Recruiting

Phase 3

Givinostat vs. HydroxyureaStudy on Efficacy and Safety of Givinostat Versus Hydroxyurea in Patients With Polycythemia Vera

Sponsor:

Italfarmaco

Code:

NCT06093672

Conditions

Polycythemia Vera

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Givinostat

Hydroxyurea

Study Details

Brief 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.

Conditions

Polycythemia Vera

Study ID

NCT06093672

Start date

Mar 26, 2024

Status verified date

Mar, 2026

Completion date

Jul, 2026

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

220 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Givinostat - Core phase

Givinostat 50 mg BID from baseline till week 48

active comparator: Hydroxyurea - Core phase

HU 500 mg BID from baseline till week 48

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.

Primary outcome measure

Proportion of patients achieving a response at Week 48. [ Time Frame: week 25 - week 48 ]

Central Contacts and Locations

Central contacts

Maurizio Caserini

+39 02 6443 1 patientadvocacy@italfarmacogroup.com

Locations

Emad Ibrahim, MD, Inc

Recruiting

Redlands, California, United States, 92373

US Oncology Inc

Recruiting

Englewood, Colorado, United States, 80113

American Oncology Partners of Maryland, PA

Recruiting

Bethesda, Maryland, United States, 20852

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

The Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Oncology Associates of Oregon, P.C.

Recruiting

Eugene, Oregon, United States, 97401

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Texas Oncology (Webster) - USOR

Recruiting

Houston, Texas, United States, 77089

Texas Oncology-Denison Cancer Center

Recruiting

Sherman, Texas, United States, 75090

Principal Investigator:

Amir Faridi

University of Utah - Huntsman Cancer Institute - PPDS

Recruiting

Salt Lake City, Utah, United States, 84112

The James Cancer Hospital and Solove Research Institute

Recruiting

Roanoke, Virginia, United States, 43210

VA Puget Sound Health Care System - NAVREF - PPDS

Recruiting

Seattle, Washington, United States, 98108-1532

More Information

Sponsor

Italfarmaco

Last update posted

Mar 25, 2026

Last verified

Mar, 2026

Keywords

Polycythemia Vera
Givinostat

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-21. This information was provided to ClinicalTrials.gov by Italfarmaco on 2026-03-25.