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Polycythemia VeraPhase 3GIV-IN-PVNCT06093672

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

A Phase 3 study testing Givinostat and Hydroxyurea in people with Polycythemia Vera, run by Italfarmaco at 90 sites in 16 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Polycythemia Vera
What is being tested?
Givinostat and Hydroxyurea
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
220 participants
Where
90 sitesin 16 countries
Study dates
26 Mar 2024to Jul 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

90 sites in 16 countries. Contact the study team or a site near you to ask about taking part.

Maurizio Caserini contact

+39 02 6443 1

patientadvocacy@italfarmacogroup.com

90 sites in 16 countries

Italy16 sites, 16 recruiting

  • Azienda Ospedaliero Universitaria delle Marche

    Ancona, The Marches, 60126

    Recruiting

  • Istituto Tumori "Giovanni Paolo II" I.R.C.C.S.

    Bari, Apulia, 70124

    Paolo Ditonno

    Recruiting

  • Azienda Ospedaliera Papa Giovanni XXIII

    Bergamo, Lombardy, 24127

    Federico Lussana

    Recruiting

  • Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico

    Bologna, Emilia-Romagna, 40138

    Recruiting

  • Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco di Catania

    Catania, Sicily, 95123

    Not yet recruiting

  • Azienda Sanitaria Ospedaliera S. Croce e Carle

    Cuneo, Piedmont, 12100

    Recruiting

  • Azienda Ospedaliera Universitaria Careggi

    Florence, Tuscany, 50134

    Recruiting

  • Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l

    Meldola, Emilia-Romagna, 47014

    Recruiting

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

    Milan, Lombardy, 20122

    Recruiting

  • A.O.U. Maggiore della Carità

    Novara, Piedmont, 28100

    Recruiting

  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

    Palermo, Sicily, 90127

    Recruiting

  • Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli

    Reggio Calabria, Calabria, 89133

    Recruiting

  • Azienda USL IRCCS di Reggio Emilia

    Reggio Emilia, Emilia-Romagna, 42123

    Recruiting

  • Fondazione Policlinico Universitario Campus Bio-Medico di Roma

    Rome, Lazio, 00128

    Recruiting

  • Azienda Ospedaliera Città della Salute e della Scienza di Torino

    Turin, Piedmont, 10126

    Recruiting

  • Azienda Sanitaria Universitaria Friuli Centrale

    Udine, Friuli Venezia Giulia, 33100

    Recruiting

Other trials in Italy

United States14 sites, 14 recruiting

  • American Oncology Partners of Maryland, PA

    Bethesda, Maryland, 20852

    Victor Priego

    Recruiting

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294-0001

    Not yet recruiting

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

    Recruiting

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

    Recruiting

  • US Oncology Inc

    Englewood, Colorado, 80113

    Recruiting

  • Oncology Associates of Oregon, P.C.

    Eugene, Oregon, 97401

    Recruiting

  • MD Anderson Cancer Center

    Houston, Texas, 77030

    Recruiting

  • Texas Oncology (Webster) - USOR

    Houston, Texas, 77089

    Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

    Recruiting

  • Emad Ibrahim, MD, Inc

    Redlands, California, 92373

    Recruiting

  • The James Cancer Hospital and Solove Research Institute

    Roanoke, Virginia, 43210

    Recruiting

  • University of Utah - Huntsman Cancer Institute - PPDS

    Salt Lake City, Utah, 84112

    Recruiting

  • VA Puget Sound Health Care System - NAVREF - PPDS

    Seattle, Washington, 98108-1532

    Recruiting

  • Texas Oncology-Denison Cancer Center

    Sherman, Texas, 75090

    Amir Faridi

    Recruiting

Other trials in United States

France9 sites, 9 recruiting

  • CHU Amiens Hôpital Sud

    Amiens, Somme, 80054

    Recruiting

  • CHU Angers

    Angers, Maine-et-Loire, 49000

    Recruiting

  • Hopital d'Argenteuil

    Argenteuil, Île-de-France Region, 95107

    Recruiting

  • CHU Nantes

    Nantes, Loire-Atlantique, 44000

    Recruiting

  • CHU de Nice

    Nice, Alpes-Maritimes, 6202

    Recruiting

  • Hôpital Saint Louis

    Paris, 75010

    Recruiting

  • Centre Hospitalier de Saint-Quentin

    Saint-Quentin, Aisne, 2100

    Recruiting

  • Hôpital Bretonneau

    Tours, Indre-et-Loire, 37044

    Recruiting

  • Centre Hospitalier de Troyes

    Troyes, Aube, 10000

    Recruiting

Other trials in France

United Kingdom6 sites, 5 recruiting

  • Belfast City Hospital

    Belfast, BT9 7AB

    Withdrawn

  • Pilgrim Hospital

    Boston

    Ciro Rinaldi

    Ciro Rinaldi

    Recruiting

  • Imperial College Healthcare NHS Trust

    London, W12 0HS

    Recruiting

  • Milton Keynes University Hospital

    Milton Keynes

    Magbor Akanni

    Magbor Akanni

    Recruiting

  • University of Oxford - The Weatherall Institute of Molecular Medicine (WIMM)

    Oxford

    Recruiting

  • Southampton General Hospital

    Southampton

    Srinivasan Narayanan

    Recruiting

Other trials in United Kingdom

Serbia5 sites, 4 recruiting

  • Clinical Hospital Center Bezanijska Kosa

    Belgrade, 11000

    Recruiting

  • Clinical Hospital Center Zemun

    Belgrade, 11000

    Recruiting

  • University Clinical Center of Serbia

    Belgrade, 11000

    Withdrawn

  • University Clinical Center Nis

    Niš, 18000

    Recruiting

  • Clinical Center of Vojvodina

    Novi Sad, 21000

    Recruiting

Other trials in Serbia

Spain5 sites, 4 recruiting

  • Hospital General Universitario Dr. Balmis

    Alicante, 3010

    Withdrawn

  • ICO Badalona-H.U. Germans Trias i Pujol

    Badalona, Barcelona, 8916

    Not yet recruiting

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

    Recruiting

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010

    Recruiting

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026

    Recruiting

Other trials in Spain

Austria4 sites, 4 recruiting

  • Ordensklinikum Linz GmbH Elisabethinen

    Linz, Upper Austria, 4020

    Recruiting

  • Medizinische Universitat Wien (Medical University of Vienna)

    Vienna, State of Vienna, 1090

    Recruiting

  • Klinikum Wels-Grieskirchen GmbH

    Wels, Upper Austria, 4600

    Recruiting

  • Landesklinikum Wiener Neustadt

    Wiener Neustadt, Lower Austria, 2700

    Recruiting

Other trials in Austria

Croatia4 sites, 4 recruiting

  • Clinical Hospital Center Rijeka - PPDS

    Rijeka, 51000

    Recruiting

  • Clinical Hospital Center Rijeka

    Rijeka, 51000

    Not yet recruiting

  • General Hospital Sibenik

    Šibenik, 22000

    Not yet recruiting

  • Clinical Hospital Dubrava

    Zagreb, City of Zagreb, 10000

    Recruiting

Other trials in Croatia

Germany4 sites, 3 recruiting

  • Gemeinschaftspraxis Hämatologie - Onkologie

    Dresden, Saxony, 01307

    Recruiting

  • Universitätsmedizin Halle, Universitätsklinikum Halle, Klinik für Innere Medizin IV

    Halle, Saxony-Anhalt, 06120

    Withdrawn

  • OncoResearch Lerchenfeld GmbH

    Hamburg, 22081

    Recruiting

  • Medizinische Fakultät Mannheim der Universität Heidelberg, Universitätsmedizin Mannheim

    Mannheim, Baden-Wurttemberg, 68167

    Recruiting

Other trials in Germany

Israel4 sites, 1 recruiting

  • Bnai Zion Medical Center

    Haifa, 31048

    Terminated

  • Carmel Medical Center

    Haifa, 34362

    Terminated

  • Hadassah Medical Center - PPDS

    Jerusalem, Jerusalem, 91120

    Terminated

  • Assuta Medical Center

    Tel Aviv, Tel Aviv, 60000

    Recruiting

Other trials in Israel

Turkey (Türkiye)4 sites, 4 recruiting

  • Namik Kemal Universitesi Saglik Uygulama ve Arastirma Merkezi

    Altınova, Terkirdag

    Seval Akapinar

    Seval Akapinar

    Recruiting

  • Medical Park Bahcelievler Hastanesi

    Bahçelievler, Istanbul

    Enrolling by invitation

  • Ege Universitesi Tip Fakultesi

    Bornova, İzmir

    Mahmut Tobu

    Recruiting

  • VM Medical Park Mersin Hospital - Ataturk

    Mezitli, Mersin

    Anil Tombak

    Anil Tombak

    Recruiting

Other trials in Turkey (Türkiye)

Bulgaria3 sites, 3 recruiting

  • University Multiprofile Hospital for Active Treatment Sveti Georgi EAD

    Plovdiv, 4001

    Recruiting

  • Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda

    Sofia, Sofia-Grad, 1407

    Recruiting

  • University Multiprofile Hospital for Active Treatment - Prof. Dr. Stoyan Kirkovich AD

    Stara Zagora, 6003

    Recruiting

Other trials in Bulgaria

Hungary3 sites, 3 recruiting

  • Gyor-Moson-Sopron Vármegyei Petz Aladár Egyetemi Oktató Kórház

    Győr, Győr-Moson-Sopron, 9024

    Recruiting

  • Szabolcs-Szatmár-Bereg Vármegyei Oktatókórház

    Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400

    Recruiting

  • Tolna Vármegyei Megyei Balassa János Kórház

    Szekszárd, Tolna County, 7100

    Recruiting

Other trials in Hungary

Ireland3 sites, 2 recruiting

  • Cork University Hospital

    Cork

    Recruiting

  • Connolly Hospital Blanchardstown

    Dublin, 15

    Withdrawn

  • Mater Misericordiae University Hospital

    Dublin, 7

    Recruiting

Other trials in Ireland

Netherlands3 sites, 3 recruiting

  • Albert Schweitzer Ziekenhuis

    Dordrecht, South Holland, 3318 AT

    Not yet recruiting

  • Medisch Spectrum Twente

    Enschede, Overijssel, 7512 KZ

    Not yet recruiting

  • Spaarne Gasthuis

    Hoofddorp, North Holland, 2134 TM

    Not yet recruiting

Other trials in Netherlands

Poland3 sites, 3 recruiting

  • Indywidualna Specjalistyczna Praktyka Lekarska Tomasz Woźny

    Poznan, 60-549

    Recruiting

  • Specjalistyczny Szpital im. dra Alfreda Sokołowskiego

    Wałbrzych, 58-309

    Recruiting

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza- Radeckiego we Wrocławiu

    Wroclaw, 50-367

    Not yet recruiting

Other trials in Poland

About this study

Official title: 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.

Read the 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 myeloid leukemia.

Patients ≥ 60 years of age and/or with a previous thrombotic event (TE) are considered at High Risk (HR) for thrombosis. The association of absolute values of circulating neutrophil, lymphocyte and monocyte and the high value of JAK2V617F allele burden are additional risk factors for the occurrence of thrombosis and for progression to MF, respectively.

Overall, most patients treated with HU are not adequately under control for both symptoms and long-term risks.

In recent years, data have shown that histone deacetylase (HDACs) inhibitors induce growth arrest, differentiation, and/or apoptosis in neoplastic cells. Givinostat has demonstrated preliminary signs of clinical activity and an acceptable safety profile in patients with JAK2V617F-positive cMPNs in three phase 2 studies.

The core treatment phase (pivotal phase 3 study) is designed to demonstrate the superiority of givinostat versus HU on efficacy, in JAK2V617F-positive, HR PV patients.

The extended treatment phase will allow eligible patients to receive givinostat in the long-term, with the objective of collecting long-term safety and efficacy data.

Being tested
Givinostat, Hydroxyurea
Keywords
Polycythemia Vera, Givinostat
Medical subject headings
Polycythemia Vera

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GivinostatDrug

    Also called ITF2357

    Oral. The dosage must be modified, according to the manifestation of toxicities or lack of efficacy, with the aim to achieve an optimized dose.

  • HydroxyureaDrug

    Also called ITF2357

    Oral. The dosage must be modified, according to the manifestation of toxicities or lack of efficacy, with the aim to achieve an optimized dose.

Study groups in NCT06093672
Study groupRoleWhat they receive
Givinostat - Core phaseExperimentalGivinostat 50 mg BID from baseline till week 48
Receives: Drug: Givinostat
Hydroxyurea - Core phaseActive comparatorHU 500 mg BID from baseline till week 48
Receives: Drug: Hydroxyurea

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients achieving a response at 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.

    Measured: week 25 - week 48

Secondary outcomes (4)

  1. Proportion of patients achieving a complete hematological response (CHR) at Week 48.

    CHR 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

    Measured: week 48

  2. Time from randomization to the first observed CHR

    Measured: Randomization - week 48

  3. Proportion of patients with a normal spleen size at Week 48.

    Measured: week 48

  4. Safety and tolerability up to Week 48.

    Measured: Randomization - week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2023
  2. Study start26 Mar 2024
  3. Primary completionJul 2026 (estimated)
  4. Study completionJul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
220 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06093672
Sponsor's protocol ID
DSC/08/2357/32
Other IDs
2022-502276-23-00
Acronym
GIV-IN-PV
Status last verified
Mar 2026
First submitted
10 Oct 2023
Last updated
25 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Givinostat and Hydroxyurea in people with Polycythemia Vera, run by Italfarmaco at 90 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 90 sites in Italy, United States, France, United Kingdom, Serbia and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Maurizio Caserini (+39 02 6443 1, patientadvocacy@italfarmacogroup.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients achieving a response at Week 48. (time frame: week 25 - week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06093672.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.

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