Status:
COMPLETED
Dasatinib in Relapsed Chronic Lymphocytic Leukemia
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Brigham and Women's Hospital
Dana-Farber Cancer Institute
Conditions:
Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this research study is to see if Dasatinib is effective and safe to give to people with relapsed chronic lymphocytic leukemia (CLL) and to determine the effects of the drug on LYN kinas...
Detailed Description
* After the screening procedures confirm that the participant is eligible and willing to participate in the research study, they will have the following tests and procedures. * Dasatinib is given oral...
Eligibility Criteria
Inclusion
- 18 years of age or older
- CLL/SLL with cells positive by flow cytometry (or immunostaining) for CD19, CD23 and CD. Patients may be CD23 negative as long as they are also cyclin D1 negative.
- Must have failed at least 1 prior fludarabine containing regimen or have failed at least 2 non-fludarabine containing regimens or have a contraindication to fludarabine use
- ECOG performance status of 2 or better
- Adequate organ function to tolerate chemotherapy
- Adequate method of contraception
Exclusion
- Pregnant or breast-feeding women
- Uncontrolled angina within 3 months
- Diagnosed or suspected congenital long QT syndrome
- History of clinically significant ventricular arrhythmias
- Prolonged QTc interval on pre-entry electrocardiogram
- Uncontrolled hypertension
- Drugs that are generally accepted to have a risk of causing Torsades de Pointes
- Patient known to be HIV positive
- Known significant bleeding disorder unrelated to CLL
- Drugs that interfere with platelet function or coagulation must be stopped at least 7 days prior to entry
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00438854
Start Date
December 1 2006
End Date
March 1 2013
Last Update
December 13 2017
Active Locations (2)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115