Trial record 1 of 1 for:    01190449
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Ofatumumab in Treating Patients With Previously Untreated Stage II, Stage III, or Stage IV Follicular Non-Hodgkin Lymphoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by National Cancer Institute (NCI)
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01190449
First received: August 26, 2010
Last updated: February 15, 2013
Last verified: February 2013
  Purpose

RATIONALE: Monoclonal antibodies, such as ofatumumab, can block cancer growth in different 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.

PURPOSE: This randomized phase II trial is studying ofatumumab to see how well it works in treating patients with previously untreated stage II, stage III, or stage IV follicular non-Hodgkin lymphoma.


Condition Intervention Phase
Lymphoma
Biological: ofatumumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Ofatumumab (CALGB IND #) in Previously Untreated Follicular Non-Hodgkin's Lymphoma (NHL)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Overall response (complete or partial response) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Designated as safety issue: No ]
  • Tolerability [ Designated as safety issue: Yes ]
  • Comparison of two ofatumumab doses efficacy with historical controls [ Designated as safety issue: No ]
  • Comparison of two ofatumumab doses toxicity with historical controls [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: August 2011
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive high-dose ofatumumab IV over 2-8 hours on days 1, 8, 15, and 22 and then once monthly in months 3-9.
Biological: ofatumumab
Given IV
Experimental: Arm II
Patients receive a lower dose of ofatumumab IV over 2-8 hours on days 1, 8, 15, and 22 and then once monthly in months 3-9.
Biological: ofatumumab
Given IV

Detailed Description:

OBJECTIVES:

Primary

  • To determine the response rate in patients with previously untreated CD20-positive bulky stage II, or stage III or IV follicular non-Hodgkin lymphoma (NHL) treated with a lower- or high-dose of ofatumumab.

Secondary

  • To determine the progression-free survival (PFS) of patients treated with these regimens.
  • To determine the toxicity profile of these regimens in these patients.
  • To establish whether the therapeutic effect of single-agent ofatumumab is sufficiently promising to warrant evaluation in subsequent randomized, ofatumumab-based, biologic doublet trials.
  • To evaluate the two ofatumumab doses by independent comparison of response, PFS, and toxicity to a historical control in previously untreated patients with follicular NHL.
  • To prospectively validate the FLIPI2 prognostic index in low- and intermediate-risk patients and compare to low- and intermediate-risk stratified patients by standard FLIPI scoring to determine a more reliable indicator of response and PFS.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive high-dose ofatumumab IV over 2-8 hours on days 1, 8, 15, and 22 and then once monthly in months 3-9.
  • Arm II: Patients receive a lower dose of ofatumumab IV over 2-8 hours on days 1, 8, 15, and 22 and then once monthly in months 3-9.

In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.

Patients may undergo blood and bone marrow sample collection for correlative studies.

After completion of study therapy, patients are followed up every 4 months for 2 years and then every 6 months for 8 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed follicular non-Hodgkin lymphoma (NHL) meeting 1 of the following criteria:

    • Bulky (i.e., single mass ≥ 7cm in any uni-dimensional measurement) stage II disease
    • Stage III or IV disease
  • WHO grade 1, 2, or 3a disease
  • Bone marrow biopsies allowed provided they are submitted in conjunction with nodal biopsies

    • No fine-needle aspirates for diagnosis
  • Tumor tissue must express the CD20-positive antigen by flow cytometry or IHC
  • At least 1 site of measurable disease that is > 1 cm in diameter in ≥ 1 dimension present either on physical exam or imaging studies

    • Non-measurable disease alone not allowed, including the following:

      • Bone lesions (lesions if present should be noted)
      • Ascites
      • Pleural/pericardial effusion
      • Lymphangitis cutis/pulmonis
      • Bone marrow (involvement by NHL should be noted)
  • Low- or intermediate-risk disease by the Follicular Lymphoma International Prognostic Index (FLIPI)

    • FLIPI score meeting 1 or 2 of the following risk factors:

      • Age > 60 years
      • Involvement of > 4 nodal sites
      • Stage III-IV disease
      • Hemoglobin < 12.0 g/dL
      • LDH normal
    • Risk determined by the following:

      • Low Risk: 0-1 of the above risk factors
      • Intermediate Risk: 2 risk factors
      • Poor Risk: ≥ 3 risk factors
  • No known CNS involvement

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • ANC ≥ 1,000/μL
  • Platelet count ≥ 75,000/μL
  • Creatinine clearance ≥ 30 mL/min
  • Bilirubin ≤ 2 times upper limit of normal (unless secondary to Gilbert syndrome or hepatic involvement of NHL)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after completion of study treatment
  • Patients with HIV infection allowed provided the following criteria are met:

    • No evidence of coinfection with hepatitis B or C
    • CD4+ cell count ≥ 400/mm³
    • No evidence of resistant strains of HIV
    • HIV viral load < 10,000 copies HIV RNA/mL if not on anti-HIV therapy OR HIV viral load < 50 copies if on anti-HIV therapy
    • No history of AIDS-defining conditions
  • No evidence of active hepatitis B (HBV) or C (HCV) infection (i.e., no positive serology for anti-HBc or anti-HCV antibodies)

    • HBV seropositivity allowed (HBsAg+) provided they are closely monitored for evidence of active HBV infection by HBV DNA testing
    • After completing treatment, HBsAg + patients must be monitored by HBV DNA testing every 2 months for 6 months post-treatment, while continuing lamivudine (required)

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy or immunotherapy (e.g., monoclonal antibody-based therapy) for NHL

    • Prior involved-field radiation therapy allowed
  • More than 2 weeks since prior corticosteroids except for maintenance therapy for a non-malignant disease

    • No concurrent dexamethasone or other steroids as antiemetics
  • No live virus vaccination within 6 weeks prior to study entry
  • No concurrent zidvoudine or stavudine
  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: NCT01190449

  Hide Study Locations
Locations
United States, Delaware
Tunnell Cancer Center at Beebe Medical Center Recruiting
Lewes, Delaware, United States, 19958
Contact: Clinical Trials Office - Tunnell Cancer Center    302-645-3171      
CCOP - Christiana Care Health Services Recruiting
Newark, Delaware, United States, 19713
Contact: Clinical Trial Office - CCOP - Christiana Care Health Services    302-623-4450      
United States, Florida
Cleveland Clinic Florida - Weston Recruiting
Weston, Florida, United States, 33331
Contact: Clinical Trials Office - Cleveland Clinic Florida - Weston    954-659-5705      
United States, Illinois
Illinois CancerCare - Bloomington Recruiting
Bloomington, Illinois, United States, 61701
Contact: Nguyet A. Le-Lindqwister    309-662-2102      
Illinois CancerCare - Canton Recruiting
Canton, Illinois, United States, 61520
Contact: Nguyet A. Le-Lindqwister    309-647-5240      
Illinois CancerCare - Eureka Recruiting
Eureka, Illinois, United States, 61530
Contact: Nguyet A. Le-Lindqwister    309-467-2371      
Eureka Community Hospital Recruiting
Eureka, Illinois, United States, 61530
Contact: Nguyet A. Le-Lindqwister    309-467-2371      
Galesburg Clinic, PC Recruiting
Galesburg, Illinois, United States, 61401
Contact: Nguyet A. Le-Lindqwister    309-344-1000      
Illinois CancerCare - Macomb Recruiting
Macomb, Illinois, United States, 61455
Contact: Nguyet A. Le-Lindqwister    309-833-3503      
Community Cancer Center Recruiting
Normal, Illinois, United States, 61761
Contact: Nguyet A. Le-Lindqwister    309-451-8500      
BroMenn Regional Medical Center Recruiting
Normal, Illinois, United States, 61761
Contact: Nguyet A. Le-Lindqwister    309-454-1400      
Illinois CancerCare - Community Cancer Center Recruiting
Normal, Illinois, United States, 61761
Contact: Nguyet A. Le-Lindqwister    309-662-2102      
Community Hospital of Ottawa Recruiting
Ottawa, Illinois, United States, 61350
Contact: Nguyet A. Le-Lindqwister    815-433-3100      
Oncology Hematology Associates of Central Illinois, PC - Ottawa Recruiting
Ottawa, Illinois, United States, 61350
Contact: Nguyet A. Le-Lindqwister    815-431-9270      
Cancer Treatment Center at Pekin Hospital Recruiting
Pekin, Illinois, United States, 61554
Contact: Nguyet A. Le-Lindqwister    309-353-0512      
Illinois CancerCare - Pekin Recruiting
Pekin, Illinois, United States, 61603
Contact: Nguyet A. Le-Lindqwister    309-353-0214      
CCOP - Illinois Oncology Research Association Recruiting
Peoria, Illinois, United States, 61615
Contact: Nguyet A. Le-Lindqwister    309-243-3605      
Oncology Hematology Associates of Central Illinois, PC - Peoria Recruiting
Peoria, Illinois, United States, 61615
Contact: Nguyet A. Le-Lindqwister    309-243-3000      
Proctor Hospital Recruiting
Peoria, Illinois, United States, 61614
Contact: Nguyet A. Le-Lindqwister    309-691-1000      
Methodist Medical Center of Illinois Recruiting
Peoria, Illinois, United States, 61636
Contact: Clinical Trials Office - Methodist Medical Center of Illinois    309-243-3000      
Illinois CancerCare - Peru Recruiting
Peru, Illinois, United States, 61354
Contact: Nguyet A. Le-Lindqwister    815-780-3185      
Illinois Valley Community Hospital Recruiting
Peru, Illinois, United States, 61354
Contact: Nguyet A. Le-Lindqwister    815-223-3000      
Illinois CancerCare - Spring Valley Recruiting
Spring Valley, Illinois, United States, 61362
Contact: Nguyet A. Le-Lindqwister    815-664-1487      
United States, Iowa
Iowa Blood and Cancer Care Recruiting
Cedar Rapids, Iowa, United States, 52402
Contact: David O. Zenk, MD    319-369-7091      
United States, Maryland
Union Hospital of Cecil County Recruiting
Elkton MD, Maryland, United States, 21921
Contact: Stephen S. Grubbs, MD    302-366-1200      
United States, Michigan
Battle Creek Health System Cancer Care Center Recruiting
Battle Creek, Michigan, United States, 49017
Contact: Gilbert D.A. Padula    616-966-8000      
Mecosta County Medical Center Recruiting
Big Rapids, Michigan, United States, 49307
Contact: Gilbert D.A. Padula    231-796-8691      
CCOP - Grand Rapids Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Gilbert D.A. Padula    616-391-1230      
Lacks Cancer Center at Saint Mary's Health Care Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Gilbert D.A. Padula    616-752-5222      
Butterworth Hospital at Spectrum Health Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Gilbert D.A. Padula    616-391-2799      
Mercy General Health Partners Recruiting
Muskegon, Michigan, United States, 49444
Contact: Gilbert D.A. Padula    231-672-2000      
Spectrum Health Reed City Hospital Recruiting
Reed City, Michigan, United States, 49677
Contact: Gilbert D.A. Padula    231-832-3271      
Munson Medical Center Recruiting
Traverse City, Michigan, United States, 49684
Contact: Gilbert D.A. Padula    231-935-6202      
United States, Missouri
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Nancy L. Bartlett, MD    314-362-5654      
United States, New Hampshire
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care Recruiting
Concord, New Hampshire, United States, 03301
Contact: Frederick M. Briccetti, MD    603-224-2556      
New Hampshire Oncology - Hematology, PA - Hooksett Recruiting
Hooksett, New Hampshire, United States, 03106
Contact: Frederick M. Briccetti, MD    603-224-2556      
Lakes Region General Hospital Recruiting
Laconia, New Hampshire, United States, 03246
Contact: Frederick M. Briccetti, MD    603-224-2556      
United States, New Jersey
Cancer Institute of New Jersey at Cooper - Voorhees Recruiting
Voorhees, New Jersey, United States, 08043
Contact: Clinical Trials Office - Cancer Institute of New Jersey at Coo    856-325-6757      
United States, New York
Monter Cancer Center of the North Shore-LIJ Health System Recruiting
Lake Success, New York, United States, 11042
Contact: Dilip V. Patel, MD    718-470-8931      
Don Monti Comprehensive Cancer Center at North Shore University Hospital Recruiting
Manhasset, New York, United States, 11030
Contact: Clinical Trials Office - Don Monti Comprehensive Cancer Center    516-734-8900      
Mount Kisco Medical Group, PC Recruiting
Mount Kisco, New York, United States, 10549-3417
Contact: Jonathan S. Goldberg    914-241-1050      
Long Island Jewish Medical Center Recruiting
New Hyde Park, New York, United States, 11040
Contact: Dilip V. Patel, MD    718-470-8931      
New York Weill Cornell Cancer Center at Cornell University Recruiting
New York, New York, United States, 10021
Contact: Clinical Trials Office - New York Weill Cornell Cancer Center    212-746-1848      
SUNY Upstate Medical University Hospital Recruiting
Syracuse, New York, United States, 13210
Contact: Clinical Trials Office - SUNY Upstate Medical University Hospi    315-464-5476      
United States, North Carolina
Kinston Medical Specialists Recruiting
Kinston, North Carolina, United States, 28501
Contact: Peter R. Watson, MD    252-559-2200ext.201      
Wake Forest University Comprehensive Cancer Center Recruiting
Winston-Salem, North Carolina, United States, 27157-1096
Contact: Clinical Trials Office - Wake Forest University Comprehensive    336-713-6771      
United States, Ohio
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210-1240
Contact: Ohio State University Cancer Clinical Trial Matching Service    866-627-7616    Jamesline@osumc.edu   
United States, Virginia
Virginia Commonwealth University Massey Cancer Center Recruiting
Richmond, Virginia, United States, 23298-0037
Contact: Clinical Trials Office -Virginia Commonwealth University Masse    804-628-1939      
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Principal Investigator: Cara A. Rosenbaum, MD University of Chicago
  More Information

Additional Information:
No publications provided

Responsible Party: Richard L. Schilsky, Cancer and Leukemia Group B
ClinicalTrials.gov Identifier: NCT01190449     History of Changes
Other Study ID Numbers: CDR0000683083, CALGB-50901, GSK-CALGB-50901
Study First Received: August 26, 2010
Last Updated: February 15, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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
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

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on August 27, 2014