yoshida I, Hiramatsu Y, Uno M, Masaki Y, Sunami K, Masunari T, Nawa Y, Yamane H, Gomyo H, Takahashi T, Yano T, Matsuo K, Ohshima K, Nakamura S, Yoshino T, Tanimoto M. Dose-adjusted EPOCH chemotherapy for untreated peripheral T-cell lymphomas: a multicenter phase II trial of West-JHOG PTCL0707. Haematologica. 2017 Dec;102(12):2097-2103. Epub 2017 Sep 29. [http://www.haematologica.org/content/102/12/2097 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/28971899 PubMed] UMIN000000829 | #Maeda Y, Nishimori H, Yoshida I, Hiramatsu Y, Uno M, Masaki Y, Sunami K, Masunari T, Nawa Y, Yamane H, Gomyo H, Takahashi T, Yano T, Matsuo K, Ohshima K, Nakamura S, Yoshino T, Tanimoto M. Dose-adjusted EPOCH chemotherapy for untreated peripheral T-cell lymphomas: a multicenter phase II trial of West-JHOG PTCL0707. Haematologica. 2017 Dec;102(12):2097-2103. Epub 2017 Sep 29. [http://www.haematologica.org/content/102/12/2097 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/28971899 PubMed] UMIN000000829 | ||
− | |||
==DD-CHOP {{#subobject:b07d3a|Regimen=1}}== | ==DD-CHOP {{#subobject:b07d3a|Regimen=1}}== | ||
− | |||
DD-CHOP: '''<u>D</u>'''enileukin, '''<u>D</u>'''iftitox, '''<u>C</u>'''yclophosphamide, '''<u>H</u>'''ydroxydaunorubicin (Doxorubicin), '''<u>O</u>'''ncovin (Vincristine), '''<u>P</u>'''redniso(lo)ne | DD-CHOP: '''<u>D</u>'''enileukin, '''<u>D</u>'''iftitox, '''<u>C</u>'''yclophosphamide, '''<u>H</u>'''ydroxydaunorubicin (Doxorubicin), '''<u>O</u>'''ncovin (Vincristine), '''<u>P</u>'''redniso(lo)ne | ||
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
===Regimen {{#subobject:897f8d|Variant=1}}=== | ===Regimen {{#subobject:897f8d|Variant=1}}=== | ||
{| class="wikitable" style="width: 60%; text-align:center;" | {| class="wikitable" style="width: 60%; text-align:center;" | ||
Line 501: | Line 445: | ||
|- | |- | ||
|} | |} | ||
− | + | <div class="toccolours" style="background-color:#b3e2cd"> | |
====Targeted therapy==== | ====Targeted therapy==== | ||
*[[Denileukin diftitox (Ontak)]] 18 mcg/kg IV over 60 minutes once per day on days 1 & 2 | *[[Denileukin diftitox (Ontak)]] 18 mcg/kg IV over 60 minutes once per day on days 1 & 2 | ||
Line 508: | Line 452: | ||
*[[Doxorubicin (Adriamycin)]] 50 mg/m<sup>2</sup> IV once on day 3 | *[[Doxorubicin (Adriamycin)]] 50 mg/m<sup>2</sup> IV once on day 3 | ||
*[[Vincristine (Oncovin)]] 1.4 mg/m<sup>2</sup> (maximum dose of 2 mg) IV once on day 3 | *[[Vincristine (Oncovin)]] 1.4 mg/m<sup>2</sup> (maximum dose of 2 mg) IV once on day 3 | ||
− | |||
====Glucocorticoid therapy==== | ====Glucocorticoid therapy==== | ||
*[[Prednisone (Sterapred)]] 100 mg PO once per day on days 3 to 7 | *[[Prednisone (Sterapred)]] 100 mg PO once per day on days 3 to 7 | ||
− | |||
====Supportive therapy==== | ====Supportive therapy==== | ||
− | |||
*[[Dexamethasone (Decadron)]] 4 to 8 mg IV or PO once per day on days 1 & 2, prior to [[Denileukin diftitox (Ontak)]] | *[[Dexamethasone (Decadron)]] 4 to 8 mg IV or PO once per day on days 1 & 2, prior to [[Denileukin diftitox (Ontak)]] | ||
*[[Acetaminophen (Tylenol)]] 650 mg PO once per day on days 1 & 2, prior to [[Denileukin diftitox (Ontak)]] | *[[Acetaminophen (Tylenol)]] 650 mg PO once per day on days 1 & 2, prior to [[Denileukin diftitox (Ontak)]] | ||
Line 520: | Line 461: | ||
*Antiemetics "per institutional standard" | *Antiemetics "per institutional standard" | ||
*[[:Category:Granulocyte colony-stimulating factors|G-CSF]] support beginning on day 4 | *[[:Category:Granulocyte colony-stimulating factors|G-CSF]] support beginning on day 4 | ||
− | |||
'''21-day cycle for 6 to 8 cycles''' | '''21-day cycle for 6 to 8 cycles''' | ||
− | + | </div></div> | |
===References=== | ===References=== | ||
− | |||
#'''CONCEPT:''' Foss FM, Sjak-Shie N, Goy A, Jacobsen E, Advani R, Smith MR, Komrokji R, Pendergrass K, Bolejack V. A multicenter phase II trial to determine the safety and efficacy of combination therapy with denileukin diftitox and cyclophosphamide, doxorubicin, vincristine and prednisone in untreated peripheral T-cell lymphoma: the CONCEPT study. Leuk Lymphoma. 2013 Jul;54(7):1373-9. Epub 2013 Jan 29. [https://doi.org/10.3109/10428194.2012.742521 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/23278639 PubMed] NCT00211185 | #'''CONCEPT:''' Foss FM, Sjak-Shie N, Goy A, Jacobsen E, Advani R, Smith MR, Komrokji R, Pendergrass K, Bolejack V. A multicenter phase II trial to determine the safety and efficacy of combination therapy with denileukin diftitox and cyclophosphamide, doxorubicin, vincristine and prednisone in untreated peripheral T-cell lymphoma: the CONCEPT study. Leuk Lymphoma. 2013 Jul;54(7):1373-9. Epub 2013 Jan 29. [https://doi.org/10.3109/10428194.2012.742521 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/23278639 PubMed] NCT00211185 | ||
− | |||
==HyperCHidam {{#subobject:2cecf3|Regimen=1}}== | ==HyperCHidam {{#subobject:2cecf3|Regimen=1}}== | ||
− | |||
HyperCHidam: '''<u>Hyper</u>'''fractionated '''<u>C</u>'''yclophosphamide, '''<u>Hi</u>'''igh-'''<u>d</u>'''ose '''<u>a</u>'''ra-c (Cytarabine) & '''<u>m</u>'''ethotrexate | HyperCHidam: '''<u>Hyper</u>'''fractionated '''<u>C</u>'''yclophosphamide, '''<u>Hi</u>'''igh-'''<u>d</u>'''ose '''<u>a</u>'''ra-c (Cytarabine) & '''<u>m</u>'''ethotrexate | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen {{#subobject:46bec8|Variant=1}}=== | ===Regimen {{#subobject:46bec8|Variant=1}}=== | ||
{| class="wikitable" style="width: 60%; text-align:center;" | {| class="wikitable" style="width: 60%; text-align:center;" | ||
Line 542: | Line 479: | ||
|- | |- | ||
|} | |} | ||
− | ''These are the details for "Clin A" which was the regimen used for patients younger than 60. Note: this is a component of a sequential treatment protocol; to our knowledge there are no references to support using it as a stand-alone treatment.'' | + | ''Note: These are the details for "Clin A" which was the regimen used for patients younger than 60. Note: this is a component of a sequential treatment protocol; to our knowledge there are no references to support using it as a stand-alone treatment.'' |
+ | <div class="toccolours" style="background-color:#cbd5e8"> | ||
====Preceding treatment==== | ====Preceding treatment==== | ||
− | |||
*PTCL-06: [[#CHOP-AL|CHOP-AL]] x 2 | *PTCL-06: [[#CHOP-AL|CHOP-AL]] x 2 | ||
− | + | </div> | |
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | |||
*[[Methotrexate (MTX)]] 1600 mg/m<sup>2</sup> IV continuous infusion (duration not specified), started on day 1 | *[[Methotrexate (MTX)]] 1600 mg/m<sup>2</sup> IV continuous infusion (duration not specified), started on day 1 | ||
*[[Cyclophosphamide (Cytoxan)]] 300 mg/m<sup>2</sup> IV every 12 hours for 3 days (start day not specified) | *[[Cyclophosphamide (Cytoxan)]] 300 mg/m<sup>2</sup> IV every 12 hours for 3 days (start day not specified) | ||
*[[Cytarabine (Ara-C)]] 2000 mg/m<sup>2</sup> IV every 12 hours for 3 days (start day not specified) | *[[Cytarabine (Ara-C)]] 2000 mg/m<sup>2</sup> IV every 12 hours for 3 days (start day not specified) | ||
− | |||
====Supportive therapy==== | ====Supportive therapy==== | ||
− | |||
*[[:Category:Granulocyte_colony-stimulating_factors|Granulocyte-colony stimulating factor]] (type not specified) 5 mcg/kg once per day was given from day +5 (stop date not specified) | *[[:Category:Granulocyte_colony-stimulating_factors|Granulocyte-colony stimulating factor]] (type not specified) 5 mcg/kg once per day was given from day +5 (stop date not specified) | ||
− | |||
'''Duration not specified for 2 cycles''' | '''Duration not specified for 2 cycles''' | ||
+ | </div> | ||
+ | <div class="toccolours" style="background-color:#cbd5e7"> | ||
====Subsequent treatment==== | ====Subsequent treatment==== | ||
− | |||
*Responders (PR/CR): [[#Allogeneic_hematopoietic_stem_cell_transplant|allogeneic HSCT]] | *Responders (PR/CR): [[#Allogeneic_hematopoietic_stem_cell_transplant|allogeneic HSCT]] | ||
− | + | </div></div> | |
===References=== | ===References=== | ||
− | |||
#'''PTCL-06:''' Corradini P, Vitolo U, Rambaldi A, Miceli R, Patriarca F, Gallamini A, Olivieri A, Benedetti F, Todeschini G, Rossi G, Salvi F, Bruno B, Baldini L, Ferreri A, Patti C, Tarella C, Pileri S, Dodero A. Intensified chemo-immunotherapy with or without stem cell transplantation in newly diagnosed patients with peripheral T-cell lymphoma. Leukemia. 2014 Sep;28(9):1885-91. Epub 2014 Feb 20. [https://doi.org/10.1038/leu.2014.79 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/24662801 PubMed] EudraCT 2006-004234-33 | #'''PTCL-06:''' Corradini P, Vitolo U, Rambaldi A, Miceli R, Patriarca F, Gallamini A, Olivieri A, Benedetti F, Todeschini G, Rossi G, Salvi F, Bruno B, Baldini L, Ferreri A, Patti C, Tarella C, Pileri S, Dodero A. Intensified chemo-immunotherapy with or without stem cell transplantation in newly diagnosed patients with peripheral T-cell lymphoma. Leukemia. 2014 Sep;28(9):1885-91. Epub 2014 Feb 20. [https://doi.org/10.1038/leu.2014.79 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/24662801 PubMed] EudraCT 2006-004234-33 | ||
− | |||
=Consolidation and/or maintenance after upfront therapy= | =Consolidation and/or maintenance after upfront therapy= | ||
− | |||
==BEAM, then auto HSCT {{#subobject:1e26e2|Regimen=1}}== | ==BEAM, then auto HSCT {{#subobject:1e26e2|Regimen=1}}== | ||
− | |||
BEAM: '''<u>B</u>'''iCNU (Carmustine), '''<u>E</u>'''toposide, '''<u>A</u>'''ra-C (Cytarabine), '''<u>M</u>'''elphalan | BEAM: '''<u>B</u>'''iCNU (Carmustine), '''<u>E</u>'''toposide, '''<u>A</u>'''ra-C (Cytarabine), '''<u>M</u>'''elphalan | ||
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
===Regimen variant #1 {{#subobject:16f67g|Variant=1}}=== | ===Regimen variant #1 {{#subobject:16f67g|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
Line 586: | Line 518: | ||
|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#cbd5e8"> | ||
====Preceding treatment==== | ====Preceding treatment==== | ||
*MYS-07-HMO-CTIL: [[#CHOEP-14|CHOEP-14]] x 4, then [[#DHAP_88|DHAP]] x 1 | *MYS-07-HMO-CTIL: [[#CHOEP-14|CHOEP-14]] x 4, then [[#DHAP_88|DHAP]] x 1 | ||
{{#lst:Autologous HSCT|fa5ca6}} | {{#lst:Autologous HSCT|fa5ca6}} | ||
+ | </div></div><br> | ||
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
===Regimen variant #2 {{#subobject:16f7a3|Variant=1}}=== | ===Regimen variant #2 {{#subobject:16f7a3|Variant=1}}=== | ||
{| class="wikitable" style="width: 40%; text-align:center;" | {| class="wikitable" style="width: 40%; text-align:center;" | ||
Line 599: | Line 534: | ||
|} | |} | ||
{{#lst:Autologous HSCT|16f7a3}} | {{#lst:Autologous HSCT|16f7a3}} | ||
+ | </div></div> | ||
===References=== | ===References=== | ||
<!-- Presented orally in part at the 48th Annual Meeting of the American Society of Hematology, Orlando, FL, December 9-12, 2006; 14th Annual Meeting of the European Hematology Association, Berlin, Germany, June 4-7, 2009; 11th International Conference on Malignant Lymphoma, Lugano, Switzerland, June 15-18, 2011; and American Society of Hematology Annual Meeting, San Diego, CA, December 10-13, 2011. --> | <!-- Presented orally in part at the 48th Annual Meeting of the American Society of Hematology, Orlando, FL, December 9-12, 2006; 14th Annual Meeting of the European Hematology Association, Berlin, Germany, June 4-7, 2009; 11th International Conference on Malignant Lymphoma, Lugano, Switzerland, June 15-18, 2011; and American Society of Hematology Annual Meeting, San Diego, CA, December 10-13, 2011. --> | ||
− | |||
#'''NLG-T-01:''' d'Amore F, Relander T, Lauritzsen GF, Jantunen E, Hagberg H, Anderson H, Holte H, Österborg A, Merup M, Brown P, Kuittinen O, Erlanson M, Østenstad B, Fagerli UM, Gadeberg OV, Sundström C, Delabie J, Ralfkiaer E, Vornanen M, Toldbod HE. Up-front autologous stem-cell transplantation in peripheral T-cell lymphoma: NLG-T-01. J Clin Oncol. 2012 Sep 1;30(25):3093-9. Epub 2012 Jul 30. [https://doi.org/10.1200/jco.2011.40.2719 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/22851556 PubMed] NCT00791947 | #'''NLG-T-01:''' d'Amore F, Relander T, Lauritzsen GF, Jantunen E, Hagberg H, Anderson H, Holte H, Österborg A, Merup M, Brown P, Kuittinen O, Erlanson M, Østenstad B, Fagerli UM, Gadeberg OV, Sundström C, Delabie J, Ralfkiaer E, Vornanen M, Toldbod HE. Up-front autologous stem-cell transplantation in peripheral T-cell lymphoma: NLG-T-01. J Clin Oncol. 2012 Sep 1;30(25):3093-9. Epub 2012 Jul 30. [https://doi.org/10.1200/jco.2011.40.2719 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/22851556 PubMed] NCT00791947 | ||
# '''MYS-07-HMO-CTIL:''' Schmitz N, Truemper L, Bouabdallah K, Ziepert M, Leclerc M, Cartron G, Jaccard A, Reimer P, Wagner E, Wilhelm M, Sanhes L, Lamy T, de Leval L, Rosenwald A, Roussel M, Kroschinsky F, Lindemann W, Dreger P, Viardot A, Milpied N, Gisselbrecht C, Wulf G, Gyan E, Gaulard P, Bay JO, Glass B, Poeschel V, Damaj G, Sibon D, Delmer A, Bilger K, Banos A, Haenel M, Dreyling M, Metzner B, Keller U, Braulke F, Friedrichs B, Nickelsen M, Altmann B, Tournilhac O. A randomized phase 3 trial of autologous vs allogeneic transplantation as part of first-line therapy in poor-risk peripheral T-NHL. Blood. 2021 May 13;137(19):2646-2656. [https://doi.org/10.1182/blood.2020008825 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/33512419/ PubMed] NCT00984412 | # '''MYS-07-HMO-CTIL:''' Schmitz N, Truemper L, Bouabdallah K, Ziepert M, Leclerc M, Cartron G, Jaccard A, Reimer P, Wagner E, Wilhelm M, Sanhes L, Lamy T, de Leval L, Rosenwald A, Roussel M, Kroschinsky F, Lindemann W, Dreger P, Viardot A, Milpied N, Gisselbrecht C, Wulf G, Gyan E, Gaulard P, Bay JO, Glass B, Poeschel V, Damaj G, Sibon D, Delmer A, Bilger K, Banos A, Haenel M, Dreyling M, Metzner B, Keller U, Braulke F, Friedrichs B, Nickelsen M, Altmann B, Tournilhac O. A randomized phase 3 trial of autologous vs allogeneic transplantation as part of first-line therapy in poor-risk peripheral T-NHL. Blood. 2021 May 13;137(19):2646-2656. [https://doi.org/10.1182/blood.2020008825 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/33512419/ PubMed] NCT00984412 | ||
− | |||
==Cyclophosphamide & TBI, then auto HSCT {{#subobject:0a4915|Regimen=1}}== | ==Cyclophosphamide & TBI, then auto HSCT {{#subobject:0a4915|Regimen=1}}== | ||
− | |||
Cy/TBI: '''<u>Cy</u>'''clophosphamide & '''<u>T</u>'''otal '''<u>B</u>'''ody '''<u>I</u>'''rradiation | Cy/TBI: '''<u>Cy</u>'''clophosphamide & '''<u>T</u>'''otal '''<u>B</u>'''ody '''<u>I</u>'''rradiation | ||
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
===Regimen {{#subobject:a2b2d3|Variant=1}}=== | ===Regimen {{#subobject:a2b2d3|Variant=1}}=== | ||
{| class="wikitable" style="width: 40%; text-align:center;" | {| class="wikitable" style="width: 40%; text-align:center;" | ||
Line 618: | Line 552: | ||
|} | |} | ||
{{#lst:Autologous HSCT|a2b2d3}} | {{#lst:Autologous HSCT|a2b2d3}} | ||
+ | </div></div> | ||
===References=== | ===References=== | ||
− | |||
#Reimer P, Schertlin T, Rüdiger T, Geissinger E, Roth S, Kunzmann V, Weissinger F, Nerl C, Schmitz N, Müller-Hermelink HK, Wilhelm M. Myeloablative radiochemotherapy followed by autologous peripheral blood stem cell transplantation as first-line therapy in peripheral T-cell lymphomas: first results of a prospective multicenter study. Hematol J. 2004;5(4):304-11. [https://doi.org/10.1038/sj.thj.6200359 link to original article] [https://pubmed.ncbi.nlm.nih.gov/15297846 PubMed] | #Reimer P, Schertlin T, Rüdiger T, Geissinger E, Roth S, Kunzmann V, Weissinger F, Nerl C, Schmitz N, Müller-Hermelink HK, Wilhelm M. Myeloablative radiochemotherapy followed by autologous peripheral blood stem cell transplantation as first-line therapy in peripheral T-cell lymphomas: first results of a prospective multicenter study. Hematol J. 2004;5(4):304-11. [https://doi.org/10.1038/sj.thj.6200359 link to original article] [https://pubmed.ncbi.nlm.nih.gov/15297846 PubMed] | ||
##'''Update:''' Reimer P, Rüdiger T, Geissinger E, Weissinger F, Nerl C, Schmitz N, Engert A, Einsele H, Müller-Hermelink HK, Wilhelm M. Autologous stem-cell transplantation as first-line therapy in peripheral T-cell lymphomas: results of a prospective multicenter study. J Clin Oncol. 2009 Jan 1;27(1):106-13. Epub 2008 Nov 24. [https://doi.org/10.1200/jco.2008.17.4870 link to original article] [https://pubmed.ncbi.nlm.nih.gov/19029417 PubMed] | ##'''Update:''' Reimer P, Rüdiger T, Geissinger E, Weissinger F, Nerl C, Schmitz N, Engert A, Einsele H, Müller-Hermelink HK, Wilhelm M. Autologous stem-cell transplantation as first-line therapy in peripheral T-cell lymphomas: results of a prospective multicenter study. J Clin Oncol. 2009 Jan 1;27(1):106-13. Epub 2008 Nov 24. [https://doi.org/10.1200/jco.2008.17.4870 link to original article] [https://pubmed.ncbi.nlm.nih.gov/19029417 PubMed] | ||
− | |||
==Radiation therapy {{#subobject:784759|Regimen=1}}== | ==Radiation therapy {{#subobject:784759|Regimen=1}}== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen {{#subobject:ac7acb|Variant=1}}=== | ===Regimen {{#subobject:ac7acb|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 60%; text-align:center;" | {| class="wikitable sortable" style="width: 60%; text-align:center;" | ||
Line 636: | Line 569: | ||
|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#cbd5e8"> | ||
====Preceding treatment==== | ====Preceding treatment==== | ||
− | |||
*GOELAMS LTP95: [[#CHOP|CHOP]] x 8 versus [[#vVIP-rABVD_99|vVIP-rABVD]] | *GOELAMS LTP95: [[#CHOP|CHOP]] x 8 versus [[#vVIP-rABVD_99|vVIP-rABVD]] | ||
− | + | </div> | |
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Radiotherapy==== | ====Radiotherapy==== | ||
− | |||
*[[External beam radiotherapy]] 40 Gy at 1.8 Gy/day to the involved field | *[[External beam radiotherapy]] 40 Gy at 1.8 Gy/day to the involved field | ||
− | |||
'''4.5-week course''' | '''4.5-week course''' | ||
− | + | </div></div> | |
===References=== | ===References=== | ||
− | |||
#'''GOELAMS-LTP95:''' Simon A, Peoch M, Casassus P, Deconinck E, Colombat P, Desablens B, Tournilhac O, Eghbali H, Foussard C, Jaubert J, Vilque JP, Rossi JF, Lucas V, Delwail V, Thyss A, Maloisel F, Milpied N, le Gouill S, Lamy T, Gressin R. Upfront VIP-reinforced-ABVD (VIP-rABVD) is not superior to CHOP/21 in newly diagnosed peripheral T cell lymphoma: results of the randomized phase III trial GOELAMS-LTP95. Br J Haematol. 2010 Oct;151(2):159-66. Epub 2010 Aug 25. [https://doi.org/10.1111/j.1365-2141.2010.08329.x link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/20738307 PubMed] | #'''GOELAMS-LTP95:''' Simon A, Peoch M, Casassus P, Deconinck E, Colombat P, Desablens B, Tournilhac O, Eghbali H, Foussard C, Jaubert J, Vilque JP, Rossi JF, Lucas V, Delwail V, Thyss A, Maloisel F, Milpied N, le Gouill S, Lamy T, Gressin R. Upfront VIP-reinforced-ABVD (VIP-rABVD) is not superior to CHOP/21 in newly diagnosed peripheral T cell lymphoma: results of the randomized phase III trial GOELAMS-LTP95. Br J Haematol. 2010 Oct;151(2):159-66. Epub 2010 Aug 25. [https://doi.org/10.1111/j.1365-2141.2010.08329.x link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/20738307 PubMed] | ||
==TFC, then allo HSCT {{#subobject:ee93e3|Regimen=1}}== | ==TFC, then allo HSCT {{#subobject:ee93e3|Regimen=1}}== | ||
− | |||
TFC: '''<u>T</u>'''hiotepa, '''<u>F</u>'''ludarabine, '''<u>C</u>'''yclophosphamide | TFC: '''<u>T</u>'''hiotepa, '''<u>F</u>'''ludarabine, '''<u>C</u>'''yclophosphamide | ||
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
===Regimen {{#subobject:81245f|Variant=1}}=== | ===Regimen {{#subobject:81245f|Variant=1}}=== | ||
{| class="wikitable" style="width: 40%; text-align:center;" | {| class="wikitable" style="width: 40%; text-align:center;" | ||
Line 666: | Line 597: | ||
|} | |} | ||
Details to be completed. | Details to be completed. | ||
+ | <div class="toccolours" style="background-color:#cbd5e8"> | ||
====Preceding treatment==== | ====Preceding treatment==== | ||
− | |||
*PTCL-06: [[#CHOP-AL|CHOP-AL]] x 2, then [[#HyperCHidam|HyperCHidam]] x 2 | *PTCL-06: [[#CHOP-AL|CHOP-AL]] x 2, then [[#HyperCHidam|HyperCHidam]] x 2 | ||
− | + | </div> | |
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | |||
*[[Thiotepa (Thioplex)]] | *[[Thiotepa (Thioplex)]] | ||
*[[Fludarabine (Fludara)]] | *[[Fludarabine (Fludara)]] | ||
*[[Cyclophosphamide (Cytoxan)]] | *[[Cyclophosphamide (Cytoxan)]] | ||
− | |||
====Immunotherapy==== | ====Immunotherapy==== | ||
*[[Allogeneic stem cells]] | *[[Allogeneic stem cells]] | ||
'''Stem cells transfused on day 0''' | '''Stem cells transfused on day 0''' | ||
+ | </div></div> | ||
===References=== | ===References=== | ||
− | |||
#Corradini P, Tarella C, Olivieri A, Gianni AM, Voena C, Zallio F, Ladetto M, Falda M, Lucesole M, Dodero A, Ciceri F, Benedetti F, Rambaldi A, Sajeva MR, Tresoldi M, Pileri A, Bordignon C, Bregni M. Reduced-intensity conditioning followed by allografting of hematopoietic cells can produce clinical and molecular remissions in patients with poor-risk hematologic malignancies. Blood. 2002 Jan 1;99(1):75-82. [http://www.bloodjournal.org/content/99/1/75.long link to original article] [https://pubmed.ncbi.nlm.nih.gov/11756155 PubMed] | #Corradini P, Tarella C, Olivieri A, Gianni AM, Voena C, Zallio F, Ladetto M, Falda M, Lucesole M, Dodero A, Ciceri F, Benedetti F, Rambaldi A, Sajeva MR, Tresoldi M, Pileri A, Bordignon C, Bregni M. Reduced-intensity conditioning followed by allografting of hematopoietic cells can produce clinical and molecular remissions in patients with poor-risk hematologic malignancies. Blood. 2002 Jan 1;99(1):75-82. [http://www.bloodjournal.org/content/99/1/75.long link to original article] [https://pubmed.ncbi.nlm.nih.gov/11756155 PubMed] | ||
#'''PTCL-06:''' Corradini P, Vitolo U, Rambaldi A, Miceli R, Patriarca F, Gallamini A, Olivieri A, Benedetti F, Todeschini G, Rossi G, Salvi F, Bruno B, Baldini L, Ferreri A, Patti C, Tarella C, Pileri S, Dodero A. Intensified chemo-immunotherapy with or without stem cell transplantation in newly diagnosed patients with peripheral T-cell lymphoma. Leukemia. 2014 Sep;28(9):1885-91. Epub 2014 Feb 20. [https://doi.org/10.1038/leu.2014.79 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/24662801 PubMed] EudraCT 2006-004234-33 | #'''PTCL-06:''' Corradini P, Vitolo U, Rambaldi A, Miceli R, Patriarca F, Gallamini A, Olivieri A, Benedetti F, Todeschini G, Rossi G, Salvi F, Bruno B, Baldini L, Ferreri A, Patti C, Tarella C, Pileri S, Dodero A. Intensified chemo-immunotherapy with or without stem cell transplantation in newly diagnosed patients with peripheral T-cell lymphoma. Leukemia. 2014 Sep;28(9):1885-91. Epub 2014 Feb 20. [https://doi.org/10.1038/leu.2014.79 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/24662801 PubMed] EudraCT 2006-004234-33 | ||
− | |||
=Relapsed or refractory, randomized data= | =Relapsed or refractory, randomized data= | ||
− | |||
==DHAP {{#subobject:f4e87b|Regimen=1}}== | ==DHAP {{#subobject:f4e87b|Regimen=1}}== | ||
− | |||
DHAP: '''<u>D</u>'''examethasone, '''<u>H</u>'''igh-dose '''<u>A</u>'''ra-C (Cytarabine), '''<u>P</u>'''latinol (Cisplatin) | DHAP: '''<u>D</u>'''examethasone, '''<u>H</u>'''igh-dose '''<u>A</u>'''ra-C (Cytarabine), '''<u>P</u>'''latinol (Cisplatin) | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen {{#subobject:f5009d|Variant=1}}=== | ===Regimen {{#subobject:f5009d|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
Line 706: | Line 633: | ||
|} | |} | ||
''<sup>1</sup>Reported efficacy is based on the 2017 subgroup analysis.'' | ''<sup>1</sup>Reported efficacy is based on the 2017 subgroup analysis.'' | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
*[[Cytarabine (Ara-C)]] 2000 mg/m<sup>2</sup> IV over 3 hours every 12 hours on day 2 (total dose per cycle: 4000 mg/m<sup>2</sup>) | *[[Cytarabine (Ara-C)]] 2000 mg/m<sup>2</sup> IV over 3 hours every 12 hours on day 2 (total dose per cycle: 4000 mg/m<sup>2</sup>) | ||
*[[Cisplatin (Platinol)]] 100 mg/m<sup>2</sup> IV continuous infusion over 24 hours, started on day 1 | *[[Cisplatin (Platinol)]] 100 mg/m<sup>2</sup> IV continuous infusion over 24 hours, started on day 1 | ||
− | |||
====Glucocorticoid therapy==== | ====Glucocorticoid therapy==== | ||
*[[Dexamethasone (Decadron)]] 40 mg PO once per day on days 1 to 4 | *[[Dexamethasone (Decadron)]] 40 mg PO once per day on days 1 to 4 | ||
− | |||
'''21-day cycle for up to 3 cycles''' | '''21-day cycle for up to 3 cycles''' | ||
− | + | </div></div> | |
===References=== | ===References=== | ||
<!-- Presented in part at the Annual Meeting of the American Society of Hematology, Atlanta, GA, December 7-10, 2013, and the International Conference on Malignant Lymphoma, Lugano, Switzerland, June 19-22, 2013. --> | <!-- Presented in part at the Annual Meeting of the American Society of Hematology, Atlanta, GA, December 7-10, 2013, and the International Conference on Malignant Lymphoma, Lugano, Switzerland, June 19-22, 2013. --> | ||
− | |||
#'''NCIC-CTG LY.12:''' Crump M, Kuruvilla J, Couban S, MacDonald DA, Kukreti V, Kouroukis CT, Rubinger M, Buckstein R, Imrie KR, Federico M, Di Renzo N, Howson-Jan K, Baetz T, Kaizer L, Voralia M, Olney HJ, Turner AR, Sussman J, Hay AE, Djurfeldt MS, Meyer RM, Chen BE, Shepherd LE. Randomized comparison of gemcitabine, dexamethasone, and cisplatin versus dexamethasone, cytarabine, and cisplatin chemotherapy before autologous stem-cell transplantation for relapsed and refractory aggressive lymphomas: NCIC-CTG LY.12. J Clin Oncol. 2014 Nov 1;32(31):3490-6. Epub 2014 Sep 29. [https://doi.org/10.1200/jco.2013.53.9593 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/25267740 PubMed] NCT00078949 | #'''NCIC-CTG LY.12:''' Crump M, Kuruvilla J, Couban S, MacDonald DA, Kukreti V, Kouroukis CT, Rubinger M, Buckstein R, Imrie KR, Federico M, Di Renzo N, Howson-Jan K, Baetz T, Kaizer L, Voralia M, Olney HJ, Turner AR, Sussman J, Hay AE, Djurfeldt MS, Meyer RM, Chen BE, Shepherd LE. Randomized comparison of gemcitabine, dexamethasone, and cisplatin versus dexamethasone, cytarabine, and cisplatin chemotherapy before autologous stem-cell transplantation for relapsed and refractory aggressive lymphomas: NCIC-CTG LY.12. J Clin Oncol. 2014 Nov 1;32(31):3490-6. Epub 2014 Sep 29. [https://doi.org/10.1200/jco.2013.53.9593 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/25267740 PubMed] NCT00078949 | ||
##'''Subgroup analysis:''' Skamene T, Crump M, Savage KJ, Reiman T, Kuruvilla J, Good D, LeBrun D, Meyer RM, Sehn LH, Soulières D, Stakiw J, Laferriere N, Luminari S, Shepherd LE, Djurfeldt M, Zhu L, Chen BE, Hay AE. Salvage chemotherapy and autologous stem cell transplantation for peripheral T-cell lymphoma: a subset analysis of the Canadian Cancer Trials Group LY.12 randomized phase 3 study(). Leuk Lymphoma. 2017 Oct;58(10):2319-2327. Epub 2017 May 15. [https://doi.org/10.1080/10428194.2017.1312379 link to original article] [https://pubmed.ncbi.nlm.nih.gov/28504033 PubMed] | ##'''Subgroup analysis:''' Skamene T, Crump M, Savage KJ, Reiman T, Kuruvilla J, Good D, LeBrun D, Meyer RM, Sehn LH, Soulières D, Stakiw J, Laferriere N, Luminari S, Shepherd LE, Djurfeldt M, Zhu L, Chen BE, Hay AE. Salvage chemotherapy and autologous stem cell transplantation for peripheral T-cell lymphoma: a subset analysis of the Canadian Cancer Trials Group LY.12 randomized phase 3 study(). Leuk Lymphoma. 2017 Oct;58(10):2319-2327. Epub 2017 May 15. [https://doi.org/10.1080/10428194.2017.1312379 link to original article] [https://pubmed.ncbi.nlm.nih.gov/28504033 PubMed] | ||
− | |||
==GDP {{#subobject:7ceb1c|Regimen=1}}== | ==GDP {{#subobject:7ceb1c|Regimen=1}}== | ||
− | |||
GDP: '''<u>G</u>'''emcitabine, '''<u>D</u>'''examethasone, '''<u>P</u>'''latinol (Cisplatin) | GDP: '''<u>G</u>'''emcitabine, '''<u>D</u>'''examethasone, '''<u>P</u>'''latinol (Cisplatin) | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen {{#subobject:67023b|Variant=1}}=== | ===Regimen {{#subobject:67023b|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
Line 741: | Line 664: | ||
|} | |} | ||
''<sup>1</sup>Reported efficacy is based on the 2017 subgroup analysis.'' | ''<sup>1</sup>Reported efficacy is based on the 2017 subgroup analysis.'' | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
*[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV once per day on days 1 & 8 | *[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV once per day on days 1 & 8 | ||
*[[Cisplatin (Platinol)]] 75 mg/m<sup>2</sup> IV once on day 1 | *[[Cisplatin (Platinol)]] 75 mg/m<sup>2</sup> IV once on day 1 | ||
− | |||
====Glucocorticoid therapy==== | ====Glucocorticoid therapy==== | ||
*[[Dexamethasone (Decadron)]] 40 mg PO once per day on days 1 to 4 | *[[Dexamethasone (Decadron)]] 40 mg PO once per day on days 1 to 4 | ||
− | |||
'''21-day cycle for up to 3 cycles''' | '''21-day cycle for up to 3 cycles''' | ||
− | + | </div></div> | |
===References=== | ===References=== | ||
<!-- Presented in part at the Annual Meeting of the American Society of Hematology, Atlanta, GA, December 7-10, 2013, and the International Conference on Malignant Lymphoma, Lugano, Switzerland, June 19-22, 2013. --> | <!-- Presented in part at the Annual Meeting of the American Society of Hematology, Atlanta, GA, December 7-10, 2013, and the International Conference on Malignant Lymphoma, Lugano, Switzerland, June 19-22, 2013. --> | ||
− | |||
#'''NCIC-CTG LY.12:''' Crump M, Kuruvilla J, Couban S, MacDonald DA, Kukreti V, Kouroukis CT, Rubinger M, Buckstein R, Imrie KR, Federico M, Di Renzo N, Howson-Jan K, Baetz T, Kaizer L, Voralia M, Olney HJ, Turner AR, Sussman J, Hay AE, Djurfeldt MS, Meyer RM, Chen BE, Shepherd LE. Randomized comparison of gemcitabine, dexamethasone, and cisplatin versus dexamethasone, cytarabine, and cisplatin chemotherapy before autologous stem-cell transplantation for relapsed and refractory aggressive lymphomas: NCIC-CTG LY.12. J Clin Oncol. 2014 Nov 1;32(31):3490-6. Epub 2014 Sep 29. [https://doi.org/10.1200/jco.2013.53.9593 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/25267740 PubMed] NCT00078949 | #'''NCIC-CTG LY.12:''' Crump M, Kuruvilla J, Couban S, MacDonald DA, Kukreti V, Kouroukis CT, Rubinger M, Buckstein R, Imrie KR, Federico M, Di Renzo N, Howson-Jan K, Baetz T, Kaizer L, Voralia M, Olney HJ, Turner AR, Sussman J, Hay AE, Djurfeldt MS, Meyer RM, Chen BE, Shepherd LE. Randomized comparison of gemcitabine, dexamethasone, and cisplatin versus dexamethasone, cytarabine, and cisplatin chemotherapy before autologous stem-cell transplantation for relapsed and refractory aggressive lymphomas: NCIC-CTG LY.12. J Clin Oncol. 2014 Nov 1;32(31):3490-6. Epub 2014 Sep 29. [https://doi.org/10.1200/jco.2013.53.9593 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/25267740 PubMed] NCT00078949 | ||
##'''Subgroup analysis:''' Skamene T, Crump M, Savage KJ, Reiman T, Kuruvilla J, Good D, LeBrun D, Meyer RM, Sehn LH, Soulières D, Stakiw J, Laferriere N, Luminari S, Shepherd LE, Djurfeldt M, Zhu L, Chen BE, Hay AE. Salvage chemotherapy and autologous stem cell transplantation for peripheral T-cell lymphoma: a subset analysis of the Canadian Cancer Trials Group LY.12 randomized phase 3 study(). Leuk Lymphoma. 2017 Oct;58(10):2319-2327. Epub 2017 May 15. [https://doi.org/10.1080/10428194.2017.1312379 link to original article] [https://pubmed.ncbi.nlm.nih.gov/28504033 PubMed] | ##'''Subgroup analysis:''' Skamene T, Crump M, Savage KJ, Reiman T, Kuruvilla J, Good D, LeBrun D, Meyer RM, Sehn LH, Soulières D, Stakiw J, Laferriere N, Luminari S, Shepherd LE, Djurfeldt M, Zhu L, Chen BE, Hay AE. Salvage chemotherapy and autologous stem cell transplantation for peripheral T-cell lymphoma: a subset analysis of the Canadian Cancer Trials Group LY.12 randomized phase 3 study(). Leuk Lymphoma. 2017 Oct;58(10):2319-2327. Epub 2017 May 15. [https://doi.org/10.1080/10428194.2017.1312379 link to original article] [https://pubmed.ncbi.nlm.nih.gov/28504033 PubMed] | ||
− | |||
==Gemcitabine monotherapy {{#subobject:7dbc1c|Regimen=1}}== | ==Gemcitabine monotherapy {{#subobject:7dbc1c|Regimen=1}}== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen {{#subobject:51923b|Variant=1}}=== | ===Regimen {{#subobject:51923b|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
Line 774: | Line 694: | ||
|} | |} | ||
''Note: to our knowledge, this regimen was not tested as an experimental arm in an RCT in this context, prior to becoming a standard comparator arm.'' | ''Note: to our knowledge, this regimen was not tested as an experimental arm in an RCT in this context, prior to becoming a standard comparator arm.'' | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | |||
*[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV once per day on days 1, 8, 15 | *[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV once per day on days 1, 8, 15 | ||
− | |||
'''28-day cycles''' | '''28-day cycles''' | ||
− | + | </div></div> | |
===References=== | ===References=== | ||
− | |||
#'''LUMIERE:''' O'Connor OA, Özcan M, Jacobsen ED, Roncero JM, Trotman J, Demeter J, Masszi T, Pereira J, Ramchandren R, Beaven A, Caballero D, Horwitz SM, Lennard A, Turgut M, Hamerschlak N, d'Amore FA, Foss F, Kim WS, Leonard JP, Zinzani PL, Chiattone CS, Hsi ED, Trümper L, Liu H, Sheldon-Waniga E, Ullmann CD, Venkatakrishnan K, Leonard EJ, Shustov AR; Lumiere Study Investigators. Randomized phase III study of alisertib or investigator's choice (selected single agent) in patients with relapsed or refractory peripheral T-cell lymphoma. J Clin Oncol. 2019 Mar 10;37(8):613-623. Epub 2019 Feb 1. [https://doi.org/10.1200/JCO.18.00899 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/30707661 PubMed] NCT01482962 | #'''LUMIERE:''' O'Connor OA, Özcan M, Jacobsen ED, Roncero JM, Trotman J, Demeter J, Masszi T, Pereira J, Ramchandren R, Beaven A, Caballero D, Horwitz SM, Lennard A, Turgut M, Hamerschlak N, d'Amore FA, Foss F, Kim WS, Leonard JP, Zinzani PL, Chiattone CS, Hsi ED, Trümper L, Liu H, Sheldon-Waniga E, Ullmann CD, Venkatakrishnan K, Leonard EJ, Shustov AR; Lumiere Study Investigators. Randomized phase III study of alisertib or investigator's choice (selected single agent) in patients with relapsed or refractory peripheral T-cell lymphoma. J Clin Oncol. 2019 Mar 10;37(8):613-623. Epub 2019 Feb 1. [https://doi.org/10.1200/JCO.18.00899 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/30707661 PubMed] NCT01482962 | ||
− | |||
==Pralatrexate monotherapy {{#subobject:c2c35b|Regimen=1}}== | ==Pralatrexate monotherapy {{#subobject:c2c35b|Regimen=1}}== | ||
− | |||
===Example orders=== | ===Example orders=== | ||
− | |||
*[[Example orders for Pralatrexate (Folotyn) in peripheral T-cell lymphoma]] | *[[Example orders for Pralatrexate (Folotyn) in peripheral T-cell lymphoma]] | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen {{#subobject:9606fa|Variant=1}}=== | ===Regimen {{#subobject:9606fa|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
Line 812: | Line 727: | ||
|} | |} | ||
''Note: to our knowledge, this regimen was not tested as an experimental arm in an RCT in this context, prior to becoming a standard comparator arm.'' | ''Note: to our knowledge, this regimen was not tested as an experimental arm in an RCT in this context, prior to becoming a standard comparator arm.'' | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | |||
*[[Pralatrexate (Folotyn)]] 30 mg/m<sup>2</sup> IV over 3 to 5 minutes once per day on days 1, 8, 15, 22, 29, 36 | *[[Pralatrexate (Folotyn)]] 30 mg/m<sup>2</sup> IV over 3 to 5 minutes once per day on days 1, 8, 15, 22, 29, 36 | ||
− | |||
====Supportive therapy==== | ====Supportive therapy==== | ||
− | |||
*[[Cyanocobalamin (Vitamin B12)]] 1 mg IM once every 8 to 10 weeks | *[[Cyanocobalamin (Vitamin B12)]] 1 mg IM once every 8 to 10 weeks | ||
*[[Folic acid (Folate)]] 1 to 1.25 mg PO once per day | *[[Folic acid (Folate)]] 1 to 1.25 mg PO once per day | ||
**"Elevated methylmalonic acid (greater than 200 nmol/L) and/or homocysteine (greater than 10 µmol/L) at screening required initiation of [[Folic acid (Folate)]] and [[Cyanocobalamin (Vitamin B12)]] at least 10 days before the first dose of [[Pralatrexate (Folotyn)]]." | **"Elevated methylmalonic acid (greater than 200 nmol/L) and/or homocysteine (greater than 10 µmol/L) at screening required initiation of [[Folic acid (Folate)]] and [[Cyanocobalamin (Vitamin B12)]] at least 10 days before the first dose of [[Pralatrexate (Folotyn)]]." | ||
− | |||
'''7-week cycles''' | '''7-week cycles''' | ||
− | + | </div></div> | |
===References=== | ===References=== | ||
<!-- Presented in part at the 52nd Annual Meeting of the American Society of Hematology, Orlando, FL, December 4-7, 2010; at the 5th Biennial Workshop on the Clinical Translation of Epigenetics in Cancer Therapy, San Diego, CA, January 14-16, 2011; at the T-Cell Lymphoma Forum, San Francisco, CA, January 27-29, 2011; and at the 47th Annual Meeting of the American Society of Clinical Oncology, Chicago, IL, June 3-7, 2011. --> | <!-- Presented in part at the 52nd Annual Meeting of the American Society of Hematology, Orlando, FL, December 4-7, 2010; at the 5th Biennial Workshop on the Clinical Translation of Epigenetics in Cancer Therapy, San Diego, CA, January 14-16, 2011; at the T-Cell Lymphoma Forum, San Francisco, CA, January 27-29, 2011; and at the 47th Annual Meeting of the American Society of Clinical Oncology, Chicago, IL, June 3-7, 2011. --> | ||
− | |||
#'''PROPEL:''' O'Connor OA, Pro B, Pinter-Brown L, Bartlett N, Popplewell L, Coiffier B, Lechowicz MJ, Savage KJ, Shustov AR, Gisselbrecht C, Jacobsen E, Zinzani PL, Furman R, Goy A, Haioun C, Crump M, Zain JM, Hsi E, Boyd A, Horwitz S. Pralatrexate in patients with relapsed or refractory peripheral T-cell lymphoma: results from the pivotal PROPEL study. J Clin Oncol. 2011 Mar 20;29(9):1182-9. Epub 2011 Jan 18. [https://doi.org/10.1200/jco.2010.29.9024 link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3083873/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/21245435 PubMed] NCT00364923 | #'''PROPEL:''' O'Connor OA, Pro B, Pinter-Brown L, Bartlett N, Popplewell L, Coiffier B, Lechowicz MJ, Savage KJ, Shustov AR, Gisselbrecht C, Jacobsen E, Zinzani PL, Furman R, Goy A, Haioun C, Crump M, Zain JM, Hsi E, Boyd A, Horwitz S. Pralatrexate in patients with relapsed or refractory peripheral T-cell lymphoma: results from the pivotal PROPEL study. J Clin Oncol. 2011 Mar 20;29(9):1182-9. Epub 2011 Jan 18. [https://doi.org/10.1200/jco.2010.29.9024 link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3083873/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/21245435 PubMed] NCT00364923 | ||
#'''LUMIERE:''' Connor OA, Özcan M, Jacobsen ED, Roncero JM, Trotman J, Demeter J, Masszi T, Pereira J, Ramchandren R, Beaven A, Caballero D, Horwitz SM, Lennard A, Turgut M, Hamerschlak N, d'Amore FA, Foss F, Kim WS, Leonard JP, Zinzani PL, Chiattone CS, Hsi ED, Trümper L, Liu H, Sheldon-Waniga E, Ullmann CD, Venkatakrishnan K, Leonard EJ, Shustov AR; Lumiere Study Investigators. Randomized phase III study of alisertib or investigator's choice (selected single agent) in patients with relapsed or refractory peripheral T-cell lymphoma. J Clin Oncol. 2019 Mar 10;37(8):613-623. Epub 2019 Feb 1. [https://doi.org/10.1200/JCO.18.00899 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/30707661 PubMed] NCT01482962 | #'''LUMIERE:''' Connor OA, Özcan M, Jacobsen ED, Roncero JM, Trotman J, Demeter J, Masszi T, Pereira J, Ramchandren R, Beaven A, Caballero D, Horwitz SM, Lennard A, Turgut M, Hamerschlak N, d'Amore FA, Foss F, Kim WS, Leonard JP, Zinzani PL, Chiattone CS, Hsi ED, Trümper L, Liu H, Sheldon-Waniga E, Ullmann CD, Venkatakrishnan K, Leonard EJ, Shustov AR; Lumiere Study Investigators. Randomized phase III study of alisertib or investigator's choice (selected single agent) in patients with relapsed or refractory peripheral T-cell lymphoma. J Clin Oncol. 2019 Mar 10;37(8):613-623. Epub 2019 Feb 1. [https://doi.org/10.1200/JCO.18.00899 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/30707661 PubMed] NCT01482962 | ||
− | |||
=Relapsed or refractory, non-randomized or retrospective data= | =Relapsed or refractory, non-randomized or retrospective data= | ||
==Belinostat monotherapy {{#subobject:2a8653|Regimen=1}}== | ==Belinostat monotherapy {{#subobject:2a8653|Regimen=1}}== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
− | |||
===Regimen {{#subobject:682543|Variant=1}}=== | ===Regimen {{#subobject:682543|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 80%; text-align:center;" | {| class="wikitable sortable" style="width: 80%; text-align:center;" | ||
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|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Targeted therapy==== | ====Targeted therapy==== | ||
− | |||
*[[Belinostat (Beleodaq)]] 1000 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1 to 5 | *[[Belinostat (Beleodaq)]] 1000 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1 to 5 | ||
− | |||
'''21-day cycles''' | '''21-day cycles''' | ||
− | + | </div></div> | |
===References=== | ===References=== | ||
<!-- # '''Abstract:''' Pohlman, Brad, Advani, Ranjana, Duvic, Madeleine, Hymes, Kenneth B., Intragumtornchai, Tanin, Lekhakula, Arnuparp, Shpilberg, Ofer, Lerner, Adam, Ben-Yehuda, Dina, beylot-Barry, Marie, Hillen, Uwe, Fagerberg, Jan, Foss, Francine M. Final Results of a Phase II Trial of Belinostat (PXD101) in Patients with Recurrent or Refractory Peripheral or Cutaneous T-Cell Lymphoma. ASH Annual Meeting Abstracts 2009 114: 920. [http://abstracts.hematologylibrary.org/cgi/content/abstract/114/22/920 link to abstract] --> | <!-- # '''Abstract:''' Pohlman, Brad, Advani, Ranjana, Duvic, Madeleine, Hymes, Kenneth B., Intragumtornchai, Tanin, Lekhakula, Arnuparp, Shpilberg, Ofer, Lerner, Adam, Ben-Yehuda, Dina, beylot-Barry, Marie, Hillen, Uwe, Fagerberg, Jan, Foss, Francine M. Final Results of a Phase II Trial of Belinostat (PXD101) in Patients with Recurrent or Refractory Peripheral or Cutaneous T-Cell Lymphoma. ASH Annual Meeting Abstracts 2009 114: 920. [http://abstracts.hematologylibrary.org/cgi/content/abstract/114/22/920 link to abstract] --> | ||
− | |||
#'''PXD101-CLN-6:''' Foss F, Advani R, Duvic M, Hymes KB, Intragumtornchai T, Lekhakula A, Shpilberg O, Lerner A, Belt RJ, Jacobsen ED, Laurent G, Ben-Yehuda D, Beylot-Barry M, Hillen U, Knoblauch P, Bhat G, Chawla S, Allen LF, Pohlman B. A phase II trial of belinostat (PXD101) in patients with relapsed or refractory peripheral or cutaneous T-cell lymphoma. Br J Haematol. 2015 Mar;168(6):811-9. Epub 2014 Nov 17. [https://doi.org/10.1111/bjh.13222 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/25404094 PubMed] NCT00274651 | #'''PXD101-CLN-6:''' Foss F, Advani R, Duvic M, Hymes KB, Intragumtornchai T, Lekhakula A, Shpilberg O, Lerner A, Belt RJ, Jacobsen ED, Laurent G, Ben-Yehuda D, Beylot-Barry M, Hillen U, Knoblauch P, Bhat G, Chawla S, Allen LF, Pohlman B. A phase II trial of belinostat (PXD101) in patients with relapsed or refractory peripheral or cutaneous T-cell lymphoma. Br J Haematol. 2015 Mar;168(6):811-9. Epub 2014 Nov 17. [https://doi.org/10.1111/bjh.13222 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/25404094 PubMed] NCT00274651 | ||
<!-- # '''Abstract:''' Owen A. O'Connor, Tamás Masszi, Kerry J. Savage, Lauren C. Pinter-Brown, Francine M. Foss, Leslie Popplewell, Amanda F. Cashen, Jeanette Doorduijn, Shanta Chawla, Poul Knoblauch, Pier Luigi Zinzani, Peter Brown, Georg Hess, Achiel Van Hoof, Steven M. Horwitz, Andrei R. Shustov. Belinostat, a novel pan-histone deacetylase inhibitor (HDACi), in relapsed or refractory peripheral T-cell lymphoma (R/R PTCL): Results from the BELIEF trial. J Clin Oncol 31, 2013 (suppl; abstr 8507) [http://meetinglibrary.asco.org/content/111439-132 link to abstract] --> | <!-- # '''Abstract:''' Owen A. O'Connor, Tamás Masszi, Kerry J. Savage, Lauren C. Pinter-Brown, Francine M. Foss, Leslie Popplewell, Amanda F. Cashen, Jeanette Doorduijn, Shanta Chawla, Poul Knoblauch, Pier Luigi Zinzani, Peter Brown, Georg Hess, Achiel Van Hoof, Steven M. Horwitz, Andrei R. Shustov. Belinostat, a novel pan-histone deacetylase inhibitor (HDACi), in relapsed or refractory peripheral T-cell lymphoma (R/R PTCL): Results from the BELIEF trial. J Clin Oncol 31, 2013 (suppl; abstr 8507) [http://meetinglibrary.asco.org/content/111439-132 link to abstract] --> | ||
#'''BELIEF:''' O'Connor OA, Horwitz S, Masszi T, Van Hoof A, Brown P, Doorduijn J, Hess G, Jurczak W, Knoblauch P, Chawla S, Bhat G, Choi MR, Walewski J, Savage K, Foss F, Allen LF, Shustov A. Belinostat in patients with relapsed or refractory peripheral T-cell lymphoma: results of the pivotal phase II BELIEF (CLN-19) study. J Clin Oncol. 2015 Aug 10;33(23):2492-9. Epub 2015 Jun 22. [https://doi.org/10.1200/jco.2014.59.2782 link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5087312/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/26101246 PubMed] NCT00865969 | #'''BELIEF:''' O'Connor OA, Horwitz S, Masszi T, Van Hoof A, Brown P, Doorduijn J, Hess G, Jurczak W, Knoblauch P, Chawla S, Bhat G, Choi MR, Walewski J, Savage K, Foss F, Allen LF, Shustov A. Belinostat in patients with relapsed or refractory peripheral T-cell lymphoma: results of the pivotal phase II BELIEF (CLN-19) study. J Clin Oncol. 2015 Aug 10;33(23):2492-9. Epub 2015 Jun 22. [https://doi.org/10.1200/jco.2014.59.2782 link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5087312/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/26101246 PubMed] NCT00865969 | ||
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==Bendamustine monotherapy {{#subobject:47c984|Regimen=1}}== | ==Bendamustine monotherapy {{#subobject:47c984|Regimen=1}}== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
− | |||
===Regimen {{#subobject:1e407d|Variant=1}}=== | ===Regimen {{#subobject:1e407d|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 80%; text-align:center;" | {| class="wikitable sortable" style="width: 80%; text-align:center;" | ||
Line 881: | Line 786: | ||
|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | |||
*[[Bendamustine]] 120 mg/m<sup>2</sup> IV once per day on days 1 & 2 | *[[Bendamustine]] 120 mg/m<sup>2</sup> IV once per day on days 1 & 2 | ||
− | |||
'''21-day cycle for 6 cycles''' | '''21-day cycle for 6 cycles''' | ||
− | + | </div></div> | |
===References=== | ===References=== | ||
<!-- Presented in part at the 11th International Conference on Malignant Lymphoma, Lugano, Switzerland, June 15-18, 2011; at the T-Cell Lymphoma Forum, San Francisco, CA, January 26-28, 2012; and at the 48th Annual Meeting of the American Society of Clinical Oncology, Chicago, IL, June 1-6, 2012. --> | <!-- Presented in part at the 11th International Conference on Malignant Lymphoma, Lugano, Switzerland, June 15-18, 2011; at the T-Cell Lymphoma Forum, San Francisco, CA, January 26-28, 2012; and at the 48th Annual Meeting of the American Society of Clinical Oncology, Chicago, IL, June 1-6, 2012. --> | ||
− | |||
#'''BENTLY:''' Damaj G, Gressin R, Bouabdallah K, Cartron G, Choufi B, Gyan E, Banos A, Jaccard A, Park S, Tournilhac O, Schiano-de Collela JM, Voillat L, Joly B, Le Gouill S, Saad A, Cony-Makhoul P, Vilque JP, Sanhes L, Schmidt-Tanguy A, Bubenheim M, Houot R, Diouf M, Marolleau JP, Béné MC, Martin A, Lamy T. Results from a prospective, open-label, phase II trial of bendamustine in refractory or relapsed T-cell lymphomas: the BENTLY trial. J Clin Oncol. 2013 Jan 1;31(1):104-10. Epub 2012 Oct 29. [https://doi.org/10.1200/jco.2012.43.7285 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/23109692 PubMed] NCT00959686 | #'''BENTLY:''' Damaj G, Gressin R, Bouabdallah K, Cartron G, Choufi B, Gyan E, Banos A, Jaccard A, Park S, Tournilhac O, Schiano-de Collela JM, Voillat L, Joly B, Le Gouill S, Saad A, Cony-Makhoul P, Vilque JP, Sanhes L, Schmidt-Tanguy A, Bubenheim M, Houot R, Diouf M, Marolleau JP, Béné MC, Martin A, Lamy T. Results from a prospective, open-label, phase II trial of bendamustine in refractory or relapsed T-cell lymphomas: the BENTLY trial. J Clin Oncol. 2013 Jan 1;31(1):104-10. Epub 2012 Oct 29. [https://doi.org/10.1200/jco.2012.43.7285 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/23109692 PubMed] NCT00959686 | ||
− | |||
==Brentuximab vedotin monotherapy {{#subobject:b71ea8|Regimen=1}}== | ==Brentuximab vedotin monotherapy {{#subobject:b71ea8|Regimen=1}}== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
− | |||
===Regimen {{#subobject:e3235|Variant=1}}=== | ===Regimen {{#subobject:e3235|Variant=1}}=== | ||
{| class="wikitable" style="width: 60%; text-align:center;" | {| class="wikitable" style="width: 60%; text-align:center;" | ||
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|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Antibody-drug conjugate therapy==== | ====Antibody-drug conjugate therapy==== | ||
− | |||
*[[Brentuximab vedotin (Adcetris)]] 1.8 mg/kg IV once on day 1 | *[[Brentuximab vedotin (Adcetris)]] 1.8 mg/kg IV once on day 1 | ||
− | |||
'''21-day cycles''' | '''21-day cycles''' | ||
− | + | </div></div> | |
===References=== | ===References=== | ||
<!-- Presented in part at the 13th International Conference on Malignant Lymphoma, Lugano, Switzerland, June 2013. --> | <!-- Presented in part at the 13th International Conference on Malignant Lymphoma, Lugano, Switzerland, June 2013. --> | ||
− | |||
#'''SGN35-012:''' Horwitz SM, Advani RH, Bartlett NL, Jacobsen ED, Sharman JP, O'Connor OA, Siddiqi T, Kennedy DA, Oki Y. Objective responses in relapsed T-cell lymphomas with single-agent brentuximab vedotin. Blood. 2014 May 15;123(20):3095-100. Epub 2014 Mar 20. [https://doi.org/10.1182/blood-2013-12-542142 link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4425442/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/24652992 PubMed] NCT01421667 | #'''SGN35-012:''' Horwitz SM, Advani RH, Bartlett NL, Jacobsen ED, Sharman JP, O'Connor OA, Siddiqi T, Kennedy DA, Oki Y. Objective responses in relapsed T-cell lymphomas with single-agent brentuximab vedotin. Blood. 2014 May 15;123(20):3095-100. Epub 2014 Mar 20. [https://doi.org/10.1182/blood-2013-12-542142 link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4425442/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/24652992 PubMed] NCT01421667 | ||
− | |||
==Chidamide monotherapy {{#subobject:5a869f|Regimen=1}}== | ==Chidamide monotherapy {{#subobject:5a869f|Regimen=1}}== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen {{#subobject:3a6a27|Variant=1}}=== | ===Regimen {{#subobject:3a6a27|Variant=1}}=== | ||
{| class="wikitable" style="width: 60%; text-align:center;" | {| class="wikitable" style="width: 60%; text-align:center;" | ||
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|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Targeted therapy==== | ====Targeted therapy==== | ||
− | |||
*[[Chidamide (Epidaza)]] 30 mg PO twice per week | *[[Chidamide (Epidaza)]] 30 mg PO twice per week | ||
− | |||
'''Continued indefinitely''' | '''Continued indefinitely''' | ||
− | + | </div></div> | |
===References=== | ===References=== | ||
− | |||
#Shi Y, Dong M, Hong X, Zhang W, Feng J, Zhu J, Yu L, Ke X, Huang H, Shen Z, Fan Y, Li W, Zhao X, Qi J, Huang H, Zhou D, Ning Z, Lu X. Results from a multicenter, open-label, pivotal phase II study of chidamide in relapsed or refractory peripheral T-cell lymphoma. Ann Oncol. 2015 Aug;26(8):1766-71. Epub 2015 Jun 23. [https://doi.org/10.1093/annonc/mdv237 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/26105599 PubMed] | #Shi Y, Dong M, Hong X, Zhang W, Feng J, Zhu J, Yu L, Ke X, Huang H, Shen Z, Fan Y, Li W, Zhao X, Qi J, Huang H, Zhou D, Ning Z, Lu X. Results from a multicenter, open-label, pivotal phase II study of chidamide in relapsed or refractory peripheral T-cell lymphoma. Ann Oncol. 2015 Aug;26(8):1766-71. Epub 2015 Jun 23. [https://doi.org/10.1093/annonc/mdv237 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/26105599 PubMed] | ||
− | |||
==Forodesine monotherapy {{#subobject:2310b4|Regimen=1}}== | ==Forodesine monotherapy {{#subobject:2310b4|Regimen=1}}== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen {{#subobject:d759e9|Variant=1}}=== | ===Regimen {{#subobject:d759e9|Variant=1}}=== | ||
{| class="wikitable" style="width: 60%; text-align:center;" | {| class="wikitable" style="width: 60%; text-align:center;" | ||
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|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | |||
*[[Forodesine (Fodosine)]] 300 mg PO twice per day | *[[Forodesine (Fodosine)]] 300 mg PO twice per day | ||
− | |||
'''Continued indefinitely''' | '''Continued indefinitely''' | ||
− | + | </div></div> | |
===References=== | ===References=== | ||
− | |||
#'''FDS-J02:''' Maruyama D, Tsukasaki K, Uchida T, Maeda Y, Shibayama H, Nagai H, Kurosawa M, Suehiro Y, Hatake K, Ando K, Yoshida I, Hidaka M, Murayama T, Okitsu Y, Tsukamoto N, Taniwaki M, Suzumiya J, Tamura K, Yamauchi T, Ueda R, Tobinai K. Multicenter phase 1/2 study of forodesine in patients with relapsed peripheral T cell lymphoma. Ann Hematol. 2019 Jan;98(1):131-142. Epub 2018 Jul 5. Erratum in: Ann Hematol. 2018 Jul 27. [https://doi.org/10.1007/s00277-018-3418-2 link to original article] '''contains dosing details in abstract''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6334730/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/29974231 PubMed] NCT01776411 | #'''FDS-J02:''' Maruyama D, Tsukasaki K, Uchida T, Maeda Y, Shibayama H, Nagai H, Kurosawa M, Suehiro Y, Hatake K, Ando K, Yoshida I, Hidaka M, Murayama T, Okitsu Y, Tsukamoto N, Taniwaki M, Suzumiya J, Tamura K, Yamauchi T, Ueda R, Tobinai K. Multicenter phase 1/2 study of forodesine in patients with relapsed peripheral T cell lymphoma. Ann Hematol. 2019 Jan;98(1):131-142. Epub 2018 Jul 5. Erratum in: Ann Hematol. 2018 Jul 27. [https://doi.org/10.1007/s00277-018-3418-2 link to original article] '''contains dosing details in abstract''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6334730/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/29974231 PubMed] NCT01776411 | ||
− | |||
==Lenalidomide monotherapy {{#subobject:372121|Regimen=1}}== | ==Lenalidomide monotherapy {{#subobject:372121|Regimen=1}}== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen variant #1, limited duration {{#subobject:b6993e|Variant=1}}=== | ===Regimen variant #1, limited duration {{#subobject:b6993e|Variant=1}}=== | ||
{| class="wikitable" style="width: 60%; text-align:center;" | {| class="wikitable" style="width: 60%; text-align:center;" | ||
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|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Targeted therapy==== | ====Targeted therapy==== | ||
− | |||
*[[Lenalidomide (Revlimid)]] 25 mg PO once per day on days 1 to 21 | *[[Lenalidomide (Revlimid)]] 25 mg PO once per day on days 1 to 21 | ||
− | |||
'''28-day cycle for up to 26 cycles (2 years)''' | '''28-day cycle for up to 26 cycles (2 years)''' | ||
− | + | </div></div><br> | |
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
===Regimen variant #2, indefinite {{#subobject:868aa6|Variant=1}}=== | ===Regimen variant #2, indefinite {{#subobject:868aa6|Variant=1}}=== | ||
{| class="wikitable" style="width: 60%; text-align:center;" | {| class="wikitable" style="width: 60%; text-align:center;" | ||
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|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Targeted therapy==== | ====Targeted therapy==== | ||
*[[Lenalidomide (Revlimid)]] 25 mg PO once per day on days 1 to 21 | *[[Lenalidomide (Revlimid)]] 25 mg PO once per day on days 1 to 21 | ||
− | |||
'''28-day cycles''' | '''28-day cycles''' | ||
− | + | </div></div> | |
===References=== | ===References=== | ||
− | |||
#Dueck G, Chua N, Prasad A, Finch D, Stewart D, White D, van der Jagt R, Johnston J, Belch A, Reiman T. Interim report of a phase 2 clinical trial of lenalidomide for T-cell non-Hodgkin lymphoma. Cancer. 2010 Oct 1;116(19):4541-8. [https://doi.org/10.1002/cncr.25377 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/20572046 PubMed] | #Dueck G, Chua N, Prasad A, Finch D, Stewart D, White D, van der Jagt R, Johnston J, Belch A, Reiman T. Interim report of a phase 2 clinical trial of lenalidomide for T-cell non-Hodgkin lymphoma. Cancer. 2010 Oct 1;116(19):4541-8. [https://doi.org/10.1002/cncr.25377 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/20572046 PubMed] | ||
##'''Update:''' Toumishey E, Prasad A, Dueck G, Chua N, Finch D, Johnston J, van der Jagt R, Stewart D, White D, Belch A, Reiman T. Final report of a phase 2 clinical trial of lenalidomide monotherapy for patients with T-cell lymphoma. Cancer. 2015 Mar 1;121(5):716-23. Epub 2014 Oct 29. [https://doi.org/10.1002/cncr.29103 link to original article] [https://pubmed.ncbi.nlm.nih.gov/25355245 PubMed] | ##'''Update:''' Toumishey E, Prasad A, Dueck G, Chua N, Finch D, Johnston J, van der Jagt R, Stewart D, White D, Belch A, Reiman T. Final report of a phase 2 clinical trial of lenalidomide monotherapy for patients with T-cell lymphoma. Cancer. 2015 Mar 1;121(5):716-23. Epub 2014 Oct 29. [https://doi.org/10.1002/cncr.29103 link to original article] [https://pubmed.ncbi.nlm.nih.gov/25355245 PubMed] | ||
#'''EXPECT:''' Morschhauser F, Fitoussi O, Haioun C, Thieblemont C, Quach H, Delarue R, Glaisner S, Gabarre J, Bosly A, Lister J, Li J, Coiffier B. A phase 2, multicentre, single-arm, open-label study to evaluate the safety and efficacy of single-agent lenalidomide (Revlimid®) in subjects with relapsed or refractory peripheral T-cell non-Hodgkin lymphoma: The EXPECT trial. Eur J Cancer. 2013 Sep;49(13):2869-76. Epub 2013 May 31. [https://www.ejcancer.com/article/S0959-8049(13)00363-8 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/23731832 PubMed] | #'''EXPECT:''' Morschhauser F, Fitoussi O, Haioun C, Thieblemont C, Quach H, Delarue R, Glaisner S, Gabarre J, Bosly A, Lister J, Li J, Coiffier B. A phase 2, multicentre, single-arm, open-label study to evaluate the safety and efficacy of single-agent lenalidomide (Revlimid®) in subjects with relapsed or refractory peripheral T-cell non-Hodgkin lymphoma: The EXPECT trial. Eur J Cancer. 2013 Sep;49(13):2869-76. Epub 2013 May 31. [https://www.ejcancer.com/article/S0959-8049(13)00363-8 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/23731832 PubMed] | ||
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==Mogamulizumab monotherapy {{#subobject:8d8ae3|Regimen=1}}== | ==Mogamulizumab monotherapy {{#subobject:8d8ae3|Regimen=1}}== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen {{#subobject:2848bf|Variant=1}}=== | ===Regimen {{#subobject:2848bf|Variant=1}}=== | ||
{| class="wikitable" style="width: 40%; text-align:center;" | {| class="wikitable" style="width: 40%; text-align:center;" | ||
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|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Targeted therapy==== | ====Targeted therapy==== | ||
− | |||
*[[Mogamulizumab (Poteligeo)]] 1 mg/kg IV once per day on days 1, 8, 15, 22 | *[[Mogamulizumab (Poteligeo)]] 1 mg/kg IV once per day on days 1, 8, 15, 22 | ||
− | |||
'''28-day cycle for 2 cycles''' | '''28-day cycle for 2 cycles''' | ||
− | + | </div></div> | |
===References=== | ===References=== | ||
− | |||
#'''KW-0761-004:''' Ogura M, Ishida T, Hatake K, Taniwaki M, Ando K, Tobinai K, Fujimoto K, Yamamoto K, Miyamoto T, Uike N, Tanimoto M, Tsukasaki K, Ishizawa K, Suzumiya J, Inagaki H, Tamura K, Akinaga S, Tomonaga M, Ueda R. Multicenter phase II study of mogamulizumab (KW-0761), a defucosylated anti-cc chemokine receptor 4 antibody, in patients with relapsed peripheral T-cell lymphoma and cutaneous T-cell lymphoma. J Clin Oncol. 2014 Apr 10;32(11):1157-63. Epub 2014 Mar 10. [https://doi.org/10.1200/jco.2013.52.0924 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/24616310 PubMed] NCT01192984 | #'''KW-0761-004:''' Ogura M, Ishida T, Hatake K, Taniwaki M, Ando K, Tobinai K, Fujimoto K, Yamamoto K, Miyamoto T, Uike N, Tanimoto M, Tsukasaki K, Ishizawa K, Suzumiya J, Inagaki H, Tamura K, Akinaga S, Tomonaga M, Ueda R. Multicenter phase II study of mogamulizumab (KW-0761), a defucosylated anti-cc chemokine receptor 4 antibody, in patients with relapsed peripheral T-cell lymphoma and cutaneous T-cell lymphoma. J Clin Oncol. 2014 Apr 10;32(11):1157-63. Epub 2014 Mar 10. [https://doi.org/10.1200/jco.2013.52.0924 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/24616310 PubMed] NCT01192984 | ||
− | |||
=Consolidation after salvage therapy= | =Consolidation after salvage therapy= | ||
==FluBuCy, then allo HSCT {{#subobject:84acb0|Regimen=1}}== | ==FluBuCy, then allo HSCT {{#subobject:84acb0|Regimen=1}}== | ||
− | |||
FluBuCy: '''<u>Flu</u>'''darabine, '''<u>Bu</u>'''sulfan, '''<u>Cy</u>'''clophosphamide | FluBuCy: '''<u>Flu</u>'''darabine, '''<u>Bu</u>'''sulfan, '''<u>Cy</u>'''clophosphamide | ||
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
===Regimen {{#subobject:bfe434|Variant=1}}=== | ===Regimen {{#subobject:bfe434|Variant=1}}=== | ||
{| class="wikitable" style="width: 40%; text-align:center;" | {| class="wikitable" style="width: 40%; text-align:center;" | ||
Line 1,042: | Line 929: | ||
*[[Allogeneic stem cells]] | *[[Allogeneic stem cells]] | ||
'''Stem cells transfused on day 0''' | '''Stem cells transfused on day 0''' | ||
+ | </div></div> | ||
===References=== | ===References=== | ||
<!-- # Glass B, rabbits Kamp J, Wulf G, Dreger P, Pfreundschuh M, Gramatzki M Silling G, Wilhelm C, Zeis M, Görlitz A, Pfeiffer S, Hilgers R, Truemper L, Schmitz N. High-dose chemotherapy Followed by allogeneic stem cell transplantation in relapsed and refractory high-risk aggressive non-Hodgkin's lymphoma: Results of a prospective study of the German high-grade non-Hodgkin's lymphoma study group. J Clin Oncol 30, 2012 (suppl; abstr 8004) --> | <!-- # Glass B, rabbits Kamp J, Wulf G, Dreger P, Pfreundschuh M, Gramatzki M Silling G, Wilhelm C, Zeis M, Görlitz A, Pfeiffer S, Hilgers R, Truemper L, Schmitz N. High-dose chemotherapy Followed by allogeneic stem cell transplantation in relapsed and refractory high-risk aggressive non-Hodgkin's lymphoma: Results of a prospective study of the German high-grade non-Hodgkin's lymphoma study group. J Clin Oncol 30, 2012 (suppl; abstr 8004) --> | ||
− | |||
#'''DSHNHL R3:''' Glass B, Hasenkamp J, Wulf G, Dreger P, Pfreundschuh M, Gramatzki M, Silling G, Wilhelm C, Zeis M, Görlitz A, Pfeiffer S, Hilgers R, Truemper L, Schmitz N; German High-Grade Lymphoma Study Group. Rituximab after lymphoma-directed conditioning and allogeneic stem-cell transplantation for relapsed and refractory aggressaive non-Hodgkin lymphoma (DSHNHL R3): an open-label, randomised, phase 2 trial. Lancet Oncol. 2014 Jun;15(7):757-66. Epub 2014 May 11. [https://doi.org/10.1016/S1470-2045(14)70161-5 link to original article] [http://www.dshnhl.org/app/download/9495510598/Studienprotokoll+DSHNHL+alloFBC+final+vollst.pdf link to original protocol (in German)] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/24827808 PubMed] NCT00785330 | #'''DSHNHL R3:''' Glass B, Hasenkamp J, Wulf G, Dreger P, Pfreundschuh M, Gramatzki M, Silling G, Wilhelm C, Zeis M, Görlitz A, Pfeiffer S, Hilgers R, Truemper L, Schmitz N; German High-Grade Lymphoma Study Group. Rituximab after lymphoma-directed conditioning and allogeneic stem-cell transplantation for relapsed and refractory aggressaive non-Hodgkin lymphoma (DSHNHL R3): an open-label, randomised, phase 2 trial. Lancet Oncol. 2014 Jun;15(7):757-66. Epub 2014 May 11. [https://doi.org/10.1016/S1470-2045(14)70161-5 link to original article] [http://www.dshnhl.org/app/download/9495510598/Studienprotokoll+DSHNHL+alloFBC+final+vollst.pdf link to original protocol (in German)] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/24827808 PubMed] NCT00785330 | ||
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=Investigational agents= | =Investigational agents= | ||
''These are drugs under study or approved outside of the United States, with at least some promising results for this disease.'' | ''These are drugs under study or approved outside of the United States, with at least some promising results for this disease.'' | ||
− | |||
*[[Alisertib (MLN8237)]] | *[[Alisertib (MLN8237)]] | ||
*[[Chidamide (Epidaza)]] | *[[Chidamide (Epidaza)]] | ||
− | |||
[[Category:Peripheral T-cell lymphoma regimens]] | [[Category:Peripheral T-cell lymphoma regimens]] | ||
[[Category:Disease-specific pages]] | [[Category:Disease-specific pages]] | ||
[[Category:T-cell lymphomas]] | [[Category:T-cell lymphomas]] |
Revision as of 12:04, 14 October 2022
Page editor | Section editor | ||
---|---|---|---|
Nishi N. Shah, MD Montefiore Medical Center Bronx, NY ![]() |
Bhagirathbhai Dholaria, MBBS Vanderbilt University Nashville, TN |
30 regimens on this page
37 variants on this page
|
Are you looking for a regimen but can't find it here? It is possible that we've moved it to the historical regimens page. If you still can't find it, please let us know so we can add it!.
Note: some subtypes of PTCL have been moved to dedicated pages:
- Anaplastic large cell lymphoma
- Extranodal NK- and T-cell lymphoma, nasal type
- NK- and T-cell lymphoma
Guidelines
ESMO
- 2015: d'Amore et al. Peripheral T-cell lymphomas: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up
Older
- 2013: Dreyling et al. ESMO Consensus conferences: guidelines on malignant lymphoma. part 2: marginal zone lymphoma, mantle cell lymphoma, peripheral T-cell lymphoma. PubMed
NCCN
Untreated, randomized data
BV-CHP
BV-CHP: Brentuximab Vedotin, Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin), Prednisone
A+CHP: Adcetris (Brentuximab vedotin), Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin), Prednisone
Regimen
FDA-recommended dose |
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Horwitz et al. 2018 (ECHELON-2) | 2013-2016 | Phase 3 (E-RT-switch-ooc) | CHOP | Seems to have superior OS1 OS60: 70.1% vs 61% (HR 0.72, 95% CI 0.53-0.99) |
1Reported efficacy based on the 2021 update.
Antibody-drug conjugate therapy
- Brentuximab vedotin (Adcetris) 1.8 mg/kg IV once on day 1, given fourth
Chemotherapy
- Cyclophosphamide (Cytoxan) 750 mg/m2 IV once on day 1
- Doxorubicin (Adriamycin) 50 mg/m2 IV once on day 1
Glucocorticoid therapy
- Prednisone (Sterapred) 100 mg PO once per day on days 1 to 5
21-day cycle for 6 to 8 cycles
References
- ECHELON-2: Horwitz S, O'Connor OA, Pro B, Illidge T, Fanale M, Advani R, Bartlett NL, Christensen JH, Morschhauser F, Domingo-Domenech E, Rossi G, Kim WS, Feldman T, Lennard A, Belada D, Illés Á, Tobinai K, Tsukasaki K, Yeh SP, Shustov A, Hüttmann A, Savage KJ, Yuen S, Iyer S, Zinzani PL, Hua Z, Little M, Rao S, Woolery J, Manley T, Trümper L; ECHELON-2 Study Group. Brentuximab vedotin with chemotherapy for CD30-positive peripheral T-cell lymphoma (ECHELON-2): a global, double-blind, randomised, phase 3 trial. Lancet. 2019 Jan 19;393(10168):229-240. Epub 2018 Dec 4. Erratum in: Lancet. 2019 Jan 19;393(10168):228. link to original article contains dosing details in abstract link to PMC article PubMed NCT01777152
- Update: Horwitz S, O'Connor OA, Pro B, Trümper L, Iyer S, Advani R, Bartlett NL, Christensen JH, Morschhauser F, Domingo-Domenech E, Rossi G, Kim WS, Feldman T, Menne T, Belada D, Illés Á, Tobinai K, Tsukasaki K, Yeh SP, Shustov A, Hüttmann A, Savage KJ, Yuen S, Zinzani PL, Miao H, Bunn V, Fenton K, Fanale M, Puhlmann M, Illidge T. The ECHELON-2 Trial: 5-year results of a randomized, phase III study of brentuximab vedotin with chemotherapy for CD30-positive peripheral T-cell lymphoma. Ann Oncol. 2022 Mar;33(3):288-298. Epub 2021 Dec 16. link to original article PubMed
CHOP
CHOP: Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin), Oncovin (Vincristine), Prednisone
Regimen variant #1, 6 cycles, 40 mg/m2
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Bachy et al. 2021 (LYSA Ro-CHOP) | 2013-2017 | Phase 3 (C) | Ro-CHOP | Might have inferior PFS Median PFS: 10.2 vs 12 mo (HR 1.23, 95% CI 0.96-1.59) |
Chemotherapy
- Cyclophosphamide (Cytoxan) 750 mg/m2 IV once on day 1
- Doxorubicin (Adriamycin) 50 mg/m2 IV once on day 1
- Vincristine (Oncovin) by the following age-based criteria:
- Age 70 or younger: 1.4 mg/m2 (maximum dose of 2 mg) IV once on day 1
- Age older than 70: 1.4 mg/m2 (maximum dose of 1.5 mg) IV once on day 1
Glucocorticoid therapy
- Prednisone (Sterapred) 40 mg/m2 PO once per day on days 1 to 5
21-day cycle for 6 cycles
Regimen variant #2, 6 cycles, prednisone 60 mg/m2
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Reimer et al. 2004 | 2000-2002 | Non-randomized | ||
Li et al. 2017 (hnslblzlzx2011-3) | 2010-2016 | Phase 3 (C) | GDPT | Inferior OS |
Note: the abstract of Reimer et al. 2004 does not have dosing details.
Chemotherapy
- Cyclophosphamide (Cytoxan) 750 mg/m2 IV once on day 1
- Doxorubicin (Adriamycin) 50 mg/m2 IV once on day 1
- Vincristine (Oncovin) 1.4 mg/m2 (maximum dose of 2 mg) IV once on day 1
Glucocorticoid therapy
- Prednisone (Sterapred) 60 mg/m2 PO once per day on days 1 to 5
21-day cycle for 6 cycles
Regimen variant #2, 8 cycles
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Simon et al. 2010 (GOELAMS LTP95) | 1996-2002 | Phase 3 (C) | VIP-rABVD | Did not meet primary endpoint of EFS24 |
Chemotherapy
- Cyclophosphamide (Cytoxan) 750 mg/m2 IV once on day 1
- Doxorubicin (Adriamycin) 50 mg/m2 IV once on day 1
- Vincristine (Oncovin) 1.4 mg/m2 (maximum dose of 2 mg) IV once on day 1
Glucocorticoid therapy
- Prednisone (Sterapred) 100 mg/m2 PO once per day on days 1 to 5
21-day cycle for 8 cycles
Subsequent treatment
- Patients with initial bulky disease (diameter at least 5 cm): IFRT x 40 Gy
References
- Reimer P, Schertlin T, Rüdiger T, Geissinger E, Roth S, Kunzmann V, Weissinger F, Nerl C, Schmitz N, Müller-Hermelink HK, Wilhelm M. Myeloablative radiochemotherapy followed by autologous peripheral blood stem cell transplantation as first-line therapy in peripheral T-cell lymphomas: first results of a prospective multicenter study. Hematol J. 2004;5(4):304-11. link to original article does not contain dosing details PubMed
- Update: Reimer P, Rüdiger T, Geissinger E, Weissinger F, Nerl C, Schmitz N, Engert A, Einsele H, Müller-Hermelink HK, Wilhelm M. Autologous stem-cell transplantation as first-line therapy in peripheral T-cell lymphomas: results of a prospective multicenter study. J Clin Oncol. 2009 Jan 1;27(1):106-13. Epub 2008 Nov 24. link to original article PubMed
- GOELAMS-LTP95: Simon A, Peoch M, Casassus P, Deconinck E, Colombat P, Desablens B, Tournilhac O, Eghbali H, Foussard C, Jaubert J, Vilque JP, Rossi JF, Lucas V, Delwail V, Thyss A, Maloisel F, Milpied N, le Gouill S, Lamy T, Gressin R. Upfront VIP-reinforced-ABVD (VIP-rABVD) is not superior to CHOP/21 in newly diagnosed peripheral T cell lymphoma: results of the randomized phase III trial GOELAMS-LTP95. Br J Haematol. 2010 Oct;151(2):159-66. Epub 2010 Aug 25. link to original article contains dosing details in manuscript PubMed
- Meta-analysis: Abouyabis AN, Shenoy PJ, Sinha R, Flowers CR, Lechowicz MJ. A systematic review and meta-analysis of front-line anthracycline-based chemotherapy regimens for peripheral T-cell lymphoma. ISRN Hematol. 2011;2011:623924. Epub 2011 Jun 16. link to original article link to PMC article PubMed
- hnslblzlzx2011-3: Li L, Duan W, Zhang L, Li X, Fu X, Wang X, Wu J, Sun Z, Zhang X, Chang Y, Nan F, Yan J, Li Z, Young KH, Zhang M. The efficacy and safety of gemcitabine, cisplatin, prednisone, thalidomide versus CHOP in patients with newly diagnosed peripheral T-cell lymphoma with analysis of biomarkers. Br J Haematol. 2017 Sep;178(5):772-780. Epub 2017 Jun 9. link to original article contains dosing details in manuscript PubMed NCT01664975
- ECHELON-2: Horwitz S, O'Connor OA, Pro B, Illidge T, Fanale M, Advani R, Bartlett NL, Christensen JH, Morschhauser F, Domingo-Domenech E, Rossi G, Kim WS, Feldman T, Lennard A, Belada D, Illés Á, Tobinai K, Tsukasaki K, Yeh SP, Shustov A, Hüttmann A, Savage KJ, Yuen S, Iyer S, Zinzani PL, Hua Z, Little M, Rao S, Woolery J, Manley T, Trümper L; ECHELON-2 Study Group. Brentuximab vedotin with chemotherapy for CD30-positive peripheral T-cell lymphoma (ECHELON-2): a global, double-blind, randomised, phase 3 trial. Lancet. 2019 Jan 19;393(10168):229-240. Epub 2018 Dec 4. Erratum in: Lancet. 2019 Jan 19;393(10168):228. link to original article contains dosing details in abstract link to PMC article PubMed NCT01777152
- Update: Horwitz S, O'Connor OA, Pro B, Trümper L, Iyer S, Advani R, Bartlett NL, Christensen JH, Morschhauser F, Domingo-Domenech E, Rossi G, Kim WS, Feldman T, Menne T, Belada D, Illés Á, Tobinai K, Tsukasaki K, Yeh SP, Shustov A, Hüttmann A, Savage KJ, Yuen S, Zinzani PL, Miao H, Bunn V, Fenton K, Fanale M, Puhlmann M, Illidge T. The ECHELON-2 Trial: 5-year results of a randomized, phase III study of brentuximab vedotin with chemotherapy for CD30-positive peripheral T-cell lymphoma. Ann Oncol. 2022 Mar;33(3):288-298. Epub 2021 Dec 16. link to original article PubMed
- LYSA Ro-CHOP: Bachy E, Camus V, Thieblemont C, Sibon D, Casasnovas RO, Ysebaert L, Damaj G, Guidez S, Pica GM, Kim WS, Lim ST, André M, García-Sancho AM, Penarrubia MJ, Staber PB, Trotman J, Hüttmann A, Stefoni V, Re A, Gaulard P, Delfau-Larue MH, de Leval L, Meignan M, Li J, Morschhauser F, Delarue R. Romidepsin Plus CHOP Versus CHOP in Patients With Previously Untreated Peripheral T-Cell Lymphoma: Results of the Ro-CHOP Phase III Study (Conducted by LYSA). J Clin Oncol. 2022 Jan 20;40(3):242-251. Epub 2021 Nov 29. link to original article contains dosing details in manuscript PubMed NCT01796002
CHOP-14 (Prednisolone)
CHOP-14: Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin), Oncovin (Vincristine), Prednisolone every 14 days
Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Wulf et al. 2020 (ACT-2) | 2007-2013 | Phase 3 (C) | A-CHOP-14 | Did not meet primary endpoint of EFS |
Preceding treatment
- ACT-2: Vincristine & Prednisolone pre-phase
Chemotherapy
- Cyclophosphamide (Cytoxan) 750 mg/m2 IV once on day 1
- Doxorubicin (Adriamycin) 50 mg/m2 IV once on day 1
- Vincristine (Oncovin) 1.4 mg/m2 (maximum dose of 2 mg) IV once on day 1
Glucocorticoid therapy
- Prednisolone (Millipred) 100 mg PO once per day on days 1 to 5
Supportive therapy
- G-CSF support
14-day cycle for 6 cycles
References
- ACT-2: Wulf GG, Altmann B, Ziepert M, D'Amore F, Held G, Greil R, Tournilhac O, Relander T, Viardot A, Wilhelm M, Wilhelm C, Pezzutto A, Zijlstra JM, van den Neste E, Lugtenburg PJ, Doorduijn JK, Gelder MV, van Imhoff GW, Zettl F, Braulke F, Nickelsen M, Glass B, Rosenwald A, Gaulard P, Loeffler M, Pfreundschuh M, Schmitz N, Trümper L; DSHNHL. Alemtuzumab plus CHOP versus CHOP in elderly patients with peripheral T-cell lymphoma: the DSHNHL2006-1B/ACT-2 trial. Leukemia. 2021 Jan;35(1):143-155. Epub 2020 May 7. link to original article contains dosing details in manuscript PubMed
CMED
CMED: Cyclophosphamide, Methotrexate, Etoposide, Dexamethasone
Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Avilés et al. 2008 | 1994-2001 | Phase 3 (E-switch-ic) | CHOP | Superior OS |
Chemotherapy
- Cyclophosphamide (Cytoxan) 2000 mg/m2 IV once on day 1
- Methotrexate (MTX) 300 mg/m2 IV once on day 1
- Etoposide (Vepesid) 400 mg/m2 IV once per day on days 1 & 2
Glucocorticoid therapy
- Dexamethasone (Decadron) 20 mg/m2 PO once per day on days 1 to 5
Supportive therapy
- Folinic acid (Leucovorin) 15 mg IV every 6 hours for 12 doses, started 24 hours after MTX
14-day cycle for 6 cycles
References
- Avilés A, Castañeda C, Neri N, Cleto S, Talavera A, González M, Huerta-Guzmán J, Nambo MJ. Results of a phase III clinical trial: CHOP versus CMED in peripheral T-cell lymphoma unspecified. Med Oncol. 2008;25(3):360-4. Epub 2008 Feb 5. link to original article contains dosing details in manuscript PubMed
GDPT
GDPT: Gemcitabine, DDP (Cisplatin), Prednisone, Thalidomide
Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Li et al. 2017 (hnslblzlzx2011-3) | 2010-2016 | Phase 3 (E-switch-ooc) | CHOP | Superior OS24 OS24: 71% vs 50% |
Chemotherapy
- Gemcitabine (Gemzar) 800 mg/m2 IV over 30 minutes once per day on days 1 & 8
- Cisplatin (Platinol) 25 mg/m2 IV once per day on days 1 to 3
Glucocorticoid therapy
- Prednisone (Sterapred) 60 mg/m2 PO once per day on days 1 to 5
Targeted therapy
- Thalidomide (Thalomid) 50 mg PO once per day, increased by 50 mg per day until target dose of 200 mg PO once per day
Supportive therapy
- Aspirin 100 mg PO once per day
21-day cycle for 6 cycles
References
- hnslblzlzx2011-3: Li L, Duan W, Zhang L, Li X, Fu X, Wang X, Wu J, Sun Z, Zhang X, Chang Y, Nan F, Yan J, Li Z, Young KH, Zhang M. The efficacy and safety of gemcitabine, cisplatin, prednisone, thalidomide versus CHOP in patients with newly diagnosed peripheral T-cell lymphoma with analysis of biomarkers. Br J Haematol. 2017 Sep;178(5):772-780. Epub 2017 Jun 9. link to original article contains dosing details in manuscript PubMed NCT01664975
Untreated, non-randomized or retrospective data
A-CHOP
A-CHOP: Alemtuzumab, Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin), Oncovin (Vincristine), Predniso(lo)ne
CHOP-AL: Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin), Oncovin (Vincristine), Predniso(lo)ne, ALemtuzumab
CHOP-C: Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin), Oncovin (Vincristine), Predniso(lo)ne, Campath (Alemtuzumab)
Regimen variant #1, 2 cycles
Study | Years of enrollment | Evidence |
---|---|---|
Corradini et al. 2014 (PTCL-06) | 2006-2010 | Phase 2 |
Note: These are the details for "Clin A" which was the regimen used for patients younger than 60. Note: this is a component of a sequential treatment protocol; to our knowledge there are no references to support using it as a stand-alone treatment.
Chemotherapy
- Cyclophosphamide (Cytoxan) 750 mg/m2 IV once on day 1
- Doxorubicin (Adriamycin) 50 mg/m2 IV once on day 1
- Vincristine (Oncovin) 1.4 mg/m2 (maximum dose of 2 mg) IV once on day 1
Glucocorticoid therapy
- Prednisone (Sterapred) 100 mg PO once per day on days 1 to 5
Targeted therapy
- Alemtuzumab (Campath) as follows:
- Cycle 1: 3 mg IV once on day -2, then 10 mg IV once on day -1, then 20 mg IV once on day 0
- Cycle 2: 30 mg IV once on day 0 (= day 21 of cycle 1)
21-day cycle for 2 cycles
Subsequent treatment
- HyperCHidam x 2
Regimen variant #2, 8 cycles
Study | Evidence |
---|---|
Gallamini et al. 2007 | Phase 2 |
Note: the paper reports using the CHOP dosing as specified by Fisher et al. 1993; however, note that the cycle length here is 28 days.
Chemotherapy
- Cyclophosphamide (Cytoxan) 750 mg/m2 IV once on day 1
- Doxorubicin (Adriamycin) 50 mg/m2 IV once on day 1
- Vincristine (Oncovin) 1.4 mg/m2 (maximum dose of 2 mg) IV once on day 1
Glucocorticoid therapy
- Prednisone (Sterapred) 100 mg PO once per day on days 1 to 5
Targeted therapy
- Alemtuzumab (Campath) as follows:
- Cycle 1: 3 mg IV once on day -2, then 10 mg IV once on day -1, then 20 mg IV once on day 0, then 30 mg IV once on day 1
- Cycles 2 to 8: 30 mg IV once on day 1
Supportive therapy
- Chlorpheniramine (Chlor-Trimeton) 10 mg IV once per infusion; 60 minutes prior to Alemtuzumab (Campath)
- Acetaminophen (Tylenol) 500 mg PO once per infusion; 30 minutes prior to Alemtuzumab (Campath)
- Alizapride (Litican) 100 mg IV once per infusion; 30 minutes prior to Alemtuzumab (Campath)
28-day cycle for 8 cycles
References
- Gallamini A, Zaja F, Patti C, Billio A, Specchia MR, Tucci A, Levis A, Manna A, Secondo V, Rigacci L, Pinto A, Iannitto E, Zoli V, Torchio P, Pileri S, Tarella C. Alemtuzumab (Campath-1H) and CHOP chemotherapy as first-line treatment of peripheral T-cell lymphoma: results of a GITIL (Gruppo Italiano Terapie Innovative nei Linfomi) prospective multicenter trial. Blood. 2007 Oct 1;110(7):2316-23. Epub 2007 Jun 20. link to original article contains partial protocol PubMed
- PTCL-06: Corradini P, Vitolo U, Rambaldi A, Miceli R, Patriarca F, Gallamini A, Olivieri A, Benedetti F, Todeschini G, Rossi G, Salvi F, Bruno B, Baldini L, Ferreri A, Patti C, Tarella C, Pileri S, Dodero A. Intensified chemo-immunotherapy with or without stem cell transplantation in newly diagnosed patients with peripheral T-cell lymphoma. Leukemia. 2014 Sep;28(9):1885-91. Epub 2014 Feb 20. link to original article contains dosing details in manuscript PubMed EudraCT 2006-004234-33
CHOEP-14
CHOEP-14: Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin), Oncovin (Vincristine), Etoposide, Prednisone every 14 days
Regimen
Study | Evidence |
---|---|
d'Amore et al. 2012 (NLG-T-01) | Phase 2 |
Chemotherapy
- Cyclophosphamide (Cytoxan) 750 mg/m2 IV once on day 1
- Doxorubicin (Adriamycin) 50 mg/m2 IV once on day 1
- Vincristine (Oncovin) 1.4 mg/m2 (maximum dose of 2 mg) IV once on day 1
- Etoposide (Vepesid) by the following age-based criteria:
- Up to age 60: 100 mg/m2 IV once per day on days 1 to 3
Glucocorticoid therapy
- Prednisone (Sterapred) 50 mg PO twice per day on days 1 to 5
14-day cycle for 6 cycles
Subsequent treatment
- If patients in PR or CR after three cycles, stem cells are mobilized off of cycles 5 and 6, followed by BEAC or BEAM, then auto HSCT
References
- NLG-T-01: d'Amore F, Relander T, Lauritzsen GF, Jantunen E, Hagberg H, Anderson H, Holte H, Österborg A, Merup M, Brown P, Kuittinen O, Erlanson M, Østenstad B, Fagerli UM, Gadeberg OV, Sundström C, Delabie J, Ralfkiaer E, Vornanen M, Toldbod HE. Up-front autologous stem-cell transplantation in peripheral T-cell lymphoma: NLG-T-01. J Clin Oncol. 2012 Sep 1;30(25):3093-9. Epub 2012 Jul 30. link to original article contains dosing details in manuscript PubMed NCT00791947
CHOP & Everolimus
CHOP & Everolimus: Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin), Oncovin (Vincristine), Predniso(lo)ne, Everolimus
Regimen
Study | Evidence | Efficacy |
---|---|---|
Kim et al. 2016 (RADCHOP) | Phase 2 | ORR: 90% |
Chemotherapy
- Cyclophosphamide (Cytoxan) 750 mg/m2 IV once on day 1
- Doxorubicin (Adriamycin) 50 mg/m2 IV once on day 1
- Vincristine (Oncovin) 1.4 mg/m2 (maximum dose of 2 mg) IV once on day 1
Glucocorticoid therapy
- Prednisone (Sterapred) 100 mg PO once per day on days 1 to 5
Targeted therapy
- Everolimus (Afinitor) 5 mg PO once per day on days 1 to 14
21-day cycle for up to 6 cycles
References
- RADCHOP: Kim SJ, Shin DY, Kim JS, Yoon DH, Lee WS, Lee H, Do YR, Kang HJ, Eom HS, Ko YH, Lee SH, Yoo HY, Hong M, Suh C, Kim WS. A phase II study of everolimus (RAD001), an mTOR inhibitor plus CHOP for newly diagnosed peripheral T-cell lymphomas. Ann Oncol. 2016 Apr;27(4):712-8. link to original article contains dosing details in manuscript PubMed NCT01198665
DA-EPOCH
DA-EPOCH: Dose Adjusted Etoposide, Prednisone, Oncovin (Vincristine), Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin)
Regimen
Study | Evidence | Efficacy |
---|---|---|
Maeda et al. 2017 (West-JHOG PTCL0707) | Phase 2 | ORR: 78% (95% CI 62-89) |
Note: the authors state that they followed the Wilson et al. 2002 protocol, but there are some differences, in particular 1) it isn't clear whether prednisone is given once or twice per day; and 2) dose adjustments below level 1 are different based on age.
Chemotherapy
- Etoposide (Vepesid) 50 mg/m2/day IV continuous infusion over 96 hours, started on day 1 (total dose per cycle: 200 mg/m2)
- Vincristine (Oncovin) 0.4 mg/m2/day IV continuous infusion over 96 hours, started on day 1 (total dose per cycle: 1.6 mg/m2)
- Cyclophosphamide (Cytoxan) 750 mg/m2 IV over 2 hours once on day 5
- Doxorubicin (Adriamycin) 10 mg/m2/day IV continuous infusion over 96 hours, started on day 1 (total dose per cycle: 40 mg/m2)
Glucocorticoid therapy
- Prednisone (Sterapred) 60 mg/m2/day PO on days 1 to 5
Supportive therapy
- G-CSF starting on day 6 and continuing until ANC greater than 5000/uL past nadir
- Trimethoprim-Sulfamethoxazole (Bactrim DS) (dose not specified)
- Fluconazole (Diflucan) (dose not specified)
21-day cycle for 6 to 8 cycles
Dose modifications
- Start cycle 1 as described above.
- Obtain CBCs twice per week for nadir measurements.
- If nadir ANC greater than 500/uL, increase etoposide, doxorubicin, and cyclophosphamide by 20% compared to previous cycle.
- If nadir ANC less than 500/uL on 1 or 2 measurements, use same doses as last cycle.
- If nadir ANC less than 500/uL on at least 3 measurements, decrease etoposide, doxorubicin, and cyclophosphamide by 20% compared to previous cycle.
- And/or if nadir platelet count less than 25 x 109/L on at least 1 measurement, decrease etoposide, doxorubicin, and cyclophosphamide by 20% compared to previous cycle.
- Patients younger than 70: Dose adjustments below the cycle 1 starting dose only apply to cyclophosphamide. That is, the lowest etoposide and doxorubicin would be dosed is at the original cycle 1 dose.
- Patients 70 and older: Dose adjustments below the cycle 1 starting dose apply to all drugs
- (Presumed, based on Wilson et al. 2002): Can start new cycle every 21 days if ANC greater than 1000/uL and platelets greater than 100 x 109/L. If counts are below those levels, check daily CBC and continue growth factor support until counts are adequate and next cycle can start.
References
- Maeda Y, Nishimori H, Yoshida I, Hiramatsu Y, Uno M, Masaki Y, Sunami K, Masunari T, Nawa Y, Yamane H, Gomyo H, Takahashi T, Yano T, Matsuo K, Ohshima K, Nakamura S, Yoshino T, Tanimoto M. Dose-adjusted EPOCH chemotherapy for untreated peripheral T-cell lymphomas: a multicenter phase II trial of West-JHOG PTCL0707. Haematologica. 2017 Dec;102(12):2097-2103. Epub 2017 Sep 29. link to original article contains dosing details in manuscript PubMed UMIN000000829
DD-CHOP
DD-CHOP: Denileukin, Diftitox, Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin), Oncovin (Vincristine), Predniso(lo)ne
Regimen
Study | Evidence | Efficacy |
---|---|---|
Foss et al. 2013 (CONCEPT) | Phase 2 | ORR: 65% |
Targeted therapy
- Denileukin diftitox (Ontak) 18 mcg/kg IV over 60 minutes once per day on days 1 & 2
Chemotherapy
- Cyclophosphamide (Cytoxan) 750 mg/m2 IV once on day 3
- Doxorubicin (Adriamycin) 50 mg/m2 IV once on day 3
- Vincristine (Oncovin) 1.4 mg/m2 (maximum dose of 2 mg) IV once on day 3
Glucocorticoid therapy
- Prednisone (Sterapred) 100 mg PO once per day on days 3 to 7
Supportive therapy
- Dexamethasone (Decadron) 4 to 8 mg IV or PO once per day on days 1 & 2, prior to Denileukin diftitox (Ontak)
- Acetaminophen (Tylenol) 650 mg PO once per day on days 1 & 2, prior to Denileukin diftitox (Ontak)
- Diphenhydramine (Benadryl) 25 mg IV once per day on days 1 & 2, prior to Denileukin diftitox (Ontak)
- Normal saline 250 to 500 cc before and after each Denileukin diftitox (Ontak) infusion
- Antiemetics "per institutional standard"
- G-CSF support beginning on day 4
21-day cycle for 6 to 8 cycles
References
- CONCEPT: Foss FM, Sjak-Shie N, Goy A, Jacobsen E, Advani R, Smith MR, Komrokji R, Pendergrass K, Bolejack V. A multicenter phase II trial to determine the safety and efficacy of combination therapy with denileukin diftitox and cyclophosphamide, doxorubicin, vincristine and prednisone in untreated peripheral T-cell lymphoma: the CONCEPT study. Leuk Lymphoma. 2013 Jul;54(7):1373-9. Epub 2013 Jan 29. link to original article contains dosing details in manuscript PubMed NCT00211185
HyperCHidam
HyperCHidam: Hyperfractionated Cyclophosphamide, Hiigh-dose ara-c (Cytarabine) & methotrexate
Regimen
Study | Years of enrollment | Evidence |
---|---|---|
Corradini et al. 2014 (PTCL-06) | 2006-2010 | Phase 2 |
Note: These are the details for "Clin A" which was the regimen used for patients younger than 60. Note: this is a component of a sequential treatment protocol; to our knowledge there are no references to support using it as a stand-alone treatment.
Preceding treatment
- PTCL-06: CHOP-AL x 2
Chemotherapy
- Methotrexate (MTX) 1600 mg/m2 IV continuous infusion (duration not specified), started on day 1
- Cyclophosphamide (Cytoxan) 300 mg/m2 IV every 12 hours for 3 days (start day not specified)
- Cytarabine (Ara-C) 2000 mg/m2 IV every 12 hours for 3 days (start day not specified)
Supportive therapy
- Granulocyte-colony stimulating factor (type not specified) 5 mcg/kg once per day was given from day +5 (stop date not specified)
Duration not specified for 2 cycles
Subsequent treatment
- Responders (PR/CR): allogeneic HSCT
References
- PTCL-06: Corradini P, Vitolo U, Rambaldi A, Miceli R, Patriarca F, Gallamini A, Olivieri A, Benedetti F, Todeschini G, Rossi G, Salvi F, Bruno B, Baldini L, Ferreri A, Patti C, Tarella C, Pileri S, Dodero A. Intensified chemo-immunotherapy with or without stem cell transplantation in newly diagnosed patients with peripheral T-cell lymphoma. Leukemia. 2014 Sep;28(9):1885-91. Epub 2014 Feb 20. link to original article contains dosing details in manuscript PubMed EudraCT 2006-004234-33
Consolidation and/or maintenance after upfront therapy
BEAM, then auto HSCT
BEAM: BiCNU (Carmustine), Etoposide, Ara-C (Cytarabine), Melphalan
Regimen variant #1
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Schmitz et al. 2021 (MYS-07-HMO-CTIL) | 2011-2014 | Phase 3 (C) | Fludarabine, Busulfan, Cyclophosphamide, then allo HSCT | Did not meet primary endpoint of EFS36 |
Preceding treatment
Chemotherapy
- Carmustine (BCNU) 300 mg/m2 IV once on day -7
- Etoposide (Vepesid) 200 mg/m2 IV once per day on days -6 to -3
- Cytarabine (Ara-C) 200 mg/m2 IV every 12 hours on days -6 to -3 (total dose: 1600 mg/m2)
- Melphalan (Alkeran) 140 mg/m2 IV once on day -2
Supportive therapy
- Autologous stem cells re-infused on day 0
One course
Regimen variant #2
Study | Evidence |
---|---|
d'Amore et al. 2012 (NLG-T-01) | Non-randomized |
Chemotherapy
- Carmustine (BCNU) 300 mg/m2 IV once on day -6
- Etoposide (Vepesid) 100 mg/m2 IV every 12 hours on days -5 to -2 (total dose: 800 mg/m2)
- Cytarabine (Ara-C) 200 mg/m2 IV every 12 hours on days -5 to -2 (total dose: 1600 mg/m2)
- Melphalan (Alkeran) 140 mg/m2 IV once on day -1
Supportive therapy
- Autologous stem cells re-infused on day 0
- (described in some publications)
- Filgrastim (Neupogen) by the following weight-based criteria:
- Less than 70 kg: 300 mcg SC once per day, starting on day +7 after stem cell transplant
- More than 70 kg (reference did not clarify which dosage to use for patients who are exactly 70 kg): 480 mcg SC once per day, starting on day +7 after stem cell transplant
- Trimethoprim-Sulfamethoxazole (Bactrim DS) 160/800 mg PO twice per day on Monday and Thursdays, until 6 months after BEAM
- Ciprofloxacin (Cipro) 500 mg PO twice per day while ANC less than 500/μL
- Antifungal prophylaxis with one of the following:
- Fluconazole (Diflucan) 100 mg PO once per day while ANC less than 500/μL
- Nystatin (Mycostatin) 500,000 units swish & swallow four times per day while ANC less than 500/μL
- Acyclovir (Zovirax) 400 mg PO three times per day while ANC less than 500/μL
One course
References
- NLG-T-01: d'Amore F, Relander T, Lauritzsen GF, Jantunen E, Hagberg H, Anderson H, Holte H, Österborg A, Merup M, Brown P, Kuittinen O, Erlanson M, Østenstad B, Fagerli UM, Gadeberg OV, Sundström C, Delabie J, Ralfkiaer E, Vornanen M, Toldbod HE. Up-front autologous stem-cell transplantation in peripheral T-cell lymphoma: NLG-T-01. J Clin Oncol. 2012 Sep 1;30(25):3093-9. Epub 2012 Jul 30. link to original article contains dosing details in manuscript PubMed NCT00791947
- MYS-07-HMO-CTIL: Schmitz N, Truemper L, Bouabdallah K, Ziepert M, Leclerc M, Cartron G, Jaccard A, Reimer P, Wagner E, Wilhelm M, Sanhes L, Lamy T, de Leval L, Rosenwald A, Roussel M, Kroschinsky F, Lindemann W, Dreger P, Viardot A, Milpied N, Gisselbrecht C, Wulf G, Gyan E, Gaulard P, Bay JO, Glass B, Poeschel V, Damaj G, Sibon D, Delmer A, Bilger K, Banos A, Haenel M, Dreyling M, Metzner B, Keller U, Braulke F, Friedrichs B, Nickelsen M, Altmann B, Tournilhac O. A randomized phase 3 trial of autologous vs allogeneic transplantation as part of first-line therapy in poor-risk peripheral T-NHL. Blood. 2021 May 13;137(19):2646-2656. link to original article contains dosing details in manuscript PubMed NCT00984412
Cyclophosphamide & TBI, then auto HSCT
Cy/TBI: Cyclophosphamide & Total Body Irradiation
Regimen
Study | Evidence |
---|---|
Reimer et al. 2004 | Phase 2 |
Chemotherapy
- Cyclophosphamide (Cytoxan) 60 mg/kg IV once per day on days -3 & -2
Radiotherapy
- Total body irradiation (TBI) 1200 cGy in fractions on days –6 to –4 (pulmonary dosage was limited to 800 cGy)
Supportive therapy
- Autologous stem cells re-infused on day 0
One course
References
- Reimer P, Schertlin T, Rüdiger T, Geissinger E, Roth S, Kunzmann V, Weissinger F, Nerl C, Schmitz N, Müller-Hermelink HK, Wilhelm M. Myeloablative radiochemotherapy followed by autologous peripheral blood stem cell transplantation as first-line therapy in peripheral T-cell lymphomas: first results of a prospective multicenter study. Hematol J. 2004;5(4):304-11. link to original article PubMed
- Update: Reimer P, Rüdiger T, Geissinger E, Weissinger F, Nerl C, Schmitz N, Engert A, Einsele H, Müller-Hermelink HK, Wilhelm M. Autologous stem-cell transplantation as first-line therapy in peripheral T-cell lymphomas: results of a prospective multicenter study. J Clin Oncol. 2009 Jan 1;27(1):106-13. Epub 2008 Nov 24. link to original article PubMed
Radiation therapy
Regimen
Study | Years of enrollment | Evidence |
---|---|---|
Simon et al. 2010 (GOELAMS LTP95) | 1996-2002 | Non-randomized portion of RCT |
Preceding treatment
- GOELAMS LTP95: CHOP x 8 versus vVIP-rABVD
References
- GOELAMS-LTP95: Simon A, Peoch M, Casassus P, Deconinck E, Colombat P, Desablens B, Tournilhac O, Eghbali H, Foussard C, Jaubert J, Vilque JP, Rossi JF, Lucas V, Delwail V, Thyss A, Maloisel F, Milpied N, le Gouill S, Lamy T, Gressin R. Upfront VIP-reinforced-ABVD (VIP-rABVD) is not superior to CHOP/21 in newly diagnosed peripheral T cell lymphoma: results of the randomized phase III trial GOELAMS-LTP95. Br J Haematol. 2010 Oct;151(2):159-66. Epub 2010 Aug 25. link to original article contains dosing details in manuscript PubMed
TFC, then allo HSCT
TFC: Thiotepa, Fludarabine, Cyclophosphamide
Regimen
Study | Evidence |
---|---|
Corradini et al. 2002 | Non-randomized |
Corradini et al. 2014 (PTCL-06) | Phase 2 |
Details to be completed.
Preceding treatment
- PTCL-06: CHOP-AL x 2, then HyperCHidam x 2
Chemotherapy
Immunotherapy
Stem cells transfused on day 0
References
- Corradini P, Tarella C, Olivieri A, Gianni AM, Voena C, Zallio F, Ladetto M, Falda M, Lucesole M, Dodero A, Ciceri F, Benedetti F, Rambaldi A, Sajeva MR, Tresoldi M, Pileri A, Bordignon C, Bregni M. Reduced-intensity conditioning followed by allografting of hematopoietic cells can produce clinical and molecular remissions in patients with poor-risk hematologic malignancies. Blood. 2002 Jan 1;99(1):75-82. link to original article PubMed
- PTCL-06: Corradini P, Vitolo U, Rambaldi A, Miceli R, Patriarca F, Gallamini A, Olivieri A, Benedetti F, Todeschini G, Rossi G, Salvi F, Bruno B, Baldini L, Ferreri A, Patti C, Tarella C, Pileri S, Dodero A. Intensified chemo-immunotherapy with or without stem cell transplantation in newly diagnosed patients with peripheral T-cell lymphoma. Leukemia. 2014 Sep;28(9):1885-91. Epub 2014 Feb 20. link to original article contains dosing details in manuscript PubMed EudraCT 2006-004234-33
Relapsed or refractory, randomized data
DHAP
DHAP: Dexamethasone, High-dose Ara-C (Cytarabine), Platinol (Cisplatin)
Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Crump et al. 2014 (NCIC-CTG LY.12) | 2003-2011 | Phase 3 (C) | GDP | Inconclusive whether non-inferior ORR1 |
1Reported efficacy is based on the 2017 subgroup analysis.
Chemotherapy
- Cytarabine (Ara-C) 2000 mg/m2 IV over 3 hours every 12 hours on day 2 (total dose per cycle: 4000 mg/m2)
- Cisplatin (Platinol) 100 mg/m2 IV continuous infusion over 24 hours, started on day 1
Glucocorticoid therapy
- Dexamethasone (Decadron) 40 mg PO once per day on days 1 to 4
21-day cycle for up to 3 cycles
References
- NCIC-CTG LY.12: Crump M, Kuruvilla J, Couban S, MacDonald DA, Kukreti V, Kouroukis CT, Rubinger M, Buckstein R, Imrie KR, Federico M, Di Renzo N, Howson-Jan K, Baetz T, Kaizer L, Voralia M, Olney HJ, Turner AR, Sussman J, Hay AE, Djurfeldt MS, Meyer RM, Chen BE, Shepherd LE. Randomized comparison of gemcitabine, dexamethasone, and cisplatin versus dexamethasone, cytarabine, and cisplatin chemotherapy before autologous stem-cell transplantation for relapsed and refractory aggressive lymphomas: NCIC-CTG LY.12. J Clin Oncol. 2014 Nov 1;32(31):3490-6. Epub 2014 Sep 29. link to original article contains dosing details in manuscript PubMed NCT00078949
- Subgroup analysis: Skamene T, Crump M, Savage KJ, Reiman T, Kuruvilla J, Good D, LeBrun D, Meyer RM, Sehn LH, Soulières D, Stakiw J, Laferriere N, Luminari S, Shepherd LE, Djurfeldt M, Zhu L, Chen BE, Hay AE. Salvage chemotherapy and autologous stem cell transplantation for peripheral T-cell lymphoma: a subset analysis of the Canadian Cancer Trials Group LY.12 randomized phase 3 study(). Leuk Lymphoma. 2017 Oct;58(10):2319-2327. Epub 2017 May 15. link to original article PubMed
GDP
GDP: Gemcitabine, Dexamethasone, Platinol (Cisplatin)
Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Crump et al. 2014 (NCIC-CTG LY.12) | 2003-2011 | Phase 3 (E-switch-ic) | DHAP | Inconclusive whether non-inferior ORR1 |
1Reported efficacy is based on the 2017 subgroup analysis.
Chemotherapy
- Gemcitabine (Gemzar) 1000 mg/m2 IV once per day on days 1 & 8
- Cisplatin (Platinol) 75 mg/m2 IV once on day 1
Glucocorticoid therapy
- Dexamethasone (Decadron) 40 mg PO once per day on days 1 to 4
21-day cycle for up to 3 cycles
References
- NCIC-CTG LY.12: Crump M, Kuruvilla J, Couban S, MacDonald DA, Kukreti V, Kouroukis CT, Rubinger M, Buckstein R, Imrie KR, Federico M, Di Renzo N, Howson-Jan K, Baetz T, Kaizer L, Voralia M, Olney HJ, Turner AR, Sussman J, Hay AE, Djurfeldt MS, Meyer RM, Chen BE, Shepherd LE. Randomized comparison of gemcitabine, dexamethasone, and cisplatin versus dexamethasone, cytarabine, and cisplatin chemotherapy before autologous stem-cell transplantation for relapsed and refractory aggressive lymphomas: NCIC-CTG LY.12. J Clin Oncol. 2014 Nov 1;32(31):3490-6. Epub 2014 Sep 29. link to original article contains dosing details in manuscript PubMed NCT00078949
- Subgroup analysis: Skamene T, Crump M, Savage KJ, Reiman T, Kuruvilla J, Good D, LeBrun D, Meyer RM, Sehn LH, Soulières D, Stakiw J, Laferriere N, Luminari S, Shepherd LE, Djurfeldt M, Zhu L, Chen BE, Hay AE. Salvage chemotherapy and autologous stem cell transplantation for peripheral T-cell lymphoma: a subset analysis of the Canadian Cancer Trials Group LY.12 randomized phase 3 study(). Leuk Lymphoma. 2017 Oct;58(10):2319-2327. Epub 2017 May 15. link to original article PubMed
Gemcitabine monotherapy
Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
O'Connor et al. 2019 (LUMIERE) | 2012-2014 | Phase 3 (C) | Alisertib | Did not meet primary endpoints of ORR/PFS |
Note: to our knowledge, this regimen was not tested as an experimental arm in an RCT in this context, prior to becoming a standard comparator arm.
References
- LUMIERE: O'Connor OA, Özcan M, Jacobsen ED, Roncero JM, Trotman J, Demeter J, Masszi T, Pereira J, Ramchandren R, Beaven A, Caballero D, Horwitz SM, Lennard A, Turgut M, Hamerschlak N, d'Amore FA, Foss F, Kim WS, Leonard JP, Zinzani PL, Chiattone CS, Hsi ED, Trümper L, Liu H, Sheldon-Waniga E, Ullmann CD, Venkatakrishnan K, Leonard EJ, Shustov AR; Lumiere Study Investigators. Randomized phase III study of alisertib or investigator's choice (selected single agent) in patients with relapsed or refractory peripheral T-cell lymphoma. J Clin Oncol. 2019 Mar 10;37(8):613-623. Epub 2019 Feb 1. link to original article contains dosing details in abstract PubMed NCT01482962
Pralatrexate monotherapy
Example orders
Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
O'Connor et al. 2011 (PROPEL) | 2006-2008 | Phase 2 (RT) | ORR: 29% | |
O'Connor et al. 2019 (LUMIERE) | 2012-2014 | Phase 3 (C) | Alisertib | Did not meet primary endpoints of ORR/PFS |
Note: to our knowledge, this regimen was not tested as an experimental arm in an RCT in this context, prior to becoming a standard comparator arm.
Chemotherapy
- Pralatrexate (Folotyn) 30 mg/m2 IV over 3 to 5 minutes once per day on days 1, 8, 15, 22, 29, 36
Supportive therapy
- Cyanocobalamin (Vitamin B12) 1 mg IM once every 8 to 10 weeks
- Folic acid (Folate) 1 to 1.25 mg PO once per day
- "Elevated methylmalonic acid (greater than 200 nmol/L) and/or homocysteine (greater than 10 µmol/L) at screening required initiation of Folic acid (Folate) and Cyanocobalamin (Vitamin B12) at least 10 days before the first dose of Pralatrexate (Folotyn)."
7-week cycles
References
- PROPEL: O'Connor OA, Pro B, Pinter-Brown L, Bartlett N, Popplewell L, Coiffier B, Lechowicz MJ, Savage KJ, Shustov AR, Gisselbrecht C, Jacobsen E, Zinzani PL, Furman R, Goy A, Haioun C, Crump M, Zain JM, Hsi E, Boyd A, Horwitz S. Pralatrexate in patients with relapsed or refractory peripheral T-cell lymphoma: results from the pivotal PROPEL study. J Clin Oncol. 2011 Mar 20;29(9):1182-9. Epub 2011 Jan 18. link to original article contains dosing details in manuscript link to PMC article PubMed NCT00364923
- LUMIERE: Connor OA, Özcan M, Jacobsen ED, Roncero JM, Trotman J, Demeter J, Masszi T, Pereira J, Ramchandren R, Beaven A, Caballero D, Horwitz SM, Lennard A, Turgut M, Hamerschlak N, d'Amore FA, Foss F, Kim WS, Leonard JP, Zinzani PL, Chiattone CS, Hsi ED, Trümper L, Liu H, Sheldon-Waniga E, Ullmann CD, Venkatakrishnan K, Leonard EJ, Shustov AR; Lumiere Study Investigators. Randomized phase III study of alisertib or investigator's choice (selected single agent) in patients with relapsed or refractory peripheral T-cell lymphoma. J Clin Oncol. 2019 Mar 10;37(8):613-623. Epub 2019 Feb 1. link to original article contains dosing details in abstract PubMed NCT01482962
Relapsed or refractory, non-randomized or retrospective data
Belinostat monotherapy
Regimen
Study | Years of enrollment | Evidence | Efficacy |
---|---|---|---|
Foss et al. 2014 (PXD101-CLN-6) | 2006-2009 | Phase 2 | ORR: 25% |
O'Connor et al. 2015 (BELIEF) | 2009-2011 | Phase 2 (RT) | ORR: 26% |
Targeted therapy
- Belinostat (Beleodaq) 1000 mg/m2 IV over 30 minutes once per day on days 1 to 5
21-day cycles
References
- PXD101-CLN-6: Foss F, Advani R, Duvic M, Hymes KB, Intragumtornchai T, Lekhakula A, Shpilberg O, Lerner A, Belt RJ, Jacobsen ED, Laurent G, Ben-Yehuda D, Beylot-Barry M, Hillen U, Knoblauch P, Bhat G, Chawla S, Allen LF, Pohlman B. A phase II trial of belinostat (PXD101) in patients with relapsed or refractory peripheral or cutaneous T-cell lymphoma. Br J Haematol. 2015 Mar;168(6):811-9. Epub 2014 Nov 17. link to original article contains dosing details in abstract PubMed NCT00274651
- BELIEF: O'Connor OA, Horwitz S, Masszi T, Van Hoof A, Brown P, Doorduijn J, Hess G, Jurczak W, Knoblauch P, Chawla S, Bhat G, Choi MR, Walewski J, Savage K, Foss F, Allen LF, Shustov A. Belinostat in patients with relapsed or refractory peripheral T-cell lymphoma: results of the pivotal phase II BELIEF (CLN-19) study. J Clin Oncol. 2015 Aug 10;33(23):2492-9. Epub 2015 Jun 22. link to original article contains dosing details in manuscript link to PMC article PubMed NCT00865969
Bendamustine monotherapy
Regimen
Study | Years of enrollment | Evidence | Efficacy |
---|---|---|---|
Demaj et al. 2013 (BENTLY) | 2009-2011 | Phase 2 | ORR: 50% |
References
- BENTLY: Damaj G, Gressin R, Bouabdallah K, Cartron G, Choufi B, Gyan E, Banos A, Jaccard A, Park S, Tournilhac O, Schiano-de Collela JM, Voillat L, Joly B, Le Gouill S, Saad A, Cony-Makhoul P, Vilque JP, Sanhes L, Schmidt-Tanguy A, Bubenheim M, Houot R, Diouf M, Marolleau JP, Béné MC, Martin A, Lamy T. Results from a prospective, open-label, phase II trial of bendamustine in refractory or relapsed T-cell lymphomas: the BENTLY trial. J Clin Oncol. 2013 Jan 1;31(1):104-10. Epub 2012 Oct 29. link to original article contains dosing details in manuscript PubMed NCT00959686
Brentuximab vedotin monotherapy
Regimen
Study | Evidence | Efficacy |
---|---|---|
Horwitz et al. 2014 (SGN35-012) | Phase 2 | ORR: 41% |
Antibody-drug conjugate therapy
- Brentuximab vedotin (Adcetris) 1.8 mg/kg IV once on day 1
21-day cycles
References
- SGN35-012: Horwitz SM, Advani RH, Bartlett NL, Jacobsen ED, Sharman JP, O'Connor OA, Siddiqi T, Kennedy DA, Oki Y. Objective responses in relapsed T-cell lymphomas with single-agent brentuximab vedotin. Blood. 2014 May 15;123(20):3095-100. Epub 2014 Mar 20. link to original article contains dosing details in manuscript link to PMC article PubMed NCT01421667
Chidamide monotherapy
Regimen
Study | Evidence | Efficacy |
---|---|---|
Shi et al. 2015 | Phase 2 | ORR: 28% |
References
- Shi Y, Dong M, Hong X, Zhang W, Feng J, Zhu J, Yu L, Ke X, Huang H, Shen Z, Fan Y, Li W, Zhao X, Qi J, Huang H, Zhou D, Ning Z, Lu X. Results from a multicenter, open-label, pivotal phase II study of chidamide in relapsed or refractory peripheral T-cell lymphoma. Ann Oncol. 2015 Aug;26(8):1766-71. Epub 2015 Jun 23. link to original article contains dosing details in abstract PubMed
Forodesine monotherapy
Regimen
Study | Evidence | Efficacy |
---|---|---|
Maruyama et al. 2018 (FDS-J02) | Phase 1/2 | ORR: 22% |
References
- FDS-J02: Maruyama D, Tsukasaki K, Uchida T, Maeda Y, Shibayama H, Nagai H, Kurosawa M, Suehiro Y, Hatake K, Ando K, Yoshida I, Hidaka M, Murayama T, Okitsu Y, Tsukamoto N, Taniwaki M, Suzumiya J, Tamura K, Yamauchi T, Ueda R, Tobinai K. Multicenter phase 1/2 study of forodesine in patients with relapsed peripheral T cell lymphoma. Ann Hematol. 2019 Jan;98(1):131-142. Epub 2018 Jul 5. Erratum in: Ann Hematol. 2018 Jul 27. link to original article contains dosing details in abstract link to PMC article PubMed NCT01776411
Lenalidomide monotherapy
Regimen variant #1, limited duration
Study | Evidence | Efficacy |
---|---|---|
Morschhauser et al. 2013 (EXPECT) | Phase 2 | ORR: 41% |
Targeted therapy
- Lenalidomide (Revlimid) 25 mg PO once per day on days 1 to 21
28-day cycle for up to 26 cycles (2 years)
Regimen variant #2, indefinite
Study | Evidence | Efficacy |
---|---|---|
Dueck et al. 2010 | Phase 2 | ORR: 30% |
References
- Dueck G, Chua N, Prasad A, Finch D, Stewart D, White D, van der Jagt R, Johnston J, Belch A, Reiman T. Interim report of a phase 2 clinical trial of lenalidomide for T-cell non-Hodgkin lymphoma. Cancer. 2010 Oct 1;116(19):4541-8. link to original article contains dosing details in manuscript PubMed
- Update: Toumishey E, Prasad A, Dueck G, Chua N, Finch D, Johnston J, van der Jagt R, Stewart D, White D, Belch A, Reiman T. Final report of a phase 2 clinical trial of lenalidomide monotherapy for patients with T-cell lymphoma. Cancer. 2015 Mar 1;121(5):716-23. Epub 2014 Oct 29. link to original article PubMed
- EXPECT: Morschhauser F, Fitoussi O, Haioun C, Thieblemont C, Quach H, Delarue R, Glaisner S, Gabarre J, Bosly A, Lister J, Li J, Coiffier B. A phase 2, multicentre, single-arm, open-label study to evaluate the safety and efficacy of single-agent lenalidomide (Revlimid®) in subjects with relapsed or refractory peripheral T-cell non-Hodgkin lymphoma: The EXPECT trial. Eur J Cancer. 2013 Sep;49(13):2869-76. Epub 2013 May 31. link to original article contains dosing details in abstract PubMed
Mogamulizumab monotherapy
Regimen
Study | Evidence |
---|---|
Ogura et al. 2014 (KW-0761-004) | Phase 2 |
Targeted therapy
- Mogamulizumab (Poteligeo) 1 mg/kg IV once per day on days 1, 8, 15, 22
28-day cycle for 2 cycles
References
- KW-0761-004: Ogura M, Ishida T, Hatake K, Taniwaki M, Ando K, Tobinai K, Fujimoto K, Yamamoto K, Miyamoto T, Uike N, Tanimoto M, Tsukasaki K, Ishizawa K, Suzumiya J, Inagaki H, Tamura K, Akinaga S, Tomonaga M, Ueda R. Multicenter phase II study of mogamulizumab (KW-0761), a defucosylated anti-cc chemokine receptor 4 antibody, in patients with relapsed peripheral T-cell lymphoma and cutaneous T-cell lymphoma. J Clin Oncol. 2014 Apr 10;32(11):1157-63. Epub 2014 Mar 10. link to original article contains dosing details in abstract PubMed NCT01192984
Consolidation after salvage therapy
FluBuCy, then allo HSCT
FluBuCy: Fludarabine, Busulfan, Cyclophosphamide
Regimen
Study | Evidence |
---|---|
Glass et al. 2014 (DSHNHL R3) | Phase 2 |
Chemotherapy
- Fludarabine (Fludara) 25 mg/m2/day IV on days -8 to -4
- Busulfan (Myleran) 4 mg/kg/day PO on days -6 to -4
- Cyclophosphamide (Cytoxan) 60 mg/kg/day IV on days -3 and -2
Immunotherapy
- Allogeneic stem cells transfused on day 0
GVHD prophylaxis
- Antithymocyte globulin, rabbit ATG (Thymoglobulin) 2 mg/kg IV from day -3 to -1 (unclear if this is a total dose or a daily dose)
- Option also to use ATG-Fresenius S at a higher dose of 10 mg/kg
- Tacrolimus (Prograf) 8 to 12 mcg/L (route/frequency not specified) starting on day -1, tapered from day +100 in absence of GVHD
- Mycophenolate mofetil (CellCept) 1000 mg (route not specified) twice per day from day +1 to +28
One course
Immunotherapy
Stem cells transfused on day 0
References
- DSHNHL R3: Glass B, Hasenkamp J, Wulf G, Dreger P, Pfreundschuh M, Gramatzki M, Silling G, Wilhelm C, Zeis M, Görlitz A, Pfeiffer S, Hilgers R, Truemper L, Schmitz N; German High-Grade Lymphoma Study Group. Rituximab after lymphoma-directed conditioning and allogeneic stem-cell transplantation for relapsed and refractory aggressaive non-Hodgkin lymphoma (DSHNHL R3): an open-label, randomised, phase 2 trial. Lancet Oncol. 2014 Jun;15(7):757-66. Epub 2014 May 11. link to original article link to original protocol (in German) contains dosing details in manuscript PubMed NCT00785330
Investigational agents
These are drugs under study or approved outside of the United States, with at least some promising results for this disease.