GIV-IN PV Trial

About this trial

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.

Patient Profile

Patients must have been diagnosed with PV according to the 2016 WHO criteria within 3 years before randomization

Patients must have JAK2V617F-positive disease.

Patients with PV must meet the definition of HR for thrombosis (i.e., HR) at 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

Where’s this trial being run?

Cork University Hospital and Mater Misericordiae University Hospital

Can I join this study / trial?

The first step we recommend is to talk to your doctor or the cancer trials team at your hospital. You can find contact details for cancer trials research units in Ireland here.

It’s also a good idea to print this page and bring it with you to your appointment. It can help guide the conversation and remind you of what to ask. You may also want to talk to your family or friends about your options, as they can offer support as you make decisions.

For more detailed information

Click Here

Questions?

Here’s a list of questions you may have for your doctor or local cancer research team.

Questions

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Summary Data

Name:	GIV-IN PV Trial
Number:	24-99
Full Title:	Randomized, open-label, multicentre phase 3 study to assess the efficacy and safety of GIVinostat versus hydroxyurea IN JAK2V617F-positive high-risk Polycythemia Vera patients: the GIV-IN PV Trial.

Principal Investigator:
Type:	Industry Sponsored
Sponsor:	Italfarmaco S.p.A.
Recruitment Started:	Global: March 2024 Ireland:

Global Recruitment Target:	220
Ireland Recruitment Target: