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Golidocitinib and Chidamide for Cutaneous T-Cell Lymphoma Phase I/II Trial
Sponsor: Peking Union Medical College Hospital
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.
Official title: A Prospective Single-Center Phase I/II Clinical Study of Golidocitinib Combined With Chidamide in Patients With Systemically-Treated Cutaneous T-Cell Lymphoma
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
65
Start Date
2025-08-26
Completion Date
2030-12-31
Last Updated
2026-08-10
Healthy Volunteers
No
Conditions
Interventions
golidocitinib
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.
Chidamide
Chidamide is administered at a fixed dose of 20 mg twice weekly.
Locations (1)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China