Trial Title:
Study on Efficacy and Safety of Givinostat Versus Hydroxyurea in Patients With Polycythemia Vera
NCT ID:
NCT06093672
Condition:
Polycythemia Vera
Conditions: Official terms:
Polycythemia Vera
Polycythemia
Hydroxyurea
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Givinostat
Description:
Oral.
Arm group label:
Givinostat
Intervention type:
Drug
Intervention name:
Hydroxyurea
Description:
Oral.
Arm group label:
Hydroxyurea
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients must have been diagnosed with PV according to the 2016 WHO criteria within
3 years before randomization
- Patients must have JAK2V617F-positive disease
- Patients with PV must meet the definition of HR for thrombosis (i.e., HR) at
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
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Alabama at Birmingham
Address:
City:
Birmingham
Zip:
35294-0001
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Emad Ibrahim, MD, Inc
Address:
City:
Redlands
Zip:
92373
Country:
United States
Status:
Recruiting
Facility:
Name:
Icahn School of Medicine at Mount Sinai
Address:
City:
New York
Zip:
10029
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
The Cleveland Clinic Foundation
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Status:
Recruiting
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
University of Utah - Huntsman Cancer Institute - PPDS
Address:
City:
Salt Lake City
Zip:
84112
Country:
United States
Status:
Recruiting
Facility:
Name:
VA Puget Sound Health Care System - NAVREF - PPDS
Address:
City:
Seattle
Zip:
98108-1532
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Landesklinikum Wiener Neustadt
Address:
City:
Wiener Neustadt
Zip:
2700
Country:
Austria
Status:
Not yet recruiting
Facility:
Name:
Ordensklinikum Linz GmbH Elisabethinen
Address:
City:
Linz
Zip:
4020
Country:
Austria
Status:
Not yet recruiting
Facility:
Name:
Klinikum Wels-Grieskirchen GmbH
Address:
City:
Wels
Zip:
4600
Country:
Austria
Status:
Recruiting
Facility:
Name:
Medizinische Universitat Wien (Medical University of Vienna)
Address:
City:
Vienna
Zip:
1090
Country:
Austria
Status:
Not yet recruiting
Facility:
Name:
Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda
Address:
City:
Sofia
Zip:
1407
Country:
Bulgaria
Status:
Recruiting
Facility:
Name:
University Multiprofile Hospital for Active Treatment Sveti Georgi EAD
Address:
City:
Plovdiv
Zip:
4001
Country:
Bulgaria
Status:
Recruiting
Facility:
Name:
University Multiprofile Hospital for Active Treatment - Prof. Dr. Stoyan Kirkovich AD
Address:
City:
Stara Zagora
Zip:
6003
Country:
Bulgaria
Status:
Recruiting
Facility:
Name:
Clinical Hospital Center Zagreb
Address:
City:
Zagreb
Zip:
10000
Country:
Croatia
Status:
Not yet recruiting
Facility:
Name:
Clinical Hospital Dubrava
Address:
City:
Zagreb
Zip:
10000
Country:
Croatia
Status:
Not yet recruiting
Facility:
Name:
Clinical Hospital Center Rijeka
Address:
City:
Rijeka
Zip:
51000
Country:
Croatia
Status:
Not yet recruiting
Facility:
Name:
General Hospital Sibenik
Address:
City:
Šibenik
Zip:
22000
Country:
Croatia
Status:
Not yet recruiting
Facility:
Name:
Centre Hospitalier de Saint-Quentin
Address:
City:
Saint-Quentin
Zip:
2100
Country:
France
Status:
Not yet recruiting
Facility:
Name:
CHU de Nice
Address:
City:
Nice
Zip:
6202
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Centre Hospitalier de Troyes
Address:
City:
Troyes
Zip:
10000
Country:
France
Status:
Recruiting
Facility:
Name:
Hôpital Bretonneau
Address:
City:
Tours
Zip:
37044
Country:
France
Status:
Not yet recruiting
Facility:
Name:
CHU Nantes
Address:
City:
Nantes
Zip:
44000
Country:
France
Status:
Recruiting
Facility:
Name:
CHU Angers
Address:
City:
Angers
Zip:
49000
Country:
France
Status:
Recruiting
Facility:
Name:
CHU Amiens Hôpital Sud
Address:
City:
Amiens
Zip:
80054
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Hôpital Saint Louis
Address:
City:
Paris
Zip:
75010
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Hopital d'Argenteuil
Address:
City:
Argenteuil
Zip:
95107
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Medizinische Fakultät Mannheim der Universität Heidelberg, Universitätsmedizin Mannheim
Address:
City:
Mannheim
Zip:
68167
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
Universitätsmedizin Halle, Universitätsklinikum Halle, Klinik für Innere Medizin IV
Address:
City:
Halle (Saale)
Zip:
06120
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
Gemeinschaftspraxis Hämatologie - Onkologie
Address:
City:
Dresden
Zip:
01307
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
OncoResearch Lerchenfeld GmbH
Address:
City:
Hamburg
Zip:
22081
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz
Address:
City:
Székesfehérvár
Zip:
8000
Country:
Hungary
Status:
Not yet recruiting
Facility:
Name:
Gyor-Moson-Sopron Vármegyei Petz Aladár Egyetemi Oktató Kórház
Address:
City:
Győr
Zip:
9024
Country:
Hungary
Status:
Not yet recruiting
Facility:
Name:
Szabolcs-Szatmár-Bereg Vármegyei Oktatókórház
Address:
City:
Nyíregyháza
Zip:
4400
Country:
Hungary
Status:
Recruiting
Facility:
Name:
Tolna Vármegyei Megyei Balassa János Kórház
Address:
City:
Szekszárd
Zip:
7100
Country:
Hungary
Status:
Recruiting
Facility:
Name:
Cork University Hospital
Address:
City:
Cork
Country:
Ireland
Status:
Recruiting
Facility:
Name:
Connolly Hospital Blanchardstown
Address:
City:
Dublin
Zip:
15
Country:
Ireland
Status:
Not yet recruiting
Facility:
Name:
Mater Misericordiae University Hospital
Address:
City:
Dublin
Zip:
7
Country:
Ireland
Status:
Not yet recruiting
Facility:
Name:
Assuta Medical Center
Address:
City:
Tel Aviv-Yafo
Zip:
60000
Country:
Israel
Status:
Recruiting
Facility:
Name:
Hadassah Medical Center - PPDS
Address:
City:
Jerusalem
Zip:
91120
Country:
Israel
Status:
Recruiting
Facility:
Name:
Bnai Zion Medical Center
Address:
City:
Haifa
Zip:
31048
Country:
Israel
Status:
Recruiting
Facility:
Name:
Carmel Medical Center
Address:
City:
Haifa
Zip:
34362
Country:
Israel
Status:
Recruiting
Facility:
Name:
Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli
Address:
City:
Reggio Calabria
Zip:
89133
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Address:
City:
Bologna
Zip:
40138
Country:
Italy
Status:
Recruiting
Facility:
Name:
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l
Address:
City:
Meldola
Zip:
47014
Country:
Italy
Status:
Recruiting
Facility:
Name:
Azienda USL IRCCS di Reggio Emilia
Address:
City:
Reggio Emilia
Zip:
42123
Country:
Italy
Status:
Recruiting
Facility:
Name:
Azienda Sanitaria Universitaria Friuli Centrale
Address:
City:
Udine
Zip:
33100
Country:
Italy
Status:
Recruiting
Facility:
Name:
Fondazione Policlinico Universitario Campus Bio-Medico di Roma
Address:
City:
Roma
Zip:
00128
Country:
Italy
Status:
Recruiting
Facility:
Name:
Azienda Ospedaliera Papa Giovanni XXIII
Address:
City:
Bergamo
Zip:
24127
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Address:
City:
Milano
Zip:
20122
Country:
Italy
Status:
Recruiting
Facility:
Name:
Azienda Ospedaliero Universitaria delle Marche
Address:
City:
Ancona
Zip:
60126
Country:
Italy
Status:
Recruiting
Facility:
Name:
Azienda Sanitaria Ospedaliera S. Croce e Carle
Address:
City:
Cuneo
Zip:
12100
Country:
Italy
Status:
Recruiting
Facility:
Name:
A.O.U. Maggiore della Carità
Address:
City:
Novara
Zip:
28100
Country:
Italy
Status:
Recruiting
Facility:
Name:
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Address:
City:
Torino
Zip:
10126
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Istituto Tumori "Giovanni Paolo II" I.R.C.C.S.
Address:
City:
Bari
Zip:
70124
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco di Catania
Address:
City:
Catania
Zip:
95123
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Address:
City:
Palermo
Zip:
90127
Country:
Italy
Status:
Recruiting
Facility:
Name:
Azienda Ospedaliera Universitaria Careggi
Address:
City:
Firenze
Zip:
50134
Country:
Italy
Status:
Recruiting
Facility:
Name:
Spaarne Gasthuis
Address:
City:
Hoofddorp
Zip:
2134 TM
Country:
Netherlands
Status:
Not yet recruiting
Facility:
Name:
Medisch Spectrum Twente
Address:
City:
Enschede
Zip:
7512 KZ
Country:
Netherlands
Status:
Not yet recruiting
Facility:
Name:
Albert Schweitzer Ziekenhuis
Address:
City:
Dordrecht
Zip:
3318 AT
Country:
Netherlands
Status:
Not yet recruiting
Facility:
Name:
Indywidualna Specjalistyczna Praktyka Lekarska Tomasz Woźny
Address:
City:
Poznań
Zip:
60-549
Country:
Poland
Status:
Not yet recruiting
Facility:
Name:
Specjalistyczny Szpital im. dra Alfreda Sokołowskiego
Address:
City:
Wałbrzych
Zip:
58-309
Country:
Poland
Status:
Not yet recruiting
Facility:
Name:
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza- Radeckiego we Wrocławiu
Address:
City:
Wrocław
Zip:
50-367
Country:
Poland
Status:
Not yet recruiting
Facility:
Name:
Clinical Hospital Center Bezanijska Kosa
Address:
City:
Belgrade
Zip:
11000
Country:
Serbia
Status:
Recruiting
Facility:
Name:
Clinical Hospital Center Zemun
Address:
City:
Belgrade
Zip:
11000
Country:
Serbia
Status:
Recruiting
Facility:
Name:
University Clinical Center of Serbia
Address:
City:
Belgrade
Zip:
11000
Country:
Serbia
Status:
Recruiting
Facility:
Name:
University Clinical Center Nis
Address:
City:
Nis
Zip:
18000
Country:
Serbia
Status:
Recruiting
Facility:
Name:
Clinical Center of Vojvodina
Address:
City:
Novi Sad
Zip:
21000
Country:
Serbia
Status:
Recruiting
Facility:
Name:
ICO Badalona-H.U. Germans Trias i Pujol
Address:
City:
Badalona
Zip:
8916
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Hospital General Universitario Dr. Balmis
Address:
City:
Alicante
Zip:
3010
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Ramon y Cajal
Address:
City:
Madrid
Zip:
28034
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Virgen de la Victoria
Address:
City:
Málaga
Zip:
29010
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitari i Politecnic La Fe de Valencia
Address:
City:
Valencia
Zip:
46026
Country:
Spain
Status:
Recruiting
Facility:
Name:
Belfast City Hospital
Address:
City:
Belfast
Zip:
BT9 7AB
Country:
United Kingdom
Status:
Not yet recruiting
Facility:
Name:
Imperial College Healthcare NHS Trust
Address:
City:
London
Zip:
W12 0HS
Country:
United Kingdom
Status:
Recruiting
Start date:
March 26, 2024
Completion date:
July 2026
Lead sponsor:
Agency:
Italfarmaco
Agency class:
Industry
Source:
Italfarmaco
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06093672
