drugset / Trial / NCT07261163
Obinutuzumab, Zanubrutinib, and Lenalidomide in First-line Treatment of Mantle Cell Lymphoma
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lenalidomide | Other / unclassified | 10 mg | Oral |
| Subject | Obinutuzumab | Monoclonal antibody | 1000 mg | Intravenous |
| Subject | Zanubrutinib | Small molecule | 160 mg | Oral |