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Study on Conditioning Treatments with Busulfan, Clofarabine, and Fludarabine for Children with Acute Myeloid Leukemia Undergoing Stem Cell Transplantation

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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 Acute Myeloid Leukemia (AML) in children. The study will compare two different treatment plans, known as conditioning regimens, which are used before a stem cell transplant. The first regimen, called CloFluBu, includes a combination of medications: Busulfan, Clofarabine, and Fludarabine Phosphate. The second regimen, known as BuCyMel, combines Busulfan, Cyclophosphamide, and Melphalan. These medications are given through an infusion, which means they are delivered directly into the bloodstream through a vein.

The purpose of this study is to determine which of these two regimens is more effective in helping children with AML remain free from severe complications and relapse for two years after their transplant. The study will involve children who are undergoing a stem cell transplant as part of their treatment for AML. Participants will be randomly assigned to receive one of the two regimens. The study will monitor their health and progress over time to see how well each regimen works.

Throughout the study, researchers will keep track of various health outcomes, such as survival rates, the occurrence of any complications, and the overall recovery process. This information will help doctors understand which treatment plan might offer the best chance of success for children with AML undergoing a stem cell transplant.

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, eligibility is confirmed based on specific criteria, including age and health status related to acute myeloid leukemia (AML).
A negative pregnancy test is required for women of childbearing potential before starting treatment.
Step 2
Randomization
Participants are randomly assigned to one of two treatment groups to compare different conditioning regimens before stem cell transplantation.
Step 3
Conditioning regimen
The conditioning regimen involves receiving medications through IV infusion to prepare the body for transplantation.
One group receives a combination of clofarabine, fludarabine phosphate, and busulfan.
The other group receives busulfan, cyclophosphamide, and melphalan.
Step 4
Stem cell transplantation
After completing the conditioning regimen, participants undergo allogeneic stem cell transplantation.
This involves receiving healthy stem cells from a donor to replace damaged or diseased bone marrow.
Step 5
Post-transplant monitoring
Participants are monitored for two years to assess survival without severe complications such as graft-versus-host disease (GvHD) or relapse.
Regular follow-ups are conducted to evaluate overall health, disease status, and any side effects from the treatment.

Who can join the trial?

11 criteria

Patients must be aged 18 years or younger at the time of initial diagnosis of **Acute Myeloid Leukemia (AML)**, and 21 years or younger at the time of transplantation.
Patients must be in **hematological remission**, which means:
No signs of disease outside the bone marrow, including in the **central nervous system (CNS)**.
Less than 5% of **leukemic blasts** (cancerous cells) in the bone marrow, confirmed by a test called **flow cytometry**, within 14 days before starting treatment.
No cancerous cells in the blood, confirmed by flow cytometry if immature cells are found in the blood.
Patients must have a donor who is either:
A sibling with a perfect **HLA match** (10 out of 10 alleles) for bone marrow donation.
A related or unrelated donor with a 9 or 10 out of 10 HLA match for bone marrow or **peripheral blood stem cell (PBSC)** donation.
All women who can have children must have a negative pregnancy test within 2 weeks before starting treatment.
Patients must provide signed informed consent, which means they agree to participate after understanding the study details.
Patients with AML that has returned after initial treatment according to a specific international protocol, or those in first remission with transplant indications following a national protocol, are eligible.

Who cannot join the trial?

10 criteria

Patients with other serious health conditions that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have had a different type of cancer in the past, unless it was treated and cured.
Patients who have had a bone marrow transplant before.
Patients who are currently participating in another clinical trial.
Patients who have an active infection that requires treatment.
Patients who have a known allergy to any of the study medications.
Patients who have a history of drug or alcohol abuse.
Patients who have a mental health condition that could affect their ability to participate in the study.
Patients who are unable to follow the study procedures for any reason.

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Verified sites

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Cliniques Universitaires Saint-Luc
Responsive
Woluwe-Saint-Lambert, Belgium
Katholieke Universiteit te Leuven
Responsive
Leuven, Belgium
Universitair Ziekenhuis Gent
Responsive
Gent, Belgium

Trial locations

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Investigated drugs

CloFluBu
is a combination of medications used as a conditioning regimen before stem cell transplantation. It includes one alkylating agent and two antimetabolites. The purpose of this combination is to prepare the body for the transplant by suppressing the immune system and making space for the new stem cells. This regimen aims to improve survival rates and reduce complications after the transplant.
BuCyMel
is another conditioning regimen used before stem cell transplantation. It consists of three alkylating agents. This combination is designed to effectively prepare the body for receiving new stem cells by eliminating existing bone marrow cells and suppressing the immune system. The goal is to achieve successful engraftment of the transplanted cells and minimize the risk of relapse or complications.

What is already known about the treatment

Clofarabine
This medication is administered intravenously and is used in the treatment of Acute Myeloid Leukemia, particularly in children undergoing stem cell transplantation. It is currently being studied in clinical trials to determine its effectiveness in combination with other drugs. Clofarabine works by interfering with the DNA synthesis of cancer cells, thereby inhibiting their growth and proliferation. It is classified as an antimetabolite, which is a type of chemotherapy drug that targets rapidly dividing cells.
Fludarabine
Administered intravenously, Fludarabine is used in the treatment of Acute Myeloid Leukemia and is part of ongoing clinical trials to assess its efficacy in combination therapies. It acts by disrupting the DNA replication process in cancer cells, leading to cell death. Fludarabine is also classified as an antimetabolite, targeting cells that divide quickly, such as cancer cells.
Busulfan
This medication is given intravenously and is used as part of a conditioning regimen for patients with Acute Myeloid Leukemia undergoing stem cell transplantation. It is being evaluated in clinical trials to compare its effectiveness in different drug combinations. Busulfan works by cross-linking DNA strands, which prevents cancer cells from dividing and growing. It is classified as an alkylating agent, a type of chemotherapy that damages the DNA of cancer cells.
Cyclophosphamide
Administered intravenously, Cyclophosphamide is used in the treatment of Acute Myeloid Leukemia and is part of clinical trials to test its role in combination regimens. It functions by forming cross-links in DNA, which disrupts the replication of cancer cells. Cyclophosphamide is an alkylating agent, known for its ability to target and destroy rapidly dividing cells.
Melphalan
This medication is given intravenously and is used in the treatment of Acute Myeloid Leukemia, particularly in pre-transplant conditioning regimens. It is being studied in clinical trials to evaluate its effectiveness in combination with other drugs. Melphalan works by binding to DNA and preventing cancer cells from multiplying. It is classified as an alkylating agent, which targets the DNA of cancer cells to inhibit their growth.

Investigated diseases

Acute Myeloid Leukemia – Acute Myeloid Leukemia (AML) 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. This leads 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, including the lymph nodes, liver, spleen, and central nervous system. AML is more common in adults and can develop suddenly, requiring prompt medical attention. The progression of the disease can vary, with some cases advancing more rapidly than others.