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

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari	Bari	Italy
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy

Other Sites

Site Name	City	Country
Istituto Tumori Bari Giovanni Paolo II	Bari	Italy
Azienda Unita Locale Socio Sanitaria N 8 Berica	Vicenza	Italy
Azienda Sanitaria Locale Di Pescara	Pescara	Italy
Grande Ospedale Metropolitano Bianchi Melacrino Morelli	Reggio Calabria	Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Universita’ Campus Bio-medico Di Roma	Rome	Italy
Awwiulr Omwqhzupukn Pnrk Gkxxedjr Xxyfc	Bergamo	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	28.03.2013

Trial locations

Investigated drugs:

Givinostat

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.

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.

Trial ID:

2024-512413-40-00

Protocol code:

DSC/11/2357/44

NCT ID:

NCT01761968

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?