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.
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* Histopathologically confirmed cutaneous T-cell lymphoma.
* Patients with measurable disease, with or without extracutaneous lesions, and clinical stage IB-IVB.
* Disease that has not responded to or has relapsed after at least one prior systemic therapy (including, but not limited to, total skin electron beam therapy, bexarotene, retinoids, interferon, extracorporeal photopheresis, methotrexate, or chidamide).
* An ECOG performance status of 0 to 2.
* Adequate bone marrow function: Absolute Neutrophil Count (ANC) ≥1.5×10⁹/L, Platelet count (PLT) ≥80×10⁹/L, Hemoglobin (HGB) ≥90 g/L.
* Adequate organ function: Cardiac function Class 1-2 (NYHA), Left Ventricular Ejection Fraction (LVEF) ≥50%, Alanine Aminotransferase (ALT) \< 2.5 × Upper Limit of Normal (ULN), Total Bilirubin (TBil) \< 1.5 × ULN, Oxygen Saturation (SpO₂) \> 93% on Room Air, estimated Glomerular Filtration Rate (eGFR) based on serum creatinine (sCr) \> 60 mL/min/1.73m².
Exclusion Criteria:
* Acute myocardial infarction, unstable angina, congestive heart failure, symptomatic arrhythmia within the past 6 months, or significant QT interval prolongation (corrected QT interval \>450 ms in males or \>470 ms in females).
* Uncontrolled active infection.
* Active tuberculosis infection.
* Active Hepatitis B (HBV DNA \> 1×10³ copies/mL) or Hepatitis C (HCV RNA \> 1×10³ copies/mL) infection.
* Pregnancy or lactation.
* Any other condition deemed by the investigator as unsuitable for participation in this study.
Primary outcome measure(s)
Recommended Phase II Dose (RP2D) — From enrollment to the end of treatment at 4 weeks The RP2D is determined based on the occurrence of dose-limiting toxicities (DLTs) during the first cycle (28 days) of treatment. It is defined as the highest dose level at which fewer than 33% of participants experience a DLT.
Objective Response Rate (ORR) — From enrollment to the end of 2-year follow-up phase or disease progression or death due to any cause ORR is defined as the proportion of participants achieving a best overall response of complete response (CR) or partial response (PR).
Trial sites (1)
Facility
City
Region
Status
Peking Union Medical College Hospital
Beijing
Beijing Municipality
Recruiting
More Peking Union Medical College Hospital trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.