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

Study Purpose

The goal of this clinical trial is to compare in the efficacy and safety of givinostat to hydroxyurea in Jak2V617F-positive high risk polycythemia vera patients.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06093672
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Italfarmaco
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Polycythemia Vera
Arms & Interventions

Arms

Experimental: Givinostat

Active Comparator: Hydroxyurea

Interventions

Drug: - Givinostat Hydrochloride

Oral. Starting dose of 50 mg BID with individualized dose titration ranging from 50 mg OD to 100 mg BID based on safety and efficacy

Drug: - Hydroxy Urea

Oral. Starting dose of 500 mg BID with individualized dose titration ranging from 500 mg OD to 1500 mg BID based on safety and efficacy

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Emad Ibrahim, MD, Inc, Redlands, California

Status

Recruiting

Address

Emad Ibrahim, MD, Inc

Redlands, California, 92373

The Cleveland Clinic Foundation, Cleveland, Ohio

Status

Recruiting

Address

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195

MD Anderson Cancer Center, Houston, Texas

Status

Not yet recruiting

Address

MD Anderson Cancer Center

Houston, Texas, 77030

Salt Lake City, Utah

Status

Recruiting

Address

University of Utah - Huntsman Cancer Institute - PPDS

Salt Lake City, Utah, 84112

Seattle, Washington

Status

Not yet recruiting

Address

VA Puget Sound Health Care System - NAVREF - PPDS

Seattle, Washington, 98108-1532

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