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NCT01286272CompletedPhase 2

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

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

Source: ClinicalTrials.gov · Last updated 24 Nov 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
135 (actual)
First submitted
27 Jan 2011
Start date
28 Apr 2011
Primary completion date
24 May 2017
Lead sponsor
National Cancer Institute (NCI)
NCT number
NCT01286272

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 135
  • From 28 Apr 2011 to the primary completion date, 24 May 2017
  • 96 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

  • 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)
  • Patients must have no known central nervous system (CNS) involvement by lymphoma
  • Patients must have Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Patients must be non-pregnant and non-nursing; pregnant or nursing patients may not be enrolled; women of childbearing potential must have a negative serum or urine pregnancy test within 14 days prior to registration; in addition, women and men of childbearing potential must commit to use an effective form of contraception throughout their participation in this study; appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives (Norplant), or double barrier method (diaphragm plus condom)
  • Patients with human immunodeficiency virus (HIV) infection are eligible; patients with HIV infection must meet the following: no evidence of co-infection with hepatitis B or C; CD4+ count \> 400/ul; no evidence of resistant strains of HIV; on anti-HIV therapy with an HIV viral load \< 50 copies HIV RNA/mL; no history of acquired immunodeficiency syndrome (AIDS)-defining conditions; no zidovudine or stavudine are allowed owing to overlapping toxicity with chemotherapy
  • Patients must have no evidence of active hepatitis B or C infection (i.e., no positive serology for anti-hepatitis B core \[HBc\] or anti-hepatitis C virus \[HCV\] antibodies); hepatitis B virus (HBV) seropositive patients (hepatitis B surface antigen \[HBsAg\] +) are eligible if HBV deoxyribonucleic acid (DNA) is undetectable at baseline and they are closely monitored for evidence of active HBV infection by HBV DNA testing at each treatment cycle; after completing treatment, HBsAg + patients must be monitored by HBV DNA testing every 2 months for 6 months post-treatment, while continuing lamivudine
  • Granulocytes \>= 1,000/uL
  • Platelet count \>= 75,000/uL
  • Creatinine =\< 2.0 mg/dL
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x upper limits of normal (ULN)
  • Bilirubin =\< 2 x ULN

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (96)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Queen's Cancer Center - Pearlridge
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‘AieaUnited StatesUnknown status
Pali Momi Medical Center
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‘AieaUnited StatesUnknown status
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
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Ann ArborUnited StatesUnknown status
Randolph Hospital
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AsheboroUnited StatesUnknown status
Harold Alfond Center for Cancer Care
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AugustaUnited StatesUnknown status
Sinai Hospital of Baltimore
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BaltimoreUnited StatesUnknown status
Eastern Maine Medical Center
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BangorUnited StatesUnknown status
Billings Clinic Cancer Center
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BillingsUnited StatesUnknown status
Saint Alphonsus Cancer Care Center-Boise
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BoiseUnited StatesUnknown status
Central Care Cancer Center - Bolivar
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BolivarUnited StatesUnknown status
Fairview Ridges Hospital
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BurnsvilleUnited StatesUnknown status
Mercy Hospital
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Cedar RapidsUnited StatesUnknown status
Oncology Associates at Mercy Medical Center
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Cedar RapidsUnited StatesUnknown status
UNC Lineberger Comprehensive Cancer Center
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Chapel HillUnited StatesUnknown status
Weiss Memorial Hospital
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ChicagoUnited StatesUnknown status
University of Illinois
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ChicagoUnited StatesUnknown status
University of Chicago Comprehensive Cancer Center
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ChicagoUnited StatesUnknown status
MU Health - University Hospital/Ellis Fischel Cancer Center
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ColumbiaUnited StatesUnknown status
Ohio State University Comprehensive Cancer Center
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ColumbusUnited StatesUnknown status
Miami Valley Hospital North
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DaytonUnited StatesUnknown status
Decatur Memorial Hospital
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DecaturUnited StatesUnknown status
Cancer Care Specialists of Illinois - Decatur
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DecaturUnited StatesUnknown status
Henry Ford Health Saint John Hospital
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DetroitUnited StatesUnknown status
Hematology Oncology Associates of Central New York-East Syracuse
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East SyracuseUnited StatesUnknown status
Fairview Southdale Hospital
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EdinaUnited StatesUnknown status
NorthShore University HealthSystem-Evanston Hospital
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EvanstonUnited StatesUnknown status
Fort Wayne Medical Oncology and Hematology Inc-Parkview
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Fort WayneUnited StatesUnknown status
Wayne Memorial Hospital
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GoldsboroUnited StatesUnknown status
Altru Cancer Center
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Grand ForksUnited StatesUnknown status
Trinity Health Grand Rapids Hospital
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Grand RapidsUnited StatesUnknown status
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
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Grand RapidsUnited StatesUnknown status
Benefis Sletten Cancer Institute
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Great FallsUnited StatesUnknown status
Cone Health Cancer Center
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GreensboroUnited StatesUnknown status
Saint Francis Cancer Center
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GreenvilleUnited StatesUnknown status
Saint Francis Hospital
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GreenvilleUnited StatesUnknown status
Ingalls Memorial Hospital
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HarveyUnited StatesUnknown status
Kuakini Medical Center
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HonoluluUnited StatesUnknown status
Queen's Medical Center
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HonoluluUnited StatesUnknown status
Hawaii Cancer Care Inc - Waterfront Plaza
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HonoluluUnited StatesUnknown status
Straub Clinic and Hospital
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HonoluluUnited StatesUnknown status
Kapiolani Medical Center for Women and Children
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HonoluluUnited StatesUnknown status
Hawaii Cancer Care Inc-Liliha
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HonoluluUnited StatesUnknown status
Franciscan Health Indianapolis
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IndianapolisUnited StatesUnknown status
Castle Medical Center
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KailuaUnited StatesUnknown status
Saint Luke's Hospital of Kansas City
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Kansas CityUnited StatesUnknown status
Kettering Medical Center
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KetteringUnited StatesUnknown status
ECU Health Oncology Kinston
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KinstonUnited StatesUnknown status
UC San Diego Moores Cancer Center
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La JollaUnited StatesUnknown status
Northwell Health NCORP
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Lake SuccessUnited StatesUnknown status
Northwell Health/Center for Advanced Medicine
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Lake SuccessUnited StatesUnknown status
Nevada Cancer Research Foundation NCORP
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Las VegasUnited StatesUnknown status
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
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LebanonUnited StatesUnknown status
Wilcox Memorial Hospital and Kauai Medical Clinic
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LihueUnited StatesUnknown status
North Shore University Hospital
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ManhassetUnited StatesUnknown status
Saint John's Hospital - Healtheast
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MaplewoodUnited StatesUnknown status
Minnesota Oncology Hematology PA-Maplewood
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MaplewoodUnited StatesUnknown status
Toledo Clinic Cancer Centers-Maumee
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MaumeeUnited StatesUnknown status
Mount Sinai Medical Center
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Miami BeachUnited StatesUnknown status
Middlesex Hospital
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MiddletownUnited StatesUnknown status
Minneapolis VA Medical Center
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MinneapolisUnited StatesUnknown status
Memorial Regional Cancer Center Day Road
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MishawakaUnited StatesUnknown status
Michiana Hematology Oncology PC-Mishawaka
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MishawakaUnited StatesUnknown status
West Virginia University Healthcare
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MorgantownUnited StatesUnknown status
Long Island Jewish Medical Center
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New Hyde ParkUnited StatesUnknown status
NYP/Weill Cornell Medical Center
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New YorkUnited StatesUnknown status
Mercy Hospital Oklahoma City
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Oklahoma CityUnited StatesUnknown status
University of Oklahoma Health Sciences Center
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Oklahoma CityUnited StatesUnknown status
Saint Charles Hospital
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OregonUnited StatesUnknown status
Providence Saint Vincent Medical Center
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PortlandUnited StatesUnknown status
Providence Portland Medical Center
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PortlandUnited StatesUnknown status
Kootenai Clinic Cancer Services - Post Falls
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Post FallsUnited StatesUnknown status
Annie Penn Memorial Hospital
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ReidsvilleUnited StatesUnknown status
VCU Massey Comprehensive Cancer Center
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RichmondUnited StatesUnknown status
Penobscot Bay Medical Center
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RockportUnited StatesUnknown status
Park Nicollet Clinic - Saint Louis Park
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Saint Louis ParkUnited StatesUnknown status
Regions Hospital
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Saint PaulUnited StatesUnknown status
Guthrie Medical Group PC-Robert Packer Hospital
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SayreUnited StatesUnknown status
Siouxland Regional Cancer Center
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Sioux CityUnited StatesUnknown status
Memorial Hospital of South Bend
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South BendUnited StatesUnknown status
Spartanburg Medical Center
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SpartanburgUnited StatesUnknown status
Mercy Hospital Springfield
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SpringfieldUnited StatesUnknown status
Springfield Memorial Hospital
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SpringfieldUnited StatesUnknown status
Springfield Clinic
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SpringfieldUnited StatesUnknown status
Southern Illinois University School of Medicine
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SpringfieldUnited StatesUnknown status
CoxHealth South Hospital
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SpringfieldUnited StatesUnknown status
Iredell Memorial Hospital
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StatesvilleUnited StatesUnknown status
Saint Helena Hospital
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St. HelenaUnited StatesUnknown status
Mercy Hospital Saint Louis
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St LouisUnited StatesUnknown status
Missouri Baptist Medical Center
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St LouisUnited StatesUnknown status
Washington University School of Medicine
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St LouisUnited StatesUnknown status
ProMedica Flower Hospital
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SylvaniaUnited StatesUnknown status
State University of New York Upstate Medical University
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SyracuseUnited StatesUnknown status
Toledo Clinic Cancer Centers-Toledo
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ToledoUnited StatesUnknown status
Mercy Health - Saint Anne Hospital
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ToledoUnited StatesUnknown status
Michiana Hematology Oncology PC-Westville
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WestvilleUnited StatesUnknown status
Wake Forest University Health Sciences
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Winston-SalemUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.