Study of Orelabrutinib Combined With Bendamustine and Rituximab Versus Bendamustine and Rituximab Alone for Treating Adults With Intermediate- to High-Risk Mantle Cell Lymphoma Not Eligible for Transplant

What this Trial Is About

Researchers are evaluating the safety and effectiveness of Orelabrutinib combined with Bendamustine and Rituximab OBR compared to Bendamustine and Rituximab BR alone in patients with intermediate- to high-risk mantle cell lymphoma MCL who cannot undergo transplantation. This phase 3, multicenter, open-label, randomized controlled trial aims to measure the complete response rate during the induction phase. Secondary goals include progression-free survival, overall survival, objective response rate, and investigating how tumor biomarkers relate to treatment effects. During the induction phase, participants are randomly assigned to one of two groups the OBR group receives rituximab and bendamustine by intravenous infusion plus daily oral Orelabrutinib for six 28-day cycles the BR group receives rituximab and bendamustine without Orelabrutinib for the same duration. In the maintenance phase, treatment depends on specific genetic markers and disease variants. Patients with TP53 mutation or blasticpleomorphic variants receive daily Orelabrutinib and gradually increased Venetoclax doses for up to two years. Those without these markers receive daily Orelabrutinib alone for up to two years. Participants will undergo regular assessments including blood tests, imaging, and physical exams to monitor treatment response and safety. Researchers will measure complete response rates about 6 to 8 weeks after induction treatment ends and track progression-free and overall survival for up to two years. Study involvement includes scheduled visits for treatment administration and evaluation, with ongoing monitoring for side effects and disease status throughout the trial duration.

Bendamustine and Rituximab With or Without Orelabrutinib in MCL Treatment