Obinutuzumab, Zanubrutinib, and Lenalidomide in First-line Treatment of Mantle Cell Lymphoma
Obinutuzumab, Zanubrutinib, and Lenalidomide as First-Line Therapy for Mantle Cell Lymphoma: A Prospective, Single-Arm, Open-Label, Multicenter Study
Institute of Hematology & Blood Diseases Hospital, China
37 participants
Dec 20, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
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This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Zanubrutinib 160 mg orally twice daily (bid), continuously administered. Used during the induction phase as part of the ZGR regimen for 6 cycles, and continued as maintenance therapy for up to 2 years. For patients not achieving complete response, treatment may be extended beyond 2 years until disease progression or intolerance.
Obinutuzumab 1000 mg administered intravenously. Dosing schedule: Days 1, 8, and 15 of Cycle 1; Day 1 of each subsequent cycle starting from Cycle 2. Each cycle is 28 days. Administered as part of the ZGR induction regimen for 6 cycles.
Lenalidomide 20 mg orally once daily on Days 1-21 of each 28-day cycle. Administered during the induction phase as part of the ZGR regimen for 6 cycles. For maintenance, the dose is reduced to 10 mg once daily on Days 1-21 of each 28-day cycle, for a duration of 1 year.
For high-risk patients, CAR-T cell therapy is permitted after completion of the induction phase. Initiation of CAR-T therapy is followed by a 2-month recovery period before starting maintenance therapy with zanubrutinib and lenalidomide.
Locations(2)
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NCT07261163