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

This study has been terminated.
(Unable to accrue patients due to change in standard CLL therapy)
Sponsor:
Collaborators:
GlaxoSmithKline
Cephalon
Information provided by (Responsible Party):
Georgetown University
ClinicalTrials.gov Identifier:
NCT01010568
First received: October 19, 2009
Last updated: November 10, 2015
Last verified: September 2015
  Purpose
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 Intervention Phase
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Drug: Ofatumumab and Bendamustine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ofatumumab and Bendamustine in Previously Treated Chronic Lymphocytic Leukemia/ Small Lymphocytic Leukemia

Resource links provided by NLM:


Further study details as provided by Georgetown University:

Primary Outcome Measures:
  • Overall Response Rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    40% per the National Cancer Institute Working Group Response Criteria for Chronic Lymphocytic Leukemia


Secondary Outcome Measures:
  • Complete Response Rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    NCI IWG response criteria

  • Median PFS [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Kaplan Meyer PFS


Enrollment: 10
Study Start Date: April 2010
Study Completion Date: August 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT01010568

Locations
United States, District of Columbia
Georgetown University
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
GlaxoSmithKline
Cephalon
Investigators
Principal Investigator: Bruce Cheson, MD Georgetown University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Georgetown University
ClinicalTrials.gov Identifier: NCT01010568     History of Changes
Other Study ID Numbers: OB2009-315 
Study First Received: October 19, 2009
Results First Received: July 22, 2015
Last Updated: November 10, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Georgetown University:
CLL
SLL
Bendamustine
Ofatumumab

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Immune System Diseases
Immunoproliferative Disorders
Leukemia, B-Cell
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Antibodies, Monoclonal
Bendamustine Hydrochloride
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 30, 2016