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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by National Cancer Institute (NCI)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01286272
First received: January 27, 2011
Last updated: July 9, 2014
Last verified: July 2014
  Purpose

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, can block cancer growth in difference ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. 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.


Condition Intervention Phase
Contiguous Stage II Grade 1 Follicular Lymphoma
Contiguous Stage II Grade 2 Follicular Lymphoma
Contiguous Stage II Grade 3 Follicular Lymphoma
Noncontiguous Stage II Grade 1 Follicular Lymphoma
Noncontiguous Stage II Grade 2 Follicular Lymphoma
Noncontiguous Stage II Grade 3 Follicular Lymphoma
Stage I Grade 1 Follicular Lymphoma
Stage I Grade 2 Follicular Lymphoma
Stage I Grade 3 Follicular Lymphoma
Stage III Grade 1 Follicular Lymphoma
Stage III Grade 2 Follicular Lymphoma
Stage III Grade 3 Follicular Lymphoma
Stage IV Grade 1 Follicular Lymphoma
Stage IV Grade 2 Follicular Lymphoma
Stage IV Grade 3 Follicular Lymphoma
Biological: ofatumumab
Drug: bendamustine hydrochloride
Drug: bortezomib
Other: laboratory biomarker analysis
Procedure: positron emission tomography with radiolabeled targeting agents
Radiation: fludeoxyglucose F 18
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase II Trial of Ofatumumab and Bendamustine vs. Ofatumumab, Bortezomib (NSC # 681239) and Bendamustine in Patients With Untreated Follicular Lymphoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • CR rate [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PFS [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
    Kaplan-Meier curves of PFS and overall survival (OS) will be generated for the two arms. The p-values of the log-rank test will be calculated to compare PFS and OS between the two arms.

  • Grade 3 or higher toxicities assessed according to NCI Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 10 years ] [ Designated as safety issue: Yes ]
    The toxicity profile of the two arms will be summarized using frequency tables. The chi-squared test will be conducted to compare the toxicity rate of grade 3 or higher between the two arms.

  • Pre-treatment single nucleotide polymorphisms (SNP) [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
    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 pvalue) of the max test will be obtained by a permutation method. No multiple testing adjustment may be applied because of the small sample size.

  • Immunohistochemical (IHC) markers [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
    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.

  • Predictive value of FDG-PET [ Time Frame: Baseline and at 70 days ] [ Designated as safety issue: No ]
    The ratio will be correlated with response (using the two-sample t-test) and PFS (using the Cox regression method) data.


Estimated Enrollment: 130
Study Start Date: April 2011
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Biological: ofatumumab
Given IV
Other Names:
  • Arzerra
  • HuMax-CD20
Drug: bendamustine hydrochloride
Given IV
Other Names:
  • bendamustin hydrochloride
  • bendamustine
  • cytostasan hydrochloride
  • Treanda
Other: laboratory biomarker analysis
Correlative studies
Procedure: positron emission tomography with radiolabeled targeting agents
Undergo FDG-PET
Other Name: PET with radiolabeled targeting agents
Radiation: fludeoxyglucose F 18
Undergo FDG-PET
Other Names:
  • 18FDG
  • FDG
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 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 on days 1, 8, 15, and 22. Treatment repeats every 56 days for up to 4 courses.

Biological: ofatumumab
Given IV
Other Names:
  • Arzerra
  • HuMax-CD20
Drug: bendamustine hydrochloride
Given IV
Other Names:
  • bendamustin hydrochloride
  • bendamustine
  • cytostasan hydrochloride
  • Treanda
Drug: bortezomib
Given IV
Other Names:
  • LDP 341
  • MLN341
  • VELCADE
Other: laboratory biomarker analysis
Correlative studies
Procedure: positron emission tomography with radiolabeled targeting agents
Undergo FDG-PET
Other Name: PET with radiolabeled targeting agents
Radiation: fludeoxyglucose F 18
Undergo FDG-PET
Other Names:
  • 18FDG
  • FDG

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • Patients must have at least one of the following indicators of poor risk disease:

    • >= 3 risk factors by the Follicular Lymphoma International Prognostic Index (FLIPI score), or 2 risk factors by the FLIPI and at least one bulky mass or lymph node > 6 cm in size;
    • 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 10-14 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 ribonucleic acid (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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01286272

  Hide Study Locations
Locations
United States, California
UC San Diego Moores Cancer Center Recruiting
La Jolla, California, United States, 92093
Contact: Erin G. Reid    858-822-5354    cancercto@ucsd.edu   
Principal Investigator: Erin G. Reid         
Saint Helena Hospital Recruiting
Saint Helena, California, United States, 94574
Contact: Gregory B. Smith    707-967-3698      
Principal Investigator: Gregory B. Smith         
United States, Connecticut
Middlesex Hospital Recruiting
Middletown, Connecticut, United States, 06457
Contact: Susanna Hong    860-358-2058      
Principal Investigator: Susanna Hong         
United States, Florida
Mount Sinai Medical Center CCOP Recruiting
Miami Beach, Florida, United States, 33140
Contact: Michael A. Schwartz    305-674-2625    info@msccop.com   
Principal Investigator: Michael A. Schwartz         
United States, Hawaii
Pali Momi Medical Center Recruiting
Aiea, Hawaii, United States, 96701
Contact: Jeffrey L. Berenberg    808-586-2979      
Principal Investigator: Jeffrey L. Berenberg         
Oncare Hawaii Inc-Pali Momi Recruiting
Aiea, Hawaii, United States, 96701
Contact: Jeffrey L. Berenberg    808-586-2979      
Principal Investigator: Jeffrey L. Berenberg         
Kapiolani Medical Center for Women and Children Recruiting
Honolulu, Hawaii, United States, 96826
Contact: Jeffrey L. Berenberg    808-586-2979      
Principal Investigator: Jeffrey L. Berenberg         
Kuakini Medical Center Recruiting
Honolulu, Hawaii, United States, 96817
Contact: Jeffrey L. Berenberg    808-586-2979      
Principal Investigator: Jeffrey L. Berenberg         
Oncare Hawaii Inc-POB II Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Jeffrey L. Berenberg    808-586-2979      
Principal Investigator: Jeffrey L. Berenberg         
OnCare Hawaii-Liliha Recruiting
Honolulu, Hawaii, United States, 96817-3169
Contact: Jeffrey L. Berenberg    808-586-2979      
Principal Investigator: Jeffrey L. Berenberg         
Queen's Medical Center Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Jeffrey L. Berenberg    808-586-2979      
Principal Investigator: Jeffrey L. Berenberg         
Straub Clinic and Hospital Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Jeffrey L. Berenberg    808-586-2979      
Principal Investigator: Jeffrey L. Berenberg         
Castle Medical Center Recruiting
Kailua, Hawaii, United States, 96734
Contact: Jeffrey L. Berenberg    808-586-2979      
Principal Investigator: Jeffrey L. Berenberg         
Wilcox Memorial Hospital and Kauai Medical Clinic Recruiting
Lihue, Hawaii, United States, 96766
Contact: Jeffrey L. Berenberg    808-586-2979      
Principal Investigator: Jeffrey L. Berenberg         
United States, Idaho
Kootenai Cancer Center Recruiting
Post Falls, Idaho, United States, 83854
Contact: Benjamin T. Marchello    800-648-6274      
Principal Investigator: Benjamin T. Marchello         
United States, Illinois
Weiss Memorial Hospital Terminated
Chicago, Illinois, United States, 60640
University of Chicago Active, not recruiting
Chicago, Illinois, United States, 60637
University of Illinois Recruiting
Chicago, Illinois, United States, 60612
Contact: David J. Peace    312-355-3046      
Principal Investigator: David J. Peace         
NorthShore University HealthSystem-Evanston Hospital Recruiting
Evanston, Illinois, United States, 60201
Contact: Lynne S. Kaminer    847-570-2109      
Principal Investigator: Lynne S. Kaminer         
Ingalls Memorial Hospital Recruiting
Harvey, Illinois, United States, 60426
Contact: Mark F. Kozloff    708-915-4673    clinicaltrials@ingalls.org   
Principal Investigator: Mark F. Kozloff         
United States, Indiana
Fort Wayne Medical Oncology and Hematology Inc-Parkview Withdrawn
Fort Wayne, Indiana, United States, 46845
Franciscan Saint Francis Health-Indianapolis Active, not recruiting
Indianapolis, Indiana, United States, 46237
Michiana Hematology Oncology PC-Mishawaka Recruiting
Mishawaka, Indiana, United States, 46545-1470
Contact: Rafat H. Ansari    574-234-5123      
Principal Investigator: Rafat H. Ansari         
Michiana Hematology Oncology-PC Westville Recruiting
Westville, Indiana, United States, 46391
Contact: Rafat H. Ansari    574-234-5123      
Principal Investigator: Rafat H. Ansari         
United States, Iowa
Mercy Hospital Recruiting
Cedar Rapids, Iowa, United States, 52403
Contact: Deborah W. Wilbur    319-363-2690      
Principal Investigator: Deborah W. Wilbur         
Oncology Associates at Mercy Medical Center Recruiting
Cedar Rapids, Iowa, United States, 52403
Contact: Deborah W. Wilbur    319-363-2690      
Principal Investigator: Deborah W. Wilbur         
Siouxland Hematology Oncology Associates Recruiting
Sioux City, Iowa, United States, 51101
Contact: Donald B. Wender    712-252-0088      
Principal Investigator: Donald B. Wender         
United States, Maine
Eastern Maine Medical Center Recruiting
Bangor, Maine, United States, 04401
Contact: Thomas H. Openshaw    207-973-4274      
Principal Investigator: Thomas H. Openshaw         
Penobscot Bay Medical Center Recruiting
Rockport, Maine, United States, 04856
Contact: Thomas H. Openshaw    207-973-4274      
Principal Investigator: Thomas H. Openshaw         
United States, Maryland
Sinai Hospital of Baltimore Recruiting
Baltimore, Maryland, United States, 21215
Contact: Roberto F. Martinez    410-601-6120    pridgely@lifebridgehealth.org   
Principal Investigator: Roberto F. Martinez         
United States, Michigan
Saint Joseph Mercy Hospital Recruiting
Ann Arbor, Michigan, United States, 48106-0995
Contact: Christopher M. Reynolds    734-712-3456      
Principal Investigator: Christopher M. Reynolds         
Saint John Hospital and Medical Center Recruiting
Detroit, Michigan, United States, 48236
Contact: Christopher M. Reynolds    734-712-3456      
Principal Investigator: Christopher M. Reynolds         
Mercy Health Saint Mary's Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Gilbert D. Padula    616-685-5225      
Principal Investigator: Gilbert D. Padula         
Spectrum Health at Butterworth Campus Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Gilbert D. Padula    616-685-5225      
Principal Investigator: Gilbert D. Padula         
United States, Minnesota
Minneapolis Veterans Medical Center Recruiting
Minneapolis, Minnesota, United States, 55417
Contact: Sharon D. Luikart    612-467-2800      
Principal Investigator: Sharon D. Luikart         
United States, Missouri
University of Missouri - Ellis Fischel Recruiting
Columbia, Missouri, United States, 65212
Contact: Carl E. Freter    573-882-7440      
Principal Investigator: Carl E. Freter         
Saint Luke's Hospital of Kansas City Recruiting
Kansas City, Missouri, United States, 64111
Contact: Rakesh Gaur    913-948-5588    aroland@kccop.org   
Principal Investigator: Rakesh Gaur         
Missouri Baptist Medical Center Recruiting
Saint Louis, Missouri, United States, 63131
Contact: Alan P. Lyss    800-392-0936      
Principal Investigator: Alan P. Lyss         
Saint John's Mercy Medical Center Recruiting
Saint Louis, Missouri, United States, 63141
Contact: Jay W. Carlson    800-821-7532    sherrijr@iora.org   
Principal Investigator: Jay W. Carlson         
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Nancy L. Bartlett    800-600-3606    info@siteman.wustl.edu   
Principal Investigator: Nancy L. Bartlett         
Mercy Hospital Springfield Recruiting
Springfield, Missouri, United States, 65804
Contact: Jay W. Carlson    800-821-7532    sherrijr@iora.org   
Principal Investigator: Jay W. Carlson         
CoxHealth South Hospital Recruiting
Springfield, Missouri, United States, 65807
Contact: Jay W. Carlson    800-821-7532    sherrijr@iora.org   
Principal Investigator: Jay W. Carlson         
United States, Montana
Billings Clinic Recruiting
Billings, Montana, United States, 59107-7000
Contact: Benjamin T. Marchello    800-648-6274      
Principal Investigator: Benjamin T. Marchello         
United States, Nevada
Nevada Cancer Research Foundation CCOP Recruiting
Las Vegas, Nevada, United States, 89106
Contact: John A. Ellerton    702-384-0013      
Principal Investigator: John A. Ellerton         
United States, New York
Hematology Oncology Associates of Central New York PC-East Syracuse Recruiting
East Syracuse, New York, United States, 13057
Contact: Jeffrey J. Kirshner    315-472-7504      
Principal Investigator: Jeffrey J. Kirshner         
North Shore-LIJ Health System CCOP Active, not recruiting
Manhasset, New York, United States, 11030
North Shore University Hospital Recruiting
Manhasset, New York, United States, 11030
Contact: Cristina M. Ghiuzeli    516-562-3467      
Principal Investigator: Cristina M. Ghiuzeli         
Long Island Jewish Medical Center Withdrawn
New Hyde Park, New York, United States, 11040
North Shore-LIJ Health System/Center for Advanced Medicine Withdrawn
New Hyde Park, New York, United States, 11040
Weill Medical College of Cornell University Active, not recruiting
New York, New York, United States, 10065
State University of New York Upstate Medical University Recruiting
Syracuse, New York, United States, 13210
Contact: Teresa C. Gentile    315-464-5476      
Principal Investigator: Teresa C. Gentile         
United States, North Carolina
Randolph Hospital Recruiting
Asheboro, North Carolina, United States, 27203
Contact: Peter Rubin    336-832-0821      
Principal Investigator: Peter Rubin         
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Steven I. Park    877-668-0683    cancerclinicaltrials@med.unc.edu   
Principal Investigator: Steven I. Park         
Wayne Memorial Hospital Recruiting
Goldsboro, North Carolina, United States, 27534
Contact: James N. Atkins    919-580-0000      
Principal Investigator: James N. Atkins         
Cone Health Cancer Center Recruiting
Greensboro, North Carolina, United States, 27403
Contact: Peter Rubin    336-832-0821      
Principal Investigator: Peter Rubin         
Kinston Medical Specialists PA Recruiting
Kinston, North Carolina, United States, 28501
Contact: Peter R. Watson    252-559-2200      
Principal Investigator: Peter R. Watson         
Annie Penn Memorial Hospital Recruiting
Reidsville, North Carolina, United States, 27320
Contact: Peter Rubin    336-832-0821      
Principal Investigator: Peter Rubin         
Iredell Memorial Hospital Recruiting
Statesville, North Carolina, United States, 28677
Contact: Ruby A. Grimm    704-873-5661      
Principal Investigator: Ruby A. Grimm         
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: David D. Hurd    336-713-6771      
Principal Investigator: David D. Hurd         
United States, North Dakota
Altru Cancer Center Recruiting
Grand Forks, North Dakota, United States, 58201
Contact: Grant R. Seeger    701-780-6520      
Principal Investigator: Grant R. Seeger         
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Kristie A. Blum    866-627-7616    osu@emergingmed.com   
Principal Investigator: Kristie A. Blum         
Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Kristie A. Blum       Kristie.Blum@osumc.edu   
Principal Investigator: Kristie A. Blum         
Samaritan North Health Center Recruiting
Dayton, Ohio, United States, 45415
Contact: Howard M. Gross    765-983-3000      
Principal Investigator: Howard M. Gross         
Kettering Medical Center Recruiting
Kettering, Ohio, United States, 45429
Contact: Howard M. Gross    765-983-3000      
Principal Investigator: Howard M. Gross         
Saint Charles Hospital Recruiting
Oregon, Ohio, United States, 43616
Contact: Rex B. Mowat    517-265-0116      
Principal Investigator: Rex B. Mowat         
Flower Hospital Recruiting
Sylvania, Ohio, United States, 43560
Contact: Rex B. Mowat    517-265-0116      
Principal Investigator: Rex B. Mowat         
Mercy Saint Anne Hospital Recruiting
Toledo, Ohio, United States, 43623
Contact: Rex B. Mowat    517-265-0116      
Principal Investigator: Rex B. Mowat         
Toledo Clinic Cancer Centers-Toledo Recruiting
Toledo, Ohio, United States, 43623
Contact: Rex B. Mowat    517-265-0116      
Principal Investigator: Rex B. Mowat         
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Carla Kurkjian    405-271-4272    julie-traylor@ouhsc.edu   
Principal Investigator: Carla Kurkjian         
United States, Oregon
Providence Portland Medical Center Recruiting
Portland, Oregon, United States, 97213
Contact: Alison K. Conlin    503-215-6412      
Principal Investigator: Alison K. Conlin         
United States, South Carolina
Saint Francis Hospital Recruiting
Greenville, South Carolina, United States, 29601
Contact: Charles E. Bowers    800-486-5941      
Principal Investigator: Charles E. Bowers         
Spartanburg Regional Medical Center Recruiting
Spartanburg, South Carolina, United States, 29303
Contact: Charles E. Bowers    800-486-5941      
Principal Investigator: Charles E. Bowers         
United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Contact: Beata Holkova    804-628-1939      
Principal Investigator: Beata Holkova         
United States, West Virginia
West Virginia University Healthcare Recruiting
Morgantown, West Virginia, United States, 26506
Contact: Michael D. Craig    304-293-2745    sfilburn@hsc.wvu.edu   
Principal Investigator: Michael D. Craig         
Sponsors and Collaborators
Investigators
Principal Investigator: Kristie Blum Cancer and Leukemia Group B
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01286272     History of Changes
Other Study ID Numbers: NCI-2011-02625, NCI-2011-02625, CDR0000694298, CALGB 50904, CALGB-50904, U10CA031946
Study First Received: January 27, 2011
Last Updated: July 9, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Fluorodeoxyglucose F18
Bendamustine
Nitrogen Mustard Compounds
Bortezomib
Radiopharmaceuticals
Diagnostic Uses of Chemicals
Pharmacologic Actions
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 26, 2014