Thymoglobulin® Pharmacokinetics in Patients Undergoing Hematopoietic Stem Cell Transplantation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Thymoglobulin 25 milligrams (mg) Injection, blood test.
- Who it may be relevant to
- Registry conditions: Hematopoietic Stem Cell Transplantation-Associated Thrombotic Microangiopathy. Basic parameters: from 2 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Thymoglobulin® Pharmacokinetics for Graft-versus Host Disease in Children and Adults Undergoing Hematopoietic Stem Cell Transplantation
Overview
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.
Interventions
- Drug Thymoglobulin 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. - Biological blood 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.
Primary outcome measures
- Area under the concentration-time curve (AUC) [Time frame: until elimination tf the drug (maximum 3 weeks post hematopoietic stem cell transplantation)]
Secondary outcome measures (2)
- Objective function value (OFV) [Time frame: until elimination tf the drug (maximum 3 weeks post hematopoietic stem cell transplantation)]
- Coefficient of variation of AUC [Time frame: until elimination tf the drug (maximum 3 weeks post hematopoietic stem cell transplantation)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 2 centers
- Institut d'Hématologie et d'Oncologie Pédiatrique — Lyon
- Centre Hospitalier Lyon Sud — Pierre-Bénite
Identifiers
NCT: NCT05743400 · 69HCL21_1186 · 2022-501594-39-00