CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 289 enrolled
Drug / intervention
rituximab +3 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT01216683
NCT01216683Phase 2Completed

A 3-Arm Randomized Phase II Trial of Bendamustine-Rituximab (BR) Followed by Rituximab vs Bortezomib-BR (BVR) Followed by Rituximab vs BR Followed by Lenalidomide/Rituximab in High Risk Follicular Lymphoma

ECOG-ACRIN Cancer Research Group·interventional·Posted Oct 7, 2010·Updated Jun 29, 2023

In Brief

A Phase 2 clinical trial evaluating rituximab, Bendamustin, and 2 other interventions for Lymphoma. Completed, enrolled 289 participants across 227 sites.

Detailed Summary

RATIONALE: Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. It is not yet known whether giving bendamustine hydrochloride and rituximab together alone is more effective than giving bendamustine hydrochloride and rituximab together with bortezomib or lenalidomide in treating follicular lymphoma. PURPOSE: This randomized phase II trial is studying giving bendamustine hydrochloride and rituximab together with or without bortezomib followed by rituximab with or without lenalidomide to see how well they work in treating patients with high-risk stage II, stage III, or stage IV follicular lymphoma.

Study Details

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

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 7, 2010
Enrollment StartFeb 9, 2011
Primary CompletionDec 2, 2019
TodayJul 2, 2026
Enrollment to primary: 8.8 yearsPosted 15.7 years ago

Interventions

rituximabbiological

Given IV

Bendamustindrug

Given IV

bortezomibdrug

Given IV

lenalidomidedrug

Given orally