Phase III Study of Golidocitinib Combined with CHOP Treatment for Newly Diagnosed Peripheral T-Cell Lymphoma

What this Trial Is About

Researchers are evaluating the safety and effectiveness of golidocitinib combined with the CHOP chemotherapy regimen for patients newly diagnosed with peripheral T-cell lymphoma PTCL. This single-arm phase III study includes two stages phase I focuses on finding the maximum tolerated dose and recommended dose for phase II, while phase II aims to measure the complete response rate of the combination treatment. The study addresses important treatment options for PTCL, a type of lymphoma affecting certain white blood cells. The study treatment involves giving golidocitinib along with the CHOP regimen, which includes cyclophosphamide, epirubicin, vindesine, and prednisone. In phase I, two doses of golidocitinib will be tested 150 mg every other day and 150 mg daily alongside the CHOP drugs in cycles of 21 days. Phase II will use the recommended dose from phase I with the same CHOP schedule to see how well patients respond. Each cycle involves specific intravenous and oral doses given on set days. Participants will be closely monitored throughout the study with evaluations after three cycles of treatment and one month after completing therapy. Researchers will assess response rates, progression-free survival, overall survival, and document any side effects during and after treatment. The study follow-up may continue up to three years to track these outcomes and ensure patient safety. The total duration includes treatment cycles plus extended monitoring of health and disease status.

Golidocitinib Plus CHOP in Newly Diagnosed PTCL