Study of Ruxolitinib for Patients with High-Risk Polycythemia Vera or High-Risk Essential Thrombocythemia

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What is this study about?

This clinical trial is focused on studying two blood disorders: Polycythemia Vera and Essential Thrombocythemia. These conditions are characterized by the overproduction of blood cells, which can lead to complications such as blood clots. The trial will compare the effects of a medication called Ruxolitinib, also known by its code name INCB018424, with the best available therapy currently used for these disorders. Ruxolitinib is a type of medication known as a JAK1 and JAK2 inhibitor, which works by blocking certain proteins that can contribute to the overproduction of blood cells.

The purpose of the study is to evaluate how safe and effective Ruxolitinib is compared to other treatments for patients with high-risk forms of these blood disorders. Participants in the study will receive either Ruxolitinib or the best available therapy, which may include other medications or treatments that are commonly used for these conditions. The study will last for a period of up to 145 days, during which participants will be monitored to assess their response to the treatment and any side effects they may experience.

Throughout the study, researchers will look at various outcomes, such as the rate of complete responses in blood cell counts and the reduction of symptoms related to the disorders. The study aims to provide valuable information on the potential benefits and risks of using Ruxolitinib for treating high-risk Polycythemia Vera and Essential Thrombocythemia, helping to improve future treatment options for these conditions.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current health status.

Eligibility criteria include being 18 years or older, having a specific performance status, and meeting diagnostic criteria for either polycythemia vera or essential thrombocythemia.

2 treatment allocation

Participants are randomly assigned to receive either ruxolitinib or the best available therapy.

Ruxolitinib is administered in the form of Jakavi tablets, available in 5 mg and 20 mg doses, taken orally.

3 treatment phase

During the treatment phase, participants take the assigned medication as directed. The dosage and frequency depend on individual health needs and the specific treatment plan.

Regular monitoring is conducted to assess the safety and effectiveness of the treatment.

4 follow-up assessments

Follow-up assessments occur at specified intervals, such as at month 6, month 12, and month 24.

These assessments evaluate the rate of complete clinicohematologic responses and other health indicators.

5 end of trial

The trial is estimated to conclude by December 31, 2027.

Final assessments are conducted to gather comprehensive data on the long-term effects and outcomes of the treatment.

Who Can Join the Study?

Subjects must provide written informed consent before any study-specific procedures or assessments that are not usually done for diagnosis or monitoring of polycythemia vera (PV) or essential thrombocythemia (ET). They must also be willing to follow the treatment and assessments.
Patient must be 18 years of age or older.
Patient’s ECOG performance status must be between 0 and 2. This is a scale used to assess how a disease affects a patient’s daily living abilities, with 0 being fully active and 2 being able to do all self-care but unable to carry out any work activities.
Patient must meet the WHO 2008 diagnostic criteria for either polycythemia vera (PV) or essential thrombocythemia (ET). They must also be classified as high risk based on specific criteria, such as age over 60, previous blood clots, high platelet count, or other symptoms.
For PV patients, they must not have been treated with cytoreductive drugs except for hydroxyurea, anagrelide, or interferon for up to 6 weeks. Phlebotomy (removal of blood) and aspirin are allowed. ET patients can be either new or previously treated.
Patient must have adequate liver function, which means certain liver tests must be within normal limits unless the condition is directly related to their myeloproliferative neoplasm (MPN).
Patient must have a creatinine clearance greater than 40 ml/min. This is a measure of kidney function, and it can be calculated using a formula or measured directly.
Patient must be able to swallow and keep down oral medication.

Who Cannot Join the Study?

Patients with conditions other than polycythemia vera or essential thrombocythemia cannot participate. These are specific blood disorders.
Patients who are not considered high-risk for these conditions are excluded. High-risk means having a greater chance of complications.
Patients who are not within the specified age range for the study cannot participate. The study has specific age requirements.
Patients who are part of a vulnerable population are not eligible. Vulnerable populations include groups that may need special protection.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Technische Universitaet Dresden	Dresden	Germany
University Hospital Jena KöR	Jena	Germany
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany

Other Sites

Site Name	City	Country
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Universitaetsklinikum Aachen AöR	Aachen	Germany
Muehlenkreiskliniken AöR	Minden	Germany
Marien Hospital Duesseldorf GmbH	Duesseldorf	Germany
Klinikum Chemnitz gGmbH	Chemnitz	Germany
Rheinische Friedrich-Wilhelms-Universitaet Bonn	Bonn	Germany
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Otto Von Guericke Universitaet Magdeburg	Magdeburg	Germany
Urdttfcoof Mxpaydk Cpyxlw Hispnoiibguffdpmh	Hamburg	Germany
Uzyhoqlmfvvrsbgxdjkvc Efbax Ane	Essen	Germany
Msebnzzqqoputznvzscqmftpyb Htncyssdcmrtiwzl	Halle (Saale)	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	02.11.2015

Trial locations

Investigated drugs:

Ruxolitinib

Ruxolitinib is a medication used in this trial to treat patients with high-risk polycythemia vera or high-risk essential thrombocythemia. It works by inhibiting certain enzymes in the body that are involved in the production of blood cells, helping to reduce the number of blood cells and alleviate symptoms associated with these conditions.

Best Available Therapy refers to the standard treatments that are currently used for managing high-risk polycythemia vera or high-risk essential thrombocythemia. This can include a variety of medications and approaches that are considered effective based on current medical practice. The specific treatments can vary depending on the patient’s condition and the healthcare provider’s recommendations.

Polycythemia Vera – Polycythemia vera is a blood disorder characterized by the overproduction of red blood cells in the bone marrow. This excess of red blood cells thickens the blood, slowing its flow and potentially leading to complications such as blood clots. Symptoms may include headaches, dizziness, and a ruddy complexion. Over time, the condition can cause an enlarged spleen and other issues related to increased blood volume and viscosity. It is a chronic condition that progresses slowly, often requiring ongoing management to control symptoms and prevent complications.

Essential Thrombocythemia – Essential thrombocythemia is a chronic blood disorder where the bone marrow produces too many platelets. This overproduction can lead to abnormal blood clotting or, conversely, bleeding problems. Individuals with this condition may experience headaches, dizziness, and vision changes, and in some cases, an enlarged spleen. The disease progresses slowly and can remain stable for many years, but it requires monitoring to manage symptoms and reduce the risk of complications. It is often discovered incidentally during routine blood tests.

Trial ID:

2024-515619-23-00

Protocol code:

12-181

NCT ID:

NCT02577926

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Ruxolitinib for Patients with High-Risk Polycythemia Vera or High-Risk Essential Thrombocythemia

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