Phase 3 Study Comparing Golidocitinib to Doctors Choice in Adults with Relapsed or Resistant Peripheral T-cell Lymphoma

What this Trial Is About

Researchers are evaluating the anti-tumor effects of golidocitinib compared to investigators choice treatments in adults with relapsed or refractory peripheral T-cell lymphoma PTCL. This phase 3, open-label, randomized study includes patients who have confirmed PTCL and have not responded to or tolerated at least one prior systemic therapy. The study focuses on several PTCL subtypes and aims to improve treatment options for this condition. Participants will be randomly assigned to receive either golidocitinib orally once daily in repeated 21-day cycles or one of the investigators choice treatments, which may include chidamide taken orally twice a week or gemcitabine given intravenously on specific days within 28-day cycles. Treatments continue according to protocol with no masking or blinding involved. During the study, participants will be monitored for progression-free survival as the primary outcome, measured from the date of randomization until disease progression or death, over approximately four years. Secondary outcomes like overall survival will also be tracked. Eligibility assessments, compliance with contraceptive requirements, organ function tests, and ongoing safety monitoring will be part of the participant involvement throughout the study duration.

A Phase 3 Multinational Study of Golidocitinib Versus Investigator's Choice in r/r PTCL (JACKPOT19)