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)
- Diseases
- Follicular lymphoma
- 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
Sites (96)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Queen's Cancer Center - Pearlridge Coordinator of this site? Confirm its status | ‘Aiea | United States | Unknown status |
| Pali Momi Medical Center Coordinator of this site? Confirm its status | ‘Aiea | United States | Unknown status |
| Trinity Health Saint Joseph Mercy Hospital Ann Arbor Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| Randolph Hospital Coordinator of this site? Confirm its status | Asheboro | United States | Unknown status |
| Harold Alfond Center for Cancer Care Coordinator of this site? Confirm its status | Augusta | United States | Unknown status |
| Sinai Hospital of Baltimore Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Eastern Maine Medical Center Coordinator of this site? Confirm its status | Bangor | United States | Unknown status |
| Billings Clinic Cancer Center Coordinator of this site? Confirm its status | Billings | United States | Unknown status |
| Saint Alphonsus Cancer Care Center-Boise Coordinator of this site? Confirm its status | Boise | United States | Unknown status |
| Central Care Cancer Center - Bolivar Coordinator of this site? Confirm its status | Bolivar | United States | Unknown status |
| Fairview Ridges Hospital Coordinator of this site? Confirm its status | Burnsville | United States | Unknown status |
| Mercy Hospital Coordinator of this site? Confirm its status | Cedar Rapids | United States | Unknown status |
| Oncology Associates at Mercy Medical Center Coordinator of this site? Confirm its status | Cedar Rapids | United States | Unknown status |
| UNC Lineberger Comprehensive Cancer Center Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| Weiss Memorial Hospital Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| University of Illinois Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| University of Chicago Comprehensive Cancer Center Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| MU Health - University Hospital/Ellis Fischel Cancer Center Coordinator of this site? Confirm its status | Columbia | United States | Unknown status |
| Ohio State University Comprehensive Cancer Center Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Miami Valley Hospital North Coordinator of this site? Confirm its status | Dayton | United States | Unknown status |
| Decatur Memorial Hospital Coordinator of this site? Confirm its status | Decatur | United States | Unknown status |
| Cancer Care Specialists of Illinois - Decatur Coordinator of this site? Confirm its status | Decatur | United States | Unknown status |
| Henry Ford Health Saint John Hospital Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| Hematology Oncology Associates of Central New York-East Syracuse Coordinator of this site? Confirm its status | East Syracuse | United States | Unknown status |
| Fairview Southdale Hospital Coordinator of this site? Confirm its status | Edina | United States | Unknown status |
| NorthShore University HealthSystem-Evanston Hospital Coordinator of this site? Confirm its status | Evanston | United States | Unknown status |
| Fort Wayne Medical Oncology and Hematology Inc-Parkview Coordinator of this site? Confirm its status | Fort Wayne | United States | Unknown status |
| Wayne Memorial Hospital Coordinator of this site? Confirm its status | Goldsboro | United States | Unknown status |
| Altru Cancer Center Coordinator of this site? Confirm its status | Grand Forks | United States | Unknown status |
| Trinity Health Grand Rapids Hospital Coordinator of this site? Confirm its status | Grand Rapids | United States | Unknown status |
| Corewell Health Grand Rapids Hospitals - Butterworth Hospital Coordinator of this site? Confirm its status | Grand Rapids | United States | Unknown status |
| Benefis Sletten Cancer Institute Coordinator of this site? Confirm its status | Great Falls | United States | Unknown status |
| Cone Health Cancer Center Coordinator of this site? Confirm its status | Greensboro | United States | Unknown status |
| Saint Francis Cancer Center Coordinator of this site? Confirm its status | Greenville | United States | Unknown status |
| Saint Francis Hospital Coordinator of this site? Confirm its status | Greenville | United States | Unknown status |
| Ingalls Memorial Hospital Coordinator of this site? Confirm its status | Harvey | United States | Unknown status |
| Kuakini Medical Center Coordinator of this site? Confirm its status | Honolulu | United States | Unknown status |
| Queen's Medical Center Coordinator of this site? Confirm its status | Honolulu | United States | Unknown status |
| Hawaii Cancer Care Inc - Waterfront Plaza Coordinator of this site? Confirm its status | Honolulu | United States | Unknown status |
| Straub Clinic and Hospital Coordinator of this site? Confirm its status | Honolulu | United States | Unknown status |
| Kapiolani Medical Center for Women and Children Coordinator of this site? Confirm its status | Honolulu | United States | Unknown status |
| Hawaii Cancer Care Inc-Liliha Coordinator of this site? Confirm its status | Honolulu | United States | Unknown status |
| Franciscan Health Indianapolis Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| Castle Medical Center Coordinator of this site? Confirm its status | Kailua | United States | Unknown status |
| Saint Luke's Hospital of Kansas City Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| Kettering Medical Center Coordinator of this site? Confirm its status | Kettering | United States | Unknown status |
| ECU Health Oncology Kinston Coordinator of this site? Confirm its status | Kinston | United States | Unknown status |
| UC San Diego Moores Cancer Center Coordinator of this site? Confirm its status | La Jolla | United States | Unknown status |
| Northwell Health NCORP Coordinator of this site? Confirm its status | Lake Success | United States | Unknown status |
| Northwell Health/Center for Advanced Medicine Coordinator of this site? Confirm its status | Lake Success | United States | Unknown status |
| Nevada Cancer Research Foundation NCORP Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Coordinator of this site? Confirm its status | Lebanon | United States | Unknown status |
| Wilcox Memorial Hospital and Kauai Medical Clinic Coordinator of this site? Confirm its status | Lihue | United States | Unknown status |
| North Shore University Hospital Coordinator of this site? Confirm its status | Manhasset | United States | Unknown status |
| Saint John's Hospital - Healtheast Coordinator of this site? Confirm its status | Maplewood | United States | Unknown status |
| Minnesota Oncology Hematology PA-Maplewood Coordinator of this site? Confirm its status | Maplewood | United States | Unknown status |
| Toledo Clinic Cancer Centers-Maumee Coordinator of this site? Confirm its status | Maumee | United States | Unknown status |
| Mount Sinai Medical Center Coordinator of this site? Confirm its status | Miami Beach | United States | Unknown status |
| Middlesex Hospital Coordinator of this site? Confirm its status | Middletown | United States | Unknown status |
| Minneapolis VA Medical Center Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| Memorial Regional Cancer Center Day Road Coordinator of this site? Confirm its status | Mishawaka | United States | Unknown status |
| Michiana Hematology Oncology PC-Mishawaka Coordinator of this site? Confirm its status | Mishawaka | United States | Unknown status |
| West Virginia University Healthcare Coordinator of this site? Confirm its status | Morgantown | United States | Unknown status |
| Long Island Jewish Medical Center Coordinator of this site? Confirm its status | New Hyde Park | United States | Unknown status |
| NYP/Weill Cornell Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Mercy Hospital Oklahoma City Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
| University of Oklahoma Health Sciences Center Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
| Saint Charles Hospital Coordinator of this site? Confirm its status | Oregon | United States | Unknown status |
| Providence Saint Vincent Medical Center Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Providence Portland Medical Center Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Kootenai Clinic Cancer Services - Post Falls Coordinator of this site? Confirm its status | Post Falls | United States | Unknown status |
| Annie Penn Memorial Hospital Coordinator of this site? Confirm its status | Reidsville | United States | Unknown status |
| VCU Massey Comprehensive Cancer Center Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
| Penobscot Bay Medical Center Coordinator of this site? Confirm its status | Rockport | United States | Unknown status |
| Park Nicollet Clinic - Saint Louis Park Coordinator of this site? Confirm its status | Saint Louis Park | United States | Unknown status |
| Regions Hospital Coordinator of this site? Confirm its status | Saint Paul | United States | Unknown status |
| Guthrie Medical Group PC-Robert Packer Hospital Coordinator of this site? Confirm its status | Sayre | United States | Unknown status |
| Siouxland Regional Cancer Center Coordinator of this site? Confirm its status | Sioux City | United States | Unknown status |
| Memorial Hospital of South Bend Coordinator of this site? Confirm its status | South Bend | United States | Unknown status |
| Spartanburg Medical Center Coordinator of this site? Confirm its status | Spartanburg | United States | Unknown status |
| Mercy Hospital Springfield Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| Springfield Memorial Hospital Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| Springfield Clinic Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| Southern Illinois University School of Medicine Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| CoxHealth South Hospital Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| Iredell Memorial Hospital Coordinator of this site? Confirm its status | Statesville | United States | Unknown status |
| Saint Helena Hospital Coordinator of this site? Confirm its status | St. Helena | United States | Unknown status |
| Mercy Hospital Saint Louis Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Missouri Baptist Medical Center Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| ProMedica Flower Hospital Coordinator of this site? Confirm its status | Sylvania | United States | Unknown status |
| State University of New York Upstate Medical University Coordinator of this site? Confirm its status | Syracuse | United States | Unknown status |
| Toledo Clinic Cancer Centers-Toledo Coordinator of this site? Confirm its status | Toledo | United States | Unknown status |
| Mercy Health - Saint Anne Hospital Coordinator of this site? Confirm its status | Toledo | United States | Unknown status |
| Michiana Hematology Oncology PC-Westville Coordinator of this site? Confirm its status | Westville | United States | Unknown status |
| Wake Forest University Health Sciences Coordinator of this site? Confirm its status | Winston-Salem | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.