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Comparing givinostat and hydroxyurea for treating 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

Phase 3 Interventional Italfarmaco · NCT06093672

This study is testing whether givinostat works better than hydroxyurea for treating high-risk polycythemia vera in patients with a specific genetic mutation.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment220 (estimated)
Ages18 Years and up
SexAll
SponsorItalfarmaco Industry-sponsored
Locations90 sites (Birmingham, Alabama and 89 other locations)
Trial IDNCT06093672 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the efficacy and safety of givinostat compared to hydroxyurea in patients with high-risk polycythemia vera who are positive for the JAK2V617F mutation. Participants must have been diagnosed with polycythemia vera within the last three years and meet specific criteria indicating a high risk for thrombosis. The study will involve randomization of eligible patients to receive either givinostat or hydroxyurea and will monitor their health outcomes over time.

Who should consider this trial

Good fit: Ideal candidates for this study are patients diagnosed with JAK2V617F-positive polycythemia vera who are at high risk for thrombosis and require treatment.

Not a fit: Patients who have a documented history of resistance or intolerance to hydroxyurea will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients with polycythemia vera, potentially improving their quality of life and reducing complications.

How similar studies have performed: Other studies have explored treatments for polycythemia vera, but the specific comparison of givinostat and hydroxyurea in this context is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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:

  1. if the patient received givinostat, a complete hematological response (CHR) at Week 48 shall be achieved
  2. 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

Where this trial is running

Birmingham, Alabama and 89 other locations

+40 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Polycythemia VeraGivinostat
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.