DSC/11/2357/44 extension study - Givinostat in patients with cMPN
Research type
Research Study
Full title
Long-term study evaluating the effect of Givinostat in patients with JAK2V617F positive chronic myeloproliferative neoplasms.
IRAS ID
183139
Contact name
Ruth Witherall
Contact email
Sponsor organisation
Italfarmaco S.p.A.
Eudract number
2012-003499-37
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 9 months, 0 days
Research summary
This is a phase 2, multicentre, open label, long-term study testing the long-term safety, tolerability and efficacy of Givinostat in adult patients (aged 18 years or older) with Polycythemia Vera (PV), Essential Trombocytemia (ET), Primary Myelofibrosis (PMF), Post-PV Myelofibrosis (Post-PV MF), Post-ET Myelofibrosis (Post-ET MF), following core protocols in cMPN and/or patient-named compassionate use program.
At the time being, this study involves 27 study centres in 5 countries.
The main purpose of the study is to verify the long-term safety, tolerabity and efficacy of Givinostat.
Eligible patients will have tolerated previous Givinostat treatment and achieved a clinical benefit at the end of the core protocols; alternatively, eligible patients are participating in compassionate use program.
Patients will continue at their last tolerable dose and treatment schedule of Givinostat monotherapy. If patients previously received Givinostat in combination with other drugs (e.g. hydroxyurea) during a core protocol or a compassionate use program, they will be treated at the last tolerable dose of the combination.
Assessment of safety and efficacy will be performed at each quarterly visit and each visit will also include laboratory tests and ECG examination. During the visits the clinical benefit will be assessed and, if patients continue to derive clinical benefit from participating in the study, they will be allowed to continue study medication.
The treatment may continue up to Marketing Authorization of Givinostat. Patients may discontinue study treatment at any time and remain on study therapy as long as they derive clinical benefit.
REC name
HSC REC A
REC reference
15/NI/0128
Date of REC Opinion
25 Aug 2015
REC opinion
Further Information Favourable Opinion