Cutaneous T-cell lymphoma

16 regimens on this page 19 variants on this page

Guidelines

ESMO

• 2018: Willemze et al. Primary cutaneous lymphomas: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up

NCCN

• NCCN Guidelines - Primary Cutaneous Lymphomas
• NCCN Guidelines - T-cell Lymphomas

Upfront therapy

PUVA

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PUVA: Psoralen & Ultra-Violet A

Regimen

Study	Evidence	Comparator	Comparative Efficacy
Edelson et al. 1987	Non-randomized
Whittaker et al. 2012 (EORTC 21011)	Phase III (C)	PUVA & Bexarotene	Seems not superior

Note: to our knowledge, this regimen was not tested as an experimental arm in an RCT prior to becoming a standard comparator arm.

Chemotherapy

• PUVA (see papers for details)

References

1. Edelson R, Berger C, Gasparro F, Jegasothy B, Heald P, Wintroub B, Vonderheid E, Knobler R, Wolff K, Plewig G, McKiernan G, Christiansen I, Oster M, Honigsmann H, Wilford H, Kokoschka E, Rehle T, Perez M, Stingl G, Laroche L. Treatment of cutaneous T-cell lymphoma by extracorporeal photochemotherapy: preliminary results. N Engl J Med. 1987 Feb 5;316(6):297-303. link to original article PubMed
2. EORTC 21011: Whittaker S, Ortiz P, Dummer R, Ranki A, Hasan B, Meulemans B, Gellrich S, Knobler R, Stadler R, Karrasch M. Efficacy and safety of bexarotene combined with psoralen-ultraviolet A (PUVA) compared with PUVA treatment alone in stage IB-IIA mycosis fungoides: final results from the EORTC Cutaneous Lymphoma Task Force phase III randomized clinical trial (NCT00056056). Br J Dermatol. 2012 Sep;167(3):678-87. link to original article PubMed

Topical therapy

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Regimen

Study	Evidence	Comparator	Comparative Efficacy
Kaye et al. 1989	Randomized, >20 pts	CAV-E & RT	Seems not superior

Usually consists of high-dose topical steroids or nitrogen mustards; see paper for details.

References

1. Kaye FJ, Bunn PA Jr, Steinberg SM, Stocker JL, Ihde DC, Fischmann AB, Glatstein EJ, Schechter GP, Phelps RM, Foss FM, Parlette HL, Anderson MJ, Sausville EA. A randomized trial comparing combination electron-beam radiation and chemotherapy with topical therapy in the initial treatment of mycosis fungoides. N Engl J Med. 1989 Dec 28;321(26):1784-90. link to original article PubMed

Relapsed or refractory

Alemtuzumab monotherapy

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Regimen

Study	Evidence	Efficacy
Lundin et al. 2003	Phase II	ORR: 55%

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-week course

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 monotherapy

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Regimen

Study	Evidence	Efficacy
Foss et al. 2014	Phase II	ORR: 14%

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 monotherapy

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Regimen

Study	Evidence	Efficacy
Demaj et al. 2013 (BENTLY)	Phase II	ORR: 50%

Chemotherapy

• Bendamustine 120 mg/m² IV once per day on days 1 & 2

21-day cycle for 6 cycles

References

1. 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 verified protocol PubMed

Bexarotene monotherapy

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Variant #1, 48 weeks

Study	Evidence	Comparator	Comparative Efficacy
Prince et al. 2017 (ALCANZA)	Phase III (C)	Brentuximab vedotin	Inferior OGRR at 4 months

This dose is considered the target dose in ALCANZA.

Chemotherapy

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

48-week course

Variant #2, indefinite

Study	Evidence	Comparator	Comparative Efficacy
Duvic et al. 2001a	Phase II (RT)		ORR: 55%
Duvic et al. 2001b	Phase II/III (E-RT)	Bexarotene; 6.5 mg/m2/d	Superior ORR

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

Chemotherapy

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

Continued indefinitely

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
3. ALCANZA: Prince HM, Kim YH, Horwitz SM, Dummer R, Scarisbrick J, Quaglino P, Zinzani PL, Wolter P, Sanches JA, Ortiz-Romero PL, Akilov OE, Geskin L, Trotman J, Taylor K, Dalle S, Weichenthal M, Walewski J, Fisher D, Dréno B, Stadler R, Feldman T, Kuzel TM, Wang Y, Palanca-Wessels MC, Zagadailov E, Trepicchio WL, Zhang W, Lin HM, Liu Y, Huebner D, Little M, Whittaker S, Duvic M; ALCANZA study group. Brentuximab vedotin or physician's choice in CD30-positive cutaneous T-cell lymphoma (ALCANZA): an international, open-label, randomised, phase 3, multicentre trial. Lancet. 2017 Aug 5;390(10094):555-566. Epub 2017 Jun 7. link to original article contains verified protocol PubMed

Bexarotene & Pralatrexate

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Regimen

Study	Evidence	Efficacy
Duvic et al. 2017	Phase I/II	ORR: 60%

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

28-day 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	Comparator	Comparative Efficacy
Kim et al. 2015 (SU-06212011-7946)	Phase II		OGRR: 70% (90% CI, 53-83)
Duvic et al. 2015	Phase II		ORR: 73% (95% CI, 60-86)
Prince et al. 2017 (ALCANZA)	Phase III (E-RT)	Investigator's choice of: 1. Bexarotene 2. Methotrexate	Superior OGRR at 4 months

Chemotherapy

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

21-day cycle for up to 16 cycles

References

1. SU-06212011-7946: 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
3. ALCANZA: Prince HM, Kim YH, Horwitz SM, Dummer R, Scarisbrick J, Quaglino P, Zinzani PL, Wolter P, Sanches JA, Ortiz-Romero PL, Akilov OE, Geskin L, Trotman J, Taylor K, Dalle S, Weichenthal M, Walewski J, Fisher D, Dréno B, Stadler R, Feldman T, Kuzel TM, Wang Y, Palanca-Wessels MC, Zagadailov E, Trepicchio WL, Zhang W, Lin HM, Liu Y, Huebner D, Little M, Whittaker S, Duvic M; ALCANZA study group. Brentuximab vedotin or physician's choice in CD30-positive cutaneous T-cell lymphoma (ALCANZA): an international, open-label, randomised, phase 3, multicentre trial. Lancet. 2017 Aug 5;390(10094):555-566. Epub 2017 Jun 7. link to original article contains verified protocol PubMed

Denileukin diftitox monotherapy

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Regimen

Study	Evidence	Comparator	Comparative Efficacy
Olsen et al. 2001 (L4389-10)	Phase III (E-RT)	Denileukin diftitox; 9 mcg/kg	Seems not superior
Prince et al. 2010 (L4389-11)	Phase III (E-RT)	1. Denileukin diftitox; 9 mcg/kg	Superior ORR
		2. Placebo	Superior PFS

Note: Dose is that which was recommended in L4389-11 based on superior response. Up to 3 additional cycles allowed in L4389-10 for patients who had ongoing 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 (see note)

References

1. L4389-10: 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. L4389-11: 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. 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	Efficacy
Querfeld et al. 2013	Phase II	ORR: 28%

Chemotherapy

• Lenalidomide (Revlimid) as follows:
  • Cycle 1: 10 mg PO once per day on days 1 to 21
  • Cycle 2, if tolerated: 15 mg PO once per day on days 1 to 21
  • Cycle 3, if tolerated: 20 mg PO once per day on days 1 to 21
  • Cycle 4 onwards, if tolerated: 25 mg PO once per day on days 1 to 21

28-day cycle for up to 26 cycles (2 years)

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

Methotrexate monotherapy

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Regimen

Study	Evidence	Comparator	Comparative Efficacy
Prince et al. 2017 (ALCANZA)	Phase III (C)	Brentuximab vedotin	Inferior OGRR at 4 months

Note: to our knowledge, this regimen was not tested as an experimental arm in an RCT prior to becoming a standard comparator arm.

Chemotherapy

• Methotrexate (MTX) 5 to 50 mg PO once per day on days 1, 8, 15, 22

28-day cycle for 12 cycles

References

1. Retrospective: Zackheim HS, Kashani-Sabet M, McMillan A. Low-dose methotrexate to treat mycosis fungoides: a retrospective study in 69 patients. J Am Acad Dermatol. 2003 Nov;49(5):873-8. link to original article PubMed
2. ALCANZA: Prince HM, Kim YH, Horwitz SM, Dummer R, Scarisbrick J, Quaglino P, Zinzani PL, Wolter P, Sanches JA, Ortiz-Romero PL, Akilov OE, Geskin L, Trotman J, Taylor K, Dalle S, Weichenthal M, Walewski J, Fisher D, Dréno B, Stadler R, Feldman T, Kuzel TM, Wang Y, Palanca-Wessels MC, Zagadailov E, Trepicchio WL, Zhang W, Lin HM, Liu Y, Huebner D, Little M, Whittaker S, Duvic M; ALCANZA study group. Brentuximab vedotin or physician's choice in CD30-positive cutaneous T-cell lymphoma (ALCANZA): an international, open-label, randomised, phase 3, multicentre trial. Lancet. 2017 Aug 5;390(10094):555-566. Epub 2017 Jun 7. link to original article contains verified protocol PubMed

Mogamulizumab monotherapy

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Variant #1, 8-week course

Study	Evidence
Ogura et al. 2014 (KW-0761-004)	Phase II

Chemotherapy

• Mogamulizumab (Poteligeo) 1 mg/kg IV once per day on days 1, 8, 15, 22

28-day cycle for 2 cycles

Variant #2, indefinite

FDA-recommended dose

Study	Evidence	Comparator	Comparative Efficacy
Duvic et al. 2015 (KW-0761-001)	Phase I/II
Kim et al. 2018 (MAVORIC)	Phase III (E-RT)	Vorinostat	Superior PFS

Note: in KW-0761-001, a two-week "period of observation" was undertaken after cycle 1.

Chemotherapy

• Mogamulizumab (Poteligeo) as follows:
  • Cycle 1: 1 mg/kg IV once per day on days 1, 8, 15, 22
  • Subsequent cycles: 1 mg/kg IV once per day on days 1 & 15

28-day cycles

References

1. 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 protocol PubMed
2. KW-0761-001: Duvic M, Pinter-Brown LC, Foss FM, Sokol L, Jorgensen JL, Challagundla P, Dwyer KM, Zhang X, Kurman MR, Ballerini R, Liu L, Kim YH. Phase 1/2 study of mogamulizumab, a defucosylated anti-CCR4 antibody, in previously treated patients with cutaneous T-cell lymphoma. Blood. 2015 Mar 19;125(12):1883-9. Epub 2015 Jan 20. link to original article contains protocol PubMed
3. MAVORIC: Kim YH, Bagot M, Pinter-Brown L, Rook AH, Porcu P, Horwitz SM, Whittaker S, Tokura Y, Vermeer M, Zinzani PL, Sokol L, Morris S, Kim EJ, Ortiz-Romero PL, Eradat H, Scarisbrick J, Tsianakas A, Elmets C, Dalle S, Fisher DC, Halwani A, Poligone B, Greer J, Fierro MT, Khot A, Moskowitz AJ, Musiek A, Shustov A, Pro B, Geskin LJ, Dwyer K, Moriya J, Leoni M, Humphrey JS, Hudgens S, Grebennik DO, Tobinai K, Duvic M; MAVORIC Investigators. Mogamulizumab versus vorinostat in previously treated cutaneous T-cell lymphoma (MAVORIC): an international, open-label, randomised, controlled phase 3 trial. Lancet Oncol. 2018 Sep;19(9):1192-1204. Epub 2018 Aug 9. link to original article contains protocol PubMed

Placebo

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Regimen

Study	Evidence	Comparator	Comparative Efficacy
Prince et al. 2010 (L4389-11)	Phase III (C)	Denileukin diftitox	Inferior PFS

References

1. L4389-11: 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

Pralatrexate monotherapy

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Regimen

Study	Evidence	Efficacy
Horwitz et al. 2012	Phase II	RR: 45%

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

28-day cycles

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 monotherapy

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Regimen

Study	Evidence	Efficacy
Piekarz et al. 2009	Phase II (RT)	ORR: 34% (95% CI, 23-46)
Whittaker et al. 2010 (GPI-04-0001)	Phase II (RT)	ORR: 34% (95% CI, 25-45)

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; optional extension of treatment for patients with SD or better

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. GPI-04-0001: 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 monotherapy

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Regimen

FDA-recommended dose

Study	Evidence	Comparator	Comparative Efficacy
Duvic et al. 2006	Phase IIa (RT)		ORR: 24%
Olsen et al. 2007	Phase IIb (RT)		ORR: 30%
Kim et al. 2018 (MAVORIC)	Phase III (C)	Mogamulizumab	Inferior PFS

Note: Duvic et al. 2006 evaluated several different doses, but this is the one that "had the most favorable safety profile". To our knowledge, this regimen was not tested as an experimental arm in an RCT prior to becoming a standard comparator arm.

Chemotherapy

• Vorinostat (Zolinza) 400 mg PO once per day

Continued indefinitely

References

1. Duvic M, Talpur R, Ni X, Zhang C, Hazarika P, Kelly C, Chiao JH, Reilly JF, Ricker JL, Richon VM, Frankel SR. Phase 2 trial of oral vorinostat (suberoylanilide hydroxamic acid, SAHA) for refractory cutaneous T-cell lymphoma (CTCL). Blood. 2007 Jan 1;109(1):31-9. Epub 2006 Sep 7. Erratum in: Blood. 2007 Jun 15;109(12):5086. link to original article link to PMC article contains protocol PubMed
2. 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
   1. Update: Duvic M, Olsen EA, Breneman D, Pacheco TR, Parker S, Vonderheid EC, Abuav R, Ricker JL, Rizvi S, Chen C, Boileau K, Gunchenko A, Sanz-Rodriguez C, Geskin LJ. Evaluation of the long-term tolerability and clinical benefit of vorinostat in patients with advanced cutaneous T-cell lymphoma. Clin Lymphoma Myeloma. 2009 Dec;9(6):412-6. link to SD article PubMed
3. MAVORIC: Kim YH, Bagot M, Pinter-Brown L, Rook AH, Porcu P, Horwitz SM, Whittaker S, Tokura Y, Vermeer M, Zinzani PL, Sokol L, Morris S, Kim EJ, Ortiz-Romero PL, Eradat H, Scarisbrick J, Tsianakas A, Elmets C, Dalle S, Fisher DC, Halwani A, Poligone B, Greer J, Fierro MT, Khot A, Moskowitz AJ, Musiek A, Shustov A, Pro B, Geskin LJ, Dwyer K, Moriya J, Leoni M, Humphrey JS, Hudgens S, Grebennik DO, Tobinai K, Duvic M; MAVORIC Investigators. Mogamulizumab versus vorinostat in previously treated cutaneous T-cell lymphoma (MAVORIC): an international, open-label, randomised, controlled phase 3 trial. Lancet Oncol. 2018 Sep;19(9):1192-1204. Epub 2018 Aug 9. link to original article contains protocol PubMed

Relapsed or refractory, subsequent lines of treatment

Denileukin diftitox monotherapy

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Regimen

Study	Evidence
Duvic et al. 2012	Non-randomized

Chemotherapy

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

21-day cycle for up to 8 cycles

References

1. 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 contains protocol PubMed