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Recruiting Phase 1 / Phase 2

Golidocitinib and Chidamide for Cutaneous T-Cell Lymphoma

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About this study

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.

Condition
Cutaneous T-cell Lymphoma (CTCL)
Tested
golidocitinib, Chidamide
Sponsor
Peking Union Medical College Hospital

Who can join

Age
18 to 75 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 9

  • Minimum age: 18 years
  • Maximum age: 75 years
  • Study condition: Cutaneous T-cell Lymphoma (CTCL)
  • 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 6

  • 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

1 site, 1 recruiting

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.