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Givinostat vs. Hydroxyurea for Polycythemia Vera

This study is comparing two oral medications, givinostat and hydroxyurea, for people with Polycythemia Vera (PV). PV is a blood disorder where your body makes too many red blood cells, often due to a specific gene change called JAK2V617F. The goal is to see if givinostat is more effective and safer than hydroxyurea in controlling PV, especially for patients at high risk for blood clots. To join, you must have been diagnosed with PV according to specific criteria and have the JAK2V617F gene change. You also need to be considered high-risk for blood clots, meaning you are 60 years or older, or have had a blood clot before. The study will measure how many patients respond to treatment after 48 weeks. The current recruitment status is unclear.

Study design
This is an interventional study comparing givinostat to hydroxyurea, with a planned enrollment of 220 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at week 48, and there is an extended treatment phase to collect long-term data.

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NCT06093672

Study on Efficacy and Safety of Givinostat Versus Hydroxyurea in Patients With Polycythemia Vera

Recruiting
PHASE3Ages 18+InterventionalTreatment
Italfarmaco
~220 participants
Updated 2026-03-25 on ClinicalTrials.gov
What's tested:GivinostatHydroxyurea

At a glance

Recruiting sites
72 of 90 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of patients achieving a response at Week 48.
Measured over week 25 - week 48

Conditions

Polycythemia Vera

Explore related trials

Polycythemia Vera

Where it's being run

90 sites across 61 states
United Kingdom6
Serbia5
Spain4
Texas3
Croatia3
Ireland3
Emilia-Romagna3
Piedmont3

Who to contact

Maurizio Caserini
[email protected]
+39 02 6443 1
Email the study team

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Eligibility criteria

Inclusion

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:

Exclusion

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

What this trial measures

  • Proportion of patients achieving a response at Week 48.week 25 - week 48

    Response assessment based on: * Hematocrit \< 45% without phlebotomy in the prior 3 months, and * White blood cell (WBC) count ≤ 10 × 109/L, and * Platelet count ≤ 400 × 109/L, and * Normal spleen size as measured by imaging (normal spleen size is defined as: a longitudinal diameter ≤ 12 cm for female and ≤ 13 cm for male) and * During Part 2 (Week 25 to 48), absence of progressive disease, major hemorrhagic events and major thrombotic events.