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S0016 Combination Chemotherapy With Monoclonal Antibody Therapy in Newly Diagnosed Non-Hodgkin's Lymphoma

NCT00006721 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 571

Last updated 2026-03-16

Study results available
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Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies can locate tumor cells and either kill them or deliver radioactive tumor-killing substances to them without harming normal cells. It is not yet known which monoclonal antibody plus combination chemotherapy regimen is more effective in treating non-Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is comparing 2 different monoclonal antibodies given together with combination chemotherapy to see how well they work in treating patients with newly-diagnosed non-Hodgkin's lymphoma.

Conditions

Interventions

BIOLOGICAL

rituximab

Given IV

DRUG

cyclophosphamide

Given IV

DRUG

doxorubicin

Given IV

DRUG

prednisone

Given orally

DRUG

vincristine

Given IV

RADIATION

tositumomab

Given IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Cancer and Leukemia Group B

    collaborator NETWORK

  • Eastern Cooperative Oncology Group

    collaborator NETWORK

  • SWOG Cancer Research Network

    lead NETWORK

Principal Investigators

  • Oliver W. Press, MD, PhD · Fred Hutchinson Cancer Center

  • Myron S. Czuczman, MD · Roswell Park Cancer Institute

  • Sandra J. Horning, MD · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-03-31
Primary Completion
2011-09-30
Completion
2025-12-31
FDA Drug
Yes

Countries

  • United States

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 NCT00006721 on ClinicalTrials.gov