Study of Golidocitinib Combined With Chidamide to Treat Adults With Cutaneous T-Cell Lymphoma

What this Trial Is About

Researchers are evaluating the combination of golidocitinib and chidamide in adults with cutaneous T-cell lymphoma CTCL who have previously received systemic treatment. This prospective, single-center phase III study aims to find the best dose of golidocitinib to use with chidamide and to measure how well this combination works in treating CTCL. The study also monitors complete response rates, progression-free survival, duration of response, overall survival, and safety. The study uses a standard 33 design in phase I to test two dose levels of golidocitinib 150 mg every other day and 150 mg once daily. Chidamide is given at a fixed dose of 20 mg twice weekly. In phase II, participants receive golidocitinib at the recommended phase II dose RP2D established in phase I, alongside the fixed dose of chidamide. Treatment cycles last 4 weeks, with tumor response assessed every 12 weeks and safety monitored every cycle. Participants will be closely followed through treatment and up to two years afterward. Regular assessments include tumor response evaluations, safety checks, and survival tracking. The primary outcomes focus on finding the recommended dose and measuring the objective response rate, while secondary outcomes track complete responses, progression-free survival, and overall survival. The total study duration allows careful monitoring of treatment effects and participant health.

Golidocitinib and Chidamide for Cutaneous T-Cell Lymphoma