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Status:

RECRUITING

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

Lead Sponsor:

Italfarmaco

Collaborating Sponsors:

PPD Development, LP

Conditions:

Polycythemia Vera

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief 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.

Detailed Description

PV is a cMPN mainly driven by JAK2V617F mutation. The disease has an increased risk of thromboembolic complications, a predisposition to evolve into myelofibrosis (MF) and transformation into acute my...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    March 26 2024

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    July 1 2026

    Estimated Enrollment :

    220 Patients enrolled

    Trial Details

    Trial ID

    NCT06093672

    Start Date

    March 26 2024

    End Date

    July 1 2026

    Last Update

    June 22 2025

    Active Locations (76)

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    Page 1 of 19 (76 locations)

    1

    University of Alabama at Birmingham

    Birmingham, Alabama, United States, 35294-0001

    2

    Emad Ibrahim, MD, Inc

    Redlands, California, United States, 92373

    3

    American Oncology Partners of Maryland, PA

    Bethesda, Maryland, United States, 20852

    4

    Icahn School of Medicine at Mount Sinai

    New York, New York, United States, 10029