Bendamustine Plus Rituximab Versus CHOP Plus Rituximab

NCT00991211 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 549

Last updated 2024-08-22

No results posted yet for this study

Summary

The study addresses the question if the first line therapy of low malignant and mantle cell lymphomas with bendamustine plus rituximab is comparable (non inferior) with CHOP plus rituximab with regard to progression free survival (PFS).

Conditions

  • Non-Hodgkin Lymphomas
  • Follicular Lymphomas
  • Immunocytomas
  • Lymphocytic Lymphomas
  • Marginal Zone Lymphomas

Interventions

DRUG

Bendamustine

Comparison of Bendamustine + Rituximab with CHOP + Rituximab

DRUG

Standard chemotherapy CHOP + Ritiximab

Cyclophosphamid 750 mg/m² d 1 + Doxorubicin 50 mg/m² d 1 + Vincristin 1,4 mg/m² max. 2 mg d 1 + Prednison 100 mg absolute p.o. d 1-5 + Rituximab 375 mg/m² d 1 q3w as standard Chemotherapy

Sponsors & Collaborators

  • University of Giessen

    lead OTHER

Principal Investigators

  • Mathias Rummel, Dr. · Study Group of indolent Lymphom,as (StiL)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-01-31
Primary Completion
2009-08-31
Completion
2009-08-31

Countries

  • Germany

Study Locations

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Entities

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 NCT00991211 on ClinicalTrials.gov