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Study on Hydroxyurea and Valproic Acid or 6-Mercaptopurine with Valproic Acid for Patients with Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome

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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 treatments for two serious blood disorders: Acute Myeloid Leukemia (AML) and high-risk Myelodysplastic Syndrome (HR-MDS). These conditions affect the blood and bone marrow, leading to issues with blood cell production. The study is exploring the use of two treatment combinations: Hydroxyurea (HU) with Valproic Acid (VPA), and 6-Mercaptopurine (6-MP) with VPA. These medications are being tested to see if they can be effective for patients who are not suitable for standard chemotherapy treatments.

The purpose of the study is to determine how safe and tolerable these treatment combinations are, as well as to assess their potential benefits for patients. Participants will receive one of the treatment combinations, and their health will be monitored throughout the study. This includes regular check-ups and tests to ensure the treatments are working as intended and to identify any side effects. The study aims to provide valuable information on whether these combinations can offer a clinical benefit, which means improving the patient's condition or quality of life.

Participants will be involved in the study for a period of time, during which they will receive the treatment and undergo various assessments. These assessments will help researchers understand how the treatments affect the participants' health and performance status, which refers to their ability to carry out daily activities. The study is designed to gather important data that could lead to new treatment options for those with AML and HR-MDS who cannot undergo standard chemotherapy.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment will be conducted to evaluate your current health status. This includes a physical examination and laboratory tests to ensure eligibility for the trial.
You will be asked to provide a detailed medical history and undergo tests to confirm adequate kidney and liver function.
Step 2
Treatment assignment
You will be assigned to one of the treatment groups. The treatments involve combinations of medications: hydroxyurea with valproic acid or 6-mercaptopurine with valproic acid.
All medications are taken orally. The specific dosage and frequency will be determined by the study team based on established clinical doses.
Step 3
Treatment administration
You will begin taking the assigned medications as per the prescribed schedule. The duration of administration will be specified by the study protocol.
Regular monitoring will be conducted to assess the safety and tolerability of the treatment. This includes frequent check-ups and laboratory tests.
Step 4
Ongoing monitoring
Throughout the trial, your health and response to the treatment will be closely monitored. This involves regular visits to the study center for physical examinations and laboratory tests.
You will be asked to complete health-related quality of life questionnaires to evaluate any changes in your condition.
Step 5
End of treatment evaluation
At the end of the treatment period, a comprehensive evaluation will be conducted to assess the overall response to the treatment.
This includes determining any clinical benefits and documenting any side effects experienced during the trial.
Step 6
Follow-up
After completing the treatment, follow-up visits will be scheduled to monitor your long-term health and any lasting effects of the treatment.
These visits will help in understanding the overall impact of the treatment on your condition.

Who can join the trial?

10 criteria

Must be a female or male aged 18 years or older.
Must provide written informed consent, which means you agree to participate after being informed about the study.
Must not be eligible for standard therapy (usual treatment) due to certain health conditions or personal choice.
Must have a diagnosis of Acute Myeloid Leukemia (AML) or related conditions as specified by the study.
Must have adequate kidney and liver function, unless affected by the disease. This includes specific blood test results within normal ranges.
Must have an European Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2, which measures your ability to perform daily activities.
Women who are breastfeeding are eligible.
Women of childbearing potential must have a negative pregnancy test before starting the study medication.
Both male and female participants of reproductive potential must agree to use highly effective contraception methods during the study and for more than 3 months after the last dose of study medication.
Women are considered not of childbearing potential if they have had surgical sterility or are post-menopausal, which means they have not had a menstrual period for over a year due to natural, radiation, or chemotherapy-induced menopause.

Who cannot join the trial?

9 criteria

Patients who have a different type of cancer other than Acute Myeloid Leukemia (AML).
Patients who are currently pregnant or breastfeeding.
Patients who have an active infection that requires treatment.
Patients who have a history of allergic reactions to the study medications, which include hydroxyurea, valproic acid, or 6-mercaptopurine.
Patients who have severe heart, liver, or kidney problems.
Patients who are participating in another clinical trial at the same time.
Patients who have a history of drug or alcohol abuse.
Patients who have a mental health condition that might interfere with their ability to participate in the study.
Patients who are unable to follow the study procedures or attend the required visits.

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Verified sites

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Helse Bergen HF
Bergen, Norway
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St. Olavs Hospital HF
Trondheim, Norway

Trial locations

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Investigated drugs

Hydroxyurea
is a medication used in this trial to help treat certain blood disorders. It works by slowing down the growth of cancer cells, which can help manage the disease. In this study, it is being combined with another medication to see if it can improve treatment outcomes for patients with acute myeloid leukemia or high-risk myelodysplastic syndrome who cannot undergo standard chemotherapy.
Valproic Acid
is a medication that is often used to treat seizures and mood disorders. In this trial, it is being used in combination with other medications to see if it can help improve the treatment of blood disorders like acute myeloid leukemia and high-risk myelodysplastic syndrome. Researchers are interested in its potential to enhance the effects of other cancer treatments.
6-Mercaptopurine
is a medication that helps to stop the growth of cancer cells. It is commonly used in the treatment of certain types of leukemia. In this study, it is being combined with valproic acid to explore whether this combination can provide better outcomes for patients with specific blood disorders who are not suitable for standard chemotherapy treatments.

What is already known about the treatment

Hydroxyurea
Hydroxyurea is taken orally in the form of a capsule or tablet. It is currently being studied in combination with valproic acid for its potential benefits in treating acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (HR-MDS) in patients who cannot undergo standard chemotherapy. Hydroxyurea works by interfering with the DNA synthesis of cancer cells, slowing their growth and spread. It is classified as an antineoplastic agent, which means it is used to stop the growth of cancer cells.
Valproic Acid
Valproic acid is administered orally, typically as a tablet or liquid. It is being investigated in combination with hydroxyurea or 6-mercaptopurine for its effects on acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (HR-MDS) in patients unsuitable for standard chemotherapy. Valproic acid is thought to work by affecting the expression of certain genes involved in cell growth and survival, helping to control the proliferation of cancer cells. It is classified as an anticonvulsant and mood-stabilizing drug, but in this context, it is being explored for its potential anticancer properties.
6-Mercaptopurine
6-Mercaptopurine is taken orally in tablet form. It is being tested in combination with valproic acid for its potential to treat acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (HR-MDS) in patients who are not candidates for standard chemotherapy. This medication works by interfering with the synthesis of DNA and RNA, which are essential for the growth and division of cancer cells. It is classified as an antimetabolite, a type of drug that disrupts the normal metabolism of cells, particularly cancer cells.

Investigated diseases

Acute Myeloid Leukemia (AML) – Acute Myeloid Leukemia is a type of cancer that starts in the blood-forming cells of the bone marrow. It progresses rapidly, leading to the accumulation of immature white blood cells called myeloblasts. These cells crowd out normal blood cells, causing symptoms like fatigue, frequent infections, and easy bruising or bleeding. As the disease advances, it can spread to other parts of the body, including the lymph nodes, liver, and spleen. The rapid growth of abnormal cells can lead to a decrease in red blood cells and platelets, further complicating the condition. The progression of AML requires careful monitoring to manage its impact on the body.