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.
of golidocitinib in combination with chidamide and to determine the recommended phase II dose (RP2D). The study follows a standard "3+3" design. The starting dose of golidocitinib is 150 mg every other day, with pre-specified dose levels including 150 mg every other day and 150 mg once daily. Chidamide is administered at a fixed dose of 20 mg twice weekly. In the phase II segment (dose expansion phase), all participants will receive the combination therapy of golidocitinib and chidamide. Golidocitinib will be administered at the RP2D established in the phase I study, while chidamide will continue at the fixed dose of 20 mg twice weekly. Each treatment cycle is defined as 4 weeks. Tumor response will be assessed every 3 treatment cycles, and safety evaluations will be performed every cycle.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
65
The 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 is administered at a fixed dose of 20 mg twice weekly.
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
RECRUITINGRecommended 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 weeks
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 cause
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 cause
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 cause
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 cause
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