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Study on How Rabbit Anti-Human Thymocyte Immunoglobulin Helps Prevent Graft-versus-Host Disease in Children and Adults Undergoing Stem Cell Transplants

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What is this study about?

This clinical trial is focused on studying the effects of a medication called Thymoglobulin in preventing a condition known as Graft-versus-Host Disease (GvHD). GvHD can occur in patients who receive a type of treatment called allogeneic hematopoietic stem cell transplantation, which is often used for various blood disorders and cancers. The study includes both children and adults who are undergoing this transplantation procedure.

The purpose of the study is to understand how Thymoglobulin, which is an anti-lymphocyte serum, behaves in the body. This medication is given as a solution through an infusion, which means it is delivered directly into the bloodstream. The study will involve monitoring patients who are receiving Thymoglobulin as part of their treatment to see how the medication is processed by the body over time.

Participants in the study will receive Thymoglobulin and may also receive a placebo. The study will track the levels of the medication in the blood and gather data to help understand its effects. This information will help improve the use of Thymoglobulin in preventing GvHD in patients undergoing stem cell transplantation.

1 joining the study

Upon joining the study, you will be informed about the trial and asked to provide consent. If you are under 18, your parents or guardians will need to give their consent.

A pregnancy test will be conducted if applicable, and you will be required to use an effective method of contraception throughout the study.

2 initial assessment

An initial assessment will be conducted to ensure you meet the eligibility criteria, including age and health status.

Your Lansky or Karnofsky score, which measures your ability to perform daily activities, will be evaluated.

3 treatment administration

You will receive a medication called Thymoglobuline, which is a solution for infusion. This medication is used to prevent a condition called GvHD during your stem cell transplantation.

The medication will be administered through an infusion, which means it will be given directly into your bloodstream.

4 monitoring and follow-up

Throughout the study, your health and response to the medication will be closely monitored.

Blood samples will be taken to measure the levels of the medication in your body and to assess its effects.

5 completion of the study

Once the study period is over, a final assessment will be conducted to evaluate your overall health and the outcomes of the treatment.

You will be informed about the results and any further steps if necessary.

Who Can Join the Study?

  • Patient receiving Thymoglobulin therapy as part of a first HSC allograft. (HSC allograft is a type of stem cell transplant.)
  • Age 2 years or older.
  • Lansky or Karnofsky score of 50% or higher. (These scores measure a patient’s ability to perform daily activities.)
  • Enrolled in a social security plan.
  • Patient 18 years of age or older must be informed and consent to participate in the study, or if the patient is a minor, their parents/guardians must be informed and give consent for the minor’s participation.
  • Patients who can have children must use an effective method of contraception throughout the study. (A pregnancy test will also be done at the start of the study.) Examples of effective contraceptive methods include:
    • Bilateral tubal ligation (surgical procedure to block fallopian tubes)
    • Male sterilization
    • Hormonal contraceptives that prevent ovulation
    • Hormone-releasing intrauterine devices (IUDs)
    • Copper intrauterine devices (IUDs)

Who Cannot Join the Study?

  • Patients who have had a severe allergic reaction to Thymoglobulin® or any of its ingredients cannot participate.
  • Patients with a history of severe allergic reactions to other medications or treatments are not eligible.
  • Patients with active infections that are not controlled or treated cannot join the study.
  • Patients with a history of cancer, except for certain types of skin cancer, are excluded.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients with severe heart, liver, or kidney problems are not eligible.
  • Patients who have received another investigational drug within the last 30 days cannot join the study.
  • Patients with a history of drug or alcohol abuse in the past year are excluded.
  • Patients who are unable to follow the study procedures or attend the required visits cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Hospices Civils De Lyon Lyon France
Centre Hospitalier Lyon Sud Pierre Benite France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
01.04.2023

Trial locations

Investigated drugs:

Anti-lymphocyte serum (SAL) is a medication used to help prevent a condition called Graft-versus-Host Disease (GvHD) in patients who are receiving a type of treatment known as allogeneic hematopoietic stem cell transplantation. This condition can occur when the new stem cells attack the patient’s body. The anti-lymphocyte serum works by suppressing the immune system to reduce the risk of this happening.

Thymoglobulin® is another medication used in the same context to prevent GvHD. It is an immunosuppressive drug, which means it helps to lower the activity of the immune system. By doing this, Thymoglobulin® helps to prevent the new stem cells from attacking the patient’s body, making the transplantation process safer.

Investigated diseases:

Hematopoietic Stem Cell Transplantation – This procedure involves the transplantation of blood stem cells to replace damaged or diseased bone marrow. It is used to treat certain cancers, blood disorders, and immune system conditions. The process begins with the collection of healthy stem cells from a donor, followed by the administration of high-dose chemotherapy or radiation therapy to the patient. The healthy stem cells are then infused into the patient’s bloodstream, where they travel to the bone marrow and begin to produce new blood cells. Over time, the transplanted stem cells can help restore the patient’s blood cell production and immune function. The progression of recovery varies, with the initial phase focusing on engraftment and the long-term phase on immune system rebuilding.

Trial ID:
2022-501594-39-00
Protocol code:
69HCL21_1186
NCT ID:
NCT05743400
Trial Phase:
Therapeutic confirmatory (Phase III)

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