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Study on Efficacy and Safety of Givinostat Versus Hydroxyurea in Patients With Polycythemia Vera
Sponsor: Italfarmaco
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
220
Start Date
2024-03-26
Completion Date
2026-07
Last Updated
2026-03-25
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (90)
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
Medical Park Bahcelievler Hastanesi
Bahçelievler, Istanbul, Turkey (Türkiye)
Ege Universitesi Tip Fakultesi
Bornova, İzmir, Turkey (Türkiye)
VM Medical Park Mersin Hospital - Ataturk
Mezitli, Mersin, Turkey (Türkiye)
Namik Kemal Universitesi Saglik Uygulama ve Arastirma Merkezi
Altınova, Terkirdag, Turkey (Türkiye)
Belfast City Hospital
Belfast, United Kingdom
Pilgrim Hospital
Boston, United Kingdom
Imperial College Healthcare NHS Trust
London, United Kingdom
Milton Keynes University Hospital
Milton Keynes, United Kingdom
University of Oxford - The Weatherall Institute of Molecular Medicine (WIMM)
Oxford, United Kingdom
Southampton General Hospital
Southampton, United Kingdom