CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 373 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/NCT01415752
NCT01415752Phase 2Active

Intergroup Randomized Phase 2 Four Arm Study In Patients ≥ 60 With Previously Untreated Mantle Cell Lymphoma Of Therapy With: Arm A = Rituximab+ Bendamustine Followed By Rituximab Consolidation (RB → R); Arm B = Rituximab + Bendamustine + Bortezomib Followed By Rituximab Consolidation (RBV→ R), Arm C = Rituximab + Bendamustine Followed By Lenalidomide + Rituximab Consolidation (RB → LR) or Arm D = Rituximab + Bendamustine + Bortezomib Followed By Lenalidomide + Rituximab Consolidation (RBV → LR)

Eastern Cooperative Oncology Group·interventional·Posted Aug 12, 2011·Updated Jun 3, 2026

In Brief

A Phase 2 clinical trial evaluating rituximab, Bendamustine, and 2 other interventions for Lymphoma and Mantle Cell Lymphoma. Active but no longer recruiting, targeting 373 participants across 418 sites in 2 countries.

Detailed Summary

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as bendamustine hydrochloride, also work in different ways to kill cancer cells or stop them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide may stop the growth of mantle cell lymphoma by blocking blood flow to the cancer. It is not yet known whether giving rituximab together with bendamustine and bortezomib is more effective than rituximab and bendamustine, followed by rituximab alone or with lenalidomide in treating mantle cell lymphoma. PURPOSE: This randomized phase II trial studies rituximab, bortezomib, bendamustine, and lenalidomide in treating previously untreated older patients with mantle cell lymphoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, United States

Timeline

Phase 2Active
201220132014201520162017201820192020202120222023202420252026202720282029203020312032
First PostedAug 12, 2011
Enrollment StartAug 9, 2012
Primary CompletionFeb 25, 2023
Study CompletionSep 1, 2031
TodayJul 2, 2026
Enrollment to primary: 10.5 yearsPosted 14.9 years ago

Interventions

rituximabbiological

Given IV

Bendamustinedrug

Given IV

bortezomibdrug

Given IV or SC

lenalidomidedrug

Given PO