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

NCT00877214 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1272

Last updated 2024-08-22

No results posted yet for this study

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.

Conditions

  • Follicular Lymphomas
  • Immunocytomas
  • Marginal Zone Lymphomas
  • Mantle-Cell Lymphomas
  • Lymphocytic Lymphoma
  • Non-Hodgkin's Lymphoma

Interventions

DRUG

Rituximab

Follicular Lymphomas: induction therapy with bendamustine + rituximab. If CR or PR: Maintenance therapy with rituximab every 2 months for 4 years Immunocytomas, marginal zone and mantle cell lymphomas: induction therapy with bendamustine + rituximab If CR or PR: Maintenance therapy with rituximab every 2 months for 2 years

DRUG

Rituximab / observation

Follicular Lymphomas:induction therapy with bendamustine + rituximab If CR or PR: Maintenance therapy with rituximab every 2 months for 2 years (standard) Immunocytomas, marginal zone and mantle cell lymphomas: induction therapy with bendamustine + rituximab If CR or PR: observation (standard)

Sponsors & Collaborators

  • Sponsor GmbH

    collaborator OTHER

  • Jurgen Barth

    lead OTHER

Principal Investigators

  • Mathias Rummel, Dr · University of Giessen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-01
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00877214 on ClinicalTrials.gov