Difference between revisions of "Cutaneous T-cell lymphoma"
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Revision as of 02:30, 16 November 2021
Section editor | |
---|---|
Bhagirathbhai Dholaria, MBBS Vanderbilt University Nashville, TN |
Are you looking for a regimen but can't find it here? For placebo or observational studies in this condition, please visit this page. If you still can't find it, please let us know so we can add it!
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
Upfront therapy
PUVA
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PUVA: Psoralen & Ultra-Violet A
Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Edelson et al. 1987 | NR | Non-randomized (RT) | ||
Whittaker et al. 2012 (EORTC 21011) | 2003-2010 | Phase III (C) | PUVA & Bexarotene | Did not meet primary endpoint of ORR |
Note: to our knowledge, this regimen was not tested as an experimental arm in an RCT prior to becoming a standard comparator arm.
Chemotherapy
- Methoxsalen (Uvadex) (see papers for details)
References
- 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
- 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 NCT00056056
Topical therapy
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Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
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Kaye et al. 1989 | 1979-1987 | Randomized, >20 pts | CAV-E & RT | Did not meet primary endpoint of OS60 |
Usually consists of high-dose topical steroids or nitrogen mustards; see paper for details.
References
- 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% |
Targeted therapy
- 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
- 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 (PXD101-CLN-6) | Phase II | ORR: 14% |
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 protocol PubMed NCT00274651
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
- 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 NCT00959686
Bexarotene monotherapy
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Regimen variant #1, 48 weeks
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Prince et al. 2017 (ALCANZA) | 2012-2015 | 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
Regimen variant #2, indefinite
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Duvic et al. 2001a | 1996-1998 | Phase II (RT) | ORR: 55% | |
Duvic et al. 2001b | 1997-1998 | Phase II/III (E-RT-esc) | 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
- 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
- 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
- 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 NCT01578499
Bexarotene & Pralatrexate
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Regimen
Study | Years of enrollment | Evidence | Efficacy |
---|---|---|---|
Duvic et al. 2017 (PDX-018) | 2010-2015 | 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
- PDX-018: 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 NCT01134341
Brentuximab vedotin monotherapy
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Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Kim et al. 2015 (SU-06212011-7946) | NR | Phase II | OGRR: 70% (90% CI, 53-83) | |
Duvic et al. 2015 (MDACC 2010-0914) | 2011-2013 | Phase II | ORR: 73% (95% CI, 60-86) | |
Prince et al. 2017 (ALCANZA) | 2012-2015 | Phase III (E-RT-switch-ooc) | Investigator's choice of: 1. Bexarotene 2. Methotrexate |
Superior OGRR at 4 months |
Antibody-drug conjugate therapy
- Brentuximab vedotin (Adcetris) 1.8 mg/kg IV over 30 minutes once on day 1
21-day cycle for up to 16 cycles
References
- 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 NCT01396070
- MDACC 2010-0914: 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 NCT01352520
- 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 NCT01578499
Denileukin diftitox monotherapy
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Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Olsen et al. 2001 (L4389-10) | NR | Phase III (E-RT-esc) | Denileukin diftitox; 9 mcg/kg | Did not meet primary endpoint of ORR |
Prince et al. 2010 (L4389-11) | NR | Phase III (E-RT-esc) | 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.
Targeted therapy
- 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
- 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
- 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 NCT00050999
- 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 (NU 04H5) | Phase II | ORR: 28% |
Targeted therapy
- 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
- NU 04H5: 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 NCT00466921
Methotrexate monotherapy
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Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Prince et al. 2017 (ALCANZA) | 2012-2015 | 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
- 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
- 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 NCT01578499
Mogamulizumab monotherapy
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Regimen variant #1, 8-week course
Study | Evidence |
---|---|
Ogura et al. 2014 (KW-0761-004) | Phase II |
Targeted therapy
- Mogamulizumab (Poteligeo) 1 mg/kg IV once per day on days 1, 8, 15, 22
28-day cycle for 2 cycles
Regimen variant #2, indefinite
FDA-recommended dose |
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Duvic et al. 2015 (KW-0761-001) | 2009-NR | Phase I/II | ||
Kim et al. 2018 (MAVORIC) | 2012-2016 | Phase III (E-RT-switch-ooc) | Vorinostat | Superior PFS |
Note: in KW-0761-001, a two-week "period of observation" was undertaken after cycle 1.
Targeted therapy
- 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
- 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 NCT01192984
- 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 NCT00888927
- 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 NCT01728805
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
- 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 | Years of enrollment | Evidence | Efficacy |
---|---|---|---|
Piekarz et al. 2009 (NIH 01-C-0049) | NR | Phase II (RT) | ORR: 34% (95% CI, 23-46) |
Whittaker et al. 2010 (GPI-04-0001) | 2005-2007 | Phase II (RT) | ORR: 34% (95% CI, 25-45) |
Targeted therapy
- 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
- NIH 01-C-0049: 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 NCT00020436
- 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 NCT00106431
Vorinostat monotherapy
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Regimen
FDA-recommended dose |
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Duvic et al. 2006 | NR | Phase IIa (RT) | ORR: 24% | |
Olsen et al. 2007 (Merck 0683-001) | NR | Phase IIb (RT) | ORR: 30% | |
Kim et al. 2018 (MAVORIC) | 2012-2016 | 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.
Targeted therapy
- Vorinostat (Zolinza) 400 mg PO once per day
Continued indefinitely
References
- 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
- Merck 0683-001: 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 NCT00091559
- 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 original article PubMed
- 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 NCT01728805
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
- 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