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
5 other identifiers
interventional
135
1 country
96
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2011
Longer than P75 for phase_2
96 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 27, 2011
CompletedFirst Posted
Study publicly available on registry
January 31, 2011
CompletedStudy Start
First participant enrolled
April 28, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 24, 2017
CompletedResults Posted
Study results publicly available
January 10, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 2, 2025
CompletedNovember 24, 2025
October 1, 2025
6.1 years
January 27, 2011
October 12, 2018
November 7, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Complete Response Rate
A complete response was defined using International Harmonization Project Response Criteria as the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. If the bone marrow was involved by lymphoma before treatment, the infiltrate must have cleared on repeat bone marrow biopsy. The complete response (CR) rate was calculated in newly diagnosed untreated follicular lymphoma patients receiving 6 cycles of ofatumumab-bendamustine (ARM A) and 6 cycles of ofatumumab, bortezomib, and bendamustine (ARM B). The complete response rate was calculated as the number of patients with a complete response divided by the number of patients eligible for evaluation.
From date of randomization until patient stops treatment for any reason, up to 484 days post-randomization
Secondary Outcomes (2)
Progression-free Survival (PFS)
Up to 4 years
The Number of Patients Who Experienced Grade 3+ Hematologic and Non-hematologic Adverse Events at Least Possibly Related to Treatment
From date of randomization until patient stops treatment for any reason, up to 484 days post-randomization
Other Outcomes (3)
Pre-treatment Single Nucleotide Polymorphisms (SNP)
Up to 10 years
Immunohistochemical (IHC) Markers
Up to 10 years
Predictive Value of Fludeoxyglucose-positron-emission Tomography
Up to 36-38 weeks (6-8 weeks after course 6, day 1 after last course of induction chemotherapy)
Study Arms (2)
Arm A (ofatumumab, bendamustine hydrochloride)
EXPERIMENTALINDUCTION: 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.
Arm B (ofatumumab, bendamustine hydrochloride, bortezomib)
EXPERIMENTALINDUCTION: 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.
Interventions
Given IV
Given IV or SC
Undergo FDG-PET
Correlative studies
Given IV
Undergo FDG-PET
Eligibility Criteria
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)
- of the above risk factors: low risk
- risk factors: intermediate risk
- \>= 3 risk factors: poor risk
- +20 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (96)
UC San Diego Moores Cancer Center
La Jolla, California, 92093, United States
Saint Helena Hospital
St. Helena, California, 94574, United States
Middlesex Hospital
Middletown, Connecticut, 06457, United States
Mount Sinai Medical Center
Miami Beach, Florida, 33140, United States
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii, 96813, United States
Queen's Medical Center
Honolulu, Hawaii, 96813, United States
Straub Clinic and Hospital
Honolulu, Hawaii, 96813, United States
Hawaii Cancer Care Inc-Liliha
Honolulu, Hawaii, 96817, United States
Kuakini Medical Center
Honolulu, Hawaii, 96817, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826, United States
Castle Medical Center
Kailua, Hawaii, 96734, United States
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue, Hawaii, 96766, United States
Pali Momi Medical Center
‘Aiea, Hawaii, 96701, United States
Queen's Cancer Center - Pearlridge
‘Aiea, Hawaii, 96701, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706, United States
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, 83854, United States
University of Illinois
Chicago, Illinois, 60612, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
Weiss Memorial Hospital
Chicago, Illinois, 60640, United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, 60201, United States
Ingalls Memorial Hospital
Harvey, Illinois, 60426, United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62702, United States
Springfield Clinic
Springfield, Illinois, 62702, United States
Springfield Memorial Hospital
Springfield, Illinois, 62781, United States
Fort Wayne Medical Oncology and Hematology Inc-Parkview
Fort Wayne, Indiana, 46845, United States
Franciscan Health Indianapolis
Indianapolis, Indiana, 46237, United States
Memorial Regional Cancer Center Day Road
Mishawaka, Indiana, 46545, United States
Michiana Hematology Oncology PC-Mishawaka
Mishawaka, Indiana, 46545, United States
Memorial Hospital of South Bend
South Bend, Indiana, 46601, United States
Michiana Hematology Oncology PC-Westville
Westville, Indiana, 46391, United States
Mercy Hospital
Cedar Rapids, Iowa, 52403, United States
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, 52403, United States
Siouxland Regional Cancer Center
Sioux City, Iowa, 51101, United States
Harold Alfond Center for Cancer Care
Augusta, Maine, 04330, United States
Eastern Maine Medical Center
Bangor, Maine, 04401, United States
Penobscot Bay Medical Center
Rockport, Maine, 04856, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215, United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106, United States
Henry Ford Health Saint John Hospital
Detroit, Michigan, 48236, United States
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503, United States
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, 49503, United States
Fairview Ridges Hospital
Burnsville, Minnesota, 55337, United States
Fairview Southdale Hospital
Edina, Minnesota, 55435, United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109, United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109, United States
Minneapolis VA Medical Center
Minneapolis, Minnesota, 55417, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
Central Care Cancer Center - Bolivar
Bolivar, Missouri, 65613, United States
MU Health - University Hospital/Ellis Fischel Cancer Center
Columbia, Missouri, 65212, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111, United States
Mercy Hospital Springfield
Springfield, Missouri, 65804, United States
CoxHealth South Hospital
Springfield, Missouri, 65807, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Missouri Baptist Medical Center
St Louis, Missouri, 63131, United States
Mercy Hospital Saint Louis
St Louis, Missouri, 63141, United States
Billings Clinic Cancer Center
Billings, Montana, 59101, United States
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405, United States
Nevada Cancer Research Foundation NCORP
Las Vegas, Nevada, 89120, United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756, United States
Hematology Oncology Associates of Central New York-East Syracuse
East Syracuse, New York, 13057, United States
Northwell Health NCORP
Lake Success, New York, 11042, United States
Northwell Health/Center for Advanced Medicine
Lake Success, New York, 11042, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
Long Island Jewish Medical Center
New Hyde Park, New York, 11040, United States
NYP/Weill Cornell Medical Center
New York, New York, 10065, United States
State University of New York Upstate Medical University
Syracuse, New York, 13210, United States
Randolph Hospital
Asheboro, North Carolina, 27203, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599, United States
Wayne Memorial Hospital
Goldsboro, North Carolina, 27534, United States
Cone Health Cancer Center
Greensboro, North Carolina, 27403, United States
ECU Health Oncology Kinston
Kinston, North Carolina, 28501, United States
Annie Penn Memorial Hospital
Reidsville, North Carolina, 27320, United States
Iredell Memorial Hospital
Statesville, North Carolina, 28677, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Altru Cancer Center
Grand Forks, North Dakota, 58201, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Miami Valley Hospital North
Dayton, Ohio, 45415, United States
Kettering Medical Center
Kettering, Ohio, 45429, United States
Toledo Clinic Cancer Centers-Maumee
Maumee, Ohio, 43537, United States
Saint Charles Hospital
Oregon, Ohio, 43616, United States
ProMedica Flower Hospital
Sylvania, Ohio, 43560, United States
Mercy Health - Saint Anne Hospital
Toledo, Ohio, 43623, United States
Toledo Clinic Cancer Centers-Toledo
Toledo, Ohio, 43623, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, 73120, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Providence Saint Vincent Medical Center
Portland, Oregon, 97225, United States
Guthrie Medical Group PC-Robert Packer Hospital
Sayre, Pennsylvania, 18840, United States
Saint Francis Hospital
Greenville, South Carolina, 29601, United States
Saint Francis Cancer Center
Greenville, South Carolina, 29607, United States
Spartanburg Medical Center
Spartanburg, South Carolina, 29303, United States
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298, United States
West Virginia University Healthcare
Morgantown, West Virginia, 26506, United States
Related Publications (2)
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.
PMID: 35787017DERIVEDBlum 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.
PMID: 31174236DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Kristie A. Blum, MD
- Organization
- Alliance for Clinical Trials in Oncology
Study Officials
- PRINCIPAL INVESTIGATOR
Kristie A Blum
Alliance for Clinical Trials in Oncology
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 27, 2011
First Posted
January 31, 2011
Study Start
April 28, 2011
Primary Completion
May 24, 2017
Study Completion
September 2, 2025
Last Updated
November 24, 2025
Results First Posted
January 10, 2019
Record last verified: 2025-10