NCT06739265

Golidocitinib Plus CHOP in Newly Diagnosed PTCL

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Peripheral T-cell Lymphoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-09-01
• Primary completion: 2026-09-01
• Completion: 2027-09-01
• First posted: 2024-12-18
• Last updated: 2024-12-18

Locations

1 site across 1 country: China