OncoMatch/Clinical Trials/NCT06093672
Study on Efficacy and Safety of Givinostat Versus Hydroxyurea in Patients With Polycythemia Vera
Is NCT06093672 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Givinostat and Hydroxyurea for polycythemia vera.
Treatment: Givinostat · Hydroxyurea — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Myeloproliferative Neoplasm
Biomarker criteria
Required: JAK2 v617f
Prior therapy
Cannot have received: hydroxyurea (hydroxyurea)
Patients pre-treated with HU with a documented history of resistance or intolerance to HU defined by the original ELN criteria
Cannot have received: JAK2 inhibitor
Previous treatment with a JAK2 or HDAC inhibitor or 32-phosphorus (radioactive isotope) therapy.
Cannot have received: HDAC inhibitor
Previous treatment with a JAK2 or HDAC inhibitor or 32-phosphorus (radioactive isotope) therapy.
Cannot have received: radioactive isotope (32-phosphorus)
Previous treatment with a JAK2 or HDAC inhibitor or 32-phosphorus (radioactive isotope) therapy.
Lab requirements
Blood counts
PLT count > 400 × 10^9/L required at screening; PLT ≤ 150 × 10^9/L at Week 48 (extended phase, HU arm) excluded; ANC < 1.2 × 10^9/L at Week 48 (extended phase, HU arm) excluded
Kidney function
Patients with inadequate renal function at screening [excluded]
Liver function
Patients with inadequate liver function at screening [excluded]
Cardiac function
QTcF value > 450 msec for males and > 460 msec for females at screening excluded; congenital or acquired history of QTc prolongation or ventricular arrhythmias excluded; QTcF > 500 msec at Week 48 (givinostat arm, extended phase) excluded; QTcF > 450 msec for males and > 460 msec for females at Week 48 (HU arm, extended phase) excluded
Patients with a QTcF value of > 450 msec for males and > 460 msec for females at the Screening visit; congenital or acquired history of QTc prolongation or ventricular arrhythmias, at the Screening visit; PLT count ≤ 150 × 10^9/L at Week 48; ANC < 1.2 × 10^9/L at Week 48; QTcF value at Week 48 of > 500 msec (givinostat arm); QTcF value at Week 48 of > 450 msec for males and > 460 msec for female (HU arm)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Alabama at Birmingham · Birmingham, Alabama
- Emad Ibrahim, MD, Inc · Redlands, California
- US Oncology Inc · Englewood, Colorado
- American Oncology Partners of Maryland, PA · Bethesda, Maryland
- Icahn School of Medicine at Mount Sinai · New York, New York
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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