Phase 1b Study of Bexarotene With Ultra-Low Dose Total Skin Electron Beam Radiotherapy for Treating Mycosis Fungoides, a Type of Cutaneous T-Cell Lymphoma

What this Trial Is About

Researchers are evaluating the safety of combining bexarotene with total skin electron beam TSEB radiotherapy in people with mycosis fungoides MF, a common form of cutaneous T-cell lymphoma CTCL. Bexarotene, a vitamin A derivative, activates proteins that may stop the growth of cancer cells, while TSEB radiotherapy treats the entire skin surface with low-dose radiation to kill cancer cells without affecting deeper tissues. The study aims to see if using both treatments together is more effective than using them separately or one after the other. Participants start with bexarotene taken orally daily at 150 mg, increasing to 300 mg on Day 15 if tolerated. On Day 22, they receive the first cycle of TSEB radiotherapy, given as 2 Gy over two consecutive days. Safety is assessed on Day 52, with efficacy evaluations on Days 52 and 82 using global response assessments including the modified Severity Weighted Assessment Tool mSWAT. Patients with less than 70% reduction in mSWAT score may receive additional TSEB cycles of 4 Gy over two days, up to six cycles total. Treatment continues until disease progression, unacceptable side effects, physician recommendation, or study end. During the study, participants undergo safety and response evaluations including skin assessments with mSWAT scoring. The primary outcome measures the incidence of severe radiation dermatitis one month after treatment, while secondary outcomes assess overall skin response up to 82 days post-TSEB. The trial involves ongoing monitoring of treatment tolerance and disease status. Participants remain in the study until criteria for stopping treatment or study completion are met, with the expected study duration extending to March 2027.

A Study of Bexarotene Combined With Radiotherapy in People With Mycosis Fungoides