Status:
TERMINATED
Ofatumumab With High Dose Methylprednisone Followed by Ofatumumab and Alemtuzumab in 17p CLL
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
National Comprehensive Cancer Network
GlaxoSmithKline
Conditions:
CLL
SLL
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The main purpose of this study is to examine how two separate groups of 17p deletion Chronic lymphocytic leukemia (CLL) participants respond to sequential treatment with this particular combination of...
Detailed Description
Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy. Part A: Ofatumumab + HDMP 2-4 cycles Part B: Ofatumumab + Alemtuzumab 1-6 cycles Pa...
Eligibility Criteria
Inclusion
- Documented CLL/SLL
- 17p deletion by FISH in 20% or more nuclei on peripheral blood, bone marrow or lymph node
- Normal organ function
Exclusion
- Pregnant or breast feeding
- Current active hepatic or biliary disease
- Chronic or current infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment such as, but not limited to, chronic renal infection, tuberculosis and active Hepatitis C
- History of significant cerebrovascular disease in the past 6 months or ongoing event with active symptoms or sequelae
- Other past or current malignancy. Participants who have been free of malignancy for at least 2 years, or who have a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.
- Known HIV positive
- Clinically significant cardiac disease including unstable angina, acute myocardial infarction within 6 months prior to study entry, congestive heart failure, and arrhythmia unless controlled by therapy, with the exception of extra systoles or minor conduction abnormalities.
- Significant concurrent uncontrolled medical conditions including, but not limited to, renal, hepatic, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease which in the opinion of the investigator may represent a risk for the subject.
- Positive serology for Hepatitis B or C
- History of allergic reactions attributed to ofatumumab.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2017
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01465334
Start Date
December 1 2011
End Date
January 1 2017
Last Update
August 29 2023
Active Locations (2)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215