New combo therapy shows promise for lymphoma patients
NCT ID NCT01286272
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at two different drug combinations for people with a type of blood cancer called follicular lymphoma that had not been treated before. One group received ofatumumab and bendamustine, while the other got those two drugs plus bortezomib. The goal was to see which combination led to more complete remissions, where all signs of cancer disappear. The trial involved 135 adults with stage III or IV disease.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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135 people
The number who actually took part.
- Started
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Apr 2011
- Finished
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Sep 2025
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Altru Cancer Center
Grand Forks, North Dakota, 58201, United States
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Annie Penn Memorial Hospital
Reidsville, North Carolina, 27320, United States
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Benefis Sletten Cancer Institute
Great Falls, Montana, 59405, United States
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Billings Clinic Cancer Center
Billings, Montana, 59101, United States
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Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526, United States
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Castle Medical Center
Kailua, Hawaii, 96734, United States
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Central Care Cancer Center - Bolivar
Bolivar, Missouri, 65613, United States
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Cone Health Cancer Center
Greensboro, North Carolina, 27403, United States
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Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503, United States
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CoxHealth South Hospital
Springfield, Missouri, 65807, United States
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Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756, United States
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Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
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ECU Health Oncology Kinston
Kinston, North Carolina, 28501, United States
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Eastern Maine Medical Center
Bangor, Maine, 04401, United States
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Fairview Ridges Hospital
Burnsville, Minnesota, 55337, United States
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Fairview Southdale Hospital
Edina, Minnesota, 55435, United States
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Fort Wayne Medical Oncology and Hematology Inc-Parkview
Fort Wayne, Indiana, 46845, United States
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Franciscan Health Indianapolis
Indianapolis, Indiana, 46237, United States
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Guthrie Medical Group PC-Robert Packer Hospital
Sayre, Pennsylvania, 18840, United States
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Harold Alfond Center for Cancer Care
Augusta, Maine, 04330, United States
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Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii, 96813, United States
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Hawaii Cancer Care Inc-Liliha
Honolulu, Hawaii, 96817, United States
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Hematology Oncology Associates of Central New York-East Syracuse
East Syracuse, New York, 13057, United States
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Henry Ford Health Saint John Hospital
Detroit, Michigan, 48236, United States
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Ingalls Memorial Hospital
Harvey, Illinois, 60426, United States
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Iredell Memorial Hospital
Statesville, North Carolina, 28677, United States
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Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826, United States
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Kettering Medical Center
Kettering, Ohio, 45429, United States
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Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, 83854, United States
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Kuakini Medical Center
Honolulu, Hawaii, 96817, United States
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Long Island Jewish Medical Center
New Hyde Park, New York, 11040, United States
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MU Health - University Hospital/Ellis Fischel Cancer Center
Columbia, Missouri, 65212, United States
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Memorial Hospital of South Bend
South Bend, Indiana, 46601, United States
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Memorial Regional Cancer Center Day Road
Mishawaka, Indiana, 46545, United States
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Mercy Health - Saint Anne Hospital
Toledo, Ohio, 43623, United States
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Mercy Hospital
Cedar Rapids, Iowa, 52403, United States
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Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, 73120, United States
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Mercy Hospital Saint Louis
St Louis, Missouri, 63141, United States
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Mercy Hospital Springfield
Springfield, Missouri, 65804, United States
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Miami Valley Hospital North
Dayton, Ohio, 45415, United States
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Michiana Hematology Oncology PC-Mishawaka
Mishawaka, Indiana, 46545, United States
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Michiana Hematology Oncology PC-Westville
Westville, Indiana, 46391, United States
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Middlesex Hospital
Middletown, Connecticut, 06457, United States
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Minneapolis VA Medical Center
Minneapolis, Minnesota, 55417, United States
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Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109, United States
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Missouri Baptist Medical Center
St Louis, Missouri, 63131, United States
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Mount Sinai Medical Center
Miami Beach, Florida, 33140, United States
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NYP/Weill Cornell Medical Center
New York, New York, 10065, United States
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Nevada Cancer Research Foundation NCORP
Las Vegas, Nevada, 89120, United States
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North Shore University Hospital
Manhasset, New York, 11030, United States
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NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, 60201, United States
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Northwell Health NCORP
Lake Success, New York, 11042, United States
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Northwell Health/Center for Advanced Medicine
Lake Success, New York, 11042, United States
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Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
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Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, 52403, United States
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Pali Momi Medical Center
‘Aiea, Hawaii, 96701, United States
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Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416, United States
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Penobscot Bay Medical Center
Rockport, Maine, 04856, United States
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ProMedica Flower Hospital
Sylvania, Ohio, 43560, United States
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Providence Portland Medical Center
Portland, Oregon, 97213, United States
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Providence Saint Vincent Medical Center
Portland, Oregon, 97225, United States
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Queen's Cancer Center - Pearlridge
‘Aiea, Hawaii, 96701, United States
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Queen's Medical Center
Honolulu, Hawaii, 96813, United States
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Randolph Hospital
Asheboro, North Carolina, 27203, United States
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Regions Hospital
Saint Paul, Minnesota, 55101, United States
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Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706, United States
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Saint Charles Hospital
Oregon, Ohio, 43616, United States
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Saint Francis Cancer Center
Greenville, South Carolina, 29607, United States
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Saint Francis Hospital
Greenville, South Carolina, 29601, United States
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Saint Helena Hospital
St. Helena, California, 94574, United States
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Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109, United States
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Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111, United States
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Sinai Hospital of Baltimore
Baltimore, Maryland, 21215, United States
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Siouxland Regional Cancer Center
Sioux City, Iowa, 51101, United States
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Southern Illinois University School of Medicine
Springfield, Illinois, 62702, United States
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Spartanburg Medical Center
Spartanburg, South Carolina, 29303, United States
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Springfield Clinic
Springfield, Illinois, 62702, United States
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Springfield Memorial Hospital
Springfield, Illinois, 62781, United States
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State University of New York Upstate Medical University
Syracuse, New York, 13210, United States
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Straub Clinic and Hospital
Honolulu, Hawaii, 96813, United States
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Toledo Clinic Cancer Centers-Maumee
Maumee, Ohio, 43537, United States
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Toledo Clinic Cancer Centers-Toledo
Toledo, Ohio, 43623, United States
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Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, 49503, United States
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Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106, United States
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UC San Diego Moores Cancer Center
La Jolla, California, 92093, United States
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UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599, United States
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University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
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University of Illinois
Chicago, Illinois, 60612, United States
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University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
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VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298, United States
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Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
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Washington University School of Medicine
St Louis, Missouri, 63110, United States
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Wayne Memorial Hospital
Goldsboro, North Carolina, 27534, United States
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Weiss Memorial Hospital
Chicago, Illinois, 60640, United States
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West Virginia University Healthcare
Morgantown, West Virginia, 26506, United States
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Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue, Hawaii, 96766, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can two immune boosters outsmart follicular lymphoma without chemo?
- Triple-Drug cocktail aims to boost remission in follicular lymphoma
- New drug combo shows promise for untreated lymphoma patients
- New drug cocktail aims to shrink lymphoma tumors without chemo
- New drug cocktail aims to shrink lymphoma without chemo
- New drug duo aims to control lymphoma without chemo