Thymoglobulin® Pharmacokinetics in Patients Undergoing Hematopoietic Stem Cell Transplantation (PHASAL-GA)
Hematopoietic Stem Cell Transplantation-Associated Thrombotic Microangiopathy
About this trial
This is an interventional treatment trial for Hematopoietic Stem Cell Transplantation-Associated Thrombotic Microangiopathy focused on measuring Hematopoietic stem cell transplantation, Pharmacokinetics, HSCT, Anti-thymocyte globulin, Graft versus host disease
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
Sites / Locations
- Institut d'Hématologie et d'Oncologie PédiatriqueRecruiting
- Centre Hospitalier Lyon SudRecruiting
Arms of the Study
Arm 1
Experimental
Experimental treatment arm
Children over two years and adults undergoing a first hematopoietic stem cell transplantation will receiveThymoglobulin® as part of the conditioning.