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Rituximab and Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With B-Cell Non-Hodgkin's Lymphoma

NCT00278408 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 700

Last updated 2025-08-26

Study results available
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Summary

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill cancer cells. Giving rituximab and combination chemotherapy together with radiation therapy may kill more cancer cells. It is not yet known which schedule of rituximab and combination chemotherapy is more effective when given with or without radiation therapy in treating non-Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is studying two different schedules of rituximab and combination chemotherapy with or without radiation therapy to compare how well they work in treating patients with aggressive B-cell non-Hodgkin's lymphoma.

Conditions

Interventions

BIOLOGICAL

filgrastim

BIOLOGICAL

rituximab

DRUG

cyclophosphamide

DRUG

doxorubicin hydrochloride

DRUG

prednisone

DRUG

vincristine sulfate

RADIATION

radiation therapy

Sponsors & Collaborators

  • German High-Grade Non-Hodgkin's Lymphoma Study Group

    lead OTHER

Principal Investigators

  • Michael G.M. Pfreundschuh, MD † · Universitaetsklinikum des Saarlandes

  • Viola Poeschel, MD · Study Office Homburg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-01-02
Primary Completion
2018-02-28
Completion
2018-02-28

Countries

  • Denmark
  • Germany
  • Israel
  • Italy

Study Locations

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Entities

Drugs
Diseases

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 NCT00278408 on ClinicalTrials.gov