Difference between revisions of "Anaplastic large cell lymphoma"

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<big>'''Note: these studies were specific to ALCL or had ALCL subgroups; regimens used in [[Peripheral_T-cell_lymphoma|PTCL, NOS]] are also often used in this condition. Certain regimens have been moved to dedicated pages:
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*'''[[Anaplastic large cell lymphoma, pediatric|Pediatric ALCL]]
 
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''Note: these studies were specific to ALCL or had ALCL subgroups; regimens used in [[Peripheral_T-cell_lymphoma|PTCL, NOS]] are also often used in this condition.''
 
 
=Guidelines=
 
=Guidelines=
 
==[http://www.esmo.org/ ESMO]==
 
==[http://www.esmo.org/ ESMO]==
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===References===
 
===References===
 
# '''NCI 93-C-0133:''' Dunleavy K, Pittaluga S, Shovlin M, Roschewski M, Lai C, Steinberg SM, Jaffe ES, Wilson WH. Phase II trial of dose-adjusted EPOCH in untreated systemic anaplastic large cell lymphoma. Haematologica. 2016 Jan;101(1):e27-9. [http://www.haematologica.org/content/101/1/e27.long link to original article] '''refers to protocol in [https://www.nejm.org/doi/full/10.1056/NEJMoa1214561 Dunleavy et al. 2013]''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4697904/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/26518748 PubMed] NCT00001337
 
# '''NCI 93-C-0133:''' Dunleavy K, Pittaluga S, Shovlin M, Roschewski M, Lai C, Steinberg SM, Jaffe ES, Wilson WH. Phase II trial of dose-adjusted EPOCH in untreated systemic anaplastic large cell lymphoma. Haematologica. 2016 Jan;101(1):e27-9. [http://www.haematologica.org/content/101/1/e27.long link to original article] '''refers to protocol in [https://www.nejm.org/doi/full/10.1056/NEJMoa1214561 Dunleavy et al. 2013]''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4697904/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/26518748 PubMed] NCT00001337
 
==HOP {{#subobject:6964de|Regimen=1}}==
 
{| class="wikitable" style="float:right; margin-left: 5px;"
 
|-
 
|[[#top|back to top]]
 
|}
 
HOP: '''<u>H</u>'''ydroxydaunorubicin (Doxorubicin), '''<u>O</u>'''ncovin (Vincristine), '''<u>P</u>'''rednisone
 
<br>APO: '''<u>A</u>'''driamycin (Doxorubicin), '''<u>P</u>'''rednisone, '''<u>O</u>'''ncovin (Vincristine)
 
===Regimen {{#subobject:985a91|Variant=1}}===
 
{| class="wikitable" style="width: 40%; text-align:center;"
 
!style="width: 25%"|Study
 
!style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
|-
 
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4682366/ Alexander et al. 2014 (COG ANHL0131)]
 
| style="background-color:#91cf61" |Non-randomized portion of RCT
 
|-
 
|}
 
====Chemotherapy====
 
*[[Doxorubicin (Adriamycin)]]
 
*[[Prednisone (Sterapred)]]
 
*[[Vincristine (Oncovin)]]
 
====Subsequent treatment====
 
*APO versus APV maintenance
 
===References===
 
# '''COG ANHL0131:''' Alexander S, Kraveka JM, Weitzman S, Lowe E, Smith L, Lynch JC, Chang M, Kinney MC, Perkins SL, Laver J, Gross TG, Weinstein H. Advanced stage anaplastic large cell lymphoma in children and adolescents: results of ANHL0131, a randomized phase III trial of APO versus a modified regimen with vinblastine: a report from the children's oncology group. Pediatr Blood Cancer. 2014 Dec;61(12):2236-42. Epub 2014 Aug 23. [https://onlinelibrary.wiley.com/doi/abs/10.1002/pbc.25187 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4682366/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/25156886 PubMed] NCT00059839
 
  
 
=Relapsed or refractory, salvage therapy=
 
=Relapsed or refractory, salvage therapy=
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<!-- # 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 aggressive 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://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(14)70161-5/fulltext link to original article] [http://www.dshnhl.org/app/download/9495510598/Studienprotokoll+DSHNHL+alloFBC+final+vollst.pdf link to original protocol (in German)] '''contains verified protocol''' [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 aggressive 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://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(14)70161-5/fulltext link to original article] [http://www.dshnhl.org/app/download/9495510598/Studienprotokoll+DSHNHL+alloFBC+final+vollst.pdf link to original protocol (in German)] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/24827808 PubMed] NCT00785330
 
=Relapsed or refractory, subsequent lines of therapy=
 
==Crizotinib monotherapy {{#subobject:be5391|Regimen=1}}==
 
{| class="wikitable" style="float:right; margin-left: 5px;"
 
|-
 
|[[#top|back to top]]
 
|}
 
===Regimen {{#subobject:e9c195|Variant=1}}===
 
{| class="wikitable" style="color:white; background-color:#404040"
 
|<small>'''FDA-recommended dose'''</small>
 
|-
 
|}
 
{| class="wikitable sortable" style="width: 60%; text-align:center;"
 
!style="width: 33%"|Study
 
!style="width: 33%"|Years of enrollment
 
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
|-
 
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3730818/ Mossé et al. 2013 (ADVL0912)]
 
|2009-2012
 
| style="background-color:#91cf61" |Non-randomized (RT)
 
|-
 
|}
 
''Note: this was an expansion cohort of a phase I study.''
 
====Biomarker eligibility criteria====
 
*ALK rearrangement
 
====Targeted therapy====
 
*[[Crizotinib (Xalkori)]] 280 mg/m<sup>2</sup> PO twice per day
 
 
'''28-day cycles'''
 
 
===References===
 
# '''ADVL0912:''' Mossé YP, Lim MS, Voss SD, Wilner K, Ruffner K, Laliberte J, Rolland D, Balis FM, Maris JM, Weigel BJ, Ingle AM, Ahern C, Adamson PC, Blaney SM. Safety and activity of crizotinib for paediatric patients with refractory solid tumours or anaplastic large-cell lymphoma: a Children's Oncology Group phase 1 consortium study. Lancet Oncol. 2013 May;14(6):472-80. Epub 2013 Apr 16. [https://doi.org/10.1016/s1470-2045(13)70095-0 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3730818/ link to PMC article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/23598171 PubMed] NCT00939770
 
  
 
[[Category:Anaplastic large cell lymphoma regimens]]
 
[[Category:Anaplastic large cell lymphoma regimens]]
 
[[Category:Disease-specific pages]]
 
[[Category:Disease-specific pages]]
 
[[Category:T-cell lymphomas]]
 
[[Category:T-cell lymphomas]]

Revision as of 01:35, 10 July 2021

Section editor
Bdholaria.jpg
Bhagirathbhai Dholaria, MBBS
Vanderbilt University
Nashville, TN

Note: these studies were specific to ALCL or had ALCL subgroups; regimens used in PTCL, NOS are also often used in this condition. Certain regimens have been moved to dedicated pages:

9 regimens on this page
12 variants on this page


Guidelines

ESMO

Untreated

BV-CHP

back to top

BV-CHP: 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 III (E-RT-switch-ooc) CHOP Seems to have superior OS

Antibody-drug conjugate therapy

Chemotherapy

21-day cycle for 6 to 8 cycles

References

  1. 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 protocol link to PMC article PubMed NCT01777152

CHOEP-14

back to top

CHOEP-14: Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin), Oncovin (Vincristine), Etoposide, Prednisone every 14 days
CHOPE
VACOP

Example orders

Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy Comparative Toxicity
Pfreundschuh et al. 2004 (NHL-B1) 1993-2000 Phase III, <20 pts in this subgroup (E-esc) 1. CHOEP-21
2. CHOP-21
3. CHOP-14
Not reported by subgroup Not reported by subgroup

This regimen was used in 16 ALCL patients in the NHL-B1 trial. The authors did not report a subgroup analysis for this minority population.

Chemotherapy

Supportive medications

  • Filgrastim (Neupogen) as follows:
    • Patients less than 75 kg: 300 mcg SC once per day on days 4 to 13
    • Patients at least 75 kg: 480 mcg SC once per day on days 4 to 13

14-day cycle for 6 cycles, next cycle to start as long as WBC count is greater than 2.5 x 109/L and platelets greater than 80 x 109/L

Subsequent treatment

  • Patients with initial bulky disease (mass conglomerate at least 7.5 cm) received 36 Gy radiation therapy and to extranodal sites of disease when possible

References

  1. NHL-B1: Pfreundschuh M, Trümper L, Kloess M, Schmits R, Feller AC, Rudolph C, Reiser M, Hossfeld DK, Metzner B, Hasenclever D, Schmitz N, Glass B, Rübe C, Loeffler M; German High-Grade Non-Hodgkin's Lymphoma Study Group. Two-weekly or 3-weekly CHOP chemotherapy with or without etoposide for the treatment of young patients with good-prognosis (normal LDH) aggressive lymphomas: results of the NHL-B1 trial of the DSHNHL. Blood. 2004 Aug 1;104(3):626-33. Epub 2004 Feb 24. link to original article contains verified protocol PubMed

CHOEP-21

back to top

CHOEP-21: Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin), Oncovin (Vincristine), Etoposide, Prednisone every 21 days
CHOPE
VACOP

Example orders

Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy Comparative Toxicity
Pfreundschuh et al. 2004 (NHL-B1) 1993-2000 Phase III (E-esc) 1. CHOEP-14
2. CHOP-21
3. CHOP-14
Not reported by subgroup Not reported by subgroup

This regimen was used in 20 ALCL patients in the NHL-B1 trial. The authors did not report a subgroup analysis for this minority population.

Chemotherapy

Supportive medications

21-day cycle for 6 cycles, next cycle to start as long as WBC count is greater than 2.5 x 109/L and platelets greater than 80 x 109/L

Subsequent treatment

  • Patients with initial bulky disease (mass conglomerate at least 7.5 cm) received 36 Gy radiation therapy and to extranodal sites of disease when possible

References

  1. NHL-B1: Pfreundschuh M, Trümper L, Kloess M, Schmits R, Feller AC, Rudolph C, Reiser M, Hossfeld DK, Metzner B, Hasenclever D, Schmitz N, Glass B, Rübe C, Loeffler M; German High-Grade Non-Hodgkin's Lymphoma Study Group. Two-weekly or 3-weekly CHOP chemotherapy with or without etoposide for the treatment of young patients with good-prognosis (normal LDH) aggressive lymphomas: results of the NHL-B1 trial of the DSHNHL. Blood. 2004 Aug 1;104(3):626-33. Epub 2004 Feb 24. link to original article contains verified protocol PubMed

CHOP

back to top

CHOP: Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin), Oncovin (Vincristine), Prednisone
CHOP-21
ACOP
CAVP
COPA
VACP
VCAP

Regimen variant #1, capped vincristine

Study Years of enrollment Evidence Comparator Comparative Efficacy
Horwitz et al. 2018 (ECHELON-2) 2013-2016 Phase III (C) BV-CHP Seems to have inferior OS

Chemotherapy

21-day cycle for 6 to 8 cycles

Regimen variant #2, flat-dose vincristine

Study Years of enrollment Evidence Comparator Comparative Efficacy Comparative Toxicity
Pfreundschuh et al. 2004 (NHL-B1) 1993-2000 Phase III, <20 pts in arm (C) 1. CHOEP-21
2. CHOP-14
Not reported by subgroup Not reported by subgroup

This regimen was used in 14 ALCL patients in NHL-B1. The authors did not report a subgroup analysis for this minority population.

Chemotherapy

Supportive medications

  • At the discretion of ordering physician: Filgrastim (Neupogen) 300 mcg (for patients less than 75 kg) or 480 mcg (for patients at least 75 kg) SC once per day on days 4 to 13

21-day cycle for 6 cycles

References

  1. NHL-B1: Pfreundschuh M, Trümper L, Kloess M, Schmits R, Feller AC, Rudolph C, Reiser M, Hossfeld DK, Metzner B, Hasenclever D, Schmitz N, Glass B, Rübe C, Loeffler M; German High-Grade Non-Hodgkin's Lymphoma Study Group. Two-weekly or 3-weekly CHOP chemotherapy with or without etoposide for the treatment of young patients with good-prognosis (normal LDH) aggressive lymphomas: results of the NHL-B1 trial of the DSHNHL. Blood. 2004 Aug 1;104(3):626-33. Epub 2004 Feb 24. link to original article contains verified protocol PubMed
  2. 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 protocol link to PMC article PubMed NCT01777152

DA-EPOCH

back to top

DA-EPOCH: Dose Adjusted Etoposide, Prednisone, Oncovin (Vincristine), Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin)

Regimen

Study Evidence
Dunleavy et al. 2016 (NCI 93-C-0133ALCL) Phase II

Note: this should be considered a substudy under the master protocol NCI 93-C-0133.

Chemotherapy

Supportive medications

  • Filgrastim (Neupogen) 300 mcg SC once per day, starting on day 6 and continuing until ANC greater than 5000/uL past nadir
  • Trimethoprim-Sulfamethoxazole (Bactrim DS) 160/800 mg (or equivalent if allergic) PO once per day on 3 days per week
    • Note: It's assumed this is what the supplement for Dunleavy et al. 2013 meant by "Baxtrim (sulphametoxazole and trimethoprim)"
  • Omeprazole (Prilosec) 20 mg (or equivalent) PO once per day
  • Docusate (Colace) (dose not specified) and Sennosides (Senna) 2 tablets PO twice per day as needed for constipation
  • Lactulose 20 g PO every 6 hours as needed for constipation
  • Hepatitis B surface antigen positive patients received daily antiviral therapy until 8 weeks after completion of chemotherapy

21-day cycle for 6 to 8 cycles

Dose adjustments

  • 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 one level (20%) compared to previous cycle.
  • If nadir ANC less than 500/uL, use same doses as last cycle.
  • If nadir platelet count less than 25 x 109/L, decrease etoposide, doxorubicin, and cyclophosphamide by 20% compared to the previous cycle.

References

  1. NCI 93-C-0133: Dunleavy K, Pittaluga S, Shovlin M, Roschewski M, Lai C, Steinberg SM, Jaffe ES, Wilson WH. Phase II trial of dose-adjusted EPOCH in untreated systemic anaplastic large cell lymphoma. Haematologica. 2016 Jan;101(1):e27-9. link to original article refers to protocol in Dunleavy et al. 2013 link to PMC article PubMed NCT00001337

Relapsed or refractory, salvage therapy

Brentuximab vedotin monotherapy

back to top

Regimen variant #1, 16 cycles

Study Years of enrollment Evidence
Pro et al. 2012 (SG035-0004) 2009-2010 Phase II (RT)

Antibody-drug conjugate therapy

21-day cycle for up to 16 infusions

Regimen variant #2, bridge to transplant

Study Evidence
Gibb et al. 2012 Named Patient Programme

Antibody-drug conjugate therapy

21-day cycles until transplant

Regimen variant #3, indefinite

Study Evidence
Gopal et al. 2012 (SGN35-006) Phase II, <20 pts in subgroup

Note: SGN35-006 is a re-treatment trial; all patients were previously exposed to brentuximab vedotin. Patients who had received the 1.2 mg/kg dose on a prior trial also received that dose at re-treatment.

Antibody-drug conjugate therapy

21-day cycles

References

  1. SGN35-006: Gopal AK, Ramchandren R, O'Connor OA, Berryman RB, Advani RH, Chen R, Smith SE, Cooper M, Rothe A, Matous JV, Grove LE, Zain J. Safety and efficacy of brentuximab vedotin for Hodgkin lymphoma recurring after allogeneic stem cell transplantation. Blood. 2012 Jul 19;120(3):560-8. Epub 2012 Apr 17. link to original article contains verified protocol link to PMC article PubMed NCT01026233
    1. Update: Bartlett NL, Chen R, Fanale MA, Brice P, Gopal A, Smith SE, Advani R, Matous JV, Ramchandren R, Rosenblatt JD, Huebner D, Levine P, Grove L, Forero-Torres A. Retreatment with brentuximab vedotin in patients with CD30-positive hematologic malignancies. J Hematol Oncol. 2014 Mar 19;7:24. link to original article contains verified protocol link to PMC article PubMed
  2. SG035-0004: Pro B, Advani R, Brice P, Bartlett NL, Rosenblatt JD, Illidge T, Matous J, Ramchandren R, Fanale M, Connors JM, Yang Y, Sievers EL, Kennedy DA, Shustov A. Brentuximab vedotin (SGN-35) in patients with relapsed or refractory systemic anaplastic large-cell lymphoma: results of a phase II study. J Clin Oncol. 2012 Jun 20;30(18):2190-6. Epub 2012 May 21. link to original article contains verified protocol PubMed NCT00866047
    1. Update: Pro B, Advani R, Brice P, Bartlett NL, Rosenblatt JD, Illidge T, Matous J, Ramchandren R, Fanale M, Connors JM, Fenton K, Huebner D, Pinelli JM, Kennedy DA, Shustov A. Five-year results of brentuximab vedotin in patients with relapsed or refractory systemic anaplastic large cell lymphoma. Blood. 2017 Dec 21;130(25):2709-2717. Epub 2017 Oct 3. link to original article PubMed
  3. Gibb A, Jones C, Bloor A, Kulkarni S, Illidge T, Linton K, Radford J. Brentuximab vedotin in refractory CD30+ lymphomas: a bridge to allogeneic transplantation in approximately one quarter of patients treated on a Named Patient Programme at a single UK center. Haematologica. 2013 Apr;98(4):611-4. Epub 2012 Oct 12. link to original article contains verified protocol link to PMC article PubMed
  4. Retrospective: Gopal AK, Bartlett NL, Forero-Torres A, Younes A, Chen R, Friedberg JW, Matous JV, Shustov AR, Smith SE, Zain J, O'Meara MM, Fanale MA. Brentuximab vedotin in patients aged 60 years or older with relapsed or refractory CD30-positive lymphomas: a retrospective evaluation of safety and efficacy. Leuk Lymphoma. 2014 Oct;55(10):2328-34. Epub 2014 Feb 24. link to original article PubMed

DHAP

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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 III, <20 in this arm (C) GDP Non-inferior ORR

Chemotherapy

21-day cycle for up to 3 cycles

References

  1. 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 verified protocol PubMed NCT00078949

GDP

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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 III, <20 pts in this arm (E-switch-ic) DHAP Non-inferior ORR

Chemotherapy

21-day cycle for up to 3 cycles

References

  1. 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 verified protocol PubMed NCT00078949

Consolidation after salvage therapy

FluBuCy, then allo HSCT

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FluBuCy: Fludarabine, Busulfan, Cyclophosphamide

Regimen

Study Evidence
Glass et al. 2014 (DSHNHL R3) Phase II

Chemotherapy

Immunotherapy

GVHD prophylaxis

One course

Immunotherapy

Stem cells transfused on day 0

References

  1. 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 aggressive 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 verified protocol PubMed NCT00785330