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

Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Study ID
NCT07261163
Phase
PHASE2
Status
Recruiting
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Conditions

  • Mantle Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Zanubrutinib — DRUG
    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 — DRUG
    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 — DRUG
    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.
  • CAR-T Cell Therapy — OTHER
    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.

Study Details

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.

Key Dates

First listed
Dec 3, 2025
Start date
Dec 20, 2025
Status verified
May 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2029

Study Design

Enrollment
37 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ZGR

Primary Outcome Measure

complete response rate (CR) [ Time Frame: up to the end of 6 cycles of treatment (each cycle is 28 days) ]

Central Contacts

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