Clinical Trial

A Multicenter, Prospective, Open-Label, Randomized Controlled Clinical Study of Orelabrutinib Combined With Obinutuzumab and Lenalidomide Versus Obinutuzumab Plus Chemotherapy for Treatment-Naive Follicular Lymphoma

Not Yet Recruiting Phase 3
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Summary
This study intends to conduct a prospective, multicenter, open-label, randomized controlled clinical trial to systematically evaluate the efficacy and safety of the orelabrutinib plus obinutuzumab and lenalidomide (RO2) regimen versus the obinutuzumab-combined chemotherapy (O-chemo) regimen in patients with previously untreated follicular lymphoma. The primary observation is whether the RO2 regimen can maintain or improve therapeutic efficacy while significantly reducing hematological toxicities and other related adverse reactions, so as to provide a novel therapeutic option for improving the prognosis and quality of life of patients with follicular lymphoma (FL).
Trial Details
NCT Number NCT07719855
Lead Sponsor Ruijin Hospital
Conditions Follicular Lymphoma ( FL)
Enrollment 652 participants
Start Date 2026-07
Primary Completion 2030-07 (estimated)
Study Completion 2033-12 (estimated)
Updated on ClinicalTrials.gov 2026-07-22