Randomized, Open-label, Multicenter Phase 3 Study to Assess the Efficacy and Safety of GIVinostat Versus Hydroxyurea IN JAK2V617F-positive High-risk Polycythemia Vera Patients: the GIV-IN PV TRIAL
Italfarmaco
Summary
The goal of this clinical trial is to compare the efficacy and safety of givinostat to hydroxyurea in Jak2V617F-positive high risk polycythemia vera patients.
Description
PV is a cMPN mainly driven by JAK2V617F mutation. The disease has an increased risk of thromboembolic complications, a predisposition to evolve into myelofibrosis (MF) and transformation into acute myeloid leukemia. Patients ≥ 60 years of age and/or with a previous thrombotic event (TE) are considered at High Risk (HR) for thrombosis. The association of absolute values of circulating neutrophil, lymphocyte and monocyte and the high value of JAK2V617F allele burden are additional risk factors for the occurrence of thrombosis and for progression to MF, respectively. Overall, most patients trea…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Core Treatment - Inclusion Criteria: * Patients must have been diagnosed with PV according to the 2016 WHO criteria before randomization * Patients must have JAK2V617F-positive disease * Patients with PV must meet the definition of HR for thrombosis (i.e., HR) within 3 years before screening as follows: * Age ≥ 60 years, and/or * Prior thrombosis. * Patients must be in need of treatment at screening, defined by the presence of at least one of the following: * HCT ≥ 45% or HCT \< 45% with at least 1 phlebotomy performed in the 3 months before screening, or * WBC count \> 10 × 109/L,…
Interventions
- DrugGivinostat
Oral. The dosage must be modified, according to the manifestation of toxicities or lack of efficacy, with the aim to achieve an optimized dose.
- DrugHydroxyurea
Oral. The dosage must be modified, according to the manifestation of toxicities or lack of efficacy, with the aim to achieve an optimized dose.
Locations (90)
- University of Alabama at BirminghamBirmingham, Alabama
- Emad Ibrahim, MD, IncRedlands, California
- US Oncology IncEnglewood, Colorado
- American Oncology Partners of Maryland, PABethesda, Maryland
- Icahn School of Medicine at Mount SinaiNew York, New York
- University of North Carolina at Chapel HillChapel Hill, North Carolina