drugset / Trial / NCT07261163

Obinutuzumab, Zanubrutinib, and Lenalidomide in First-line Treatment of Mantle Cell Lymphoma

NCT07261163

NaSingle-groupOpen-labelTreatment

Summary

This is a prospective, open-label, single-arm clinical trial evaluating a treatment strategy for previously untreated Mantle Cell Lymphoma (MCL). The study will enroll patients who have not received prior systemic therapy for MCL. All patients will receive the ZGR induction regimen. Risk-adapted maintenance therapy will be applied: non-high-risk patients will receive lenalidomide and zanubrutinib maintenance for 1 and 2 years, respectively; high-risk patients will undergo CAR-T cell therapy followed by the same maintenance regimen. The primary objective is to assess the feasibility and preliminary efficacy of this treatment approach in the first-line setting of MCL.

Timeline

Start
2025-12-20
Primary completion
2027-07-31
Completion
2029-07-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Lenalidomide Other / unclassified 10 mg Oral
Subject Obinutuzumab Monoclonal antibody 1000 mg Intravenous
Subject Zanubrutinib Small molecule 160 mg Oral

Indications