NCT06093672 · Italfarmaco
Study on Efficacy and Safety of Givinostat Versus Hydroxyurea in Patients With Polycythemia Vera
(GIV-IN-PV)
What this study is about
The goal of this clinical trial is to compare the effectiveness and safety of givinostat to hydroxyurea in Jak2V617F-positive high risk polycythemia vera patients.
View original scientific 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.
Interventions
DRUG
Givinostat
Oral. The dosage must be modified, according to the manifestation of toxicities or lack of efficacy, with the aim to achieve an optimized dose.
DRUG
Hydroxyurea
Oral. The dosage must be modified, according to the manifestation of toxicities or lack of efficacy, with the aim to achieve an optimized dose.
Primary outcome measures
Proportion of patients achieving a response at Week 48.
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Birmingham, Alabama
- Redlands, California
- Englewood, Colorado
- Bethesda, Maryland
- New York, New York
- Chapel Hill, North Carolina
- Cleveland, Ohio
- Eugene, Oregon
- Houston, Texas
- Sherman, Texas
- Salt Lake City, Utah
- Roanoke, Virginia
And 1 more location — see the full list below.
Collaborators
PPD Development, LP
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 25, 2026 · Source of record for eligibility and locations