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Study on Allogeneic Stem Cell Transplantation for Children and Adolescents with Acute Lymphoblastic Leukemia Using Etoposide, Treosulfan, and Thiotepa

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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 Lymphoblastic Leukemia (ALL) in children and adolescents. The study aims to explore different conditioning treatments used before a stem cell transplant. Conditioning treatments help prepare the body to receive new stem cells. The trial compares a treatment that includes Total Body Irradiation (TBI) and Etoposide with other treatments that do not use TBI. The alternative treatments involve combinations of medications such as Fludarabine Phosphate, Thiotepa, Busulfan, and Treosulfan. The study also includes the use of Blincyto (blinatumomab), a medication used in certain types of leukemia, and other medications like Cyclophosphamide, Rabbit Anti-Human Thymocyte Immunoglobulin, and Anti-Human T-Lymphocyte Immunoglobulin from Rabbits.

The purpose of the study is to determine if the non-TBI treatments are as effective as the TBI treatment in terms of survival rates. The trial also looks at the impact of these treatments on the occurrence of specific side effects and overall survival. The study is divided into different groups based on the type of donor used for the stem cell transplant. One group involves donors who are a perfect match, while another group involves donors who are not a perfect match. The trial will follow participants over time to monitor their health and any side effects they may experience.

Participants in the study will receive their assigned treatment and be monitored for their response to the treatment and any side effects. The study will help researchers understand which treatment options are best for children and adolescents with Acute Lymphoblastic Leukemia undergoing stem cell transplantation. The trial is expected to continue until 2030, allowing for long-term observation of the participants' health outcomes.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be informed about the trial's purpose, procedures, and potential risks and benefits. You will be required to provide written consent, which confirms your understanding and agreement to participate.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm your eligibility. This includes reviewing your medical history and ensuring you meet the criteria, such as being in complete remission and having no previous stem cell transplants.

  3. Step 3

    Preparation for treatment

    You will undergo a series of tests and evaluations to prepare for the treatment. This may include blood tests and imaging studies to assess your current health status.

  4. Step 4

    Conditioning treatment

    You will receive a conditioning treatment to prepare your body for the stem cell transplant. This involves receiving medications through an intravenous (IV) line. The medications used may include etoposide, treosulfan, thiotepa, cyclophosphamide, busulfan, blinatumomab, rabbit anti-human thymocyte immunoglobulin, and fludarabine phosphate. The specific medications and their dosages will be determined by your healthcare team.

  5. Step 5

    Stem cell transplantation

    After the conditioning treatment, you will receive the stem cell transplant. This involves the infusion of healthy stem cells into your bloodstream through an IV line. The goal is to replace damaged or diseased bone marrow with healthy stem cells.

  6. Step 6

    Post-transplant monitoring

    Following the transplant, you will be closely monitored for any side effects or complications. Regular check-ups and tests will be conducted to assess your recovery and the success of the transplant.

  7. Step 7

    Follow-up care

    You will continue to receive follow-up care to monitor your long-term health and any potential late effects of the treatment. This may include regular visits to your healthcare provider and additional tests as needed.

Who can join the trial?

9 criteria

  • All patients with Acute Lymphoblastic Leukaemia (ALL), except for those with mature B-ALL.
  • Age at diagnosis must be 18 years or younger, or age at Hematopoietic Stem Cell Transplantation (HSCT) must be 21 years or younger.
  • Must have a medical reason for an allogeneic HSCT, which is a type of stem cell transplant using cells from a donor.
  • Must be in complete remission (CR) before the stem cell transplant. This means there are no signs of cancer in the body.
  • Written consent is required from the parents or legal guardian, and if necessary, from the minor patient, using an "Informed Consent Form".
  • Must not be pregnant.
  • Must not have any other type of cancer.
  • Must not have had a previous HSCT.
  • The HSCT must be performed in a center that is participating in the study.

Who cannot join the trial?

4 criteria

  • Patients who have a different type of cancer than Acute Lymphoblastic Leukaemia.
  • Patients who are younger than 2 years old or older than 4 years old.
  • Patients who are not able to receive a transplant from a Human Leucocyte Antigen (HLA) matched donor. HLA is a protein that helps the body recognize which cells belong to it and which do not.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

  • Fludarabine (Flu)

    is a medication used in this trial as part of a conditioning regimen before a stem cell transplant. It works by interfering with the growth of cancer cells, which helps to prepare the body to receive new stem cells. This medication is often used in combination with other drugs to improve its effectiveness.

  • Thiotepa (Thio)

    is another medication used in the conditioning regimen. It helps to destroy cancer cells and suppress the immune system, making it easier for the new stem cells to engraft and grow in the patient's body. This medication is used to increase the chances of a successful transplant.

  • Intravenous Busulfan (ivBu)

    is a form of chemotherapy given through a vein. It is used to kill cancer cells and make space in the bone marrow for new stem cells. This medication is part of the conditioning process to help ensure the success of the stem cell transplant.

  • Treosulfan (Treo)

    is used in the conditioning regimen as an alternative to total body irradiation. It helps to eliminate cancer cells and prepare the body for the transplant. This medication is chosen for its ability to reduce the risk of long-term side effects compared to other treatments.

  • Total Body Irradiation (TBI)

    is a type of radiation therapy that is used to destroy cancer cells throughout the entire body. It is part of the conditioning regimen to prepare the patient for a stem cell transplant. This therapy helps to eliminate any remaining cancer cells and suppress the immune system to prevent rejection of the new stem cells.

  • Etoposide (VP16)

    is a chemotherapy drug used in combination with total body irradiation. It works by stopping cancer cells from dividing and growing. This medication is part of the conditioning regimen to help ensure that the stem cell transplant is successful by reducing the number of cancer cells in the body.

What is already known about the treatment

Fludarabine – Fludarabine is administered intravenously, meaning it is given directly into a vein through an injection. It is currently used in medical practice and literature as part of a treatment regimen for certain types of leukemia, including Acute Lymphoblastic Leukemia (ALL). The main therapeutic indication for Fludarabine is to help treat blood cancers by interfering with the growth of cancer cells. At the molecular level, Fludarabine works by inhibiting DNA synthesis, which prevents cancer cells from multiplying. It is classified pharmacologically as an antimetabolite, a type of drug that mimics the building blocks of DNA, disrupting the cancer cell's ability to grow and divide.

Investigated diseases

Acute Lymphoblastic Leukaemia – Acute Lymphoblastic Leukaemia is a type of cancer that affects the blood and bone marrow, characterized by the overproduction of immature white blood cells, known as lymphoblasts. These abnormal cells crowd out normal cells, leading to a decrease in red blood cells, white blood cells, and platelets. The disease progresses rapidly, with symptoms such as fatigue, fever, frequent infections, and easy bruising or bleeding. As the condition advances, it can spread to other parts of the body, including the lymph nodes, liver, spleen, and central nervous system. The rapid progression requires prompt medical attention to manage the symptoms and control the spread of the disease.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-512657-24-00Protocol codeALL SCTped FORUMEstimated enrolment1 558 patientsSponsorSt. Anna Childrens Cancer Research Institute GmbH

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