Overview

This trial is active, not recruiting.

Condition cd20+ aggressive lymphoma, mantle cell lymphoma
Treatment rituximab
Phase phase 3
Target CD20
Sponsor University Hospital Heidelberg
Start date July 2002
End date December 2016
Trial size 328 participants
Trial identifier NCT01933711, HD2002

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
maintenance therapy with rituximab (375 mg/m2) administered every 3 months for 2 years.
rituximab
(No Intervention)
observational arm, no intervention

Primary Outcomes

Measure
Progression free survival
time frame: 24 months after randomization

Secondary Outcomes

Measure
time to progression (TTP)
time frame: 24 months after randomization
overall survival (OS)
time frame: 24 months after randomization
response to treatment
time frame: 24 months after randomization

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Rituximab Maintenance Therapy Versus Observation in Aggressive CD20+ Lymphoma and Mantle Cell Lymphoma - a Prospective Randomized Phase III Trial
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University Hospital Heidelberg.