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New hope for High-Risk blood cancer patients: givinostat faces off against standard therapy

NCT ID NCT06093672

Disease control Sponsor: Italfarmaco Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial compares the experimental drug givinostat to the standard drug hydroxyurea in 220 adults with high-risk polycythemia vera, a blood cancer that increases red blood cells and raises clot risk. The study measures how well each drug controls blood counts and spleen size over 48 weeks. Participants must have the JAK2V617F gene mutation and be at high risk for blood clots.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 220 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2024

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

acquired polycythemia vera

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Polycythemia vera

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    82 sites in 16 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • A.O.U. Maggiore della Carità

    RECRUITING

    Novara, Piedmont, 28100, Italy

  • Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda

    RECRUITING

    Sofia, Sofia-Grad, 1407, Bulgaria

  • Albert Schweitzer Ziekenhuis

    NOT_YET_RECRUITING

    Dordrecht, South Holland, 3318 AT, Netherlands

  • American Oncology Partners of Maryland, PA

    RECRUITING

    Bethesda, Maryland, 20852, United States

  • Assuta Medical Center

    RECRUITING

    Tel Aviv, Tel Aviv, 60000, Israel

  • Azienda Ospedaliera Città della Salute e della Scienza di Torino

    RECRUITING

    Turin, Piedmont, 10126, Italy

  • Azienda Ospedaliera Papa Giovanni XXIII

    RECRUITING

    Bergamo, Lombardy, 24127, Italy

  • Azienda Ospedaliera Universitaria Careggi

    RECRUITING

    Florence, Tuscany, 50134, Italy

  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

    RECRUITING

    Palermo, Sicily, 90127, Italy

  • Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco di Catania

    NOT_YET_RECRUITING

    Catania, Sicily, 95123, Italy

  • Azienda Ospedaliero Universitaria delle Marche

    RECRUITING

    Ancona, The Marches, 60126, Italy

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

    RECRUITING

    Bologna, Emilia-Romagna, 40138, Italy

  • Azienda Sanitaria Ospedaliera S. Croce e Carle

    RECRUITING

    Cuneo, Piedmont, 12100, Italy

  • Azienda Sanitaria Universitaria Friuli Centrale

    RECRUITING

    Udine, Friuli Venezia Giulia, 33100, Italy

  • Azienda USL IRCCS di Reggio Emilia

    RECRUITING

    Reggio Emilia, Emilia-Romagna, 42123, Italy

  • Belfast City Hospital

    WITHDRAWN

    Belfast, BT9 7AB, United Kingdom

  • Bnai Zion Medical Center

    TERMINATED

    Haifa, 31048, Israel

  • CHU Amiens Hôpital Sud

    RECRUITING

    Amiens, Somme, 80054, France

  • CHU Angers

    RECRUITING

    Angers, Maine-et-Loire, 49000, France

  • CHU Nantes

    RECRUITING

    Nantes, Loire-Atlantique, 44000, France

  • CHU de Nice

    RECRUITING

    Nice, Alpes-Maritimes, 6202, France

  • Carmel Medical Center

    TERMINATED

    Haifa, 34362, Israel

  • Centre Hospitalier de Saint-Quentin

    RECRUITING

    Saint-Quentin, Aisne, 2100, France

  • Centre Hospitalier de Troyes

    RECRUITING

    Troyes, Aube, 10000, France

  • Clinical Center of Vojvodina

    RECRUITING

    Novi Sad, 21000, Serbia

  • Clinical Hospital Center Bezanijska Kosa

    RECRUITING

    Belgrade, 11000, Serbia

  • Clinical Hospital Center Rijeka

    NOT_YET_RECRUITING

    Rijeka, 51000, Croatia

  • Clinical Hospital Center Rijeka - PPDS

    RECRUITING

    Rijeka, 51000, Croatia

  • Clinical Hospital Center Zemun

    RECRUITING

    Belgrade, 11000, Serbia

  • Clinical Hospital Dubrava

    RECRUITING

    Zagreb, City of Zagreb, 10000, Croatia

  • Connolly Hospital Blanchardstown

    WITHDRAWN

    Dublin, 15, Ireland

  • Cork University Hospital

    RECRUITING

    Cork, Ireland

  • Ege Universitesi Tip Fakultesi

    RECRUITING

    Bornova, İzmir, Turkey (Türkiye)

  • Emad Ibrahim, MD, Inc

    RECRUITING

    Redlands, California, 92373, United States

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

    RECRUITING

    Milan, Lombardy, 20122, Italy

  • Fondazione Policlinico Universitario Campus Bio-Medico di Roma

    RECRUITING

    Rome, Lazio, 00128, Italy

  • Gemeinschaftspraxis Hämatologie - Onkologie

    RECRUITING

    Dresden, Saxony, 01307, Germany

  • General Hospital Sibenik

    NOT_YET_RECRUITING

    Šibenik, 22000, Croatia

  • Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli

    RECRUITING

    Reggio Calabria, Calabria, 89133, Italy

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

    RECRUITING

    Győr, Győr-Moson-Sopron, 9024, Hungary

  • Hadassah Medical Center - PPDS

    TERMINATED

    Jerusalem, Jerusalem, 91120, Israel

  • Hopital d'Argenteuil

    RECRUITING

    Argenteuil, Île-de-France Region, 95107, France

  • Hospital General Universitario Dr. Balmis

    WITHDRAWN

    Alicante, 3010, Spain

  • Hospital Universitari i Politecnic La Fe de Valencia

    RECRUITING

    Valencia, 46026, Spain

  • Hospital Universitario Ramon y Cajal

    RECRUITING

    Madrid, 28034, Spain

  • Hospital Universitario Virgen de la Victoria

    RECRUITING

    Málaga, 29010, Spain

  • Hôpital Bretonneau

    RECRUITING

    Tours, Indre-et-Loire, 37044, France

  • Hôpital Saint Louis

    RECRUITING

    Paris, 75010, France

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

    NOT_YET_RECRUITING

    Badalona, Barcelona, 8916, Spain

  • Icahn School of Medicine at Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

  • Imperial College Healthcare NHS Trust

    RECRUITING

    London, W12 0HS, United Kingdom

  • Indywidualna Specjalistyczna Praktyka Lekarska Tomasz Woźny

    RECRUITING

    Poznan, 60-549, Poland

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

    RECRUITING

    Meldola, Emilia-Romagna, 47014, Italy

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

    RECRUITING

    Bari, Apulia, 70124, Italy

  • Klinikum Wels-Grieskirchen GmbH

    RECRUITING

    Wels, Upper Austria, 4600, Austria

  • Landesklinikum Wiener Neustadt

    RECRUITING

    Wiener Neustadt, Lower Austria, 2700, Austria

  • MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Mater Misericordiae University Hospital

    RECRUITING

    Dublin, 7, Ireland

  • Medical Park Bahcelievler Hastanesi

    ENROLLING_BY_INVITATION

    Bahçelievler, Istanbul, Turkey (Türkiye)

  • Medisch Spectrum Twente

    NOT_YET_RECRUITING

    Enschede, Overijssel, 7512 KZ, Netherlands

  • Medizinische Fakultät Mannheim der Universität Heidelberg, Universitätsmedizin Mannheim

    RECRUITING

    Mannheim, Baden-Wurttemberg, 68167, Germany

  • Medizinische Universitat Wien (Medical University of Vienna)

    RECRUITING

    Vienna, State of Vienna, 1090, Austria

  • Milton Keynes University Hospital

    RECRUITING

    Milton Keynes, United Kingdom

  • Namik Kemal Universitesi Saglik Uygulama ve Arastirma Merkezi

    RECRUITING

    Altınova, Terkirdag, Turkey (Türkiye)

  • OncoResearch Lerchenfeld GmbH

    RECRUITING

    Hamburg, 22081, Germany

  • Oncology Associates of Oregon, P.C.

    RECRUITING

    Eugene, Oregon, 97401, United States

  • Ordensklinikum Linz GmbH Elisabethinen

    RECRUITING

    Linz, Upper Austria, 4020, Austria

  • Pilgrim Hospital

    RECRUITING

    Boston, United Kingdom

  • Southampton General Hospital

    RECRUITING

    Southampton, United Kingdom

  • Spaarne Gasthuis

    NOT_YET_RECRUITING

    Hoofddorp, North Holland, 2134 TM, Netherlands

  • Specjalistyczny Szpital im. dra Alfreda Sokołowskiego

    RECRUITING

    Wałbrzych, 58-309, Poland

  • Szabolcs-Szatmár-Bereg Vármegyei Oktatókórház

    RECRUITING

    Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400, Hungary

  • Texas Oncology (Webster) - USOR

    RECRUITING

    Houston, Texas, 77089, United States

  • Texas Oncology-Denison Cancer Center

    RECRUITING

    Sherman, Texas, 75090, United States

  • The Cleveland Clinic Foundation

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • The James Cancer Hospital and Solove Research Institute

    RECRUITING

    Roanoke, Virginia, 43210, United States

  • Tolna Vármegyei Megyei Balassa János Kórház

    RECRUITING

    Szekszárd, Tolna County, 7100, Hungary

  • US Oncology Inc

    RECRUITING

    Englewood, Colorado, 80113, United States

  • University Clinical Center Nis

    RECRUITING

    Niš, 18000, Serbia

  • University Clinical Center of Serbia

    WITHDRAWN

    Belgrade, 11000, Serbia

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

    RECRUITING

    Stara Zagora, 6003, Bulgaria

  • University Multiprofile Hospital for Active Treatment Sveti Georgi EAD

    RECRUITING

    Plovdiv, 4001, Bulgaria

  • University of Alabama at Birmingham

    NOT_YET_RECRUITING

    Birmingham, Alabama, 35294-0001, United States

  • University of North Carolina at Chapel Hill

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

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

    RECRUITING

    Oxford, United Kingdom

  • University of Utah - Huntsman Cancer Institute - PPDS

    RECRUITING

    Salt Lake City, Utah, 84112, United States

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

    WITHDRAWN

    Halle, Saxony-Anhalt, 06120, Germany

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

    NOT_YET_RECRUITING

    Wroclaw, 50-367, Poland

  • VA Puget Sound Health Care System - NAVREF - PPDS

    RECRUITING

    Seattle, Washington, 98108-1532, United States

  • VM Medical Park Mersin Hospital - Ataturk

    RECRUITING

    Mezitli, Mersin, Turkey (Türkiye)

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