Cutaneous T-cell lymphoma

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16 regimens on this page 19 variants on this page

Guidelines

NCCN

• NCCN Guidelines - T-cell Lymphomas

Relapsed/refractory

Alemtuzumab (Campath)

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Regimen

Study	Evidence
Lundin et al. 2003	Phase II

Chemotherapy

• Alemtuzumab (Campath) as follows:
  • 3 mg IV once on day 1, then
  • Increased to 10 mg IV once as soon as infusion-related reactions tolerated, then
  • Increased to 30 mg IV once as soon as infusion-related reactions tolerated, then
  • 30 mg IV 3 days per week

Up to 12 weeks of therapy

References

1. Lundin J, Hagberg H, Repp R, Cavallin-Ståhl E, Fredén S, Juliusson G, Rosenblad E, Tjønnfjord G, Wiklund T, Osterborg A. Phase 2 study of alemtuzumab (anti-CD52 monoclonal antibody) in patients with advanced mycosis fungoides/Sezary syndrome. Blood. 2003 Jun 1;101(11):4267-72. Epub 2003 Jan 23. link to original article contains protocol PubMed

Belinostat (Beleodaq)

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Regimen

Study	Evidence
Foss et al. 2014	Phase II

Chemotherapy

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

21-day cycles

References

1. 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 protocol PubMed

Bendamustine

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Regimen

Study	Evidence
Demaj et al. 2013 (BENTLY)	Phase II

Chemotherapy

Note: these infusion instructions are for the Treanda formulation, which was discontinued on 3/31/2016.

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

3-week cycle for 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

Bexarotene (Targretin)

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Regimen

Study	Evidence
Duvic et al. 2001a	Phase II

This dose is considered the optimal starting dose by Duvic et al. 2001a.

Chemotherapy

• Bexarotene (Targretin) 300 mg/m² PO once per day

Duration not specified; presumptively until progression or intolerance

References

1. Duvic M, Hymes K, Heald P, Breneman D, Martin AG, Myskowski P, Crowley C, Yocum RC; Bexarotene Worldwide Study Group. Bexarotene is effective and safe for treatment of refractory advanced-stage cutaneous T-cell lymphoma: multinational phase II-III trial results. J Clin Oncol. 2001 May 1;19(9):2456-71. link to original article contains verified protocol PubMed
2. Duvic M, Martin AG, Kim Y, Olsen E, Wood GS, Crowley CA, Yocum RC; Worldwide Bexarotene Study Group. Phase 2 and 3 clinical trial of oral bexarotene (Targretin capsules) for the treatment of refractory or persistent early-stage cutaneous T-cell lymphoma. Arch Dermatol. 2001 May;137(5):581-93. link to original article contains verified protocol PubMed

Bexarotene & Pralatrexate

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Regimen

Study	Evidence
Duvic et al. 2017	Phase I/II

This dose is the MTD. Note that the abstract contains a typo for bexarotene dosing; the authors have been contacted.

Chemotherapy

• Bexarotene (Targretin) 150 mg/m² PO once per day
• Pralatrexate (Folotyn) 15 mg/m² IV once per day on days 1, 8, 15

4-week cycles

References

1. Duvic M, Kim YH, Zinzani PL, Horwitz SM. Results from a phase I/II open-label, dose-finding study of pralatrexate and oral bexarotene in patients with relapsed/refractory cutaneous T-cell lymphoma. Clin Cancer Res. 2017 Jul;23(14):3552-6. Epub 2017 Feb 6. link to original article contains verified protocol link to PMC article PubMed

Brentuximab vedotin monotherapy

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Regimen

Study	Evidence
Kim et al. 2015	Phase II
Duvic et al. 2015	Phase II

Chemotherapy

• Brentuximab vedotin (Adcetris) 1.8 mg/kg IV over 30 minutes once on day 1

3-week cycle for up to 16 infusions

References

1. Kim YH, Tavallaee M, Sundram U, Salva KA, Wood GS, Li S, Rozati S, Nagpal S, Krathen M, Reddy S, Hoppe RT, Nguyen-Lin A, Weng WK, Armstrong R, Pulitzer M, Advani RH, Horwitz SM. Phase II Investigator-Initiated Study of Brentuximab Vedotin in Mycosis Fungoides and Sézary Syndrome With Variable CD30 Expression Level: A Multi-Institution Collaborative Project. J Clin Oncol. 2015 Nov 10;33(32):3750-8. Epub 2015 Jul 20. link to original article contains verified protocol link to PMC article PubMed
2. Duvic M, Tetzlaff MT, Gangar P, Clos AL, Sui D, Talpur R. Results of a Phase II Trial of Brentuximab Vedotin for CD30+ Cutaneous T-Cell Lymphoma and Lymphomatoid Papulosis. J Clin Oncol. 2015 Nov 10;33(32):3759-65. Epub 2015 Aug 10. link to original article contains verified protocol link to PMC article PubMed

Denileukin Diftitox (Ontak)

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Regimen

Study	Evidence	Comparator	Efficacy
Olsen et al. 2001	Phase III	Alternate dosing (9 mcg/kg)	Seems not superior
Prince et al. 2010	Phase III	Alternate dosing (9 mcg/kg)	Superior ORR
		Placebo	Superior PFS

Dose is that which was recommended by Prince et al. 2010 based on superior response.

Chemotherapy

• Denileukin diftitox (Ontak) 18 mcg/kg IV over 15 to 60 minutes once per day on days 1 to 5

Supportive medications

• "Premedication with Acetaminophen (Tylenol) (650 mg in Olsen et al. 2001) and an antihistamine was required 30 to 60 minutes before each infusion" and could be used after infusions as needed.
• Olsen et al. 2001 used Promethazine (Phenergan) 25 mg or Prochlorperazine (Compazine) 10 mg (route/schedule not specified) as needed for nausea.
• Corticosteroid use was not allowed.

21-day cycles for up to 8 cycles

Up to 3 additional cycles allowed in the Olsen et al. 2001 trial for patients who had ongoing response.

References

1. Olsen E, Duvic M, Frankel A, Kim Y, Martin A, Vonderheid E, Jegasothy B, Wood G, Gordon M, Heald P, Oseroff A, Pinter-Brown L, Bowen G, Kuzel T, Fivenson D, Foss F, Glode M, Molina A, Knobler E, Stewart S, Cooper K, Stevens S, Craig F, Reuben J, Bacha P, Nichols J. Pivotal phase III trial of two dose levels of denileukin diftitox for the treatment of cutaneous T-cell lymphoma. J Clin Oncol. 2001 Jan 15;19(2):376-88. link to original article contains verified protocol PubMed
2. Prince HM, Duvic M, Martin A, Sterry W, Assaf C, Sun Y, Straus D, Acosta M, Negro-Vilar A. Phase III placebo-controlled trial of denileukin diftitox for patients with cutaneous T-cell lymphoma. J Clin Oncol. 2010 Apr 10;28(11):1870-7. Epub 2010 Mar 8. link to original article contains verified protocol PubMed
3. Duvic M, Martin AG, Olsen EA, Fivenson DP, Prince HM. Efficacy and safety of denileukin diftitox retreatment in patients with relapsed cutaneous T-cell lymphoma. Leuk Lymphoma. 2013 Mar;54(3):514-9. Epub 2012 Sep 3. link to original article PubMed
4. Meta-analysis: Duvic M, Geskin L, Prince HM. Duration of response in cutaneous T-cell lymphoma patients treated with denileukin diftitox: results from 3 phase III studies. Clin Lymphoma Myeloma Leuk. 2013 Aug;13(4):377-84. Epub 2013 Jun 14. link to original article PubMed

Lenalidomide monotherapy

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Regimen

Study	Evidence
Querfeld et al. 2013	Phase II

Chemotherapy

• Lenalidomide (Revlimid) 10 mg PO once per day on days 1 to 21
  • Dose increased by 5 mg per day with each cycle to a maximum of 25 mg PO once per day, as tolerated

28-day cycle for up to 2 years or until disease progression

References

1. Querfeld C, Rosen ST, Guitart J, Duvic M, Kim YH, Dusza SW, Kuzel TM. Results of an open-label multicenter phase II trial of lenalidomide monotherapy in refractory mycosis fungoides and Sezary syndrome. Blood. 2014 Feb 20;123(8):1159-66. Epub 2013 Dec 11. link to original article contains verified protocol PubMed

Pralatrexate (Folotyn)

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Regimen

Study	Evidence
Horwitz et al. 2012	Phase II

Dose is that identified as recommended based on de-escalation strategy.

Chemotherapy

• Pralatrexate (Folotyn) 15 mg/m² IV push once per day on days 1, 8, 15

Supportive medications

• Cyanocobalamin (Vitamin B12) 1 mg IM once every 8 to 10 weeks, within 10 weeks of treatment initiation
• Folic acid (Folate) 1 mg PO once per day, starting at least 10 days prior to treatment initiation

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

References

1. Horwitz SM, Kim YH, Foss F, Zain JM, Myskowski PL, Lechowicz MJ, Fisher DC, Shustov AR, Bartlett NL, Delioukina ML, Koutsoukos T, Saunders ME, O'Connor OA, Duvic M. Identification of an active, well-tolerated dose of pralatrexate in patients with relapsed or refractory cutaneous T-cell lymphoma. Blood. 2012 May 3;119(18):4115-22. Epub 2012 Mar 6. link to original article contains verified protocol PubMed

Romidepsin (Istodax)

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Regimen

Study	Evidence
Piekarz et al. 2009	Phase II
Whittaker et al. 2010	Phase II

Chemotherapy

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

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

References

1. Piekarz RL, Frye R, Turner M, Wright JJ, Allen SL, Kirschbaum MH, Zain J, Prince HM, Leonard JP, Geskin LJ, Reeder C, Joske D, Figg WD, Gardner ER, Steinberg SM, Jaffe ES, Stetler-Stevenson M, Lade S, Fojo AT, Bates SE. Phase II multi-institutional trial of the histone deacetylase inhibitor romidepsin as monotherapy for patients with cutaneous T-cell lymphoma. J Clin Oncol. 2009 Nov 10;27(32):5410-7. Epub 2009 Oct 13. link to original article contains verified protocol link to PMC article PubMed
2. Whittaker SJ, Demierre MF, Kim EJ, Rook AH, Lerner A, Duvic M, Scarisbrick J, Reddy S, Robak T, Becker JC, Samtsov A, McCulloch W, Kim YH. Final results from a multicenter, international, pivotal study of romidepsin in refractory cutaneous T-cell lymphoma. J Clin Oncol. 2010 Oct 10;28(29):4485-91. Epub 2010 Aug 9. link to original article contains verified protocol PubMed

Vorinostat (Zolinza)

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Regimen

Study	Evidence
Olsen et al. 2007	Phase II

Chemotherapy

• Vorinostat (Zolinza) 400 mg PO once per day

Continued until disease progression or intolerable toxicity

References

1. Olsen EA, Kim YH, Kuzel TM, Pacheco TR, Foss FM, Parker S, Frankel SR, Chen C, Ricker JL, Arduino JM, Duvic M. Phase IIb multicenter trial of vorinostat in patients with persistent, progressive, or treatment refractory cutaneous T-cell lymphoma. J Clin Oncol. 2007 Jul 20;25(21):3109-15. link to original article contains verified protocol PubMed

Investigational agents

These are drugs under study with at least some promising results for this disease.

• Mogamulizumab (KW-0761)