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Study on the Long-term Effects of Givinostat for Patients with JAK2V617F Positive Chronic Myeloproliferative Neoplasms

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called Givinostat in patients with a group of diseases known as chronic myeloproliferative neoplasms. These are a type of blood disorder where the bone marrow makes too many red blood cells, white blood cells, or platelets. The study involves patients who have a specific genetic mutation called JAK2V617F, which is often found in these conditions. The purpose of the study is to evaluate the long-term safety and effectiveness of Givinostat in these patients.

Participants in the study will take Givinostat in the form of capsules, which are available in doses of 50 mg, 75 mg, and 100 mg. The medication is taken orally, meaning it is swallowed. Some participants may receive a placebo, which looks like the medication but does not contain the active ingredient. The study will monitor how well patients tolerate the medication over a long period and will also look at how the medication affects the disease.

Throughout the study, researchers will collect information on any side effects experienced by participants and how the disease responds to the treatment. This includes looking at changes in the genetic mutation and other markers that might indicate how well the treatment is working. The study aims to provide valuable information on the potential benefits and risks of using Givinostat for treating chronic myeloproliferative neoplasms.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Participation begins after completing a previous study or compassionate use program with givinostat.
Eligibility requires a diagnosis of JAK2V617F positive chronic myeloproliferative neoplasm and a performance status below 3 on the ECOG scale.
Step 2
Medication administration
Receive givinostat in capsule form, available in 50 mg, 75 mg, and 100 mg doses.
The medication is taken orally. Dosage and frequency are determined by the study protocol and the healthcare provider.
Step 3
Monitoring and assessments
Regular monitoring for safety and tolerability of givinostat is conducted.
Assessments include tracking adverse events and evaluating the response to treatment using specific criteria for different conditions.
Step 4
Long-term evaluation
The study aims to gather information on the long-term effects of givinostat.
This includes evaluating the reduction of the JAK2v617F allele burden and identifying potential markers of clinical benefit.
Step 5
Completion of the study
The study is expected to continue until September 2029.
Participants will be informed about the outcomes and any further steps after the study concludes.

Who can join the trial?

8 criteria

Patients must have completed treatment with a medicine called **givinostat** in at least one previous study related to **chronic myeloproliferative neoplasm** (cMPN) or be part of a special program allowing the use of givinostat.
Patients must have tolerated the previous treatment with givinostat and shown improvement, as judged by the doctor, using specific criteria for different types of cMPN.
Patients must be able to understand the study and agree to participate by signing a consent form.
Patients must be adults, aged 18 years or older, of any gender, and have a confirmed diagnosis of a specific type of cMPN, known as **JAK2V617F positive cMPN**, according to updated guidelines.
Patients must have a certain level of physical ability, measured by a scale called the **Eastern Cooperative Oncology Group (ECOG) performance status**, and must score less than 3.
Patients must have acceptable organ function within 7 days before starting the study medication.
Patients who are women able to have children, or men with partners who can have children, must use effective birth control from 28 days before the first dose of the study drug until 3 months after the last dose.
Patients must be willing and able to follow the study's requirements.

Who cannot join the trial?

9 criteria

Patients who have not been diagnosed with a chronic myeloproliferative neoplasm. This is a group of diseases where the bone marrow makes too many red blood cells, white blood cells, or platelets.
Patients who are not within the specified age range for the study.
Patients who are not part of the specified clinical trial groups.
Patients who are not able to follow the study procedures or attend the required visits.
Patients who have other medical conditions that might interfere with the study or pose a risk to their health.
Patients who are pregnant or breastfeeding.
Patients who are participating in another clinical trial that might interfere with this study.
Patients who have a history of allergic reactions to the study medication or similar drugs.
Patients who have a history of substance abuse or other factors that might affect their ability to participate in the study.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, Italy
Verified
Azienda Ospedaliera Universitaria Federico II Di Napoli
Naples, Italy
Responsive
Azienda Ospedaliero Universitaria Careggi
Florence, Italy

Trial locations

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Investigated drugs

Givinostat is a medication being studied for its effects on patients with a specific type of blood disorder known as JAK2V617F positive chronic myeloproliferative neoplasms. This medication is being evaluated for its long-term safety and how well patients can tolerate it over an extended period. Additionally, the study aims to gather information on how effective givinostat is in managing the symptoms and progression of this condition.

Givinostat

What is already known about the treatment

Givinostat – Givinostat is administered orally in the form of tablets. It is currently being studied in clinical trials for its long-term safety and effectiveness in treating chronic myeloproliferative neoplasms, particularly those with the JAK2V617F mutation. The main therapeutic indication for givinostat is to manage symptoms and progression of these blood disorders. At the molecular level, givinostat works by inhibiting enzymes called histone deacetylases, which play a role in regulating gene expression and cell cycle progression. It is classified pharmacologically as a histone deacetylase inhibitor.

Investigated diseases

Chronic Myeloproliferative Neoplasm – This is a group of diseases where the bone marrow makes too many red blood cells, white blood cells, or platelets. These conditions can lead to an increased risk of bleeding or clotting problems. Over time, the excess cells can cause the blood to become too thick, leading to complications such as an enlarged spleen or other organ issues. The disease progresses slowly, and symptoms may include fatigue, headaches, and a feeling of fullness in the abdomen. As the condition advances, it may transform into a more severe form of blood cancer.