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RECRUITING
NCT07754890
PHASE1/PHASE2

Golidocitinib and Chidamide for Cutaneous T-Cell Lymphoma Phase I/II Trial

Sponsor: Peking Union Medical College Hospital

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

Chidamide

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

Locations (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China