NCT01933711

Rituximab Maintenance Therapy in Aggressive CD20 (Cluster of Differentiation Antigen 20) Positive Lymphoma and Mantle Cell Lymphoma

Rituximab Maintenance Therapy Versus Observation in Aggressive CD20+ Lymphoma and Mantle Cell Lymphoma - a Prospective Randomized Phase III Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 328 (estimated)
• Sponsor: University Hospital Heidelberg · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• CD20+ Aggressive Lymphoma, Mantle Cell Lymphoma

Interventions

Type	Name	Description
DRUG	rituximab

Timeline

• Start date: 2002-07-01
• Primary completion: 2016-12-01
• Completion: 2018-12-01
• First posted: 2013-09-02
• Last updated: 2016-05-13

Locations

3 sites across 1 country: Germany