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

This study has been terminated.
(Unable to accrue patients due to change in CLL therapy where benadmustine is being used as front-line therapy)
Sponsor:
Collaborators:
GlaxoSmithKline
Cephalon
Information provided by (Responsible Party):
Georgetown University
ClinicalTrials.gov Identifier:
NCT01010568
First received: October 19, 2009
Last updated: February 8, 2013
Last verified: February 2013
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Georgetown University:

Primary Outcome Measures:
  • Overall response rate defined as partial and complete responses. For CLL this will be defined using the NCI-WG Response Criteria for CLL and for SLL using the IWG revised response criteria for malignant lymphoma [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • complete response rate assessed by standard response criteria (NCI-WG Response Criteria for CLL and IWG revised response criteria for malignant lymphoma for SLL) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Progression-free survival in months [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Toxicity types, frequency and relationship to study drugs according to CTCAE version 3.0 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: April 2010
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: December 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
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

No publications provided

Responsible Party: Georgetown University
ClinicalTrials.gov Identifier: NCT01010568     History of Changes
Other Study ID Numbers: OB2009-315
Study First Received: October 19, 2009
Last Updated: February 8, 2013
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
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
 Bendamustine
Nitrogen Mustard Compounds
Antibodies, Monoclonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013