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

Phase 3

• Conditions: CD20+ Aggressive Lymphoma, Mantle Cell Lymphoma
• Interventions: Drug: rituximab

• Registration Number: NCT01933711
• Lead Sponsor: University Hospital Heidelberg

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 Timeline

• Study Start: 2002-07
• Study First Submitted: 2013-08-23
• Study First Submitted QC: 2013-08-28
• Study First Posted: 2013-09-02
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-11
• Last Update Posted: 2016-05-13
• Primary Completion: 2016-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 328

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rituximab maintenance	rituximab	maintenance therapy with rituximab (375 mg/m2) administered every 3 months for 2 years.

Primary Outcome Measures

Name	Time	Method
Progression free survival	24 months after randomization	Primary endpoint of the study was progression free survival (PFS)

Secondary Outcome Measures

Name	Time	Method
overall survival (OS)	24 months after randomization
time to progression (TTP)	24 months after randomization
response to treatment	24 months after randomization

Trial Locations

Locations (3)

University of Bonn Hospital; 🇩🇪 Bonn, Nordhein-Westfalen, Germany

University of Mannheim Hospital; 🇩🇪 Mannheim, Baden-Württemberg, Germany

University of Heidelberg Hospital; 🇩🇪 Heidelberg, Baden-Württemberg, Germany