Peripheral T-cell lymphoma

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30 regimens on this page 37 variants on this page

Untreated

CHOEP-14 -> upfront autologous SCT

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CHOEP: Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Etoposide, Prednisone

Regimen, d'Amore et al. 2012 (NLG-T-01)

Phase II

Etoposide is omitted for patients older than 60 years of age.

• 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) 100 mg/m2 IV once per day on days 1 to 3
• Prednisone (Sterapred) 50 mg PO BID on days 1 to 5

14-day cycle x 6 cycles

If patients in PR or CR after three cycles, stem cells are mobilized off of cycles 5 and 6, followed by:

• BEAM or BEAC autologous stem cell transplant

References

1. 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 verified protocol PubMed

CHOP

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CHOP: Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin), Oncovin (Vincristine), Prednisone

Synonyms: CHOP-21, ACOP, CAVP, COPA, VACP, VCAP

Structured Concept: C9549 (NCI-T), C0055598 (NCI-MT/UMLS)

Regimen #1, Simon et al. 2010 (GOELAMS LTP95)

Phase III

The evaluation arm, VIP-rABVD, was not superior and is not included here.

• 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 per cycle: 2 mg) IV once on day 1
• Prednisone (Sterapred) 100 mg/m2 PO once per day on days 1 to 5

21-day cycles x 8 cycles

Radiation therapy for initial bulky disease

"Initial bulky disease": patients with "diameter =5 cm"

• Radiation therapy, 40 Gy at 1.8 Gy/day to the involved field

References

1. 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 verified protocol PubMed

Regimen #2

Study	Evidence
Reimer et al. 2004	Phase II

This study reports using CHOP but doesn't specify the doses; below is a fairly standard CHOP regimen:

• 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
• Prednisone (Sterapred) 100 mg PO once per day on days 1 to 5

21-day cycle x 4 to 6 cycles

If CR obtained after 4 cycles or at least a PR after 6 cycles, patients proceeded to autologous stem cell transplant.

References

1. 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. PubMed
   1. 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
2. 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 PubMed

DD-CHOP

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DD-CHOP: Denileukin, Diftitox, Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone

Regimen, Foss et al. 2013 (CONCEPT)

Phase II

• Denileukin diftitox (Ontak) 18 mcg/kg IV over 60 minutes once per day on days 1 & 2
• 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
• Prednisone (Sterapred) 100 mg PO once per day on days 3 to 7

Supportive medications:

• Dexamethasone (Decadron) 4 to 8 mg IV/PO prior to Denileukin diftitox (Ontak)
• Acetaminophen (Tylenol) 650 mg PO prior to Denileukin diftitox (Ontak)
• Diphenhydramine (Benadryl) 25 mg IV 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 cycles x 6 to 8 cycles

References

1. 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 verified protocol PubMed

Consolidation and/or maintenance after upfront therapy

Allogeneic stem cell transplant

To be completed. Usually reserved for younger and very fit individuals. See details about preparative regimens.

Autologous stem cell transplant

To be completed. See details about preparative regimens.

Regimen

Study	Evidence
Reimer et al. 2004	Phase II

Treatment preceded by CHOP x 4 to 6 cycles.

Patients received either DexaBEAM or ESHAP followed by autologous stem cell transplant. Details are not available with regards to the conditioning regimens.

References

1. 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. PubMed
   1. 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

Relapsed/refractory

Belinostat (Beleodaq)

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Regimen, O'Connor et al. 2013 (BELIEF); Pohlman et al. 2014

Phase II

• Belinostat (Beleodaq) 1000 mg/m2 IV over 30 minutes once per day on days 1 to 5

3-week cycles

References

1. 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) link to abstract
2. 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. 2014 Nov 17. [Epub ahead of print] link to original article contains protocol PubMed

Bendamustine (Treanda)

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Regimen, Demaj et al. 2013 (BENTLY)

Phase II

• Bendamustine (Treanda) 120 mg/m2 IV once per day over 30 to 60 minutes on days 1 & 2

3-week cycles x 6 cycles

References

1. 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 verified protocol PubMed

Brentuximab vedotin (Adcetris)

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Regimen, Horwitz et al. 2014

Phase II

• Brentuximab vedotin (Adcetris) 1.8 mg/kg IV on day 1

3-week cycle until progression or unacceptable toxicity

References

1. 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 verified protocol PubMed

DHAP

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DHAP: Dexamethasone, High-dose Ara-C (cytarabine), Platinol (cisplatin)

Regimen #1, Crump et al. 2014 (NCIC-CTG LY.12)

Phase III, <20 in this arm

• Dexamethasone (Decadron) 40 mg PO once per day on days 1 to 4
• Cytarabine (Cytosar) 2000 mg/m2 IV over 3 hours Q12H x 2 doses on day 2 (total of 2 doses)
• Cisplatin (Platinol) 100 mg/m2 IV continuous infusion over 24 hours on day 1

21-day cycles x up to 3 cycles

References

1. 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

GDP

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GDP: Gemcitabine, Dexamethasone, Platinol

Regimen #1, Crump et al. 2014 (NCIC-CTG LY.12)

Phase III, <20 in this arm

• Gemcitabine (Gemzar) 1000 mg/m2 IV once per day on days 1 & 8
• Dexamethasone (Decadron) 40 mg PO once per day on days 1 to 4
• Cisplatin (Platinol) 75 mg/m2 IV once on day 1

21-day cycles x up to 3 cycles

References

1. 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

Lenalidomide (Revlimid)

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Regimen

Study	Evidence
Dueck et al. 2010	Phase II
Morschhauser et al. 2013 (EXPECT)	Phase II

• Lenalidomide (Revlimid) 25 mg PO once per day on days 1 to 21

28-day cycles

Dueck et al. 2010 specifies indefinite duration, stopping for progression or intolerance. EXPECT specifies a treatment duration of up to 2 years.

References

1. 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 protocol PubMed
2. 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 verified protocol PubMed
   1. 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. 2014 Oct 29. [Epub ahead of print] link to original article PubMed

Pralatrexate (Folotyn)

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Example orders

• Example orders for Pralatrexate (Folotyn) in peripheral T-cell lymphoma

Regimen, O'Connor et al. 2011 (PROPEL)

Phase II

• Pralatrexate (Folotyn) 30 mg/m2 IV push over 3 to 5 minutes once per day on days 1, 8, 15, 22, 29, 36

Supportive medications:

• 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 (>200 nmol/L) and/or homocysteine (>10 µmol/L) at screening required initiation of Folic acid (Folate) and Cyanocobalamin (Vitamin B12) = 10 days before the first dose of Pralatrexate (Folotyn)."

7-week cycles, given until progression of disease, unacceptable toxicity, or patient/physician preference

References

1. 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. link to original article contains verified protocol PubMed

Romidepsin (Istodax)

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Regimen, Coiffier et al. 2012

Phase II

• Romidepsin (Istodax) 14 mg/m2 IV over 4 hours once per day on days 1, 8, 15

28-day cycles, up to 6 cycles, with optional extension of treatment for patients with stable disease or response

References

1. Coiffier B, Pro B, Prince HM, Foss F, Sokol L, Greenwood M, Caballero D, Borchmann P, Morschhauser F, Wilhelm M, Pinter-Brown L, Padmanabhan S, Shustov A, Nichols J, Carroll S, Balser J, Balser B, Horwitz S. Results from a pivotal, open-label, phase II study of romidepsin in relapsed or refractory peripheral T-cell lymphoma after prior systemic therapy. J Clin Oncol. 2012 Feb 20;30(6):631-6. Epub 2012 Jan 23. link to original article contains verified protocol PubMed
   1. Update: Coiffier B, Pro B, Prince HM, Foss F, Sokol L, Greenwood M, Caballero D, Morschhauser F, Wilhelm M, Pinter-Brown L, Padmanabhan Iyer S, Shustov A, Nielsen T, Nichols J, Wolfson J, Balser B, Horwitz S. Romidepsin for the treatment of relapsed/refractory peripheral T-cell lymphoma: pivotal study update demonstrates durable responses. J Hematol Oncol. 2014 Jan 23;7(1):11. link to original article PubMed