RECRUITING

Study on Efficacy and Safety of Givinostat Versus Hydroxyurea in Patients With Polycythemia Vera

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2024-03-26

Study Completion:2026-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06093672

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Maurizio Caserini

CONTACT

+39 02 6443 1

patientadvocacy@italfarmacogroup.com

Study Locations (Sites)

University of Alabama at Birmingham

Birmingham, Alabama, 35294-0001

United States

Emad Ibrahim, MD, Inc

Redlands, California, 92373

United States

Icahn School of Medicine at Mount Sinai

New York, New York, 10029

United States

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195

United States

MD Anderson Cancer Center

Houston, Texas, 77030

United States

University of Utah - Huntsman Cancer Institute - PPDS

Salt Lake City, Utah, 84112

United States

VA Puget Sound Health Care System - NAVREF - PPDS

Seattle, Washington, 98108-1532

United States

Collaborators and Investigators

Sponsor: Italfarmaco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-26

Study Completion Date2026-07

Study Record Updates

Study Start Date2024-03-26

Study Completion Date2026-07

Terms related to this study

Additional Relevant MeSH Terms

Polycythemia Vera