Spots Global Cancer Trial Database for Pharmacokinetics of Thymoglobulin in Paediatric Haematopoietic Stem-cell Transplants
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Trial Identification
Brief Title: Pharmacokinetics of Thymoglobulin in Paediatric Haematopoietic Stem-cell Transplants
Official Title: Pharmacokinetics and Pharmacodynamics of Thymoglobulin in Paediatric Haematopoietic Stem-cell Transplant Recipients
Study ID: NCT01135537
Interventions
Study Description
Brief Summary: This study will describe the pharmacokinetic disposition of biologically active rabbit anti-thymocyte globulin (rATG) after a consistent dose of 7.5 mg/kg/course given as part of the conditioning regimen in children undergoing hematopoeitic stem cell transplantation (HSCT).
Detailed Description: Allogeneic hematopoeitic stem cell transplantation (HSCT) is a therapeutic option for patients with malignancies as well as metabolic and genetic diseases. Conditioning regimens given prior to donor cell infusion aim to ablate the recipient bone-marrow, to allow engraftment of the stem-cells infused, and to prevent acute versus host disease (aGVHD). Anti-thymocyte globulin (ATG) is one of the immunosuppressive drugs given as a preparative regimen for HSCT. Subjects will be given an ATG infusion daily for 3 days prior to HSCT and serum levels will be collected, as per schedule, with the last sample taken +100 days post-HSCT.
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
The Hospital For Sick Children, Toronto, Ontario, Canada
Contact Details
Name: Tal Schechter-Finkelstein, MD
Affiliation: The Hospital for Sick Children
Role: PRINCIPAL_INVESTIGATOR
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