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Study Comparing Thymoglobulin and Grafalon for Preventing Graft Versus Host Disease in Elderly Patients with Acute Myeloid Leukemia or Myelodysplastic Syndrome

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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 two diseases: Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS). These are types of blood cancers that affect the bone marrow and blood cells. The study aims to compare two treatments used to prevent a condition called graft versus host disease (GVHD), which can occur after a stem cell transplant. The treatments being compared are Thymoglobulin and Grafalon, both of which are given to patients to help prevent GVHD after they receive a stem cell transplant from a donor.

In this study, patients with AML or MDS will receive a stem cell transplant from a donor who is a close match. Before the transplant, patients will undergo a reduced intensity conditioning regimen, which is a less aggressive form of treatment to prepare the body for the transplant. This regimen includes the use of two medications, Fludarabine and Treosulfan. The purpose of the study is to see which of the two treatments, Thymoglobulin or Grafalon, is more effective in preventing GVHD in these patients.

Participants in the study will receive either Thymoglobulin or Grafalon as part of their treatment plan. The study will monitor the occurrence of GVHD and other health outcomes for a period of time after the transplant. This includes checking for any signs of GVHD, monitoring blood cell recovery, and assessing overall health and quality of life. The study will help determine the best approach to prevent GVHD in patients with AML or MDS undergoing stem cell transplants.

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, eligibility is confirmed based on age, health status, and specific medical conditions such as acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).

    Informed consent is required, and contraception methods must be used throughout the study.

  2. Step 2

    Preparation for treatment

    Before starting the treatment, a series of tests and evaluations are conducted to ensure readiness for the procedure.

    Lymphocyte counts are measured on standard blood counts before conditioning, approximately 7 days before the treatment begins.

  3. Step 3

    Conditioning regimen

    The conditioning regimen involves the administration of fludarabine and treosulfan through intravenous infusion. This step prepares the body for the stem cell transplantation.

  4. Step 4

    Stem cell transplantation

    An allogeneic hematopoietic stem cell transplantation is performed using a 10/10 HLA matched unrelated donor.

  5. Step 5

    GVHD prophylaxis

    To prevent graft versus host disease (GVHD), either ATG-thymoglobulin or ATLG-grafalon is administered. These are given as intravenous infusions.

  6. Step 6

    Post-transplantation monitoring

    Monitoring occurs at various intervals: day 100, month 6, month 12, and month 24 post-transplantation.

    This includes checking for GVHD, immune system recovery, chimerism, and any signs of relapse or severe infections.

  7. Step 7

    Follow-up assessments

    Regular assessments of health-related quality of life are conducted using a specific questionnaire at inclusion, day 100, month 6, and month 12.

    Overall survival, progression-free survival, and other health outcomes are evaluated at month 12 and month 24.

Who can join the trial?

13 criteria

  • Be between 50 and 70 years old.
  • If you are between 50 and 55 years old, you should not be fit for a strong treatment called myeloablative conditioning.
  • Have either Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) that requires a special type of treatment called allogeneic stem cell transplantation.
  • Do not have a related donor with a matching HLA type. HLA is a protein that helps match donors and recipients for transplants.
  • Have a matched unrelated donor with a 10/10 HLA match.
  • Meet the usual criteria for a Hematopoietic Stem Cell Transplant (HSCT), which includes:
    • An ECOG performance status of 2 or less, which measures your ability to perform daily activities.
    • No severe and uncontrolled infections.
    • A heart function with a left ventricular ejection fraction of 50% or more.
    • Lung function with a DLCO (a test for lung capacity) greater than 40%.
    • Proper organ function, with specific limits on liver and kidney tests, unless these are affected by your blood disease.
    • Have health insurance coverage.
    • Sign a written informed consent form, which means you agree to participate after understanding the study.
    • Use prescribed contraception methods during the study. For women, this includes various hormonal methods, devices, or abstinence. For men, this includes abstinence or using condoms.

Who cannot join the trial?

7 criteria

  • Patients with a medical condition other than Myelodysplastic syndrome (MDS) or Acute myeloid leukemia (AML) cannot participate.
  • Patients who are not receiving a transplant from a 10/10 matched unrelated donor (MUD) are excluded. This means the donor's tissue type must match the patient's tissue type in 10 out of 10 specific markers.
  • Patients who are not undergoing a reduced intensity conditioning with specific medications (fludarabine-treosulfan) before the transplant are excluded. Reduced intensity conditioning is a milder form of treatment to prepare the body for a transplant.
  • Patients who are not receiving GVHD prophylaxis with either ATG-thymoglobulin or ATLG-grafalon are excluded. GVHD prophylaxis is a treatment to prevent a condition called graft-versus-host disease, which can occur after a transplant.
  • Patients who are not within the specified age range for the study are excluded. The age range is not specified here, but it is important for eligibility.
  • Both male and female patients are eligible, so exclusion is not based on gender.
  • Patients who are considered part of a vulnerable population are not automatically excluded, but specific criteria may apply.
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Investigated drugs

  • ATG-thymoglobulin

    is a medication used to prevent graft-versus-host disease (GVHD) in patients receiving a stem cell transplant. It works by suppressing the immune system to reduce the risk of the body attacking the transplanted cells.

  • ATLG-grafalon

    is another medication used for preventing GVHD in patients undergoing a stem cell transplant. Similar to ATG-thymoglobulin, it helps to control the immune response, minimizing the chances of the body rejecting the new cells.

  • Fludarabine

    is a chemotherapy drug used as part of the conditioning regimen before a stem cell transplant. It helps to prepare the body for the transplant by reducing the number of existing blood cells and making space for the new stem cells to grow.

  • Treosulfan

    is another chemotherapy medication used in the conditioning regimen before a stem cell transplant. It works alongside fludarabine to help destroy existing bone marrow cells, allowing the transplanted stem cells to establish and grow in the patient's body.

What is already known about the treatment

  • ATG-thymoglobulin

    This medication is administered intravenously and is used as a prophylactic treatment to prevent graft-versus-host disease (GVHD) in patients undergoing stem cell transplantation. It is currently being studied in clinical trials for its effectiveness in elderly patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). The main therapeutic indication is to reduce the incidence of GVHD following transplantation. At the molecular level, ATG-thymoglobulin works by depleting T-cells, which are responsible for causing GVHD. It is classified as an immunosuppressive agent.

  • ATLG-grafalon

    This medication is also administered intravenously and serves as a prophylactic treatment to prevent GVHD in patients receiving stem cell transplants. It is being evaluated in clinical trials for its use in elderly patients with AML or MDS. The primary therapeutic indication is to lower the risk of GVHD after transplantation. The mechanism of action involves targeting and reducing T-cells to prevent the immune response that leads to GVHD. It is categorized as an immunosuppressive drug.

Investigated diseases

  • Myelodysplastic Syndrome (MDS)

    Myelodysplastic syndrome is a group of disorders caused by poorly formed or dysfunctional blood cells. It occurs when something goes wrong in the bone marrow, where blood cells are produced. Over time, the bone marrow becomes less effective at producing healthy blood cells, leading to symptoms like fatigue, infections, and easy bruising. The condition can progress slowly or quickly, and in some cases, it may develop into acute myeloid leukemia. MDS is more common in older adults and can vary greatly in severity. The progression of the disease depends on the specific type and the patient's overall health.

  • Acute Myeloid Leukemia (AML)

    Acute myeloid leukemia is a type of cancer that starts in the blood-forming cells of the bone marrow and quickly moves into 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. Symptoms can include fatigue, fever, frequent infections, and easy bleeding or bruising. AML progresses rapidly and requires immediate medical attention. It is more common in adults, but it can also occur in children. The disease can vary in its genetic makeup, which can influence its progression and response to treatment.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504555-27-00Protocol codeAPHP230276Estimated enrolment334 patientsSponsorAssistance Publique Hopitaux De Paris

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