Golidocitinib and Chidamide for Cutaneous T-Cell Lymphoma

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

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.

Conditions2

Interventions2

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