Study to Evaluate the Efficacy and Safety of Treatment With Bendamustine in Combination With Ofatumumab in Previously Untreated Patients With Indolent B-Cell Non-Hodgkin's Lymphoma (NHL)
NCT ID: NCT01108341
Last Updated: 2012-08-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
50 participants
INTERVENTIONAL
2010-05-31
2011-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Bendamustine and Ofatumumab
There are 6 planned and 2 optional 28-day cycles in which participants are administered both bendamustine and ofatumumab in the following doses: Bendamustine administered at 90 mg/m\^2 intravenously (iv) on study days 1 and 2. Ofatumumab administered at 300 mg iv on day 1 and 1000 mg iv on day 8 of cycle 1. Ofatumumab administered at 1000 mg iv on day 1 of all additional cycles.
Bendamustine hydrochloride
Bendamustine will be administered at 90 mg/m\^2 as a 30-minute intravenous (iv) infusion on days 1 and 2 of each cycle.
Ofatumumab
Ofatumumab will be administered at 300 mg as an iv infusion on day 1 and 1000 mg on day 8 of cycle 1 and 1000 mg on day 1 of each subsequent cycle.
Interventions
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Bendamustine hydrochloride
Bendamustine will be administered at 90 mg/m\^2 as a 30-minute intravenous (iv) infusion on days 1 and 2 of each cycle.
Ofatumumab
Ofatumumab will be administered at 300 mg as an iv infusion on day 1 and 1000 mg on day 8 of cycle 1 and 1000 mg on day 1 of each subsequent cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The patient meets 1 of the following need-for-treatment criteria:
1. Presence of at least 1 of the following B-symptoms:
* fever (\>38ºC) of unclear etiology
* night sweats
* weight loss of greater than 10% within the prior 6 months
2. large tumor mass (bulky disease) characterized by lymphomas with a diameter of more than 3 cm in 3 or more regions or by a lymphoma with a diameter of more than 7 cm in 1 region
3. presence of lymphoma-related complications
4. hyperviscosity syndrome due to monoclonal gammopathy
* The patient's tumor is verified to be CD20+ positive from current or previous excisional or incisional tissue diagnostic procedures performed within 6 months of study entry.
* The screening phase CT scan (based on local evaluation) shows:
* 2 or more clearly demarcated lesions with a largest diameter ≥1.5 cm, or
* 1 clearly demarcated lesion with a largest diameter ≥2.0 cm
* The patient was not previously treated for indolent lymphoma (with the exception of a single course of local radiation therapy not exceeding 2 adjacent lymph node regions).
* The patient has adequate hematologic and hepatic function.
* The patient has Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
* The patient has serum creatinine of 2.0 mg/dL or less or creatinine clearance of 30 mL/min or more, based on the Cockcroft-Gault method, or from a 24-hour urine collection.
* The patient is willing to comply with contraception requirements.
Exclusion Criteria
* Has small lymphocytic lymphoma or mantle cell lymphoma.
* Has documented history of central nervous system (CNS) lymphomatous involvement.
* Has or has had an active malignancy, other than NHL, within the past 3 years except for localized prostate cancer without evidence of bone metastases, bladder, cervical, or breast carcinoma in-situ, or non-melanoma skin cancer .
* Has New York Heart Association (NYHC) Class III or IV heart failure, uncontrolled arrythmias or unstable angina, electrocardiographic evidence of active ischemia or active conduction system abnormalities, or myocardial infarction within the last 6 months.
* Has known human immunodeficiency virus (HIV) infection.
* Has acute or chronic hepatitis B or hepatitis C infection.
* Is a pregnant or lactating woman. (Any women becoming pregnant during the study will be withdrawn from the study.)
* Has any serious uncontrolled, medical or psychological disorder that would impair the ability of the subject to receive study drugs.
* Has received another investigational agent within 30 days of study entry.
* Has known hypersensitivity to mannitol.
* Has Ann Arbor stage I disease.
18 Years
ALL
No
Sponsors
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Cephalon
INDUSTRY
Responsible Party
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Principal Investigators
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Sponsor's Medical Expert
Role: STUDY_DIRECTOR
Cephalon
Locations
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Birmingham Hematology and Oncology Associates, LLC
Birmingham, Alabama, United States
University of Alabama at Birmingham
Birmingham, Alabama, United States
Tower Cancer Research Foundation
Beverly Hills, California, United States
Hematology Oncology, P.C.
Stamford, Connecticut, United States
University Cancer Institute
Boynton Beach, Florida, United States
Florida Cancer Institute - New Hope
New Port Richey, Florida, United States
Dublin Hematology Oncology Care P.C.
Dublin, Georgia, United States
Northwest Georgia Oncology Center
Marietta, Georgia, United States
Georgia Cancer Specialists
Tucker, Georgia, United States
Cancer Care and Hematology Specialists of Chicagoland
Niles, Illinois, United States
Siouxland Hematology-Oncology Assoc. LLP
Sioux City, Iowa, United States
Kentucky Cancer Clinic
Hazard, Kentucky, United States
Carroll County Cancer Center
Westminster, Maryland, United States
Columbia Comprehensive Cancer Care Clinic
Jefferson City, Missouri, United States
Nevada Cancer Institute
Las Vegas, Nevada, United States
Somerset Hematology Oncology Associates
Somerville, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Monter Cancer Center
Lake Success, New York, United States
Mid Dakota Clinic
Bismarck, North Dakota, United States
Oregon Health Sciences University
Portland, Oregon, United States
University of Pittsburgh Medical Center - Cancer Institute
Pittsburgh, Pennsylvania, United States
Cancer Centers of the Carolinas
Greenville, South Carolina, United States
The West Clinic
Memphis, Tennessee, United States
Texas Oncology, P.A.
Bedford, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Longview Cancer Center
Longview, Texas, United States
Joe Arrington Cancer Research
Lubbock, Texas, United States
Texas Oncology, P.A.
McAllen, Texas, United States
Cancer Care Centers of South Texas
San Antonio, Texas, United States
Texas Oncology
Waco, Texas, United States
Texas Oncology, P.A.
Webster, Texas, United States
US Oncology Research - Texoma Cancer Center
Wichita Falls, Texas, United States
Fairfax/Northern Virginia Hematology/Oncology
Fairfax, Virginia, United States
Yakima Valley Memorial Hospital/North Start Lodge
Yakima, Washington, United States
Cephalon Investigational Site
Brussels, , Belgium
Cephalon Investigational Site
Brussels, , Belgium
Cephalon Investigational Site
Ghent, , Belgium
Cephalon Investigational Site
Haifa, , Israel
Cephalon Investigational Site
Nahariya, , Israel
Countries
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References
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Czuczman MS, Kahanic S, Forero A, Davis G, Munteanu M, Van Den Neste E, Offner F, Bron D, Quick D, Fowler N. Results of a phase II study of bendamustine and ofatumumab in untreated indolent B cell non-Hodgkin's lymphoma. Ann Hematol. 2015 Apr;94(4):633-41. doi: 10.1007/s00277-014-2269-8. Epub 2015 Jan 30.
Other Identifiers
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2009-016725-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
C18083/2048
Identifier Type: -
Identifier Source: org_study_id