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

Completed · Phase 2

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT01286272

Run by

National Cancer Institute (NCI)

People needed

135

Starts

2011-04-28

Expected to finish

2025-09-02

Last updated by the study team

2025-11-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed follicular non-Hodgkin lymphoma, World Health Organization (WHO) classification grade 1, 2, or 3a (> 15 centroblasts per high-power field with centrocytes present)
• Bone marrow biopsies as the sole means of diagnosis are not acceptable, but they may be submitted in conjunction with nodal biopsies
• Fine-needle aspirates are not acceptable
• Failure to submit pathology within 60 days of patient registration will be considered a major protocol violation
• Patients must have at least one of the following indicators of poor risk disease:
• >= 3 risk factors by the Follicular Lymphoma International Prognostic Index, or 2 risk factors by the Follicular Lymphoma International Prognostic Index and at least one bulky mass or lymph node > 6 cm in size
• Follicular Lymphoma International Prognostic Index (FLIPI score):
• Age > 60 years
• Involvement of > 4 nodal sites
• Stage III-IV disease
• Hemoglobin < 12.0 g/dL
• Lactate dehydrogenase (LDH) > upper limit of normal (ULN)
• 0-1 of the above risk factors: low risk
• 2 risk factors: intermediate risk
• >= 3 risk factors: poor risk
• No prior cytotoxic chemotherapy, radiotherapy, immunotherapy, or radioimmunotherapy
• No corticosteroids are permitted, except for maintenance therapy for a non-malignant disease or to prevent treatment-related ofatumumab reactions (maintenance therapy dose must not exceed 20 mg/day prednisone or equivalent)
• Measurable disease must be present either on physical examination or imaging studies; non-measurable disease alone is not acceptable; any tumor mass > 1 cm is acceptable; lesions that are considered non-measurable include the following:
• Bone lesions
• Leptomeningeal disease
• Ascites
• Pleural/pericardial effusion
• Inflammatory breast disease
• Lymphangitis cutis/pulmonis
• Bone marrow involvement (involvement by non-Hodgkin lymphoma should be noted)

Where it is running

• Saint Helena Hospital — St. Helena, California, United States
• Middlesex Hospital — Middletown, Connecticut, United States
• Mount Sinai Medical Center — Miami Beach, Florida, United States
• Hawaii Cancer Care Inc - Waterfront Plaza — Honolulu, Hawaii, United States
• Queen's Medical Center — Honolulu, Hawaii, United States
• Straub Clinic and Hospital — Honolulu, Hawaii, United States
• Hawaii Cancer Care Inc-Liliha — Honolulu, Hawaii, United States
• Kuakini Medical Center — Honolulu, Hawaii, United States
• Kapiolani Medical Center for Women and Children — Honolulu, Hawaii, United States
• Castle Medical Center — Kailua, Hawaii, United States
• Wilcox Memorial Hospital and Kauai Medical Clinic — Lihue, Hawaii, United States
• Pali Momi Medical Center — ‘Aiea, Hawaii, United States
• Queen's Cancer Center - Pearlridge — ‘Aiea, Hawaii, United States
• Saint Alphonsus Cancer Care Center-Boise — Boise, Idaho, United States
• Kootenai Clinic Cancer Services - Post Falls — Post Falls, Idaho, United States
• University of Illinois — Chicago, Illinois, United States
• University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
• Weiss Memorial Hospital — Chicago, Illinois, United States
• Cancer Care Specialists of Illinois - Decatur — Decatur, Illinois, United States
• Decatur Memorial Hospital — Decatur, Illinois, United States
• NorthShore University HealthSystem-Evanston Hospital — Evanston, Illinois, United States
• Ingalls Memorial Hospital — Harvey, Illinois, United States
• Southern Illinois University School of Medicine — Springfield, Illinois, United States
• Springfield Clinic — Springfield, Illinois, United States
• UC San Diego Moores Cancer Center — La Jolla, California, United States

Full record on ClinicalTrials.gov

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