Houston, TXNCT06093672Now EnrollingIRB Ready

Polycythemia Vera Clinical Trial in Houston, TX

Access cutting-edge polycythemia vera treatment through this phase 3 clinical trial at a research site in Houston. Study-provided care at no cost to qualified participants.

Sponsored by Italfarmaco

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Expert Care in Houston

Access polycythemia vera specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related polycythemia vera treatment provided free

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Check if you qualify for this polycythemia vera clinical trial in Houston, TX

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Why Participate?

  • No-Cost Study Care

  • Local to Houston

    Convenient for TX residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Houston site if eligible
  4. 4Begin participation

About This Polycythemia Vera Study in Houston

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.

Sponsor: Italfarmaco

Who Can Participate

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:
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 -

Exclusion Criteria

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 interval); congenital or acquired history of QTc prolongation or ventricular arrhythmias, at the Screening visit
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 interventional clinical study within the 30 days prior to screening or within 5 half-lives of the investigational product, whichever is longer.
Pregnant or nursing women Extended treatment phase - Exclusion criteria
For patients randomized to givinostat in the core treatment phase - Patients with a QTcF value at Week 48 of \> 500 msec
For patients randomized 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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Houston?

Yes, this clinical trial (NCT06093672) has an active research site in Houston, TX that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Polycythemia Vera Treatment Options in Houston, TX

If you're searching for polycythemia vera treatment options in Houston, TX, this clinical trial (NCT06093672) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Houston research site is actively enrolling participants for this phase 3 clinical trial. You'll receive care from experienced polycythemia vera specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all polycythemia vera clinical trials near you to find additional studies recruiting in your area.

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