A Phase II, Non-Randomized Study of the Use of Desatinib (Sprycel) in Treating Patients With Polycythemia Vera (PV) BMS Protocol Number: CA180-104
Overview
- Phase
- Phase 2
- Intervention
- Dasatinib
- Conditions
- Polycythemia Vera
- Sponsor
- Weill Medical College of Cornell University
- Enrollment
- 10
- Locations
- 4
- Primary Endpoint
- Effect of Dasatinib on the Platelet Count and the Stabilization of Hematocrit When Restored by Phlebotomy to Normal Range
- Status
- Terminated
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients must be \>= 18 years old
- •Performance Status (ECOG) 0-3
- •Previous therapies limited to interferon-alpha, hydroxyurea, anagrelide, and imatinib
- •Patients may have documented resistance or intolerance to interferon-alpha, imatinib, hydroxyurea, or anagrelide, but must have been demonstrated to be phlebotomy dependent requiring 6 or more phlebotomies per year to maintain the target HCT.
- •Patients may have newly diagnosed PV.
- •Patients may have had inadequate phlebotomy control on hydroxyurea or imatinib.
- •Adequate Organ Function
- •Total bilirubin \< 2.0 times the institutional Upper Limit of Normal (ULN)
- •Hepatic enzymes (AST, ALT ) ≤ 2.5 times the institutional ULN
- •Serum Na, K+, Mg2+, Phosphate and Ca2+³ Lower Limit of Normal (LLN)
Exclusion Criteria
- •Patients receiving busulfan within six weeks of Study Day
- •Patients receiving treatment with interferon-alpha within 4 weeks of Study Day
- •Patients receiving treatment with imatinib within 14 days of Study, Day
- •Patients with Grade 3 or 4 cardiac problems as defined by the New York Heart Association Criteria.
- •Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable.
- •A malignancy \[other than the one treated in this study\], which required radiotherapy or systemic treatment within the past 5 years.
- •Concurrent medical condition which may increase the risk of toxicity, including:
- •Pleural or pericardial effusion of any grade
- •Clinically-significant coagulation or platelet function disorder (e.g. known von Willebrand's disease)
- •Cardiac Symptoms, consider the following:
Arms & Interventions
All patients
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).
Intervention: Dasatinib
Outcomes
Primary Outcomes
Effect of Dasatinib on the Platelet Count and the Stabilization of Hematocrit When Restored by Phlebotomy to Normal Range
Time Frame: Lab tests will be performed weekly for the first month, then every 2 weeks for months 2 and 3 and monthly thereafter.
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.
Change in Performance Status and Development of Side Effects and Complications
Time Frame: Patients will evaluated weekly for the first month, then every two weeks forr months 2 and 3, and monthly thereafter.
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.
Secondary Outcomes
- Changes in Marrow Cellularity, Reticulin and Fibrous Content(Bone marrow analysis will be performed at baseline and month 6.)
- Change in Cytogenetics(Cytogenetics analysis will be performed at baseline and month 6.)
- Change in JAK2 Allele Burden(JAK2 analysis will be performed at baseline and month 3.)