RecruitingPhase 1Phase 2NCT07754890

Golidocitinib and Chidamide for Cutaneous T-Cell Lymphoma

A Prospective Single-Center Phase I/II Clinical Study of Golidocitinib Combined With Chidamide in Patients With Systemically-Treated Cutaneous T-Cell Lymphoma

Sponsor

Peking Union Medical College Hospital

Enrollment

65 participants

Start Date

Aug 26, 2025

Study Type

INTERVENTIONAL

Conditions

Cutaneous T Cell Lymphoma (CTCL)

Summary

This is a prospective, single-center phase I/II study, with the purpose of evaluating the efficiency of golidocitinib combined with chidamide in patients with systemically-treated cutaneous T-cell lymphoma. The primary endpoint of the phase I study was to determine the recommended phase II dose (RP2D), while the primary endpoint of the phase II study was the objective response rate (ORR). Secondary endpoints included the complete response (CR) rate, progression-free survival (PFS), duration of response (DOR), overall survival (OS), and safety profile.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Chidamide and a drug called golidocitinib for people with cutaneous t cell lymphoma (ctcl). The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGgolidocitinib

The phase I dose levels are golidocitinib 150 mg every other day and 150 mg once daily. In the phase II segment, golidocitinib will be administered at the RP2D established in the phase I study.

DRUGChidamide

Chidamide is administered at a fixed dose of 20 mg twice weekly.