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 study about?

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.

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.

2 randomization

Participants are randomly assigned to one of two treatment groups to compare different conditioning regimens before stem cell transplantation.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Oslo Universitetssykehus HF	Oslo	Norway
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Region Skane Skanes Universitetssjukhus	Lund	Sweden
Universitair Ziekenhuis Gent	Gent	Belgium
Karolinska University Hospital	Solna	Sweden
Prinses Maxima Centrum voor Kinderoncologie B.V.	Utrecht	The Netherlands
Rigshospitalet	Copenhagen	Denmark
University Childrens Hospital Queen Fabiola	Brussels	Belgium
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen	Gothenburg	Sweden
Vilnius University Hospital Santaros klinikos	Vilnius	Lithuania
Csomtczkb Uoexzbdocvuxfy Sjnlhzpij	Woluwe-Saint-Lambert	Belgium
Uolqqne Uvxbtpauyh Hcmhocnv	Uppsala	Sweden
Hwhxyfbe Uldhwlslxf Cfvbtax Hhaeolek	Helsinki	Finland

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	01.01.2022
Denmark	Recruiting	01.01.2022
Finland	Recruiting	01.01.2022
Lithuania	Not yet recruiting	01.01.2022
Norway	Recruiting	01.01.2022
Sweden	Recruiting	01.01.2022
The Netherlands	Recruiting	01.01.2022

Trial locations

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.

Investigated diseases:

Acute myeloid leukaemia

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.

Trial ID:

2023-505512-37-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?