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Currently Recruiting
This trial is actively seeking participants in the UK. Discuss eligibility with your patient.
Status
Recruiting
Phase
PHASE3
NCT ID
NCT06093672
Trial 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.
Lead Sponsor: Italfarmaco
Participants: ALL
Start Date: 2024-03-26
Primary Completion: 2026-07
Min Age: 18 Years
Eligibility Criteria
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…
Data sourced from ClinicalTrials.gov. Trial details may change — always check the primary source before clinical decisions.