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

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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

Tracking Information
First Submitted Date  ICMJE October 19, 2009
First Posted Date  ICMJE November 10, 2009
Results First Submitted Date  ICMJE July 22, 2015
Results First Posted Date  ICMJE December 15, 2015
Last Update Posted Date December 15, 2015
Study Start Date  ICMJE April 2010
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 10, 2015)
Overall Response Rate [ Time Frame: 6 months ]
40% per the National Cancer Institute Working Group Response Criteria for Chronic Lymphocytic Leukemia
Original Primary Outcome Measures  ICMJE
 (submitted: November 9, 2009)
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 ]
Change History Complete list of historical versions of study NCT01010568 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 10, 2015)
  • Complete Response Rate [ Time Frame: 6 months ]
    NCI IWG response criteria
  • Median PFS [ Time Frame: 2 years ]
    Kaplan Meyer PFS
Original Secondary Outcome Measures  ICMJE
 (submitted: November 9, 2009)
  • 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 ]
  • Progression-free survival in months [ Time Frame: 2 years ]
  • Toxicity types, frequency and relationship to study drugs according to CTCAE version 3.0 [ Time Frame: 6 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ofatumumab and Bendamustine for Previously Treated Chronic Lymphocytic Leukemia (CLL)
Official Title  ICMJE Ofatumumab and Bendamustine in Previously Treated Chronic Lymphocytic Leukemia/ Small Lymphocytic Leukemia
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Ofatumumab and Bendamustine
Ofatumumab and Bendamustine
Intervention: Drug: Ofatumumab and Bendamustine
Publications * Ujjani C, Ramzi P, Gehan E, Wang H, Wang Y, Cheson BD. Ofatumumab and bendamustine in previously treated chronic lymphocytic leukemia and small lymphocytic lymphoma. Leuk Lymphoma. 2015 Apr;56(4):915-20. doi: 10.3109/10428194.2014.933217. Epub 2014 Aug 6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 12, 2015)
10
Original Estimated Enrollment  ICMJE
 (submitted: November 9, 2009)
40
Actual Study Completion Date  ICMJE August 2014
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01010568
Other Study ID Numbers  ICMJE OB2009-315
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Georgetown University
Study Sponsor  ICMJE Georgetown University
Collaborators  ICMJE
  • GlaxoSmithKline
  • Cephalon
Investigators  ICMJE
Principal Investigator: Bruce Cheson, MD Georgetown University
PRS Account Georgetown University
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP