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Study on Enhanced GVH Prevention in Elderly Patients with Blood Cancer Using Rabbit Anti-Human Thymocyte Immunoglobulin During 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 the effects of a treatment for patients with hematological malignancies, which are types of blood cancers. The treatment being tested is called Thymoglobuline, a medication that contains rabbit anti-human thymocyte immunoglobulin. This medication is used to help prevent a condition known as Graft-versus-Host Disease (GVH), which can occur after a patient receives a stem cell transplant from a donor. In this study, a low dose of Thymoglobuline will be given to patients who have undergone a specific type of stem cell transplant called haploidentical allogeneic hematopoietic stem cell transplantation. This type of transplant involves using stem cells from a donor who is a partial match to the patient.

The purpose of the study is to evaluate how effective this low-dose treatment is in preventing GVH in older patients who have received this type of transplant. The study will follow patients over a period of time to monitor their health and any side effects they may experience. Patients will receive the treatment through an infusion, which means the medication is given directly into the bloodstream. The study will track the occurrence of GVH and other health outcomes at various points in time after the transplant, such as 30, 60, 90, and 100 days, and up to one year.

Throughout the study, researchers will also look at other important health measures, such as the number of certain immune cells in the blood, the incidence of infections, and overall survival rates. The quality of life of participants will be assessed using a questionnaire designed for patients who have undergone bone marrow transplants. This study aims to provide valuable information on how to better protect patients from GVH and improve their overall outcomes after a stem cell transplant.

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, eligibility is confirmed based on specific criteria such as age, medical condition, and previous treatments.

    The patient must have received an allogeneic transplant within 35 days and meet other specified conditions.

  2. Step 2

    Initial treatment phase

    The patient receives standard GVH prophylaxis, which includes medications like cyclophosphamide, ciclosporin A, and mycophenolate mofetil.

    This phase involves monitoring the patient's recovery from aplasia, a condition where the bone marrow does not produce enough blood cells.

  3. Step 3

    Administration of <b>Thymoglobuline</b>

    A low dose of Thymoglobuline (rabbit anti-human thymocyte immunoglobulin) is administered as a solution for infusion.

    This medication is given at the time of neutrophil recovery to enhance GVH prophylaxis.

  4. Step 4

    Monitoring and follow-up

    The patient is monitored for acute GVH using the MAGIC7 classification at various intervals: D30, D60, D90, D100, D120, D180, D270, and D365 post-transplant.

    Chronic GVH is assessed using the NIH classification at D100, D120, D180, D270, and D365 post-transplant.

  5. Step 5

    Additional assessments

    Blood counts for T, B, and NK lymphocytes are conducted at D30, D60, D90, D120, and D180 post-transplant.

    The incidence of infections and other complications is monitored between D30 and D120 post-transplant.

  6. Step 6

    Long-term outcomes

    The study evaluates progression-free survival and overall survival at 1 year post-transplant.

    Quality of life is assessed using a specific questionnaire designed for bone marrow transplant patients.

Who can join the trial?

10 criteria

  • Must be an adult aged 60 or older, or aged 50 to 59 with other health issues. A special score called HCT-CI10 must be 3 or higher to show these health issues.
  • Must have a type of blood cancer, but not myeloproliferative syndrome or myelodysplastic syndrome.
  • Must have received a specific type of transplant within the last 35 days. This includes:
    • First-time transplant from another person.
    • Donor is a close relative but not a perfect match.
    • Transplant uses blood-forming cells from the donor's blood.
    • Received a special type of treatment before the transplant, known as "Baltimore"-type conditioning, which includes medicines like fludarabine, cyclophosphamide, and total body irradiation.
    • Standard treatment to prevent GVH disease, which includes medicines like post-transplant cyclophosphamide, ciclosporin A, and mycophenolate mofetil.
    • Must have recovered from a condition called aplasia, which is when the bone marrow doesn't make enough blood cells, within 35 days.
    • Must have signed a form agreeing to participate in the study, known as an informed consent form.
    • Must be affiliated with a social security system.

Who cannot join the trial?

4 criteria

  • Individuals with **haematological malignancies** cannot participate. This term refers to cancers that affect the blood, bone marrow, and lymph nodes.
  • Participants must be within certain age ranges, specifically those categorized as "3" and "4". This typically refers to specific age groups, but the exact ages are not specified here.
  • Both **male** and **female** participants are eligible, but certain groups may be excluded based on other criteria.
  • Participants from vulnerable populations are not selected for this study. Vulnerable populations can include groups like children, pregnant women, or those unable to give consent.
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Investigated drugs

Anti-lymphocytic serum (ATG) is used in this clinical trial to help prevent graft-versus-host disease (GVH) in elderly patients who have received a haploidentical allogeneic hematopoietic stem cell transplant. This medication works by reducing the activity of the immune system, which can help prevent the body from attacking the transplanted cells. In this study, a low dose of ATG is given after the transplant when the patient's neutrophil levels start to recover.

What is already known about the treatment

Anti-Lymphocytic Serum – This medication is administered intravenously, typically as a low-dose infusion. It is currently being studied in clinical trials for its effectiveness in preventing graft-versus-host disease (GVHD) in elderly patients with blood cancers undergoing haploidentical stem cell transplantation. The main therapeutic indication is to reduce the risk of GVHD, a common complication after such transplants. At the molecular level, it works by targeting and reducing the activity of lymphocytes, which are a type of white blood cell involved in immune responses. It is classified pharmacologically as an immunosuppressive agent.

Investigated diseases

Haematological Malignancies – These are cancers that begin in the blood-forming tissue, such as the bone marrow, or in the cells of the immune system. They include various types of leukemia, lymphoma, and myeloma. These diseases often result in the production of abnormal blood cells, which can interfere with normal blood cell function. As they progress, they may cause symptoms like fatigue, fever, frequent infections, and easy bruising or bleeding. The progression can vary significantly depending on the specific type of haematological malignancy. They are typically diagnosed through blood tests, bone marrow examinations, and imaging studies.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-506648-18-00Estimated enrolment27 patientsSponsorInstitut Paoli Calmettes

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).