Golidocitinib and Chidamide for Cutaneous T-Cell Lymphoma
ConditionCutaneous T-cell Lymphoma (CTCL)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorPeking Union Medical College Hospital
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- golidocitinib
- Chidamide
Treatment groups
65 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov