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Ofatumumab and Bendamustine Hydrochloride With or Without Bortezomib in Treating Patients With Untreated Follicular Non-Hodgkin Lymphoma

NCT01286272 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2025-11-24

Study results available
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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.

Conditions

  • Ann Arbor Stage III Grade 1 Follicular Lymphoma
  • Ann Arbor Stage III Grade 2 Follicular Lymphoma
  • Ann Arbor Stage III Grade 3 Follicular Lymphoma
  • Ann Arbor Stage IV Grade 1 Follicular Lymphoma
  • Ann Arbor Stage IV Grade 2 Follicular Lymphoma
  • Ann Arbor Stage IV Grade 3 Follicular Lymphoma
  • Grade 3a Follicular Lymphoma

Interventions

DRUG

Bendamustine Hydrochloride

Given IV

DRUG

Bortezomib

Given IV or SC

RADIATION

Fludeoxyglucose F-18

Undergo FDG-PET

OTHER

Laboratory Biomarker Analysis

Correlative studies

BIOLOGICAL

Ofatumumab

Given IV

PROCEDURE

Positron Emission Tomography with Radiolabeled Targeting Agent

Undergo FDG-PET

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Kristie A Blum · Alliance for Clinical Trials in Oncology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-28
Primary Completion
2017-05-24
Completion
2025-09-02

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01286272 on ClinicalTrials.gov