Ofatumumab and Bendamustine Hydrochloride With or Without Bortezomib in Treating Patients With Untreated Follicular Non-Hodgkin Lymphoma
NCT ID: NCT01286272
Last Updated: 2025-11-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
135 participants
INTERVENTIONAL
2011-04-28
2025-09-02
Brief Summary
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Detailed Description
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I. To determine the complete response (CR) rate in newly diagnosed, untreated follicular lymphoma patients receiving 6 cycles of ofatumumab-bendamustine (bendamustine hydrochloride) (ARM A) and 6 cycles of ofatumumab, bortezomib, and bendamustine (ARM B) using International Harmonization Project Response Criteria.
SECONDARY OBJECTIVES:
I. To determine progression-free survival (PFS) of patients with untreated follicular lymphoma after 6 cycles of ofatumumab-bendamustine (ARM A) followed by maintenance ofatumumab and after 6 cycles of ofatumumab, bortezomib, and bendamustine followed by maintenance ofatumumab and bortezomib (ARM B).
II. To determine the toxicity profile of ofatumumab and bendamustine and ofatumumab, bortezomib, and bendamustine in patients with untreated high-risk follicular lymphoma.
III. To determine if changes in both qualitative and semi-quantitative fludeoxyglucose (FDG)-positron-emission tomography (PET) findings at baseline, after cycle 2 (day 32-35), and at end of therapy (6-8 weeks after the last cycle of induction chemotherapy but prior to maintenance therapy) with ofatumumab-bendamustine and ofatumumab, bortezomib, and bendamustine correlate with response and PFS in patients with high-risk follicular lymphoma.
IV. To assess if a combinatorial approach using both qualitative and semi-quantitative changes in FDG-PET and computed tomography (CT) or magnetic resonance imaging (MRI) studies at baseline, after cycle 2 (day 32-35), and at end of therapy (6-8 weeks after the last cycle of induction chemotherapy prior to maintenance therapy) would result in a higher predictive value for response and PFS in patients with high-risk follicular lymphoma.
V. To correlate all molecular parameters with FDG-PET parameters in determination of response and PFS.
VI. To correlate pre-treatment single nucleotide polymorphisms with response and PFS following ofatumumab-bendamustine and ofatumumab, bortezomib, and bendamustine therapy in patients with untreated high-risk follicular lymphoma.
VII. To correlate cluster of differentiation (CD)-68, B-cell chronic lymphocytic leukemia (CLL)/lymphoma (bcl)-2, marker of proliferation Ki-67 (Ki-67), forkhead box P3 (FOXP3), activated cytotoxic T-cells, lymphoma-associated macrophages (LAM), melanoma associated antigen (mutated) 1 (MUM1), CD10, nuclear v-rel avian reticuloendotheliosis viral oncogene homolog A (p65) and v-rel avian reticuloendotheliosis viral oncogene homolog C (cREL) subunits of nuclear factor of kappa light polypeptide gene enhancer in B-cells (NFkB), and selected genetic translocations by fluorescent in situ hybridization (FISH) analysis (such as Bcl-2 and Bcl-6) with response and PFS in patients receiving initial therapy for high-risk follicular lymphoma.
VIII. To determine whether immune gene signatures previously identified as prognostic factors in follicular lymphoma can be applied to paraffin-embedded tissues in ofatumumab and bendamustine or ofatumumab, bendamustine, and bortezomib treated patients; evaluate micro-ribonucleic acid (RNA) signatures associated with these gene signatures and outcome.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM A:
INDUCTION: Patients receive ofatumumab intravenously (IV) over 2-8 hours on day 1 and bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2. Treatment repeats every 35 days for up to 6 courses. Patients without disease progression continue on to maintenance therapy.
MAINTENANCE: Beginning 8 weeks after the start of induction course 6, patients receive ofatumumab IV over 2-8 hours on day 1. Treatment repeats every 56 days for up to 4 courses.
ARM B:
INDUCTION: Patients receive ofatumumab IV over 2-8 hours on day 1, bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, and bortezomib IV over 3-5 seconds or subcutaneously (SC) on days 1, 8, 15, and 22. Treatment repeats every 35 days for up to 6 courses. Patients without disease progression continue on to maintenance therapy.
MAINTENANCE: Beginning 8 weeks after the start of induction course 6, patients receive ofatumumab IV over 2-8 hours on day 1 and bortezomib IV over 3-5 seconds or SC on days 1, 8, 15, and 22. Treatment repeats every 56 days for up to 4 courses.
After completion of study treatment, patients are followed up every 4 months for 2 years and then every 6 months for up to 10 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm B (ofatumumab, bendamustine hydrochloride, bortezomib)
INDUCTION: Patients receive ofatumumab IV over 2-8 hours on day 1, bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, and bortezomib IV over 3-5 seconds or SC on days 1, 8, 15, and 22. Treatment repeats every 35 days for up to 6 courses. Patients without disease progression continue on to maintenance therapy.
MAINTENANCE: Beginning 8 weeks after the start of induction course 6, patients receive ofatumumab IV over 2-8 hours on day 1 and bortezomib IV over 3-5 seconds or SC on days 1, 8, 15, and 22. Treatment repeats every 56 days for up to 4 courses.
Bendamustine Hydrochloride
Given IV
Bortezomib
Given IV or SC
Fludeoxyglucose F-18
Undergo FDG-PET
Laboratory Biomarker Analysis
Correlative studies
Ofatumumab
Given IV
Positron Emission Tomography with Radiolabeled Targeting Agent
Undergo FDG-PET
Arm A (ofatumumab, bendamustine hydrochloride)
INDUCTION: Patients receive ofatumumab IV over 2-8 hours on day 1 and bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2. Treatment repeats every 35 days for up to 6 courses. Patients without disease progression continue on to maintenance therapy.
MAINTENANCE: Beginning 8 weeks after the start of induction course 6, patients receive ofatumumab IV over 2-8 hours on day 1. Treatment repeats every 56 days for up to 4 courses.
Bendamustine Hydrochloride
Given IV
Fludeoxyglucose F-18
Undergo FDG-PET
Laboratory Biomarker Analysis
Correlative studies
Ofatumumab
Given IV
Positron Emission Tomography with Radiolabeled Targeting Agent
Undergo FDG-PET
Interventions
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Bendamustine Hydrochloride
Given IV
Bortezomib
Given IV or SC
Fludeoxyglucose F-18
Undergo FDG-PET
Laboratory Biomarker Analysis
Correlative studies
Ofatumumab
Given IV
Positron Emission Tomography with Radiolabeled Targeting Agent
Undergo FDG-PET
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Kristie A Blum
Role: PRINCIPAL_INVESTIGATOR
Alliance for Clinical Trials in Oncology
Locations
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UC San Diego Moores Cancer Center
La Jolla, California, United States
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
Springfield Memorial Hospital
Springfield, Illinois, United States
Fort Wayne Medical Oncology and Hematology Inc-Parkview
Fort Wayne, Indiana, United States
Franciscan Health Indianapolis
Indianapolis, Indiana, United States
Memorial Regional Cancer Center Day Road
Mishawaka, Indiana, United States
Michiana Hematology Oncology PC-Mishawaka
Mishawaka, Indiana, United States
Memorial Hospital of South Bend
South Bend, Indiana, United States
Michiana Hematology Oncology PC-Westville
Westville, Indiana, United States
Mercy Hospital
Cedar Rapids, Iowa, United States
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, United States
Siouxland Regional Cancer Center
Sioux City, Iowa, United States
Harold Alfond Center for Cancer Care
Augusta, Maine, United States
Eastern Maine Medical Center
Bangor, Maine, United States
Penobscot Bay Medical Center
Rockport, Maine, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, United States
Henry Ford Health Saint John Hospital
Detroit, Michigan, United States
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, United States
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, United States
Fairview Ridges Hospital
Burnsville, Minnesota, United States
Fairview Southdale Hospital
Edina, Minnesota, United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, United States
Minneapolis VA Medical Center
Minneapolis, Minnesota, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States
Regions Hospital
Saint Paul, Minnesota, United States
Central Care Cancer Center - Bolivar
Bolivar, Missouri, United States
MU Health - University Hospital/Ellis Fischel Cancer Center
Columbia, Missouri, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Mercy Hospital Springfield
Springfield, Missouri, United States
CoxHealth South Hospital
Springfield, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Missouri Baptist Medical Center
St Louis, Missouri, United States
Mercy Hospital Saint Louis
St Louis, Missouri, United States
Billings Clinic Cancer Center
Billings, Montana, United States
Benefis Sletten Cancer Institute
Great Falls, Montana, United States
Nevada Cancer Research Foundation NCORP
Las Vegas, Nevada, United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, United States
Hematology Oncology Associates of Central New York-East Syracuse
East Syracuse, New York, United States
Northwell Health NCORP
Lake Success, New York, United States
Northwell Health/Center for Advanced Medicine
Lake Success, New York, United States
North Shore University Hospital
Manhasset, New York, United States
Long Island Jewish Medical Center
New Hyde Park, New York, United States
NYP/Weill Cornell Medical Center
New York, New York, United States
State University of New York Upstate Medical University
Syracuse, New York, United States
Randolph Hospital
Asheboro, North Carolina, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Wayne Memorial Hospital
Goldsboro, North Carolina, United States
Cone Health Cancer Center
Greensboro, North Carolina, United States
ECU Health Oncology Kinston
Kinston, North Carolina, United States
Annie Penn Memorial Hospital
Reidsville, North Carolina, United States
Iredell Memorial Hospital
Statesville, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Altru Cancer Center
Grand Forks, North Dakota, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Miami Valley Hospital North
Dayton, Ohio, United States
Kettering Medical Center
Kettering, Ohio, United States
Toledo Clinic Cancer Centers-Maumee
Maumee, Ohio, United States
Saint Charles Hospital
Oregon, Ohio, United States
ProMedica Flower Hospital
Sylvania, Ohio, United States
Mercy Health - Saint Anne Hospital
Toledo, Ohio, United States
Toledo Clinic Cancer Centers-Toledo
Toledo, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, United States
Providence Portland Medical Center
Portland, Oregon, United States
Providence Saint Vincent Medical Center
Portland, Oregon, United States
Guthrie Medical Group PC-Robert Packer Hospital
Sayre, Pennsylvania, United States
Saint Francis Hospital
Greenville, South Carolina, United States
Saint Francis Cancer Center
Greenville, South Carolina, United States
Spartanburg Medical Center
Spartanburg, South Carolina, United States
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States
West Virginia University Healthcare
Morgantown, West Virginia, United States
Countries
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References
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Rutherford SC, Yin J, Pederson L, Perez Burbano G, LaPlant B, Shadman M, Li H, LeBlanc ML, Kenkre VP, Hong F, Blum KA, Dockter T, Martin P, Jung SH, Grant B, Rosenbaum C, Ujjani C, Barr PM, Unger JM, Cheson BD, Bartlett NL, Kahl B, Friedberg JW, Mandrekar SJ, Leonard JP. Relevance of Bone Marrow Biopsies for Response Assessment in US National Cancer Institute National Clinical Trials Network Follicular Lymphoma Clinical Trials. J Clin Oncol. 2023 Jan 10;41(2):336-342. doi: 10.1200/JCO.21.02301. Epub 2022 Jul 5.
Blum KA, Polley MY, Jung SH, Dockter TJ, Anderson S, Hsi ED, Wagner-Johnston N, Christian B, Atkins J, Cheson BD, Leonard JP, Bartlett NL. Randomized trial of ofatumumab and bendamustine versus ofatumumab, bendamustine, and bortezomib in previously untreated patients with high-risk follicular lymphoma: CALGB 50904 (Alliance). Cancer. 2019 Oct 1;125(19):3378-3389. doi: 10.1002/cncr.32289. Epub 2019 Jun 7.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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NCI-2011-02625
Identifier Type: REGISTRY
Identifier Source: secondary_id
CALGB-50904
Identifier Type: -
Identifier Source: secondary_id
CDR0000694298
Identifier Type: -
Identifier Source: secondary_id
CALGB-50904
Identifier Type: OTHER
Identifier Source: secondary_id
CALGB-50904
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2011-02625
Identifier Type: -
Identifier Source: org_study_id
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