Back to resultsOfatumumab and Bendamustine for Previously Treated Chronic Lymphocytic Leukemia (CLL)
Primary Purpose
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ofatumumab and Bendamustine
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Lymphocytic Leukemia focused on measuring CLL, SLL, Bendamustine, Ofatumumab
Eligibility 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.
Sites / Locations
- Georgetown University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ofatumumab and Bendamustine
Arm Description
Ofatumumab and Bendamustine
Outcomes
Primary Outcome Measures
Overall Response Rate
40% per the National Cancer Institute Working Group Response Criteria for Chronic Lymphocytic Leukemia
Secondary Outcome Measures
Complete Response Rate
NCI IWG response criteria
Median PFS
Kaplan Meyer PFS
Full Information
NCT ID
NCT01010568
First Posted
October 19, 2009
Last Updated
November 10, 2015
Sponsor
Georgetown University
Collaborators
GlaxoSmithKline, Cephalon
1. Study Identification
Unique Protocol Identification Number
NCT01010568
Brief Title
Ofatumumab and Bendamustine for Previously Treated Chronic Lymphocytic Leukemia (CLL)
Official Title
Ofatumumab and Bendamustine in Previously Treated Chronic Lymphocytic Leukemia/ Small Lymphocytic Leukemia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Terminated
Why Stopped
Unable to accrue patients due to change in standard CLL therapy
Study Start Date
April 2010 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Georgetown University
Collaborators
GlaxoSmithKline, Cephalon
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Keywords
CLL, SLL, Bendamustine, Ofatumumab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ofatumumab and Bendamustine
Arm Type
Experimental
Arm Description
Ofatumumab and Bendamustine
Intervention Type
Drug
Intervention Name(s)
Ofatumumab and Bendamustine
Other Intervention Name(s)
Bendamustine, Treanda, Ofatumumab
Intervention Description
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
Primary Outcome Measure Information:
Title
Overall Response Rate
Description
40% per the National Cancer Institute Working Group Response Criteria for Chronic Lymphocytic Leukemia
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Complete Response Rate
Description
NCI IWG response criteria
Time Frame
6 months
Title
Median PFS
Description
Kaplan Meyer PFS
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce Cheson, MD
Organizational Affiliation
Georgetown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Georgetown University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24925211
Citation
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.
Results Reference
derived
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Ofatumumab and Bendamustine for Previously Treated Chronic Lymphocytic Leukemia (CLL)
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