The purpose for conducting this research study is to determine the feasibility of using dasatinib as a treatment for polycythemia vera and to determine the optimum treatment regimen.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Patients will receive a once-daily oral administration of dasatinib at a dose of 100 mg QD (two 50 mg tablets taken together each day) for the duration of the study with the modifications as indicated. If the platelet count remains above 600,000/microL or the spleen remains enlarged in the absence of leukopenia or other side effects, the dose of dasatinib may be escalated to 120 mg QD (two 50 mg tablets plus one 20 mg tablet taken together each day).
Emory Winship Cancer Institute
Atlanta, Georgia, United States
Hematology/Oncology Associates of Rockland
New City, New York, United States
Weill Cornell Medical College - New York Presbyterian Hospital
New York, New York, United States
The Jones Clinic
Germantown, Tennessee, United States
Effect of Dasatinib on the Platelet Count and the Stabilization of Hematocrit When Restored by Phlebotomy to Normal Range
To evaluate the effect of dasatinib on the platelet count and the stabilization of hematocrit when restored by phlebotomy to normal range (HCT \<45% for men, \<42% for women). Analysis was not completed because the study was terminated early due to lack of efficacy.
Time frame: Lab tests will be performed weekly for the first month, then every 2 weeks for months 2 and 3 and monthly thereafter.
Change in Performance Status and Development of Side Effects and Complications
To determine change in performance status and development of side effects and complications in patients treated under this protocol. Analysis was not completed because the study was terminated early due to lack of efficacy.
Time frame: Patients will evaluated weekly for the first month, then every two weeks forr months 2 and 3, and monthly thereafter.
Changes in Marrow Cellularity, Reticulin and Fibrous Content
To determine changes in marrow cellularity, reticulin and fibrous content. Analysis was not completed because the study was terminated early due to lack of efficacy.
Time frame: Bone marrow analysis will be performed at baseline and month 6.
Change in Cytogenetics
To determine change in cytogenetics if initially abnormal. Analysis was not completed because the study was terminated early due to lack of efficacy.
Time frame: Cytogenetics analysis will be performed at baseline and month 6.
Change in JAK2 Allele Burden
To determine if quantitative change in JAK2 expression occurs as measured by quantitative pyrosequencing. Analysis was not completed because the study was terminated early due to lack of efficacy.
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Time frame: JAK2 analysis will be performed at baseline and month 3.