RecruitingPhase 1Phase 2NCT06739265

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

Sponsor

Peking Union Medical College Hospital

Enrollment

68 participants

Start Date

Sep 1, 2024

Study Type

INTERVENTIONAL

Conditions

Peripheral T Cell Lymphoma

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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests the addition of golidocitinib (a targeted therapy that blocks a protein called JAK1, which promotes cancer cell growth) to standard CHOP chemotherapy in patients newly diagnosed with peripheral T-cell lymphoma (PTCL), a rare and aggressive type of blood cancer. **You may be eligible if...** - You are between 18 and 70 years old - You have a newly diagnosed and confirmed diagnosis of PTCL (such as PTCL-NOS, AITL, ALCL, or similar subtypes) - You have at least one measurable tumor lesion visible on imaging - You have not received prior treatment for this lymphoma **You may NOT be eligible if...** - You have previously been treated for PTCL - You have a different type of lymphoma not covered by this study - You have health conditions that make chemotherapy unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGolidocitinib 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.