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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Italfarmaco
Study ID
NCT06093672
Phase
PHASE3
Status
Recruiting
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Conditions

  • Polycythemia Vera

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Givinostat — DRUG
    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 — DRUG
    Oral. The dosage must be modified, according to the manifestation of toxicities or lack of efficacy, with the aim to achieve an optimized dose.

Study Details

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.

Key Dates

Start date
Mar 26, 2024
Status verified
Mar 2026
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
220 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

Primary Outcome Measure

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

Central Contacts

Locations (14)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294-0001-
Emad Ibrahim, MD, IncRedlandsCalifornia92373-
US Oncology IncEnglewoodColorado80113-
American Oncology Partners of Maryland, PABethesdaMaryland20852
Victor Priego
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-
University of North Carolina at Chapel HillChapel HillNorth Carolina27599-
The Cleveland Clinic FoundationClevelandOhio44195-
Oncology Associates of Oregon, P.C.EugeneOregon97401-
MD Anderson Cancer CenterHoustonTexas77030-
Texas Oncology (Webster) - USORHoustonTexas77089-
Texas Oncology-Denison Cancer CenterShermanTexas75090
Amir Faridi (PRINCIPAL_INVESTIGATOR)
University of Utah - Huntsman Cancer Institute - PPDSSalt Lake CityUtah84112-
The James Cancer Hospital and Solove Research InstituteRoanokeVirginia43210-
VA Puget Sound Health Care System - NAVREF - PPDSSeattleWashington98108-1532-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALEmad Ibrahim, MD, Inc· Redlands, CAUS Oncology Inc· Englewood, COAmerican Oncology Partners of Maryland, PA· Bethesda, MDIcahn School of Medicine at Mount Sinai· New York, NYUniversity of North Carolina at Chapel Hill· Chapel Hill, NC

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