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Compares treatment options for Polycythemia Vera
Official title Study on Efficacy and Safety of Givinostat Versus Hydroxyurea in Patients With Polycythemia Vera
ClinicalTrials.gov ID: NCT06093672
What this study is testing
What is Givinostat?
Givinostat is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for polycythemia vera.
Also referred to as ITF2357.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Core Treatment -
- 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
You likely can't join if
- 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...
- 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
See the full eligibility criteria
- Core Treatment -
- 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 - Patients must have completed the Week 48 visit of the DSC/08/2357/32 core treatment phase and:
- if the patient received givinostat, a complete hematological response (CHR) at Week 48 shall be achieved
- if the patient received HU, did not achieve a CHR (see above for the definition) at Week 48 Core Treatment phase -
- 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...
- 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 treatment clinical study within the 30 days prior to screening or within 5 half-lives of the investigational product...
- Pregnant or nursing women Extended treatment phase - Exclusion criteria
- For patients assigned by chance to givinostat in the core treatment phase - Patients with a QTcF value at Week 48 of \> 500 msec
- For patients assigned by chance to HU in the core treatment phase:
- PLT count ≤ 150 × 109/L at Week 48
- ANC \< 1.2 × 109/L at Week 48
- Uncontrolled hypertriglyceridemia at Week 48
- Patients with a QTcF value at Week 48 of \> 450 msec for males and \> 460 msec for female
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Redlands, California, United States
- Englewood, Colorado, United States
- Bethesda, Maryland, United States
- New York, New York, United States
- Chapel Hill, North Carolina, United States
- Cleveland, Ohio, United States
- Eugene, Oregon, United States
- Houston, Texas, United States
- Sherman, Texas, United States
- Salt Lake City, Utah, United States
- Roanoke, Virginia, United States
- Seattle, Washington, United States
- Wiener Neustadt, Lower Austria, Austria
- Vienna, State of Vienna, Austria
- Linz, Upper Austria, Austria
- Wels, Upper Austria, Austria
- Sofia, Sofia-Grad, Bulgaria
- Plovdiv, Bulgaria
- Stara Zagora, Bulgaria
+ 64 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Redlands, California, United States; Englewood, Colorado, United States; Bethesda, Maryland, United States; New York, New York, United States; Chapel Hill, North Carolina, United States and 78 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.