CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 135 enrolled
Drug / intervention
Bendamustine Hydrochloride +5 moredrug
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/NCT01286272
NCT01286272Phase 2Completed

A Randomized Phase II Trial of Ofatumumab and Bendamustine vs. Ofatumumab, Bortezomib (NSC # 681239) and Bendamustine in Patients With Untreated Follicular Lymphoma

National Cancer Institute (NCI)·interventional·Posted Jan 31, 2011·Updated Nov 24, 2025

In Brief

A Phase 2 clinical trial evaluating Bendamustine Hydrochloride, Bortezomib, and 4 other interventions for Ann Arbor Stage III Grade 1 Follicular Lymphoma and 6 related conditions. Completed, enrolled 135 participants across 96 sites.

Detailed Summary

This randomized phase II trial studies how well ofatumumab and bendamustine hydrochloride with or without bortezomib works in treating patients with untreated follicular non-Hodgkin lymphoma. Monoclonal antibodies, such as ofatumumab, may block cancer growth in different ways by targeting certain cells. Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Bortezomib may also stop the growth of cancer cells by blocking blood flow to the tumor. It is not yet known whether ofatumumab and bendamustine hydrochloride are more effective with bortezomib in treating patients with follicular non-Hodgkin lymphoma.

Study Details

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 31, 2011
Enrollment StartApr 28, 2011
Primary CompletionMay 24, 2017
Study CompletionSep 2, 2025
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 15.4 years ago

Interventions

Bendamustine Hydrochloridedrug

Given IV

Bortezomibdrug

Given IV or SC

Fludeoxyglucose F-18radiation

Undergo FDG-PET

Laboratory Biomarker Analysisother

Correlative studies

Ofatumumabbiological

Given IV

Positron Emission Tomography with Radiolabeled Targeting Agentprocedure

Undergo FDG-PET