Golidocitinib and Chidamide for Cutaneous T-Cell Lymphoma

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.

Trial Details

NCT ID
NCT07754890
Phase
PHASE1 / PHASE2
Sponsor
Peking Union Medical College Hospital
Status
RECRUITING
Cancer Type
Lymphoma
Interventions
  • golidocitinib
  • Chidamide
Locations (sample)
  • Beijing, Beijing Municipality, China|39.9075,116.39723

Key Eligibility 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 bea…
  • An ECOG performance status of 0 to 2.

For full eligibility, visit ClinicalTrials.gov.

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