Actively Recruiting
Study on Efficacy and Safety of Givinostat Versus Hydroxyurea in Patients With Polycythemia Vera
Led by Italfarmaco · Updated on 2026-03-25
220
Participants Needed
90
Research Sites
118 weeks
Total Duration
On this page
Sponsors
I
Italfarmaco
Lead Sponsor
P
PPD Development, LP
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study on Efficacy and Safety of Givinostat Versus Hydroxyurea in Patients With Polycythemia Vera
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with polycythemia vera according to 2016 WHO criteria before randomization
- Positive for JAK2V617F mutation
- High risk for thrombosis, defined by age 60 years or older and/or prior thrombosis within 3 years before screening
- In need of treatment at screening, defined by at least one of: hematocrit (HCT) ≥ 45%, or HCT < 45% with at least 1 phlebotomy in prior 3 months, or white blood cell count > 10 x 10^9/L, or platelet count > 400 x 10^9/L
- Normalized hematocrit (HCT < 45%) at randomization
- For extended treatment: completed Week 48 of core phase with complete hematological response if on givinostat, or no complete response if on hydroxyurea
You will not qualify if you...
- History of resistance or intolerance to hydroxyurea
- QTcF interval > 450 msec for males or > 460 msec for females at screening; history of QTc prolongation or ventricular arrhythmias
- History of splanchnic thrombosis, cerebral venous sinus thrombosis, or splenectomy
- Clinically significant cardiovascular disease
- Myocardial infarction, stroke, or unstable angina within 6 months prior to screening
- Inadequate liver or kidney function
- Uncontrolled hypertriglyceridemia (≥ 1.5 times upper limit of normal)
- Previous treatment with JAK2 or HDAC inhibitors or radioactive phosphorus therapy
- Current treatment with other investigational agents or recent participation in interventional clinical trials
- Pregnant or breastfeeding women
- For extended phase: QTcF > 500 msec for patients on givinostat
- For extended phase: platelet count ≤ 150 x 10^9/L, ANC < 1.2 x 10^9/L, uncontrolled hypertriglyceridemia, or QTcF > 450 msec for males and > 460 msec for females in patients on hydroxyurea
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 90 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-0001
Not Yet Recruiting
2
Emad Ibrahim, MD, Inc
Redlands, California, United States, 92373
Actively Recruiting
3
US Oncology Inc
Englewood, Colorado, United States, 80113
Actively Recruiting
4
American Oncology Partners of Maryland, PA
Bethesda, Maryland, United States, 20852
Actively Recruiting
5
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
6
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
7
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
8
Oncology Associates of Oregon, P.C.
Eugene, Oregon, United States, 97401
Actively Recruiting
9
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
10
Texas Oncology (Webster) - USOR
Houston, Texas, United States, 77089
Actively Recruiting
11
Texas Oncology-Denison Cancer Center
Sherman, Texas, United States, 75090
Actively Recruiting
12
University of Utah - Huntsman Cancer Institute - PPDS
Salt Lake City, Utah, United States, 84112
Actively Recruiting
13
The James Cancer Hospital and Solove Research Institute
Roanoke, Virginia, United States, 43210
Actively Recruiting
14
VA Puget Sound Health Care System - NAVREF - PPDS
Seattle, Washington, United States, 98108-1532
Actively Recruiting
15
Landesklinikum Wiener Neustadt
Wiener Neustadt, Lower Austria, Austria, 2700
Actively Recruiting
16
Medizinische Universitat Wien (Medical University of Vienna)
Vienna, State of Vienna, Austria, 1090
Actively Recruiting
17
Ordensklinikum Linz GmbH Elisabethinen
Linz, Upper Austria, Austria, 4020
Actively Recruiting
18
Klinikum Wels-Grieskirchen GmbH
Wels, Upper Austria, Austria, 4600
Actively Recruiting
19
Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda
Sofia, Sofia-Grad, Bulgaria, 1407
Actively Recruiting
20
University Multiprofile Hospital for Active Treatment Sveti Georgi EAD
Plovdiv, Bulgaria, 4001
Actively Recruiting
21
University Multiprofile Hospital for Active Treatment - Prof. Dr. Stoyan Kirkovich AD
Stara Zagora, Bulgaria, 6003
Actively Recruiting
22
Clinical Hospital Dubrava
Zagreb, City of Zagreb, Croatia, 10000
Actively Recruiting
23
Clinical Hospital Center Rijeka - PPDS
Rijeka, Croatia, 51000
Actively Recruiting
24
Clinical Hospital Center Rijeka
Rijeka, Croatia, 51000
Not Yet Recruiting
25
General Hospital Sibenik
Šibenik, Croatia, 22000
Not Yet Recruiting
26
Centre Hospitalier de Saint-Quentin
Saint-Quentin, Aisne, France, 2100
Actively Recruiting
27
CHU de Nice
Nice, Alpes-Maritimes, France, 6202
Actively Recruiting
28
Centre Hospitalier de Troyes
Troyes, Aube, France, 10000
Actively Recruiting
29
Hôpital Bretonneau
Tours, Indre-et-Loire, France, 37044
Actively Recruiting
30
CHU Nantes
Nantes, Loire-Atlantique, France, 44000
Actively Recruiting
31
CHU Angers
Angers, Maine-et-Loire, France, 49000
Actively Recruiting
32
CHU Amiens Hôpital Sud
Amiens, Somme, France, 80054
Actively Recruiting
33
Hôpital Saint Louis
Paris, France, 75010
Actively Recruiting
34
Hopital d'Argenteuil
Argenteuil, Île-de-France Region, France, 95107
Actively Recruiting
35
Medizinische Fakultät Mannheim der Universität Heidelberg, Universitätsmedizin Mannheim
Mannheim, Baden-Wurttemberg, Germany, 68167
Actively Recruiting
36
Gemeinschaftspraxis Hämatologie - Onkologie
Dresden, Saxony, Germany, 01307
Actively Recruiting
37
Universitätsmedizin Halle, Universitätsklinikum Halle, Klinik für Innere Medizin IV
Halle, Saxony-Anhalt, Germany, 06120
Withdrawn
38
OncoResearch Lerchenfeld GmbH
Hamburg, Germany, 22081
Actively Recruiting
39
Gyor-Moson-Sopron Vármegyei Petz Aladár Egyetemi Oktató Kórház
Győr, Győr-Moson-Sopron, Hungary, 9024
Actively Recruiting
40
Szabolcs-Szatmár-Bereg Vármegyei Oktatókórház
Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary, 4400
Actively Recruiting
41
Tolna Vármegyei Megyei Balassa János Kórház
Szekszárd, Tolna County, Hungary, 7100
Actively Recruiting
42
Cork University Hospital
Cork, Ireland
Actively Recruiting
43
Connolly Hospital Blanchardstown
Dublin, Ireland, 15
Withdrawn
44
Mater Misericordiae University Hospital
Dublin, Ireland, 7
Actively Recruiting
45
Hadassah Medical Center - PPDS
Jerusalem, Jerusalem, Israel, 91120
Terminated
46
Assuta Medical Center
Tel Aviv, Tel Aviv, Israel, 60000
Actively Recruiting
47
Bnai Zion Medical Center
Haifa, Israel, 31048
Terminated
48
Carmel Medical Center
Haifa, Israel, 34362
Terminated
49
Istituto Tumori "Giovanni Paolo II" I.R.C.C.S.
Bari, Apulia, Italy, 70124
Actively Recruiting
50
Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli
Reggio Calabria, Calabria, Italy, 89133
Actively Recruiting
51
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Bologna, Emilia-Romagna, Italy, 40138
Actively Recruiting
52
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l
Meldola, Emilia-Romagna, Italy, 47014
Actively Recruiting
53
Azienda USL IRCCS di Reggio Emilia
Reggio Emilia, Emilia-Romagna, Italy, 42123
Actively Recruiting
54
Azienda Sanitaria Universitaria Friuli Centrale
Udine, Friuli Venezia Giulia, Italy, 33100
Actively Recruiting
55
Fondazione Policlinico Universitario Campus Bio-Medico di Roma
Rome, Lazio, Italy, 00128
Actively Recruiting
56
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, Lombardy, Italy, 24127
Actively Recruiting
57
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, Lombardy, Italy, 20122
Actively Recruiting
58
Azienda Sanitaria Ospedaliera S. Croce e Carle
Cuneo, Piedmont, Italy, 12100
Actively Recruiting
59
A.O.U. Maggiore della Carità
Novara, Piedmont, Italy, 28100
Actively Recruiting
60
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Turin, Piedmont, Italy, 10126
Actively Recruiting
61
Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco di Catania
Catania, Sicily, Italy, 95123
Not Yet Recruiting
62
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo, Sicily, Italy, 90127
Actively Recruiting
63
Azienda Ospedaliero Universitaria delle Marche
Ancona, The Marches, Italy, 60126
Actively Recruiting
64
Azienda Ospedaliera Universitaria Careggi
Florence, Tuscany, Italy, 50134
Actively Recruiting
65
Spaarne Gasthuis
Hoofddorp, North Holland, Netherlands, 2134 TM
Not Yet Recruiting
66
Medisch Spectrum Twente
Enschede, Overijssel, Netherlands, 7512 KZ
Not Yet Recruiting
67
Albert Schweitzer Ziekenhuis
Dordrecht, South Holland, Netherlands, 3318 AT
Not Yet Recruiting
68
Indywidualna Specjalistyczna Praktyka Lekarska Tomasz Woźny
Poznan, Poland, 60-549
Actively Recruiting
69
Specjalistyczny Szpital im. dra Alfreda Sokołowskiego
Wałbrzych, Poland, 58-309
Actively Recruiting
70
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza- Radeckiego we Wrocławiu
Wroclaw, Poland, 50-367
Not Yet Recruiting
71
Clinical Hospital Center Bezanijska Kosa
Belgrade, Serbia, 11000
Actively Recruiting
72
Clinical Hospital Center Zemun
Belgrade, Serbia, 11000
Actively Recruiting
73
University Clinical Center of Serbia
Belgrade, Serbia, 11000
Withdrawn
74
University Clinical Center Nis
Niš, Serbia, 18000
Actively Recruiting
75
Clinical Center of Vojvodina
Novi Sad, Serbia, 21000
Actively Recruiting
76
ICO Badalona-H.U. Germans Trias i Pujol
Badalona, Barcelona, Spain, 8916
Not Yet Recruiting
77
Hospital General Universitario Dr. Balmis
Alicante, Spain, 3010
Withdrawn
78
Hospital Universitario Ramon y Cajal
Madrid, Spain, 28034
Actively Recruiting
79
Hospital Universitario Virgen de la Victoria
Málaga, Spain, 29010
Actively Recruiting
80
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, Spain, 46026
Actively Recruiting
81
Medical Park Bahcelievler Hastanesi
Bahçelievler, Istanbul, Turkey (Türkiye)
Enrolling by Invitation
82
Ege Universitesi Tip Fakultesi
Bornova, İzmir, Turkey (Türkiye)
Actively Recruiting
83
VM Medical Park Mersin Hospital - Ataturk
Mezitli, Mersin, Turkey (Türkiye)
Actively Recruiting
84
Namik Kemal Universitesi Saglik Uygulama ve Arastirma Merkezi
Altınova, Terkirdag, Turkey (Türkiye)
Actively Recruiting
85
Belfast City Hospital
Belfast, United Kingdom, BT9 7AB
Withdrawn
86
Pilgrim Hospital
Boston, United Kingdom
Actively Recruiting
87
Imperial College Healthcare NHS Trust
London, United Kingdom, W12 0HS
Actively Recruiting
88
Milton Keynes University Hospital
Milton Keynes, United Kingdom
Actively Recruiting
89
University of Oxford - The Weatherall Institute of Molecular Medicine (WIMM)
Oxford, United Kingdom
Actively Recruiting
90
Southampton General Hospital
Southampton, United Kingdom
Actively Recruiting
Research Team
M
Maurizio Caserini
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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