Cutaneous T-cell lymphoma

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Relapsed/refractory

Belinostat (Beleodaq)

Regimen, Pohlman et al. 2009

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: Pohlman, Brad, Advani, Ranjana, Duvic, Madeleine, Hymes, Kenneth B., Intragumtornchai, Tanin, Lekhakula, Arnuparp, Shpilberg, Ofer, Lerner, Adam, Ben-Yehuda, Dina, beylot-Barry, Marie, Hillen, Uwe, Fagerberg, Jan, Foss, Francine M. Final Results of a Phase II Trial of Belinostat (PXD101) in Patients with Recurrent or Refractory Peripheral or Cutaneous T-Cell Lymphoma. ASH Annual Meeting Abstracts 2009 114: 920. link to abstract

Bendamustine (Treanda)

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

Bexarotene (Targretin)

Regimen, Duvic et al. 2001

Phase II

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

• 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

Brentuximab vedotin (Adcetris)

Regimen, Krathen et al. 2012

Pilot, <20 patients reported

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

3-week cycles up to 16 infusions

References

1. Abstract: Michael Krathen, MD, Uma Sundram, MD, PhD, Sameer Bashey, MD, Katherine Sutherland, C-PA, Katrin Salva, MD, Gary S Wood, MD, Ranjana H. Advani, MD, Richard T. Hoppe, MD, Sunil Reddy, MD, Randall Armstrong, Seema Nagpal, MD, Melissa Pulitzer, MD, Steven M. Horwitz, MD and Youn H. Kim, MD. Brentuximab Vedotin Demonstrates Significant Clinical Activity in Relapsed or Refractory Mycosis Fungoides with Variable CD30 Expression. ASH 2012 abstract 797 link to abstract contains verified protocol

Denileukin Diftitox (Ontak)

Regimen, Olsen et al. 2001 & Prince et al. 2010

Phase III

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

• Denileukin diftitox (Ontak) 18 mcg/kg IV over 30 to 60 minutes once per day on days 1 to 5
  • Olsen et al. 2001 & Prince et al. 2010 also investigated Denileukin diftitox (Ontak) 9 mcg/kg IV once per day on days 1 to 5. Olsen et al. 2001's Denileukin diftitox (Ontak) was given over 15 to 60 minutes.

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 x 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 (Revlimid)

Regimen

Phase II

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

28-day cycles, 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)

Regimen

Phase II

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

• 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)

Phase II

Regimen, Whittaker et al. 2010

• 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. 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)

Regimen, Olsen et al. 2007

Phase II

• Vorinostat (Zolinza) 400 mg PO once per day

Continued on drug 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