This is a randomized study to compare the efficacy and safety of zanubrutinib plus rituximab versus bendamustine plus rituximab in previously untreated participants with mantle cell lymphoma (MCL) who are not eligible for stem cell transplantation.
This is a global, Phase 3, randomized study of zanubrutinib plus rituximab versus bendamustine plus rituximab in participants with previously untreated mantle cell lymphoma (MCL) who are ineligible for stem cell transplantation. Participants are randomized in a 1:1 manner to receive either zanubrutinib plus rituximab or bendamustine plus rituximab. The primary endpoint is progression-free survival (PFS) as assessed by an Independent Review Committee (IRC). Key secondary endpoints include investigator-assessed PFS, overall response rate (ORR), duration of response (DoR), overall survival (OS), patient-reported outcomes (PROs), and safety.
| Study Arm | Population | Intervention | Comparison | Outcome |
|---|---|---|---|---|
Previously untreated MCL ineligible for stem cell transplant |
Zanubrutinib + rituximab |
Bendamustine + rituximab |
Primary Endpoint: IRC-assessed PFS Secondary Endpoints: INV-assessed PFS, ORR, DOR, OS, PROs, safety |
