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CompletedNCT01286272Updated Nov 24, 2025Results posted

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

A Phase 2 interventional study of Bendamustine Hydrochloride and Bortezomib in Ann Arbor Stage III Grade 1 Follicular Lymphoma, Ann Arbor Stage III Grade 2 Follicular Lymphoma and Ann Arbor Stage III Grade 3 Follicular Lymphoma, sponsored by National Cancer Institute (NCI). Completed at 96 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-24.

Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
135
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

PRIMARY OBJECTIVES:

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.

02

Conditions studied

  • Ann Arbor Stage III Grade 1 Follicular Lymphoma
  • Ann Arbor Stage III Grade 2 Follicular Lymphoma
  • Ann Arbor Stage III Grade 3 Follicular Lymphoma
  • Ann Arbor Stage IV Grade 1 Follicular Lymphoma
  • Ann Arbor Stage IV Grade 2 Follicular Lymphoma
  • Ann Arbor Stage IV Grade 3 Follicular Lymphoma
  • Grade 3a Follicular Lymphoma
03

In context

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.

Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
135 participants (actual)

Study arms

  • Experimental
    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.

    Drug: Bendamustine Hydrochloride · Radiation: Fludeoxyglucose F-18 · Other: Laboratory Biomarker Analysis · Biological: Ofatumumab · Procedure: Positron Emission Tomography with Radiolabeled Targeting Agent

  • Experimental
    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.

    Drug: Bendamustine Hydrochloride · Drug: Bortezomib · Radiation: Fludeoxyglucose F-18 · Other: Laboratory Biomarker Analysis · Biological: Ofatumumab · Procedure: Positron Emission Tomography with Radiolabeled Targeting Agent

Interventions

  • DrugBendamustine Hydrochloride

    Given IV

    Also known as: Belrapzo, Bendamustin Hydrochloride, Bendeka, CEP 18083, CEP-18083, CEP18083, Cytostasan Hydrochloride, Levact, Ribomustin, SyB L-0501, Treakisym, Treanda, VIVIMUSTA

  • DrugBortezomib

    Given IV or SC

    Also known as: [(1R)-3-Methyl-1-[[(2S)-1-oxo-3-phenyl-2-[(pyrazinylcarbonyl)amino]propyl]amino]butyl]boronic Acid, LDP 341, LDP-341, LDP341, MLN 341, MLN-341, MLN341, PS 341, PS-341, PS341, Velcade

  • RadiationFludeoxyglucose F-18

    Undergo FDG-PET

    Also known as: 18FDG, FDG, Fludeoxyglucose (18F), fludeoxyglucose F 18, Fludeoxyglucose F18, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose, Fluorodeoxyglucose F18

  • OtherLaboratory Biomarker Analysis

    Correlative studies

  • BiologicalOfatumumab

    Given IV

    Also known as: Arzerra, GSK1841157, HuMax-CD20, HuMax-CD20, 2F2, Kesimpta

  • ProcedurePositron Emission Tomography with Radiolabeled Targeting Agent

    Undergo FDG-PET

    Also known as: Positron Emission Tomography with Radiolabeled Targeting Agents

06

What researchers measure

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.

    Time frame: From date of randomization until patient stops treatment for any reason, up to 484 days post-randomization

Secondary outcomes

  1. Progression-free Survival (PFS)

    Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. PFS rates (percentages) at 1, 2, ,3 and 4 years are defined as the percentage of patients who are alive and progression-free at the respective time points. The p-values of the log-rank test will be calculated to compare PFS between the two arms.

    Time frame: Up to 4 years

  2. The Number of Patients Who Experienced Grade 3+ Hematologic and Non-hematologic Adverse Events at Least Possibly Related to Treatment

    The number of patients who experienced grade 3+ hematologic and non-hematologic adverse events at least possibly related to treatment assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

    Time frame: From date of randomization until patient stops treatment for any reason, up to 484 days post-randomization

Other outcomes

  1. Pre-treatment Single Nucleotide Polymorphisms (SNP)

    The PFS will be compared among the three genotype groups of each SNP using the log-rank tests. A maxtype test will be used by taking the maximum value of the log-rank tests under dominant, recessive, and proportional hazard model. The critical value (or p-value) of the max test will be obtained by a permutation method. No multiple testing adjustment may be applied because of the small sample size.

    Time frame: Up to 10 years

  2. Immunohistochemical (IHC) Markers

    The IHC markers will be correlated with response (using the two-sample t-test) and PFS (using the Cox regression method) data. No multiple testing adjustment will be applied because of the small sample size.

    Time frame: Up to 10 years

  3. Predictive Value of Fludeoxyglucose-positron-emission Tomography

    The ratio will be correlated with response (using the two-sample t-test) and PFS (using the Cox regression method) data.

    Time frame: Up to 36-38 weeks (6-8 weeks after course 6, day 1 after last course of induction chemotherapy)

07

Results

Posted Jan 10, 2019

Participant flow

Participant flow — Overall Study
MilestoneArm A (Ofatumumab, Bendamustine Hydrochloride)Arm B (Ofatumumab, Bendamustine Hydrochloride, Bortezomib)
Started6765
Completed6662
Not completed13
Withdrew: Ineligible after beginning treatment13

Outcome measures

PrimaryComplete 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.

Time frame:
From date of randomization until patient stops treatment for any reason, up to 484 days post-randomization
Reported as:
Number · proportion of patients
Complete Response Rate
proportion of patientsArm A (Ofatumumab, Bendamustine Hydrochloride)Arm B (Ofatumumab, Bendamustine Hydrochloride, Bortezomib)
Complete Response Rate.621.597
SecondaryProgression-free Survival (PFS)

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. PFS rates (percentages) at 1, 2, ,3 and 4 years are defined as the percentage of patients who are alive and progression-free at the respective time points. The p-values of the log-rank test will be calculated to compare PFS between the two arms.

Time frame:
Up to 4 years
Reported as:
Number · percentage of patients
Progression-free Survival (PFS)
percentage of patientsArm A (Ofatumumab, Bendamustine Hydrochloride)Arm B (Ofatumumab, Bendamustine Hydrochloride, Bortezomib)
PFS at 1 year93.8 (88.2 to 99.9)84.8 (76.2 to 94.5)
PFS at 2 years80.3 (70.8 to 91.0)75.6 (65.2 to 87.7)
PFS at 3 years65.9 (53.9 to 80.7)67.1 (55.5 to 81.0)
PFS at 4 years57.3 (43.2 to 75.9)64.7 (52.8 to 79.2)
Statistical analysis
  • Arm A (Ofatumumab, Bendamustine Hydrochloride) vs Arm B (Ofatumumab, Bendamustine Hydrochloride, Bortezomib) · Log Rank · p = 0.8457 · Hazard ratio (hr): 0.94 · 95% CI 0.51 to 1.74
SecondaryThe Number of Patients Who Experienced Grade 3+ Hematologic and Non-hematologic Adverse Events at Least Possibly Related to Treatment

The number of patients who experienced grade 3+ hematologic and non-hematologic adverse events at least possibly related to treatment assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

Time frame:
From date of randomization until patient stops treatment for any reason, up to 484 days post-randomization
Reported as:
Count of participants · Participants
The Number of Patients Who Experienced Grade 3+ Hematologic and Non-hematologic Adverse Events at Least Possibly Related to Treatment
ParticipantsArm A (Ofatumumab, Bendamustine Hydrochloride)Arm B (Ofatumumab, Bendamustine Hydrochloride, Bortezomib)
Hematologic4541
Non-Hematologic1733
Other pre-specifiedPre-treatment Single Nucleotide Polymorphisms (SNP)

The PFS will be compared among the three genotype groups of each SNP using the log-rank tests. A maxtype test will be used by taking the maximum value of the log-rank tests under dominant, recessive, and proportional hazard model. The critical value (or p-value) of the max test will be obtained by a permutation method. No multiple testing adjustment may be applied because of the small sample size.

Time frame:
Up to 10 years

Results for this outcome have not been posted.

Other pre-specifiedImmunohistochemical (IHC) Markers

The IHC markers will be correlated with response (using the two-sample t-test) and PFS (using the Cox regression method) data. No multiple testing adjustment will be applied because of the small sample size.

Time frame:
Up to 10 years

Results for this outcome have not been posted.

Other pre-specifiedPredictive Value of Fludeoxyglucose-positron-emission Tomography

The ratio will be correlated with response (using the two-sample t-test) and PFS (using the Cox regression method) data.

Time frame:
Up to 36-38 weeks (6-8 weeks after course 6, day 1 after last course of induction chemotherapy)

Results for this outcome have not been posted.

Adverse events

Collected over Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Arm A (Ofatumumab, Bendamustine Hydrochloride)1/67 (1.5%)1/67 (1.5%)67/67 (100%)
Arm B (Ofatumumab, Bendamustine Hydrochloride, Bortezomib)4/65 (6.2%)4/65 (6.2%)65/65 (100%)
Most frequent serious events
Most frequent serious events
EventArm A (Ofatumumab, Bendamustine Hydrochloride)Arm B (Ofatumumab, Bendamustine Hydrochloride, Bortezomib)
Death NOSGeneral disorders0/672/65
Blood and lymphatic system disorders - Other, specifyBlood and lymphatic system disorders0/671/65
SepsisInfections and infestations0/671/65
Disseminated intravascular coagulationBlood and lymphatic system disorders1/670/65
Most frequent other events
Showing 10 of 261
Most frequent other events
EventArm A (Ofatumumab, Bendamustine Hydrochloride)Arm B (Ofatumumab, Bendamustine Hydrochloride, Bortezomib)
NauseaGastrointestinal disorders39/6755/65
FatigueGeneral disorders49/6746/65
Lymphocyte count decreasedInvestigations48/6744/65
White blood cell decreasedInvestigations37/6743/65
AnemiaBlood and lymphatic system disorders30/6740/65
DiarrheaGastrointestinal disorders22/6739/65
Neutrophil count decreasedInvestigations40/6735/65
Peripheral sensory neuropathyNervous system disorders16/6736/65
Platelet count decreasedInvestigations32/6735/65
ConstipationGastrointestinal disorders25/6734/65

Baseline characteristics

All patients that were eligible for endpoint analysis were included in the baseline characteristics.

Age, Continuous
Age, Continuous(years)Arm A (Ofatumumab, Bendamustine Hydrochloride)Arm B (Ofatumumab, Bendamustine Hydrochloride, Bortezomib)Total
Median61 (25 to 87)61.5 (31 to 81)61 (25 to 87)
Sex: Female, Male
Sex: Female, Male(Participants)Arm A (Ofatumumab, Bendamustine Hydrochloride)Arm B (Ofatumumab, Bendamustine Hydrochloride, Bortezomib)Total
Female283260
Male383068
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Arm A (Ofatumumab, Bendamustine Hydrochloride)Arm B (Ofatumumab, Bendamustine Hydrochloride, Bortezomib)Total
Hispanic or Latino246
Not Hispanic or Latino6256118
Unknown or Not Reported224
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Arm A (Ofatumumab, Bendamustine Hydrochloride)Arm B (Ofatumumab, Bendamustine Hydrochloride, Bortezomib)Total
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American000
White5458112
More than one race000
Unknown or Not Reported12416
Region of Enrollment
Region of Enrollment(participants)Arm A (Ofatumumab, Bendamustine Hydrochloride)Arm B (Ofatumumab, Bendamustine Hydrochloride, Bortezomib)Total
United States6662128
08

Study locations

96 sites
  • 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
09

References and documents

Publications

  • 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. PubMed 35787017 ↗
  • 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. PubMed 31174236 ↗

Study documents

  • Protocol and statistical analysis plan · Aug 23, 2017

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01286272
Lead sponsor
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jan 31, 2011
Start date
Apr 28, 2011
Primary completion
May 24, 2017
Completion
Sep 2, 2025
Results posted
Jan 10, 2019
Last update
Nov 24, 2025

Study contacts

Kristie A Blum
principal investigator · Alliance for Clinical Trials in Oncology

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.

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