CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 571 enrolled
Drug / intervention
rituximab +5 morebiological
Likely dose
CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) plus rituximab or tositumomab IVAI-extracted
Key inclusion· 7
  • Histologically confirmed previously untreated bulky stage II or stage III or IV follicular non-Hodgkin's lymphoma, Grade I-III
  • CD20 antigen positive
  • Fewer than 5,000/mm³ circulating lymphoid cells on WBC differential
  • Bidimensionally measurable disease
Key exclusion· 8
  • Clinical evidence of CNS involvement by lymphoma
  • Impaired cardiac status including severe coronary artery disease, cardiomyopathy, congestive heart failure, or serious arrhythmia
  • Prior monoclonal antibodies for cancer
  • Prior chemotherapy for lymphoma

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00006721
NCT00006721Phase 3Completed

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

SWOG Cancer Research Network·interventional·Posted Jan 27, 2003·Updated Mar 16, 2026

In Brief

A Phase 3 clinical trial evaluating rituximab, cyclophosphamide, and 4 other interventions for Lymphoma. Completed, enrolled 571 participants across 259 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphoma
CountriesUnited States

Timeline

Phase 3CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartMar 1, 2001
Primary CompletionSep 1, 2011
Study CompletionDec 1, 2025
TodayJul 2, 2026
Enrollment to primary: 10.5 yearsPosted 23.4 years ago

Interventions

rituximabbiological

Given IV

cyclophosphamidedrug

Given IV

doxorubicindrug

Given IV

prednisonedrug

Given orally

vincristinedrug

Given IV

tositumomabradiation

Given IV