Rituximab Maintenance Therapy Versus Observation in Aggressive CD20+ Lymphoma and Mantle Cell Lymphoma - a Prospective Randomized Phase III Trial
Trial Snapshot
- Phase
- Phase 3
- Enrollment
- 328
- Locations
- 3
- Primary Endpoint
- Progression free survival
Study Overview
Brief Summary
Clinical and pharmacokinetic data suggest that the effect of rituximab could be improved by prolonged exposure to the drug. To test for this hypothesis we performed a prospective randomized trial of rituximab maintenance therapy versus observation in patients (pts) with aggressive CD20+ B-cell lymphoma and mantle cell lymphoma.
Detailed Description
After completion of standard treatment, pts with aggressive CD20+ B-cell lymphoma and mantle cell lymphoma were randomized to either observation or maintenance therapy with rituximab (375 mg/m2) administered every 3 months for 2 years. Both pts after first line therapy and pts after relapse treatment were included in the study. Pts with aggressive lymphoma were enrolled if they had achieved a complete response (CR) after initial treatment. Pts with aggressive lymphoma with residual tumor mass underwent positron emission tomography (PET) and qualified for randomization if this examination showed no signs of tumor activity. Pts with mantle cell lymphoma were eligible for the study if at least a partial response (PR) was achieved. Primary endpoint of the study was progression free survival (PFS), secondary endpoints were time to progression (TTP), overall survival (OS) and response to treatment. Differences between PFS and OS were analysed using the logrank test and the proportional hazard model of Cox. TTP was analyzed using a competing risk model with death as competing event.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •aggressive B-cell lymphoma or mantle cell lymphoma
- •CR (complete remission) oder CRu (complete remission unconfirmed) after previous therapy
- •PR (partial remission) only when PET is negative
- •minimal age 18 years
- •CD20+ expression on tumor cells
- •effective contraception
- •Karnofsky status > 60
- •written informed consent
Exclusion Criteria
- Not provided
Arms & Interventions
Rituximab maintenance
maintenance therapy with rituximab (375 mg/m2) administered every 3 months for 2 years.
Intervention: rituximab (Drug)
Outcomes
Primary Outcomes
Progression free survival
Time Frame: 24 months after randomization
Primary endpoint of the study was progression free survival (PFS)
Secondary Outcomes
- overall survival (OS)(24 months after randomization)
- time to progression (TTP)(24 months after randomization)
- response to treatment(24 months after randomization)
Investigators
Mathias Witzens-Harig
Priv.Doz Dr.med.
University Hospital Heidelberg