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Study Comparing Clofarabine/Busulfan and Fludarabine/Busulfan for Adults with Acute Myeloid Leukemia Eligible for Stem Cell Transplantation

Verified siteRegistered drugNo placebo
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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 acute myeloid leukemia (AML), a type of cancer that affects the blood and bone marrow. The study aims to compare the effectiveness of two different treatment regimens for patients with AML who are eligible for a type of stem cell transplant called allogeneic stem cell transplantation. The treatments being compared are combinations of medications: one regimen includes clofarabine and busulfan, while the other includes fludarabine and busulfan. These medications are used to prepare the body for the transplant by reducing the intensity of the conditioning process, which is the preparation phase before receiving the stem cells.

The purpose of the study is to compare the survival rates of patients over a two-year period after receiving either of the two treatment regimens. Participants in the study will receive one of the two treatment combinations, and some may receive a placebo. The study will monitor patients' health and progress over time, assessing various outcomes such as recovery of blood cells, occurrence of any side effects, and overall quality of life. The study will also look at how well the new stem cells are accepted by the body and how the immune system recovers after the transplant.

Throughout the study, patients will undergo regular check-ups and assessments to track their health and response to the treatment. The study will last for several years, with follow-up visits to ensure the safety and effectiveness of the treatments. The ultimate goal is to determine which treatment regimen offers better outcomes for patients with acute myeloid leukemia undergoing stem cell transplantation.

The research process

The trial runs in 6 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 and procedures. You will be required to provide written consent to participate.

    Eligibility criteria include being 18 years or older, having acute myeloid leukemia in complete remission, and having a matched donor for stem cell transplantation.

  2. Step 2

    Preparation for treatment

    Before starting the treatment, a series of tests and assessments will be conducted to ensure your readiness for the trial.

    You will be assigned to one of two treatment groups: one receiving clofarabine and busulfan, and the other receiving fludarabine and busulfan.

  3. Step 3

    Treatment phase

    During the treatment phase, you will receive medications intravenously or orally, depending on the group you are assigned to.

    The treatment involves a reduced intensity conditioning regimen to prepare for stem cell transplantation.

  4. Step 4

    Stem cell transplantation

    After the conditioning regimen, you will undergo an allogeneic stem cell transplantation using peripheral blood stem cells from your matched donor.

    This procedure aims to replace your diseased bone marrow with healthy stem cells.

  5. Step 5

    Post-transplant monitoring

    Following the transplantation, you will be closely monitored for engraftment, which is the process of the new stem cells starting to grow and make healthy blood cells.

    Regular assessments will be conducted to check for any complications, such as graft-versus-host disease, and to evaluate your overall health and recovery.

  6. Step 6

    Follow-up assessments

    You will have scheduled follow-up visits at various intervals, such as 30, 60, 90, 180, and 360 days post-transplant, to assess your recovery and quality of life.

    These assessments will include blood tests, questionnaires, and possibly other evaluations to monitor your progress and any side effects.

Who can join the trial?

14 criteria

  • Must be at least 18 years old.
  • Must be part of the French social security system or a beneficiary of it.
  • Women must meet one of the following conditions:
    • Use effective birth control methods and have a negative pregnancy test before starting the study.
    • Be post-menopausal, which means over 50 years old and not having had a period for at least 12 months after stopping hormone treatments.
    • If under 50, must not have had a period for at least 12 months after stopping hormone treatments, with hormone levels showing post-menopausal status.
    • Have had a permanent surgical procedure to prevent pregnancy, such as removal of the uterus or ovaries.
    • Must have acute myeloid leukemia (AML) in complete remission, meaning less than 5% of certain cells in the bone marrow, or a related condition with specific criteria.
    • Can be in the first or second line of treatment.
    • Eligible for a specific type of treatment called RIC regimen, which is suitable for patients aged 60 or older, or younger with other health issues.
    • Must have a matched donor, either related or unrelated.
    • The transplant must use only peripheral blood stem cells.
    • Must have a performance status of 0 to 2 on the ECOG scale, which measures daily living abilities.
    • Must provide written informed consent to participate.
    • Previous transplants are allowed.

Who cannot join the trial?

4 criteria

  • Patients who do not have acute myeloid leukemia cannot participate. Acute myeloid leukemia is a type of cancer that affects the blood and bone marrow.
  • Patients who are not in complete remission cannot participate. Complete remission means that there are no signs of cancer in the body after treatment.
  • Patients who are not within the specified age range cannot participate. The age range for this study is not specified here, but it is important to be within the required age group.
  • Patients who are part of a vulnerable population cannot participate. Vulnerable populations may include groups like pregnant women, children, or those unable to give consent.
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Investigated drugs

  • Clofarabine

    is a medication used in this clinical trial. It is a type of chemotherapy drug that helps to kill cancer cells. In this study, it is being used as part of a treatment plan to prepare patients with acute myeloid leukemia for a stem cell transplant. The goal is to reduce the intensity of the treatment while still effectively targeting the cancer cells.

  • Busulfan

    is another medication involved in the trial. It is also a chemotherapy drug that works by slowing or stopping the growth of cancer cells. In this study, it is used in combination with other drugs to help prepare the body for a stem cell transplant by reducing the number of cancer cells and making room for new, healthy cells to grow.

  • Fludarabine

    is a medication used in this trial as well. It is a chemotherapy drug that helps to destroy cancer cells. In the context of this study, it is part of a treatment regimen aimed at preparing patients with acute myeloid leukemia for a stem cell transplant. The treatment aims to be less intense while still being effective in treating the cancer.

What is already known about the treatment

Clofarabine – Clofarabine is administered intravenously, meaning it is given through a vein, usually in a hospital setting. It is currently being studied in clinical trials for its effectiveness in treating acute myeloid leukemia (AML), particularly in patients eligible for stem cell transplantation. The main therapeutic use of clofarabine is to help treat certain types of leukemia by interfering with the growth of cancer cells. At the molecular level, clofarabine works by inhibiting DNA synthesis, which prevents cancer cells from multiplying. It is classified 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 Myeloid Leukemia – Acute Myeloid Leukemia is a type of cancer that starts in the blood-forming cells of the bone marrow. It progresses rapidly, leading to the accumulation of abnormal white blood cells that interfere with the production of normal blood cells. As the disease advances, it can cause symptoms such as fatigue, frequent infections, and easy bruising or bleeding. The abnormal cells can spread to other parts of the body, including the lymph nodes, liver, and spleen. Over time, the bone marrow becomes increasingly unable to produce healthy blood cells. This condition requires medical attention to manage its progression and impact on the body.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502019-12-00Estimated enrolment302 patientsSponsorCentre Hospitalier Universitaire De Nantes

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