OncoMatch/Clinical Trials/NCT06093672
Study on Efficacy and Safety of Givinostat Versus Hydroxyurea in Patients With Polycythemia Vera
Is NCT06093672 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Chemotherapy
Other
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 →Frequently asked questions
Is NCT06093672 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior hydroxyurea, JAK2 inhibitor, HDAC inhibitor disqualifies patients from enrollment.
Does this trial require JAK2?
Yes, JAK2 v617f is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages