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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

328 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-07-31

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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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

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CD20+ Aggressive Lymphoma, Mantle Cell Lymphoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rituximab maintenance

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

Group Type EXPERIMENTAL

rituximab

Intervention Type DRUG

Observation

observational arm, no intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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rituximab

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No