Pharmacokinetics of Thymoglobulin in Paediatric Haematopoietic Stem-cell Transplants

The Hospital for Sick Children

Status and phase

Terminated

Phase 2

Conditions

Genetic Disorder

Metabolic Disease

Malignancy

Treatments

Biological: Thymoglobulin (rATG)

Study type

Interventional

Funder types

Other

Identifiers

NCT01135537

1000013834

Details and patient eligibility

About

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).

Full 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.

Enrollment

30 patients

Sex

All

Ages

Under 21 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

All patients who are scheduled to receive ATG 2.5mg/kg/day for 3 days as part of the preparative regimen for HSCT, as determined by the responsible HSCT physician.
Written, informed consent

Exclusion criteria

Hypersensitivity to rabbit proteins or to any product excipients
Active acute or chronic infections, which would contraindicate any additional immunosuppression
Known pregnancy or breastfeeding