Study on Efficacy and Safety of Givinostat Versus Hydroxyurea in Patients With Polycythemia Vera (GIV-IN PV)

Italfarmaco

Status and phase

Enrolling

Phase 3

Conditions

Polycythemia Vera

Treatments

Drug: Hydroxyurea

Drug: Givinostat

Study type

Interventional

Funder types

Industry

Identifiers

NCT06093672

DSC/08/2357/32

Details and patient eligibility

About

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.

Enrollment

220 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients must have been diagnosed with PV according to the 2016 WHO criteria within 3 years before randomization
Patients must have JAK2V617F-positive disease
Patients with PV must meet the definition of HR for thrombosis (i.e., HR) at 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

Exclusion criteria

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