MedTrace Logo

Golidocitinib and Chidamide for Cutaneous T-Cell Lymphoma

NCT07754890 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2026-08-12

No results posted yet for this study

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.

Conditions

  • Cutaneous T-cell Lymphoma (CTCL)

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.

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-26
Primary Completion
2028-12-31
Completion
2030-12-31

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07754890 on ClinicalTrials.gov