Health TrialsbyHealthPanel

Study on Efficacy and Safety of Givinostat Versus Hydroxyurea in Patients With Polycythemia Vera

ConditionPolycythemia Vera
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorItalfarmaco

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Patients must have JAK2V617F-positive disease

Age ≥ 60 years, and/or

Prior thrombosis.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Givinostat

    Drug

    Oral. The dosage must be modified, according to the manifestation of toxicities or lack of efficacy, with the aim to achieve an optimized dose.

  • Hydroxyurea

    Drug

    Oral. The dosage must be modified, according to the manifestation of toxicities or lack of efficacy, with the aim to achieve an optimized dose.

Treatment groups

220 Participants
are divided into 2 treatment groups
Group A: Givinostat - Core phaseExperimental treatment 1 intervention
Group B: Hydroxyurea - Core phaseActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of patients achieving a response at Week 48.

Response assessment based on: * Hematocrit \< 45% without phlebotomy in the prior 3 months, and * White blood cell (WBC) count ≤ 10 × 109/L, and * Platelet count ≤ 400 × 109/L, and * Normal spleen size as measured by imaging (normal spleen size is defined as: a longitudinal diameter ≤ 12 cm for female and ≤ 13 cm for male) and * During Part 2 (Week 25 to 48), absence of progressive disease, major hemorrhagic events and major thrombotic events.

Time frame
week 25 - week 48

Secondary outcomes

1

Proportion of patients achieving a complete hematological response (CHR) at Week 48.

CHR based on: * Hematocrit \< 45% without phlebotomy in the prior 3 months, and * White blood cell (WBC) count ≤ 10 × 109/L, and * Platelet count ≤ 400 × 109/L

Time frame
week 48
2

Time from randomization to the first observed CHR

Time frame
Randomization - week 48
3

Proportion of patients with a normal spleen size at Week 48.

Time frame
week 48
4

Safety and tolerability up to Week 48.

Time frame
Randomization - week 48

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Italfarmaco

Lead sponsor

PPD Development, LP

Collaborator

Source ClinicalTrials.gov
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