Not recruiting

Study on the Safety and Effectiveness of Adding Hydroxycarbamide to Standard Treatment with Cytarabine and Daunorubicin for Adults with Newly Diagnosed Acute Myeloid Leukemia

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 Acute Myeloid Leukemia (AML), a type of cancer that affects the blood and bone marrow. The study is investigating the addition of a medication called hydroxyurea to the standard treatment for AML, which typically includes two other medications: cytarabine and daunorubicin. Hydroxyurea is being tested to see if it can improve the effectiveness of the standard treatment regimen.

The purpose of the study is to determine if adding hydroxyurea to the standard treatment is safe and effective for adults who have been newly diagnosed with AML. Participants in the study will receive the standard treatment of cytarabine and daunorubicin, with some also receiving hydroxyurea. The study will monitor the safety of this combination and how well it works in reducing the presence of cancer cells after the second cycle of chemotherapy.

Throughout the study, participants will be closely observed to assess any side effects and to measure how quickly their blood counts recover after each treatment cycle. The study aims to find the best dose of hydroxyurea that can be safely added to the standard treatment. The overall goal is to improve treatment outcomes for patients with AML by potentially increasing the rate of remission and survival.

The research process

The trial runs in 7 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, the patient is diagnosed with acute myeloid leukaemia (AML) and is 18 years or older.
The patient must have adequate kidney and liver function, unless the condition is related to AML.
The patient provides written informed consent and is capable of understanding the study requirements.
Step 2
Initial treatment phase
The patient begins treatment with hydroxycarbamide, administered orally in the form of a 500 mg hard capsule.
The dosage and frequency of hydroxycarbamide are determined based on the patient's specific needs and the study's dose-finding objectives.
Step 3
Standard chemotherapy cycle 1
The patient receives cytarabine and daunorubicin intravenously.
Cytarabine is administered as a 20 mg/ml solution for injection.
Daunorubicin is provided as a 20 mg powder, which is mixed into a solution for infusion.
Step 4
Assessment after cycle 1
The patient's response to the treatment is evaluated, focusing on the safety and tolerability of the medications.
The frequency and severity of any side effects are monitored closely.
Step 5
Standard chemotherapy cycle 2
The patient undergoes a second cycle of chemotherapy with cytarabine and daunorubicin, following the same administration method as in cycle 1.
Step 6
Assessment after cycle 2
The primary goal is to achieve MRD-negativity, which means no detectable cancer cells in the bone marrow or white blood cell compartment.
The patient's recovery time for blood cell counts is measured, including white blood cells and platelets.
Step 7
Ongoing monitoring
The patient's overall response to the treatment is assessed, including survival rates and any potential relapse.
The study continues to monitor the patient's health and any long-term effects of the treatment.

Who can join the trial?

9 criteria

The patient must have a diagnosis of **acute myeloid leukemia (AML)**, which is a type of blood cancer, according to specific medical guidelines. This includes certain related conditions but excludes a specific type called acute promyelocytic leukemia.
The patient must be **18 years or older**.
The patient must have **adequate kidney and liver function**, unless the issues are clearly related to AML. This is determined by specific blood test results:
Serum creatinine, a kidney function marker, should be **220 micromoles per liter or less**, unless related to AML.
Serum bilirubin, a liver function marker, should be **2.5 times the upper limit of normal or less**, unless related to AML or a condition called Gilbert's syndrome.
Alanine aminotransferase (ALAT), another liver function marker, should be **2.5 times the upper limit of normal or less**, with specific values for females and males, unless related to AML.
Male patients must use an **effective contraceptive method** during the study and for at least 6 months after the study treatment.
The patient must provide **written informed consent**, meaning they agree to participate after understanding the study details.
The patient must be **capable of giving informed consent**, meaning they understand what participation involves and can make the decision themselves.

Who cannot join the trial?

7 criteria

Patients who have not been newly diagnosed with acute myeloid leukaemia (AML). AML is a type of cancer that affects the blood and bone marrow.
Patients under the age of 18.
Patients who are not able to tolerate the standard AML therapy, which includes medications like ara-C and daunorubicin. These are drugs used to treat AML.
Patients who have other medical conditions that might interfere with the study or make it unsafe for them to participate.
Patients who are pregnant or breastfeeding, as the study may involve risks to the baby.
Patients who are unable to follow the study procedures or attend the required visits.
Patients who are participating in another clinical trial that might affect the results of this study.

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Verified sites

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Karolinska University Hospital
Verified
Solna, Sweden
Region Oestergoetland
Responsive
Linkoping, Sweden
Region Vaesterbotten
Responsive
Umea, Sweden

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Investigated drugs

Hydroxyurea
is being tested in this study to see if it can be safely added to the standard treatment for acute myeloid leukemia (AML). Researchers want to find out if it can help improve the effectiveness of the treatment by reducing the amount of cancer cells left after chemotherapy.
Ara-C
, also known as cytarabine, is a standard chemotherapy medication used to treat AML. It works by interfering with the DNA of cancer cells, preventing them from growing and multiplying.
Daunorubicin
is another standard chemotherapy drug used in the treatment of AML. It helps kill cancer cells by damaging their DNA and stopping them from dividing and growing.

What is already known about the treatment

Hydroxyurea
This medication is administered orally and is being studied for its potential to enhance the treatment of acute myeloid leukemia (AML) in adults. It is currently under investigation in clinical trials to determine its safety and effectiveness when added to standard chemotherapy regimens. Hydroxyurea is primarily used to treat certain blood disorders and works by inhibiting DNA synthesis, which slows down the growth of cancer cells. It is classified as an antineoplastic agent.
Ara-C (Cytarabine)
This medication is typically administered intravenously and is a well-established treatment for acute myeloid leukemia (AML). It is widely recognized in medical literature as a standard chemotherapy drug for AML. Ara-C works by interfering with DNA synthesis, thereby preventing cancer cells from multiplying. It belongs to the class of antimetabolites.
Daunorubicin
Administered intravenously, this medication is a key component of standard chemotherapy for acute myeloid leukemia (AML). It is well-documented in medical literature and is used to treat various types of cancer. Daunorubicin works by intercalating DNA strands, which disrupts the replication of cancer cells. It is classified as an anthracycline antibiotic.

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 and quickly progresses to affect the blood. It is characterized by the rapid growth of abnormal white blood cells that accumulate in the bone marrow and interfere with the production of normal blood cells. Patients may experience symptoms such as fatigue, fever, frequent infections, and easy bruising or bleeding. As the disease progresses, it can spread to other parts of the body, including the lymph nodes, liver, and spleen. AML is more common in adults over the age of 18 and can vary in its progression and severity. The disease requires careful monitoring and management to address its rapid development and impact on the body.