Not recruitingRare disease

Study on Hydroxycarbamide Resistance in Patients with Polycythemia Vera Identified by AI Predictors

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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 polycythemia vera, a condition where the body produces too many red blood cells, which can lead to complications like blood clots. The study will use a medication called hydroxyurea, also known as hydroxycarbamide, which is commonly used to manage this condition. The purpose of the study is to evaluate how patients with polycythemia vera respond to hydroxyurea, particularly looking at resistance or intolerance to the medication.

Participants in the study will begin their regular treatment with hydroxyurea, and researchers will monitor them over a period of up to 15 months. The study will use advanced techniques, including artificial intelligence, to identify patients who might be resistant to hydroxyurea before they start treatment. This will help in understanding which patients are more likely to benefit from the medication and who might need alternative treatments.

Throughout the study, researchers will observe how many patients develop resistance or intolerance to hydroxyurea within the first 6 to 9 months and over the entire 15-month period. They will also look at the reasons why some patients might need to switch to different therapies and the timing of these changes. This information will be valuable in improving treatment strategies for polycythemia vera in the future.

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
Upon joining the study, ensure that a signed informed consent is obtained. This confirms your understanding and agreement to participate in the clinical trial.
Eligibility criteria include being at least 18 years old, having a confirmed diagnosis of polycythemia vera, and meeting specific health conditions. A negative pregnancy test is required for female participants of childbearing potential.
Step 2
Start of treatment
Begin treatment with hydroxycarbamide, taken orally. The dosage and frequency will be determined by the study team based on your specific needs.
The main objective is to evaluate resistance or intolerance to hydroxycarbamide in patients with polycythemia vera.
Step 3
Monitoring period
Regular monitoring will occur to assess your response to the treatment. This includes checking for any signs of resistance or intolerance to hydroxycarbamide.
The primary endpoint is to determine the proportion of patients showing resistance or intolerance within 6-9 months of starting treatment.
Step 4
Follow-up assessments
Follow-up assessments will continue for a maximum period of 15 months. These assessments will help identify any changes in your condition and the effectiveness of the treatment.
Secondary endpoints include evaluating the proportion of patients developing resistance or intolerance at any time during the treatment period.
Step 5
Completion of study
Upon completion of the study, a final assessment will be conducted to summarize your overall response to the treatment.
The study aims to conclude by October 31, 2025, with all data collected and analyzed to understand the treatment's impact.

Who can join the trial?

12 criteria

Signed informed consent must be obtained before participating in the study. This means you agree to join the study after understanding all the details.
Patients must be 18 years or older.
Must have a confirmed diagnosis of Polycythemia vera according to specific medical guidelines.
Must have an ECOG score of 2 or less. The ECOG score is a way to measure how well you can perform daily activities. A score of 2 means you are up and about more than half of the day but may not be able to work.
No previous treatment with drugs that reduce blood cell production.
No blood removal (phlebotomy) in the last 14 days.
Must be eligible for HU (Hydroxyurea) treatment. This includes:
High-risk: Age 60 years or older and/or a history of blood clots.
Low-risk: Showing at least one of the following:
Signs of disease getting worse (myeloproliferation).
Increasing risk of blood clots and bleeding.
Female participants who can have children must have a negative pregnancy test within 72 hours before receiving the first dose of the study treatment.

Who cannot join the trial?

5 criteria

Patients who do not have **Polycythemia vera** cannot participate. Polycythemia vera is a condition where the body makes too many red blood cells.
Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
Patients who do not meet the **HU-resistance predictors** cannot participate. HU-resistance refers to how the body responds to a specific treatment called hydroxyurea (HU).
Patients who are not able to start regular HU-treatment cannot participate.
Patients who are part of a vulnerable population may not be eligible. Vulnerable populations include groups who might need special protection or care.

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Verified sites

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Verified
Johanniter GmbH Johanniter-Krankenhaus
Bonn, Germany

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Investigated drugs

Hydroxyurea is a medication used in this clinical trial. It is commonly used to treat a condition called polycythemia vera, which is a blood disorder where the body makes too many red blood cells. This can lead to problems like blood clots. Hydroxyurea works by slowing down the production of these extra blood cells, helping to keep the blood thinner and reducing the risk of complications. In this study, the focus is on understanding how some patients might not respond well to Hydroxyurea, which is referred to as resistance or intolerance to the medication.

Hydroxycarbamide

What is already known about the treatment

Hydroxyurea – Hydroxyurea is a medication taken orally, usually in the form of a capsule or tablet. It is currently used in the treatment of polycythemia vera, a condition where the body produces too many red blood cells. The main therapeutic indication for hydroxyurea is to reduce the number of red blood cells and prevent complications associated with this condition. At the molecular level, hydroxyurea works by inhibiting an enzyme called ribonucleotide reductase, which is essential for DNA synthesis, thereby slowing down the production of blood cells. It is classified as an antineoplastic agent, which means it is used to stop the growth of abnormal cells.

Investigated diseases

Polycythemia vera – Polycythemia vera is a blood disorder characterized by the overproduction of red blood cells in the bone marrow. This increase in red blood cells causes the blood to thicken, which can slow down blood flow and lead to complications. As the disease progresses, individuals may experience symptoms such as headaches, dizziness, and a feeling of fullness in the abdomen due to an enlarged spleen. Over time, the increased blood cell production can also lead to elevated levels of white blood cells and platelets. The condition may cause itching, especially after a warm shower, and a ruddy complexion. If left unchecked, polycythemia vera can lead to more serious issues such as blood clots.