RecruitingPhase 4NCT05743400

Thymoglobulin® Pharmacokinetics in Patients Undergoing Hematopoietic Stem Cell Transplantation

Thymoglobulin® Pharmacokinetics for Graft-versus Host Disease in Children and Adults Undergoing Hematopoietic Stem Cell Transplantation


Sponsor

Hospices Civils de Lyon

Enrollment

35 participants

Start Date

Sep 25, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Thymoglobulin is widely applied as serotherapy in order to prevent acute graft-versus-host disease (GvHD) and graft rejection in patients undergoing non-Human Leukocyte Antigen (HLA)-identical hematopoietic stem cell transplantations (HSCT), with a delicate balance between prevention of GvHD and the promotion of immune reconstitution. Thymoglobulin is known as a drug with high pharmacokinetic (PK) variability. This variability influences drug exposure, which in turn determines the drug response of pharmacodynamics (PD). In order to maintain efficacy while reducing adverse effects of drugs across the entire age range, identification of the PK/PD relationships and the effect of growth and maturation on the different PK and PD parameters involved are crucial. The investigators hypothesise that a better knowledge of Thymoglobulin PK and its covariates would help to individualise dosage regimen and would improve clinical outcomes, such as GvHD and immune reconstitution. The investigators aim to build a population PK model of Thymoglobulin in order to study PK variability and its covariates. This model will help in optimizing dosage regimen in an individually way.


Eligibility

Min Age: 2 Years

Plain Language Summary

Simplified for easier understanding

This study is examining how a medication called Thymoglobulin (anti-thymocyte globulin) behaves in the body — specifically its pharmacokinetics (how the drug is absorbed, distributed, and cleared) — in patients undergoing their first hematopoietic stem cell transplant (HSCT). HSCT is used to treat serious blood cancers and immune disorders, and Thymoglobulin is given beforehand to suppress the immune system and prevent rejection. Knowing exactly how the drug moves through the body could help doctors dose it more precisely and improve transplant outcomes. The study includes patients aged 2 and older who are receiving Thymoglobulin as part of their first HSCT, are enrolled in the French national health system, and have a performance score of 50% or above. Patients who have received similar serotherapy in the past 3 months, have uncontrolled infections, are pregnant, or are in another drug trial are not eligible. This research is important because optimal Thymoglobulin dosing is challenging — too little may allow graft rejection, while too much can lead to severe immune suppression, infections, or Epstein-Barr virus-related complications. By building a precise pharmacokinetic model across ages (including children), this study could lead to personalized dosing protocols that improve the success of stem cell transplantation for patients with leukemia, lymphoma, and other life-threatening conditions.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGThymoglobulin 25 milligrams (mg) Injection

Patients will receive thymoglobulin between 5 and 20 milligrams/kilograms (mg/kg) as an intravenous infusion over a period of 2 to 5 days depending on the dose and the transplant package chosen by the physician.

BIOLOGICALblood test

Thymoglobulin® serum levels Time frame : samples will be drawn at the following points : * 1 after each end of perfusion ; * 1 though concentration before each perfusion ; * 3 blood samples in 3 different days during the first week; * 1 weekly for 2 weeks post HSCT.


Locations(2)

Institut d'Hématologie et d'Oncologie Pédiatrique

Lyon, France

Centre Hospitalier Lyon Sud

Pierre-Bénite, France

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NCT05743400