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Long-term study evaluating the effect of givinostat in patients with JAK2V617F positive chronic myeloproliferative neoplasms
EU CTIS ID: 2024-512413-40-00
What this study is testing
1. To determine the long-term safety and tolerability of givinostat in patients with cMPN following core protocols or compassionate use program. 2. To obtain information on the long-term efficacy of givinostat in patients with cMPN following core protocols or compassionate use program
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients must have completed givinostat treatment on at least one core study in cMPN (i.e. Study DSC/07/2357/28, Study DSC/08/2357/38, Study DSC/12/2357/45 and/or any further core protocols in cMPN), or Patients must be participating in a compassionate use program with givinostat and Patients must have tolerated previous givinostat treatment and achieved a clinical benefitat the end of core protocols or compassionate use program with givinostat, assessed bythe Investigator according to the revised clinico-haematological ELN response criteria (for PV and ET) and EUMNET response criteria (for MF)
- Patients must be able to provide informed consent and be willing to sign an informed consent form
- Adult patients (age ≥18 years), of both genders, and with established diagnosis of JAK2V617F positive cMPN according to the revised WHO criteria
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status <3 at baseline
- Acceptable organ function within 7 days of initiating study drug
- Use of an effective means of contraception from the 28 days before first dose of study drug through 3 months after the last dose of study drug for women of childbearing potential and men with partners of childbearing potential
You likely can't join if
- Pregnancy or nursing(lactating) women, where pregnancy is defined as the state of a female after conception, confirmed by a positive human Chorionic Gonadotropin (hCG) laboratory test (i.e. > 5 mIU/mL) and until the termination of gestation
- Uncontrolled hypertriglyceridemia at baseline, i.e. triglycerides >1.5xULN in fasting state.
- History and/or presence of other diseases, metabolic dysfunctions, physical examination findings, or clinical laboratory findings giving reasonable suspicion of a disease or condition that contraindicated use of an investigational drug or that might affect interpretation of the results of the study or migh render the patient at high risk from treatment complications or significantly alter the absorption of the study drug
- Any investigational drug other than givinostat within 28 days before enrolment.Notably, the use of such medications within 28 days or 6 halflives - whichever is longer - prior to the first dose of study drugs (i.e.Day 1) and during the study through all the study conduct (including any safety follow-up [FU] visit) is prohibited
- Patients with known hypersensitivity to the components of potential study therapy
- A clinically significant QTc prolongation at baseline (e.g. repeated demonstration of a QTc interval > 450 msec); Of note, a repeated demonstration of a QTc interval > 450 msec means that, if the first ECG evaluation demonstrates a prolonged QTc interval (i.e. a QTc interval ≥ 450 msec), two additional ECG evaluations over a brief period of time (i.e. 5 minutes between each recording) must be performed. The averaged value of these three ECG evaluations has to be used for the evaluation of the QTc interval. In the eCRF all the performed ECG evaluations have to be entered as well as the average value of multiple ECG evaluation, if necessary
See the full eligibility criteria
Who can join
- Patients must have completed givinostat treatment on at least one core study in cMPN (i.e. Study DSC/07/2357/28, Study DSC/08/2357/38, Study DSC/12/2357/45 and/or any further core protocols in cMPN), or Patients must be participating in a compassionate use program with givinostat and Patients must have tolerated previous givinostat treatment and achieved a clinical benefitat the end of core protocols or compassionate use program with givinostat, assessed bythe Investigator according to the revised clinico-haematological ELN response criteria (for PV and ET) and EUMNET response criteria (for MF)
- Patients must be able to provide informed consent and be willing to sign an informed consent form
- Adult patients (age ≥18 years), of both genders, and with established diagnosis of JAK2V617F positive cMPN according to the revised WHO criteria
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status <3 at baseline
- Acceptable organ function within 7 days of initiating study drug
- Use of an effective means of contraception from the 28 days before first dose of study drug through 3 months after the last dose of study drug for women of childbearing potential and men with partners of childbearing potential
- Willingness and capability to comply with the requirements of the study
What rules you out
- Pregnancy or nursing(lactating) women, where pregnancy is defined as the state of a female after conception, confirmed by a positive human Chorionic Gonadotropin (hCG) laboratory test (i.e. > 5 mIU/mL) and until the termination of gestation
- Uncontrolled hypertriglyceridemia at baseline, i.e. triglycerides >1.5xULN in fasting state.
- History and/or presence of other diseases, metabolic dysfunctions, physical examination findings, or clinical laboratory findings giving reasonable suspicion of a disease or condition that contraindicated use of an investigational drug or that might affect interpretation of the results of the study or migh render the patient at high risk from treatment complications or significantly alter the absorption of the study drug
- Any investigational drug other than givinostat within 28 days before enrolment.Notably, the use of such medications within 28 days or 6 halflives - whichever is longer - prior to the first dose of study drugs (i.e.Day 1) and during the study through all the study conduct (including any safety follow-up [FU] visit) is prohibited
- Patients with known hypersensitivity to the components of potential study therapy
- A clinically significant QTc prolongation at baseline (e.g. repeated demonstration of a QTc interval > 450 msec); Of note, a repeated demonstration of a QTc interval > 450 msec means that, if the first ECG evaluation demonstrates a prolonged QTc interval (i.e. a QTc interval ≥ 450 msec), two additional ECG evaluations over a brief period of time (i.e. 5 minutes between each recording) must be performed. The averaged value of these three ECG evaluations has to be used for the evaluation of the QTc interval. In the eCRF all the performed ECG evaluations have to be entered as well as the average value of multiple ECG evaluation, if necessary
- Clinically significant cardiovascular disease including: • Uncontrolled hypertension, myocardial infarction, unstable angina at screening • New York Heart Association (NYHA) grade II or greater congestive heart failure • History of any cardiac arrhythmia requiring medication (regardless of severity) • A history of additional risk factors for TdP (eg, heart failure, hypokalemia, family history of long QTc syndrome)
- Active virus infection including HIV, HBV and HCV
- Platelets count <100 x109/L within 14 days before enrolment
- Absolute neutrophil count < 1.2 x109/L within 14 days before enrolment
- Total serum bilirubin >1.5xULN except in case of Gilbert's disease or pattern consistent with Gilbert's disease
- Serum aspartate aminotransferase/alanine aminotransferase AST/ALT >3xULN
- Serum Cystatin C > 2 x ULN for two subsequent evaluations (i.e. if the value of serum Cystatin C is > 2 x ULN, the test will be repeated once, and if the value is again > 2 x ULN, this becomes an exclusion criterion)
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.