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

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What is this study about?

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.

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.

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Region Oestergoetland	Linkoping	Sweden
Region Oerebro Laen	Orebro	Sweden
Region Dalarna	Falun	Sweden
Region Norrbotten	Lulea	Sweden
Skaraborg Hospital-Vaestra Goetalandsregionen	Skovde	Sweden
Region Skane Skanes Universitetssjukhus	Lund	Sweden
Karolinska University Hospital	Solna	Sweden
Region Vaesterbotten	Umea	Sweden
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen	Gothenburg	Sweden
Region Halland	Varberg	Sweden
Ulinrvq Uuvjfoxcai Hzrxrqfa	Uppsala	Sweden

Trial status

Country	Status	Recruitment Start
Sweden	Not recruiting	02.09.2019

Trial locations

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.

Investigated diseases:

Acute myeloid leukaemia

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.

Trial ID:

2023-509019-97-00

Trial Phase:

Human Pharmacology (Phase I) – Other

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?