Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05743400

Thymoglobulin® Pharmacokinetics in Patients Undergoing Hematopoietic Stem Cell Transplantation

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Hematopoietic Stem Cell Transplantation-Associated Thrombotic Microangiopathy Graft vs Host Disease Immune System Diseases

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Institut d'Hématologie et d'Oncologie Pédiatrique, Lyon, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient receiving Thymoglobulin therapy as part of a first HSCT
  • Age ≥ 2 years
  • Lansky or karnofsky score ≥ 50%.
  • Enrolled in a social security plan
  • Patient 18 years of age or older who is informed and has consented to participate in the study or minor patient whose parents/guardians have been informed and have given consent for the minor patient to participate in the study
  • Female patients of childbearing potential must have an effective method of contraception (a pregnancy test will also be performed at inclusion).

Exclusion criteria

  • Patient having received serotherapy (Thymoglobulin® or other) within 3 months before this HSCT
  • Patient receiving another serotherapy during conditioning (Campath®)
  • Patients with uncontrolled acute or chronic infections for which any form of immunosuppression would be contraindicated
  • Known hypersensitivity to Thymoglobulin®.
  • Pregnant or lactating women
  • Patient participating simultaneously in another study of an investigational drug (no exclusion period)
  • Patient under legal protection or deprived of liberty

Treatment and study plan

Thymoglobulin 25 milligrams (mg) Injection

Drug

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.

blood test

Biological

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.

Primary outcomes

  1. Area under the concentration-time curve (AUC)

    Time frame: until elimination tf the drug (maximum 3 weeks post hematopoietic stem cell transplantation)

    Measure of the Thymoglobulin® exposure by the PK criteria : Area under the concentration-time curve (AUC) .

    AUC is measured by day since the first day of Thymoglobulin infusion during conditioning (day 0) until elimination tf the drug. AUC is expressed as milligrams/hour/Liter. (mg/h/L)

Secondary outcomes

  1. Objective function value (OFV)

    Time frame: until elimination tf the drug (maximum 3 weeks post hematopoietic stem cell transplantation)

    Comparison of the OFV of different build population pharmacokinetic models based on results of pharmacokinetic analysis, from start of thymoglobulin® infusion until elimination of the drug

  2. Coefficient of variation of AUC

    Time frame: until elimination tf the drug (maximum 3 weeks post hematopoietic stem cell transplantation)

    Ratio of typical variation of AUC to the mean AUC. AUC is measured by day since the first day of Thymoglobulin infusion during conditioning (day 0) until elimination of the drug

Study contacts

Contact information is provided by the study sponsor or research team.

Michael Philippe, MD, PhD

CONTACT

[email protected]

0469166595 ext. +33

Sylvain Goutelle, PU, PH

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: PHASAL-GA

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 24, 2023
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.