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Ofatumumab and Bendamustine for Previously Treated Chronic Lymphocytic Leukemia (CLL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01010568
Recruitment Status : Terminated (Unable to accrue patients due to change in standard CLL therapy)
First Posted : November 10, 2009
Results First Posted : December 15, 2015
Last Update Posted : December 15, 2015
Sponsor:
Collaborators:
GlaxoSmithKline
Cephalon
Information provided by (Responsible Party):
Georgetown University

Study Description
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Brief Summary:
The purpose of this study is to evaluate the safety and effectiveness of the combination of bendamustine and ofatumumab in subjects with relapsed/refractory chronic lymphocytic leukemia and small cell lymphoma. All subjects enrolled on this study will receive both drugs by intravenous (IV) infusion.

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma Drug: Ofatumumab and Bendamustine Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ofatumumab and Bendamustine in Previously Treated Chronic Lymphocytic Leukemia/ Small Lymphocytic Leukemia
Study Start Date : April 2010
Actual Primary Completion Date : May 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Ofatumumab and Bendamustine
Ofatumumab and Bendamustine
 Drug: Ofatumumab and Bendamustine
Ofatumumab 300-mg IV on Day 1 of week -1 and then 1000 mg on Day 1 of each cycle for 6 cycles Bendamustine 70 mg/m2 IV on days 1 and 2 of each cycle for 6 cycles
Other Names:
  • Bendamustine
  • Treanda
  • Ofatumumab


Outcome Measures
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Primary Outcome Measures :
  1. Overall Response Rate [ Time Frame: 6 months ]
    40% per the National Cancer Institute Working Group Response Criteria for Chronic Lymphocytic Leukemia


Secondary Outcome Measures :
  1. Complete Response Rate [ Time Frame: 6 months ]
    NCI IWG response criteria

  2. Median PFS [ Time Frame: 2 years ]
    Kaplan Meyer PFS


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologically confirmed CLL or SLL requiring therapy
  • Age 18 years of age or older
  • ECOG performance status 0, 1, or 2
  • Normal organ and bone marrow function
  • Resolution of toxic effects from prior therapies
  • Ability to adhere to the study schedule and give written informed consent

Exclusion Criteria:

  • Any serious medical, psychiatric illness or laboratory abnormality
  • Chemotherapy or radiotherapy within 4 weeks of entering the study
  • Currently receiving other treatment for CLL/SLL or other malignancies
  • Active other malignancies
  • History of allergic reactions to bendamustine or ofatumumab
  • Ongoing corticosteroid use
  • Pregnant or lactating
  • HIV positive
  • Active hepatitis B
  • Allogeneic transplant within 6 months of entering study or graft-versus-host disease.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01010568


Locations
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United States, District of Columbia
Georgetown University
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
GlaxoSmithKline
Cephalon
Investigators
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Principal Investigator: Bruce Cheson, MD Georgetown University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Georgetown University
ClinicalTrials.gov Identifier: NCT01010568    
Other Study ID Numbers: OB2009-315
First Posted: November 10, 2009    Key Record Dates
Results First Posted: December 15, 2015
Last Update Posted: December 15, 2015
Last Verified: September 2015
Keywords provided by Georgetown University:
CLL
SLL
Bendamustine
Ofatumumab
Additional relevant MeSH terms:
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Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
 Bendamustine Hydrochloride
Ofatumumab
Antibodies, Monoclonal
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs