Study on Efficacy and Safety of Givinostat Versus Hydroxyurea in Patients With Polycythemia Vera
NCT ID: NCT06093672
Last Updated: 2026-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
220 participants
INTERVENTIONAL
2024-03-26
2026-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Givinostat - Core phase
Givinostat 50 mg BID from baseline till week 48
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.
Hydroxyurea - Core phase
HU 500 mg BID from baseline till week 48
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Exclusion 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
* 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
18 Years
ALL
No
Sponsors
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PPD Development, LP
INDUSTRY
Italfarmaco
INDUSTRY
Responsible Party
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Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Emad Ibrahim, MD, Inc
Redlands, California, United States
US Oncology Inc
Englewood, Colorado, United States
American Oncology Partners of Maryland, PA
Bethesda, Maryland, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Oncology Associates of Oregon, P.C.
Eugene, Oregon, United States
MD Anderson Cancer Center
Houston, Texas, United States
Texas Oncology (Webster) - USOR
Houston, Texas, United States
Texas Oncology-Denison Cancer Center
Sherman, Texas, United States
University of Utah - Huntsman Cancer Institute - PPDS
Salt Lake City, Utah, United States
The James Cancer Hospital and Solove Research Institute
Roanoke, Virginia, United States
VA Puget Sound Health Care System - NAVREF - PPDS
Seattle, Washington, United States
Landesklinikum Wiener Neustadt
Wiener Neustadt, Lower Austria, Austria
Ordensklinikum Linz GmbH Elisabethinen
Linz, Upper Austria, Austria
Klinikum Wels-Grieskirchen GmbH
Wels, Upper Austria, Austria
Medizinische Universitat Wien (Medical University of Vienna)
Vienna, Vienna, Austria
Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda
Sofia, Sofia-Grad, Bulgaria
University Multiprofile Hospital for Active Treatment Sveti Georgi EAD
Plovdiv, , Bulgaria
University Multiprofile Hospital for Active Treatment - Prof. Dr. Stoyan Kirkovich AD
Stara Zagora, , Bulgaria
Clinical Hospital Dubrava
Zagreb, City of Zagreb, Croatia
Clinical Hospital Center Rijeka - PPDS
Rijeka, , Croatia
Clinical Hospital Center Rijeka
Rijeka, , Croatia
General Hospital Sibenik
Šibenik, , Croatia
Centre Hospitalier de Saint-Quentin
Saint-Quentin, Aisne, France
CHU de Nice
Nice, Alpes-Maritimes, France
Centre Hospitalier de Troyes
Troyes, Aube, France
Hôpital Bretonneau
Tours, Indre-et-Loire, France
CHU Nantes
Nantes, Loire-Atlantique, France
CHU Angers
Angers, Maine-et-Loire, France
CHU Amiens Hôpital Sud
Amiens, Somme, France
Hôpital Saint Louis
Paris, , France
Hopital d'Argenteuil
Argenteuil, Île-de-France Region, France
Medizinische Fakultät Mannheim der Universität Heidelberg, Universitätsmedizin Mannheim
Mannheim, Baden-Wurttemberg, Germany
Gemeinschaftspraxis Hämatologie - Onkologie
Dresden, Saxony, Germany
Universitätsmedizin Halle, Universitätsklinikum Halle, Klinik für Innere Medizin IV
Halle, Saxony-Anhalt, Germany
OncoResearch Lerchenfeld GmbH
Hamburg, , Germany
Gyor-Moson-Sopron Vármegyei Petz Aladár Egyetemi Oktató Kórház
Győr, Győr-Moson-Sopron, Hungary
Szabolcs-Szatmár-Bereg Vármegyei Oktatókórház
Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary
Tolna Vármegyei Megyei Balassa János Kórház
Szekszárd, Tolna County, Hungary
Cork University Hospital
Cork, , Ireland
Connolly Hospital Blanchardstown
Dublin, , Ireland
Mater Misericordiae University Hospital
Dublin, , Ireland
Hadassah Medical Center - PPDS
Jerusalem, Jerusalem, Israel
Assuta Medical Center
Tel Aviv, Tel Aviv, Israel
Bnai Zion Medical Center
Haifa, , Israel
Carmel Medical Center
Haifa, , Israel
Istituto Tumori "Giovanni Paolo II" I.R.C.C.S.
Bari, Apulia, Italy
Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli
Reggio Calabria, Calabria, Italy
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Bologna, Emilia-Romagna, Italy
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l
Meldola, Emilia-Romagna, Italy
Azienda USL IRCCS di Reggio Emilia
Reggio Emilia, Emilia-Romagna, Italy
Azienda Sanitaria Universitaria Friuli Centrale
Udine, Friuli Venezia Giulia, Italy
Fondazione Policlinico Universitario Campus Bio-Medico di Roma
Rome, Lazio, Italy
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, Lombardy, Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, Lombardy, Italy
Azienda Sanitaria Ospedaliera S. Croce e Carle
Cuneo, Piedmont, Italy
A.O.U. Maggiore della Carità
Novara, Piedmont, Italy
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Turin, Piedmont, Italy
Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco di Catania
Catania, Sicily, Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo, Sicily, Italy
Azienda Ospedaliero Universitaria delle Marche
Ancona, The Marches, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, Tuscany, Italy
Spaarne Gasthuis
Hoofddorp, North Holland, Netherlands
Medisch Spectrum Twente
Enschede, Overijssel, Netherlands
Albert Schweitzer Ziekenhuis
Dordrecht, South Holland, Netherlands
Indywidualna Specjalistyczna Praktyka Lekarska Tomasz Woźny
Poznan, , Poland
Specjalistyczny Szpital im. dra Alfreda Sokołowskiego
Wałbrzych, , Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza- Radeckiego we Wrocławiu
Wroclaw, , Poland
Clinical Hospital Center Bezanijska Kosa
Belgrade, , Serbia
Clinical Hospital Center Zemun
Belgrade, , Serbia
University Clinical Center of Serbia
Belgrade, , Serbia
University Clinical Center Nis
Niš, , Serbia
Clinical Center of Vojvodina
Novi Sad, , Serbia
ICO Badalona-H.U. Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital General Universitario Dr. Balmis
Alicante, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hospital Universitario Virgen de la Victoria
Málaga, , Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, , Spain
Belfast City Hospital
Belfast, , United Kingdom
Imperial College Healthcare NHS Trust
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Victor Priego
Role: primary
Other Identifiers
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DSC/08/2357/32
Identifier Type: -
Identifier Source: org_study_id
2022-502276-23-00
Identifier Type: CTIS
Identifier Source: secondary_id
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