CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 545 enrolled
Drug / intervention
rituximabbiological
Likely dose
Not stated in record
Key inclusion· 5
  • Histologically confirmed indolent NHL: follicular grade 1-2, small lymphocytic, marginal zone (nodal or splenic), or MALT
  • Stage III or IV disease
  • Low tumor burden: no nodal/extranodal mass ≥7 cm, <3 nodal masses >3 cm, no B symptoms, splenomegaly ≤16 cm on CT, no vital organ compression risk, no leukemic phase >5000/mm³ lymphocytes, no cytopenias
  • At least 1 objective measurable disease parameter (abnormal PET only if verified by CT or other imaging)
Key exclusion· 7
  • Evidence of transformation to large cell histology
  • Prior chemotherapy for lymphoma
  • Prior immunotherapy for lymphoma
  • Prior radiotherapy for lymphoma

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

Search/NCT00075946
NCT00075946Phase 3Completed

Randomized Phase III Trial Comparing Two Different Rituximab Dosing Regimens For Patients With Low Tumor Burden Indolent Non-Hodgkin's Lymphoma

Eastern Cooperative Oncology Group·interventional·Posted Jan 14, 2004·Updated Feb 1, 2024

In Brief

A Phase 3 clinical trial evaluating rituximab for Lymphoma. Completed, enrolled 545 participants across 483 sites.

Detailed Summary

RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known which rituximab regimen is more effective in treating indolent non-Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is studying two different schedules of rituximab and comparing them to see how well they work in treating patients with low tumor burden indolent stage III non-Hodgkin's lymphoma or stage IV non-Hodgkin's lymphoma.

Study Details

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

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 14, 2004
Enrollment StartJan 23, 2004
Primary CompletionSep 1, 2013
Study CompletionAug 1, 2021
TodayJul 2, 2026
Enrollment to primary: 9.6 yearsPosted 22.5 years ago

Interventions

rituximabbiological

Given IV