Compares givinostat with hydroxyurea in high-risk polycythemia vera

Trial details

Who runs it

Italfarmaco

Trial code

NCT06093672EU 2022-502276-23-00

Record updated

25 March 2026

Original description

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.Read full original descriptionShow less

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

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.

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, or; PLT count > 400 × 109/L; Patients must have normalized HCT (i.e., HCT < 45%) at randomization; Extended Treatment - Inclusion Criteria; 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; Core Treatment phase - 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; Extended treatment phase - Exclusion criteria; 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.

ClinicalTrials.gov NCT06093672 · EU CTIS 2022-502276-23-00