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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
golidocitinib
DrugThe phase I dose levels are golidocitinib 150 mg every other day and 150 mg once daily. In the phase II segment, golidocitinib will be administered at the RP2D established in the phase I study.
Chidamide
DrugChidamide is administered at a fixed dose of 20 mg twice weekly.
Treatment groups
65 Participants
are divided into 1 treatment groupGroup A: Golidocitinib and ChidamideExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Recommended Phase II Dose (RP2D)
The RP2D is determined based on the occurrence of dose-limiting toxicities (DLTs) during the first cycle (28 days) of treatment. It is defined as the highest dose level at which fewer than 33% of participants experience a DLT.
Time frame
From enrollment to the end of treatment at 4 weeks2
Objective Response Rate (ORR)
ORR is defined as the proportion of participants achieving a best overall response of complete response (CR) or partial response (PR).
Time frame
From enrollment to the end of 2-year follow-up phase or disease progression or death due to any causeSecondary outcomes
1
Complete Response (CR) Rate
Proportion of participants achieving a complete response (CR)
Time frame
From enrollment to the end of 2-year follow-up phase or disease progression or death due to any cause2
Progression-Free Survival (PFS)
the time from the first dose of study drug to the first documented disease progression or death
Time frame
From enrollment to the end of 2-year follow-up phase or disease progression or death due to any cause3
Overall Survival (OS)
the time from the first dose of study drug to death from any cause
Time frame
From enrollment to the end of 2-year follow-up phase or death from any causeSponsors and contacts
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Source ClinicalTrials.gov