Thymoglobulin® Pharmacokinetics in Patients Undergoing Hematopoietic Stem Cell Transplantation (PHASAL-GA)

Civil Hospices of Lyon

Status and phase

Enrolling

Phase 4

Conditions

Hematopoietic Stem Cell Transplantation-Associated Thrombotic Microangiopathy

Treatments

Drug: Thymoglobulin 25 milligrams (mg) Injection

Biological: blood test

Study type

Interventional

Funder types

Other

Identifiers

NCT05743400

69HCL21_1186

2022-501594-39-00 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

35 estimated patients

Sex

All

Ages

2+ years old

Volunteers

No Healthy Volunteers

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