Phase 2 Study Evaluating Safety and Effectiveness of Tofacitinib 2% Cream for Early-Stage Cutaneous T-cell Lymphoma

What this Trial Is About

Researchers are evaluating the safety and effectiveness of tofacitinib 2% cream for treating early-stage Cutaneous T-cell Lymphoma CTCL in stages IA, IB, and IIA. The study focuses on how well the cream works on skin lesions and its safety profile. It also aims to understand the biological changes in tumors before and after treatment. Participants will apply a thin layer of tofacitinib 2% cream twice daily on up to five eligible skin lesions. The trial includes an initial 12-week treatment period with options for extended treatment up to 52 weeks. The study assesses responses using skin severity scores and tracks symptoms like itching and quality of life. During the study, participants will be evaluated at multiple time points with assessments including skin lesion evaluations by mCAILS and mSWAT scores, itch severity scales, and quality of life questionnaires. Safety is monitored throughout the study with adverse event tracking. The total study duration for participants is about one year, with follow-up assessments to monitor ongoing response and safety.

A Phase 2 Trial to Assess Safety and Efficacy of Tofacitinib 2% Cream in the Treatment of Cutaneous T-cell Lymphoma (CTCL), Stages IA, IB, and IIA