This is an 18-week open-label, multicenter study to evaluate the efficacy and tolerability of CEP-701 (lestaurtinib) treatment in patients with Polycythemia Vera (PV) and patients with Essential Thrombocytosis (ET).
This is an 18-week open-label, multicenter study to evaluate the efficacy and tolerability of CEP-701 (lestaurtinib) treatment at a dosage of 80 mg bid for 18 weeks (126 days) in patients with Polycythemia Vera (PV) who have abnormal baseline neutrophil counts or require hydroxyurea therapy and patients with Essential Thrombocytosis (ET) who require hydroxyurea therapy for disease control.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
60 mg bid - 120 mg bid for an 18 weeks (126 days) treatment duration
Johns Hopkins University
Baltimore, Maryland, United States
NY Presbyterian-Cornell
New York, New York, United States
Mount Sinai School of Medicine
New York, New York, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Determine whether a specific reduction in the JAK2 V617F allele has been indicated in this study.
Time frame: 18 weeks +
- improvements in hemoglobin values, neutrophil count, and platelet count. - reduction in dose of hydroxyurea - reduction in splenic enlargement - rate of phlebotomy
Time frame: 18 weeks +
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