Rituximab Maintenance Therapy in Aggressive CD20 (Cluster of Differentiation Antigen 20) Positive Lymphoma and Mantle Cell Lymphoma
- Sponsor
- University Hospital Heidelberg
- Study ID
- NCT01933711
- Phase
- PHASE3
- Status
- Unknown
Conditions
- CD20+ Aggressive Lymphoma, Mantle Cell Lymphoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- rituximab — DRUG
Study Details
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.
Key Dates
- Start date
- Jul 31, 2002
- Status verified
- May 2016
- Primary completion
- Dec 31, 2016
- Completion
- Dec 31, 2018
Study Design
- Enrollment
- 328 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Rituximab maintenancemaintenance therapy with rituximab (375 mg/m2) administered every 3 months for 2 years.
- No Intervention: Observationobservational arm, no intervention
Primary Outcome Measure
Progression free survival [ Time Frame: 24 months after randomization ]