Phase 12 Study Evaluating GW5282 and Golidocitinib Combination Therapy for Treating T-Cell Lymphoma

What this Trial Is About

Researchers are evaluating the combination of GW5282 and golidocitinib for treating T-cell lymphoma in a phase 12 open-label study. The study aims first to find the highest dose that can be tolerated safely through dose escalation. Then, it compares the new combination therapy to the standard CHOP regimen to see if it has potential benefits for patients with this type of lymphoma. The study has two parts. In the first part, participants receive GW5282 twice daily and golidocitinib once daily, starting at specific doses, with the possibility to increase GW5282 if tolerated. In the second part, patients are randomly assigned to receive either this combination at the established dose or the conventional CHOP chemotherapy regimen, which includes cyclophosphamide, doxorubicin, vincristine, and prednisone. Participants will be closely monitored for side effects during the 21 days after the first dose and throughout treatment cycles lasting 21 days each. Researchers will measure safety by recording adverse events and evaluate effectiveness by assessing tumor response after up to six cycles. Blood samples will be collected at specific times to check drug levels. The study also includes longer-term follow-up of about one to two years to observe ongoing effects and safety. Total participation duration depends on treatment response and continuation.

Assessing Treatment of T-Cell Lymphoma With GW5282 in Combination With Golidocitinib (BEI-DOU3)