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Pharmacokinetics of Thymoglobulin in Paediatric Haematopoietic Stem-cell Transplants

This study has been completed.
Information provided by (Responsible Party):
Tal Schechter-Finkelstein, The Hospital for Sick Children Identifier:
First received: March 26, 2010
Last updated: November 27, 2014
Last verified: November 2014
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).

Condition Intervention Phase
Malignancy Metabolic Disease Genetic Disorder Biological: Thymoglobulin (rATG) Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetics and Pharmacodynamics of Thymoglobulin in Paediatric Haematopoietic Stem-cell Transplant Recipients

Resource links provided by NLM:

Further study details as provided by Tal Schechter-Finkelstein, The Hospital for Sick Children:

Primary Outcome Measures:
  • Pharmacokinetic disposition of ATG after a 7.5 mg/kg/course [ Time Frame: 100 days ]

Secondary Outcome Measures:
  • Development of graft-versus-host disease [ Time Frame: 100 days ]
  • CD3, CD4, and CD8 recovery [ Time Frame: 12 months ]
    CD3, CD4, CD8 recovery at 1, 3, 6, 12 months post HSCT is routinely done to evaluate T-cell reconstitution.

  • Development of EBV-related complications [ Time Frame: 100 days ]

Enrollment: 30
Study Start Date: November 2009
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Thymoglobulin
Thymoglobulin 7.5 mg/kg/course prior to HSCT
Biological: Thymoglobulin (rATG)

Thymoglobulin 2.5 mg/kg of body weight IV administered daily for 3 days prior to HSCT.

Thymoglobulin infused over a minimum of 6 hours for the first infusion and over at least 4 to 6 hours on subsequent days of therapy.

Other Name: Anti-thymocyte Globulin (Rabbit)

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.

Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01135537

Canada, Ontario
The Hospital For Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Principal Investigator: Tal Schechter-Finkelstein, MD The Hospital for Sick Children
  More Information

Responsible Party: Tal Schechter-Finkelstein, Staff Physician, The Hospital for Sick Children Identifier: NCT01135537     History of Changes
Other Study ID Numbers: 1000013834
Study First Received: March 26, 2010
Last Updated: November 27, 2014

Keywords provided by Tal Schechter-Finkelstein, The Hospital for Sick Children:
allogeneic hematopoietic stem cell transplantation

Additional relevant MeSH terms:
Metabolic Diseases
Antilymphocyte Serum
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents processed this record on September 21, 2017