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 study about?

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.

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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

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Site Name	City	Country	Status
Iwctycah Pvgsappdgxpdmbv Cubimd Cdcmyl	Marseille	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	11.07.2024

Trial locations

Investigated drugs:

Rabbit Anti-Human Thymocyte Immunoglobulin

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.

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 ID:

2023-506648-18-00

NCT ID:

NCT06066255

Trial Phase:

Therapeutic exploratory (Phase II)

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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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