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RECRUITING
NCT06739265
PHASE1/PHASE2

Golidocitinib Plus CHOP in Newly Diagnosed PTCL

Sponsor: Peking Union Medical College Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: A Phase I/II Study of Golidocitinib in Combination with CHOP in Patients with Newly Diagnosed Peripheral T Cell Lymphoma

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

68

Start Date

2024-09-01

Completion Date

2027-09-01

Last Updated

2024-12-18

Healthy Volunteers

No

Interventions

DRUG

Golidocitinib plus CHOP

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.

Locations (1)

Peking Union Medical College Hospital

Beijing, China