Cutaneous T-cell lymphoma - null regimens

The purpose of this page is to provide references to "null therapy" such as placebo and observation. These references provide further insight into the historical development of the treatment landscape. See the main CTCL page for regimens that include active anticancer treatment.

Early-stage disease

Placebo

Regimen

Study	Dates of enrollment	Evidence	Comparator	Comparative Efficacy
Kim et al. 2022 (FLASH)	2015-12 to 2020-11	Phase 3 (C)	Hypericin	Seems to have inferior cycle 1 ILRR (primary endpoint) Cycle 1 ILRR: 4% vs 16%

No active anticancer treatment.

References

1. FLASH: Kim EJ, Mangold AR, DeSimone JA, Wong HK, Seminario-Vidal L, Guitart J, Appel J, Geskin L, Lain E, Korman NJ, Zeitouni N, Nikbakht N, Dawes K, Akilov O, Carter J, Shinohara M, Kuzel TM, Piette W, Bhatia N, Musiek A, Pariser D, Kim YH, Elston D, Boh E, Duvic M, Huen A, Pacheco T, Zwerner JP, Lee ST, Girardi M, Querfeld C, Bohjanen K, Olsen E, Wood GS, Rumage A, Donini O, Haulenbeek A, Schaber CJ, Straube R, Pullion C, Rook AH, Poligone B. Efficacy and Safety of Topical Hypericin Photodynamic Therapy for Early-Stage Cutaneous T-Cell Lymphoma (Mycosis Fungoides): The FLASH Phase 3 Randomized Clinical Trial. JAMA Dermatol. 2022 Sep 1;158(9):1031-1039. link to original article link to PMC article PubMed NCT02448381

Relapsed or refractory

Placebo

Regimen

Study	Dates of enrollment	Evidence	Comparator	Comparative Efficacy
Prince et al. 2010 (L4389-11)	Not reported	Phase 3 (C)	1. Denileukin diftitox; 9 mcg/kg 2. Denileukin diftitox; 18 mcg/kg	Inferior PFS

No active anticancer treatment.

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 PubMed NCT00050999