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)
An Open-Label 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)
2 other identifiers
interventional
50
3 countries
39
Brief Summary
The primary objective of the study is to determine the efficacy, as measured by overall response (complete response + partial response) of bendamustine in combination with ofatumumab in previously untreated patients with indolent B-Cell Non-Hodgkin's Lymphoma (NHL).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 2010
Shorter than P25 for phase_2
39 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
April 14, 2010
CompletedFirst Posted
Study publicly available on registry
April 22, 2010
CompletedStudy Start
First participant enrolled
May 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedResults Posted
Study results publicly available
August 28, 2012
CompletedAugust 28, 2012
July 1, 2012
1.2 years
April 14, 2010
July 24, 2012
July 24, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR), as Determined by the International Working Group (IWG) Criteria As Assessed by Investigators
The IWG criteria (Cheson et al 2007) for a CR is a complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A PR is at least a 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase should be observed in the size of other nodes, liver or spleen, and no new sites of disease should be observed.
up to Week 32
Secondary Outcomes (1)
Percentage of Participants With a Best Overall Response of Complete Response (CR), as Determined by the International Working Group (IWG) Criteria As Assessed by Investigators
up to Week 32
Study Arms (1)
Bendamustine and Ofatumumab
EXPERIMENTALThere 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.
Interventions
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 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.
Eligibility Criteria
You may qualify if:
- The patient has histopathologic confirmation of one of the protocol-specific CD20+ B-cell non-Hodgkin's lymphomas. Tissue diagnostic procedures must be performed within 6 months of study entry and with biopsy material available for review.
- The patient meets 1 of the following need-for-treatment criteria:
- 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
- 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
- presence of lymphoma-related complications
- 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:
- or more clearly demarcated lesions with a largest diameter ≥1.5 cm, or
- 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.
- +3 more criteria
You may not qualify if:
- The patient:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cephalonlead
Study Sites (39)
Birmingham Hematology and Oncology Associates, LLC
Birmingham, Alabama, 35235, United States
University of Alabama at Birmingham
Birmingham, Alabama, 35294-3300, United States
Tower Cancer Research Foundation
Beverly Hills, California, 90211-1850, United States
Hematology Oncology, P.C.
Stamford, Connecticut, 06902, United States
University Cancer Institute
Boynton Beach, Florida, 33435, United States
Florida Cancer Institute - New Hope
New Port Richey, Florida, 34655, United States
Dublin Hematology Oncology Care P.C.
Dublin, Georgia, 31021, United States
Northwest Georgia Oncology Center
Marietta, Georgia, 30060, United States
Georgia Cancer Specialists
Tucker, Georgia, 30084, United States
Cancer Care and Hematology Specialists of Chicagoland
Niles, Illinois, 60714, United States
Siouxland Hematology-Oncology Assoc. LLP
Sioux City, Iowa, 51101, United States
Kentucky Cancer Clinic
Hazard, Kentucky, 41701, United States
Carroll County Cancer Center
Westminster, Maryland, 21157, United States
Columbia Comprehensive Cancer Care Clinic
Jefferson City, Missouri, 65109, United States
Nevada Cancer Institute
Las Vegas, Nevada, 89135, United States
Somerset Hematology Oncology Associates
Somerville, New Jersey, 08876, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Monter Cancer Center
Lake Success, New York, 11042, United States
Mid Dakota Clinic
Bismarck, North Dakota, 58504, United States
Oregon Health Sciences University
Portland, Oregon, 97239, United States
University of Pittsburgh Medical Center - Cancer Institute
Pittsburgh, Pennsylvania, 15232, United States
Cancer Centers of the Carolinas
Greenville, South Carolina, 29605, United States
The West Clinic
Memphis, Tennessee, 38138, United States
Texas Oncology, P.A.
Bedford, Texas, 76022, United States
MD Anderson Cancer Center
Houston, Texas, 77030-4009, United States
Longview Cancer Center
Longview, Texas, 75601, United States
Joe Arrington Cancer Research
Lubbock, Texas, 79410, United States
Texas Oncology, P.A.
McAllen, Texas, 78503, United States
Cancer Care Centers of South Texas
San Antonio, Texas, 78229, United States
Texas Oncology
Waco, Texas, 76712, United States
Texas Oncology, P.A.
Webster, Texas, 77598, United States
US Oncology Research - Texoma Cancer Center
Wichita Falls, Texas, 76310, United States
Fairfax/Northern Virginia Hematology/Oncology
Fairfax, Virginia, 22031, United States
Yakima Valley Memorial Hospital/North Start Lodge
Yakima, Washington, 98902, United States
Cephalon Investigational Site
Brussels, 1000, Belgium
Cephalon Investigational Site
Brussels, 1200, Belgium
Cephalon Investigational Site
Ghent, Belgium
Cephalon Investigational Site
Haifa, 31096, Israel
Cephalon Investigational Site
Nahariya, 22100, Israel
Related Publications (1)
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.
PMID: 25630297DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director, Clinical Research
- Organization
- Teva Branded Pharmaceutical Products, R&D Inc.
Study Officials
- STUDY DIRECTOR
Sponsor's Medical Expert
Cephalon
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2010
First Posted
April 22, 2010
Study Start
May 1, 2010
Primary Completion
July 1, 2011
Study Completion
October 1, 2011
Last Updated
August 28, 2012
Results First Posted
August 28, 2012
Record last verified: 2012-07