Cutaneous T-cell lymphoma - null regimens

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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.

Relapsed or refractory



Study Dates of enrollment Evidence Comparator Comparative Efficacy
Prince et al. 2010 (L4389-11) NR Phase 3 (C) 1. Denileukin diftitox; 9 mcg/kg
2. Denileukin diftitox; 18 mcg/kg
Inferior PFS

No active anticancer treatment.


  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 dosing details in manuscript PubMed NCT00050999