Study on Efficacy and Safety of Givinostat Versus Hydroxyurea in Patients With Polycythemia Vera
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
220 participants
Mar 26, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria13
- 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, or
- PLT count \> 400 × 109/L.
- Patients must have normalized HCT (i.e., HCT \< 45%) at randomization
- Patients must have completed the Week 48 visit of the DSC/08/2357/32 core treatment phase and:
- if the patient received givinostat, a complete hematological response (CHR) at Week 48 shall be achieved
- if the patient received HU, did not achieve a CHR (see above for the definition) at Week 48
Exclusion Criteria16
- Patients pre-treated with HU with a documented history of resistance or intolerance to HU defined by the original ELN criteria
- Patients with a QTcF value of \> 450 msec for males and \> 460 msec for females at the Screening visit (as the mean of 3 consecutive readings 5 minutes apart in the event a first ECG demonstrates a prolonged QTcF interval); congenital or acquired history of QTc prolongation or ventricular arrhythmias, at the Screening visit
- Splanchnic thrombosis and/or thrombosis of the cerebral venous sinuses and/or splenectomy in the medical history
- Patients with clinically significant cardiovascular disease
- Patients with myocardial infarction, stroke or unstable angina within the 6 months prior to screening.
- Patients with inadequate liver or renal function at screening
- Uncontrolled hypertriglyceridemia at screening, i.e., triglycerides ˃ 1.5 × ULN
- Previous treatment with a JAK2 or HDAC inhibitor or 32-phosphorus (radioactive isotope) therapy.
- Patients being treated concurrently with any investigational agent or prior participation in an interventional clinical study within the 30 days prior to screening or within 5 half-lives of the investigational product, whichever is longer.
- Pregnant or nursing women
- For patients randomized to givinostat in the core treatment phase - Patients with a QTcF value at Week 48 of \> 500 msec
- For patients randomized to HU in the core treatment phase:
- PLT count ≤ 150 × 109/L at Week 48
- ANC \< 1.2 × 109/L at Week 48
- Uncontrolled hypertriglyceridemia at Week 48
- Patients with a QTcF value at Week 48 of \> 450 msec for males and \> 460 msec for female
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Interventions
Oral. The dosage must be modified, according to the manifestation of toxicities or lack of efficacy, with the aim to achieve an optimized dose.
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)
View Full Details on ClinicalTrials.gov
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NCT06093672