OncRef

Clinical Trial: NCT00006721

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

Status:

COMPLETED

Phase:

Phase 3

Lead Sponsor:SWOG Cancer Research Network
Information Provided By:SWOG Cancer Research Network
Last Update Posted:2026-03-16

Study Overview

Brief 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.

Official Title

A Phase III Trial of CHOP Plus Rituximab vs CHOP Plus Iodine-131-Labeled Monoclonal Anti-B1 Antibody (Tositumomab) for Treatment of Newly Diagnosed Follicular Non-Hodgkin's Lymphomas

Conditions

Lymphoma

Intervention / Treatment

  • Biological: rituximab
  • Drug: cyclophosphamide
  • Drug: doxorubicin
  • Drug: prednisone
  • Drug: vincristine
  • Radiation: tositumomab

Other Study ID Numbers

  • CDR0000068321
  • U10CA032102
  • S0016
  • CALGB-50102
  • S0016

Start Date

2001-03

Primary Completion Date (Actual)

2011-09

Study Completion Date (Actual)

2025-12

Enrollment (Actual)

571

Study Type

Interventional

Phase

Phase 3