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Study on Treating Acute Myeloid Leukemia in Children and Adolescents Using Daunorubicin, Mitoxantrone, and a Drug Combination

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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 the treatment of Acute Myeloid Leukemia (AML) in children and adolescents aged 0 to 18 years. AML is a type of cancer that affects the blood and bone marrow, where blood cells are made. The study aims to improve the outcomes for young patients with AML by using a combination of different medications and treatment strategies.

The medications being tested in this study include DaunoXome®, Mitoxantrone, Fludarabine Phosphate, Daunorubicin, Daunorubicin Hydrochloride, Cytarabine, and Etoposide. These drugs are administered intravenously, meaning they are given directly into a vein. The study will compare the effectiveness of these medications in treating AML, with the goal of finding the best treatment approach. The trial will also explore how well the disease responds to treatment by measuring the levels of cancer cells remaining in the body after treatment, known as Minimal Residual Disease (MRD).

Participants in the study will receive treatment over a period of several months, with regular monitoring to assess how well the treatment is working. The study will also look at the long-term effects of the treatment, including survival rates and any potential side effects. The ultimate goal is to improve the prognosis for children and adolescents with AML by using more effective treatment strategies.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Participation begins after meeting the criteria: diagnosis of acute myeloid leukemia (AML), age below 19 years, and providing written consent.
Step 2
First induction course
The first treatment involves the administration of DaunoXome® or Mitoxantrone through an intravenous route. The goal is to determine which medication is more effective in treating pediatric AML.
The effectiveness is measured by the level of minimal residual disease (MRD) using flow cytometry. The target is to achieve an MRD level below 0.1%.
Step 3
Second induction course
The second treatment involves the administration of FLADx or ADxE through an intravenous route. This step aims to evaluate the efficacy of these medications in further reducing AML.
MRD levels are again measured to assess the treatment's success, with the same target of achieving an MRD level below 0.1%.
Step 4
Monitoring and follow-up
Throughout the trial, regular monitoring of cardiac function and other health parameters is conducted to ensure safety and effectiveness.
The study also tracks event-free survival and overall survival over a period of five years, along with the frequency of any severe adverse events.

Who can join the trial?

3 criteria

The patient must have **Acute Myeloid Leukemia (AML)**, which is a type of blood cancer, as defined by the study's diagnostic criteria.
The patient must be younger than 19 years old at the time of diagnosis.
The patient or their guardian must provide **written informed consent**, which means they agree to participate in the study after being fully informed about it.

Who cannot join the trial?

5 criteria

Patients who do not have Acute Myeloid Leukemia (AML), which is a type of blood cancer, cannot participate.
Patients who are not within the age range of 0-18 years cannot participate.
Patients who are not children or adolescents cannot participate.
Patients who are not able to undergo the specific treatments being studied cannot participate.
Patients who are not able to follow the study procedures cannot participate.

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Verified sites

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Responsive
Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Belgium
Responsive
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Madrid, Spain
Responsive
Katholieke Universiteit te Leuven
Leuven, Belgium

Trial locations

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Investigated drugs

DaunoXome
is a medication being studied to see if it is more effective than another drug, Mitoxantrone, in treating children and adolescents with acute myeloid leukemia (AML) during the first course of treatment. It is used to help kill cancer cells and improve the chances of recovery.
Mitoxantrone
is a medication used in the study as a comparison to DaunoXome. It is also used in the first course of treatment for pediatric AML to help destroy cancer cells and improve patient outcomes.
FLADx
is a combination of medications used in the study to see if it works better than another combination called ADxE during the second course of treatment for pediatric AML. This combination aims to further reduce the number of cancer cells and improve the effectiveness of the treatment.
ADxE
is another combination of medications used in the study as a comparison to FLADx. It is given during the second course of treatment for pediatric AML to help eliminate cancer cells and improve the prognosis for patients.

What is already known about the treatment

DaunoXome
DaunoXome is administered intravenously and is currently being studied for its effectiveness in treating pediatric acute myeloid leukemia (AML). It is part of ongoing clinical trials aimed at improving treatment outcomes for children and adolescents with this condition. The medication works by interfering with the DNA of cancer cells, preventing them from growing and dividing. It belongs to the pharmacological class of anthracycline antibiotics, which are commonly used in cancer treatment.
Mitoxantrone
Mitoxantrone is given through intravenous infusion and is being compared to DaunoXome in clinical trials for treating pediatric AML. It is a well-established medication in the medical literature, used for various types of cancer. Mitoxantrone acts by disrupting DNA synthesis and repair in cancer cells, leading to cell death. It is classified as an anthracenedione antineoplastic agent.
FLADx
FLADx is a combination chemotherapy regimen administered intravenously, currently under investigation for its potential benefits in treating pediatric AML. This regimen is part of a clinical trial to determine its efficacy compared to other treatment protocols. FLADx works by targeting and killing rapidly dividing cancer cells through multiple mechanisms. It is categorized under combination chemotherapy protocols used in cancer treatment.
ADxE
ADxE is another combination chemotherapy regimen given intravenously, being evaluated in clinical trials for pediatric AML. It is used to assess its effectiveness against other treatment options like FLADx. ADxE functions by attacking cancer cells at different stages of their growth cycle, aiming to reduce the cancer burden. It falls under the category of combination chemotherapy regimens.

Investigated diseases

Acute Myeloid Leukemia (Pediatric 0-18 years) – Acute Myeloid Leukemia (AML) in children is a type of cancer that affects the blood and bone marrow. 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. Symptoms may include fatigue, fever, easy bruising or bleeding, and an increased risk of infections. The disease progresses quickly and requires prompt medical attention. AML in children can vary in its presentation and severity, and it often requires intensive treatment to manage. The condition is studied to improve understanding and treatment strategies, focusing on risk stratification and response to therapy.