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Combination Chemotherapy With or Without Rituximab in Treating Older Patients With Non-Hodgkin's Lymphoma

NCT00052936 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1506

Last updated 2021-05-18

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy is more effective with or without rituximab in treating aggressive non-Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is studying how well giving cyclophosphamide, doxorubicin, vincristine, and prednisone together with or without rituximab works in treating older patients who have aggressive non-Hodgkin's lymphoma. (This trial is no longer randomized as of 6/2005).

Conditions

Interventions

BIOLOGICAL

filgrastim

BIOLOGICAL

rituximab

DRUG

CHOP regimen

DRUG

cyclophosphamide

DRUG

doxorubicin hydrochloride

DRUG

prednisone

DRUG

vincristine sulfate

RADIATION

radiation therapy

36Gy on BULK and extranodal involvement

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

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

Timeline & Regulatory

Start
2001-01-31
Primary Completion
2010-08-05
Completion
2010-08-05

Countries

  • Germany
  • Switzerland

Study Locations

More Related Trials

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 NCT00052936 on ClinicalTrials.gov