Golidocitinib and chidamide for cutaneous T-cell lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-center phase I/II study using a 3+3 design to determine the recommended dose of golidocitinib in combination with chidamide and then to assess how well the combo works in CTCL patients. In phase I, the starting dose is 150 mg of golidocitinib every other day, with planned levels including once daily dosing, while chidamide is fixed at 20 mg twice weekly. Phase II expands at the RP2D to evaluate objective response rate, with secondary endpoints including complete responses, progression-free survival, duration of response, and overall survival, along with safety. Participants have measurable disease, prior systemic therapy, and good organ function, and will be monitored every cycle (4 weeks) with tumor assessments every three cycles.

Why it matters

Who can join: the full rules

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.

Where it's running

• Peking Union Medical College Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Wei Zhang
• Email: vv1223@vip.sina.com
• Phone: 13681473557

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.