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Obinutuzumab and Lenalidomide in R/R Marginal Zone Lymphoma
NCT05846750Phase 2
Key facts
- Status
- Recruiting
- Start
- Nov 2022
- Primary completion
- May 2026
- Countries
- 1
- Sponsor
- Institute of Hematology and Blood Diseases Hospital
- Modality
- Engineered Antibody Formats, Antibody Conjugates, Monoclonal Antibodies
- Drugs
- obinutuzumab
- Conditions
- marginal zone lymphoma (MZL)
01
Overview
Phase 2, open-label, single-arm trial of obinutuzumab in marginal zone lymphoma (MZL), sponsored by Institute of Hematology and Blood Diseases Hospital. Primary endpoint: Overall Remission Rate at 24 weeks. Started Nov 2022; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Obinutuzumab and lenalidomide
Combination therapy with Obinutuzumab and Lenalidomide
03
Who it enrols
Patients with relapsed/refractory MZL who have received at least one prior line of systemic therapy. Excludes patients refractory to lenalidomide or obinutuzumab, and those with active infections or significant comorbidities.
04
Endpoints
Primary
Overall Remission Rate
Secondary
2-year Progression Free Survival
2-year Event-Free Survival
Complete Response Rate
Overall Survival
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