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Pharmacokinetics and Pharmacodynamics of Thymoglobulin in Paediatric Haematopoietic Stem-cell Transplant Recipients


Phase 2
N/A
21 Years
Open (Enrolling)
Both
Malignancy, Metabolic Disease, Genetic Disorder

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Trial Information

Pharmacokinetics and Pharmacodynamics of Thymoglobulin in Paediatric Haematopoietic Stem-cell Transplant Recipients


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pharmacokinetic disposition of ATG after a 7.5 mg/kg/course

Outcome Time Frame:

100 days

Safety Issue:

No

Principal Investigator

Tal Schechter-Finkelstein, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Hospital for Sick Children

Authority:

Canada: Health Canada

Study ID:

1000013834

NCT ID:

NCT01135537

Start Date:

November 2009

Completion Date:

November 2011

Related Keywords:

  • Malignancy
  • Metabolic Disease
  • Genetic Disorder
  • allogeneic hematopoietic stem cell transplantation
  • pharmacokinetics
  • pediatrics
  • Neoplasms
  • Genetic Diseases, Inborn
  • Metabolic Diseases

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