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Significance of Duration of Maintenance Therapy With Rituximab in Non-Hodgkin Lymphomas | Clinical Trials | Clareo Health

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Significance of Duration of Maintenance Therapy With Rituximab in Non-Hodgkin Lymphomas

Prospective Randomized Multicenter Study in First-line Treatment of Advanced progredIeNT Follicular And Other IndoleNt and Mantle Cell Lymphomas

NCT00877214•Jurgen Barth

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine if an extended maintenance therapy with Rituximab in follicular and a maintenance therapy in other indolent and mantle cell lymphomas has advantages compared to a shorter or no maintenance therapy.

Detailed Description

Results from several randomised studies show a clinical benefit of a maintenance therapy with rituximab in follicular lymphomas. The advantage of a maintenance therapy in other indolent and mantle cell lymphomas is - due to the lower incidence of these diseases- not well investigated. This study tries to determine the significance of an extended maintenance therapy with rituximab in follicular lymphomas and the significance of a maintenance therapy other indolent and mantle cell lymphomas compared to observation.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients with histological verified CD20-positive B-Cell-Lymphoma of the following entities:
•* Follicular Lymphoma Grade 1 and 2
•* Lymphoplasmocytic lymphoma / Immunocytoma (Morbus Waldenström) and small cell lymphocytic lymphoma (CLL without leukemic hemogram)
•* Marginal zone lymphoma, nodal and extra nodal
•* Mantle cell lymphoma
•No prior therapy with cytotoxics, interferon or monoclonal antibodies
•Need for therapy, except mantle cell lymphomas
•Stadium III or IV or Stadium with II bulky disease (\> 7 cm diameter, or 3 lesions \> 5 cm)
•General condition WHO 0-2
•Age min. 18 years, max. 80 years
+18 more criteria

Locations (1)

StiL Head Office; Justus-Liebig-University

Giessen, Germany

Key Dates

Start Date

April 1, 2009

Primary Completion Date

December 1, 2024

Completion Date

December 1, 2024

Last Updated

August 22, 2024

Enrollment

1,272

ACTUAL participants

Conditions

Follicular LymphomasImmunocytomasMarginal Zone LymphomasMantle-Cell LymphomasLymphocytic LymphomaNon-Hodgkin's Lymphoma

Interventions

Rituximab

DRUG

Rituximab / observation

DRUG

ACP-196 (Acalabrutinib) in Combination With Pembrolizumab, for Treatment of Hematologic Malignancies

NCT02362035

Follicular Lymphoma (FL)CLL+11 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 22, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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