This is single-arm phase I/II study designed to evaluate the safety and efficacy of golcadotinib in combination with the CHOP regimen for patients with newly diagnosed peripheral T-cell lymphoma (PTCL). The study adopts a two-stage design, consisting of a Phase I and a Phase II parts. In the phase I study, a standard "3+3" design will be used. The primary endpoints of the Phase I study are the maximum tolerated dose (MTD) and the recommended Phase II dose (RP2D). The primary endpoint of the Phase II study is the complete response rate (CRR) of the golcadotinib combined with CHOP regimen.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
68
Phase 1: dose escalation phase. Drug Golidocitinib: 2 dose level of 150 mg qod and 150 mg qd; CHOP regimen: cyclophosphamide (750 mg/m2 intravenously on day 1), epirubicin (70 mg/m2 intravenously on day 1), vindesine (4 mg intravenously on day 1), and prednisone (60 mg/m2 orally on days 1-5) in a 3-week cycle. Phase 2: dose expansion phase. Drug Golidocitinib: RP2D established in the phase I study; CHOP regimen: cyclophosphamide (750 mg/m2 intravenously on day 1), epirubicin (70 mg/m2 intravenously on day 1), vindesine (4 mg intravenously on day 1), and prednisone (60 mg/m2 orally on days 1-5) in a 3-week cycle.
Peking Union Medical College Hospital
Beijing, China
RECRUITINGRecommended phase 2 dose (RP2D) of phase 1 study
Recommended phase 2 dose (RP2D) and/or maximum tolerated dose (MTD) will be established according to the incidence of dose-limiting toxicities (DLTs) of escalated doses of golidocitinib
Time frame: 4 weeks since the date of first dose]
complete remission rate (CRR) of the phase 2 study
Treatment responses were assessed according to the 2014 Lugano classification criteria.
Time frame: Responses were evaluated after 3 cycles of induction and 1 month after the completion of study therapy (each cycle is 21 days)
Progression-free survival
Progression-free survival was defined as the time from the date of enrollment until the date of the first documented day of disease progression or relapse, or death from any cause, whichever occurred first.
Time frame: From date of enrollment until documented disease progression or death of any reason (up to 3 years)
Overall survival
Overall survival was defined as the time from the date of enrollment to the date of death from any cause.
Time frame: From date of enrollment until documented death of any reason (up to 3 years)
adverse events
Graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Time frame: From enrollment till 28 days post the last induction cycle
Objective Response Rate (ORR)
The ORR was defined as the proportion of patients with CR or PR.
Time frame: Responses were evaluated after 3 cycles of induction and 1 month after the completion of study therapy (each cycle is 21 days)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.