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Study on the Effects of Atorvastatin for Patients with Philadelphia-Negative Chronic Myeloproliferative Neoplasms

Verified siteRegistered drugNo placebo

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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 certain types of blood cancer known as Philadelphia-negative chronic myeloproliferative neoplasms. These include essential thrombocythemia, polycythemia vera, and prefibrotic myelofibrosis. The treatment being tested in this study is a medication called atorvastatin, which is commonly used to lower cholesterol levels. In this trial, atorvastatin is being used to see if it can help reduce inflammation and improve blood cell counts in patients who are already receiving the best available therapy for their condition.

The purpose of the study is to investigate the effects of adding atorvastatin to the current treatment regimen for these blood cancers. Participants in the study will take atorvastatin in the form of film-coated tablets, which are taken orally. The study will compare the results of those taking atorvastatin with those who are not, to see if there are any differences in inflammation markers and blood cell counts. The study will last for a period of up to 24 months, during which time participants will be monitored regularly.

Throughout the study, researchers will focus on measuring certain indicators of inflammation, such as hs-CRP and inflammatory cytokines, as well as blood cell counts, including leukocyte and platelet counts. The study aims to provide more information on whether atorvastatin can be a beneficial addition to the treatment of these specific types of blood cancer. Participants will be closely monitored to ensure their safety and to gather data on the effectiveness of the treatment.

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, you will be informed about the purpose and procedures involved. The study aims to investigate the effect of additional treatment with atorvastatin on certain blood markers in patients with specific blood conditions.
Step 2
Initial assessment
An initial assessment will be conducted to evaluate your current health status. This may include blood tests to measure inflammatory markers and cell counts.
Step 3
Medication administration
You will be prescribed atorvastatin tablets, which are to be taken orally. The dosage will be determined by the study team and could be 20mg, 40mg, or 80mg, depending on your specific needs.
The medication is to be taken once daily, and the duration of administration will be specified by the study team.
Step 4
Regular monitoring
Throughout the study, regular monitoring will be conducted to assess the effects of the medication. This will involve periodic blood tests to check inflammatory markers and cell counts.
You will be informed of the schedule for these tests and any other necessary assessments.
Step 5
Completion of the study
At the end of the study period, a final assessment will be conducted to evaluate the overall impact of the treatment.
You will receive information about the results and any further steps, if necessary.

Who can join the trial?

5 criteria

Must have a type of blood cancer known as ET, PV, or prePMF, which are classified by the World Health Organization (WHO) in 2016. These conditions involve having too many blood cells.
Must be older than 18 years.
Must have an expected survival time of more than 3 years.
If currently receiving treatment to reduce blood cell counts, this treatment must have started more than 3 months ago, and there should be no expected changes in the dose or type of treatment in the next year.
Must not be taking a type of medication called a statin before joining the study. Statins are drugs used to lower cholesterol levels in the blood.

Who cannot join the trial?

1 criterion

Patients with **blood cancer** cannot participate.

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Region Sjaelland
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Holbæk, Denmark

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Investigated drugs

Atorvastatin is a medication commonly used to lower cholesterol levels in the blood. In this clinical trial, it is being used as an additional treatment for patients with certain blood disorders known as myeloproliferative neoplasms (MPNs). The goal is to see if atorvastatin can help reduce inflammation and improve blood cell counts in these patients. It is not the main treatment but is added to the best available therapy that patients are already receiving.

Atorvastatin

What is already known about the treatment

Atorvastatin – Atorvastatin is taken orally in the form of a tablet. It is currently being studied for its potential benefits in treating certain blood cancers, specifically Philadelphia-negative chronic myeloproliferative neoplasms, which include essential thrombocythemia, polycythemia vera, and prefibrotic myelofibrosis. The main therapeutic use being explored is its ability to reduce inflammation and affect blood cell counts in patients already receiving the best available therapy. At the molecular level, atorvastatin works by inhibiting an enzyme involved in cholesterol production, which may also influence inflammatory processes. It is classified as a statin, a type of medication primarily used to lower cholesterol levels.

Investigated diseases

Blood Cancer – Blood cancer is a type of cancer that affects the blood, bone marrow, or lymphatic system. It typically begins in the bone marrow, where blood is produced, and leads to the uncontrolled growth of abnormal blood cells. These abnormal cells can interfere with the production and function of normal blood cells, leading to symptoms such as fatigue, frequent infections, and easy bruising or bleeding. As the disease progresses, it can spread to other parts of the body, affecting organs and tissues. The progression of blood cancer varies depending on the specific type, such as leukemia, lymphoma, or myeloma, each having distinct characteristics and patterns of growth.