Phase 3 Study Comparing Orelabrutinib Plus Bendamustine and Rituximab Versus Bendamustine and Rituximab Alone in Patients with Untreated Mantle Cell Lymphoma Aged 60 and Older

What this Trial Is About

Researchers are evaluating the effectiveness and safety of adding Orelabrutinib to a standard treatment of bendamustine plus rituximab in patients who have not previously been treated for mantle cell lymphoma MCL. This phase 3, randomized, double-blind study aims to compare the combination of Orelabrutinib with bendamustine and rituximab versus bendamustine and rituximab alone. The study is sponsored by InnoCare Pharma Inc. and focuses on patients with treatment-naive MCL, typically older adults. Participants will be randomly assigned to one of two groups one receiving Orelabrutinib orally along with bendamustine and rituximab injections, and the other receiving a placebo oral treatment with bendamustine and rituximab injections. Treatment will continue until the disease progresses or other reasons require stopping. The study uses a quadruple masking design, ensuring that participants and researchers do not know who is receiving Orelabrutinib or placebo. Throughout the study, participants will be monitored for dose-limiting toxicity within the first 28 days and followed for progression-free survival over approximately seven years. Researchers will conduct assessments to track disease status, side effects, and overall health. The trial involves regular visits, laboratory tests, and imaging to evaluate treatment effects and safety. Participants involvement may last several years, including long-term follow-up to understand treatment outcomes and risks.

A Global Phase 3 Study of Orelabrutinib+BR Vs.BR in Pts with TN MCL