Pharmacokinetics of Thymoglobulin in Paediatric Haematopoietic Stem-cell Transplants

This study is currently recruiting participants.
Verified December 2013 by The Hospital for Sick Children
Sponsor:
Information provided by (Responsible Party):
Tal Schechter-Finkelstein, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01135537
First received: March 26, 2010
Last updated: December 2, 2013
Last verified: December 2013
  Purpose

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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 The Hospital for Sick Children:

Primary Outcome Measures:
  • Pharmacokinetic disposition of ATG after a 7.5 mg/kg/course [ Time Frame: 100 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Development of graft-versus-host disease [ Time Frame: 100 days ] [ Designated as safety issue: No ]
  • CD3, CD4, and CD8 recovery [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: November 2009
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 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.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01135537

Contacts
Contact: Tal Schechter-Finkelstein, MD 416-813-7654 ext 4505 tal.schechter-finkelstein@sickkids.ca

Locations
Canada, Ontario
The Hospital For Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Tal Schechter-Finkelstein, MD    416-813-7654 ext 4505    tal.schechter-finkelstein@sickkids.ca   
Sub-Investigator: Lee Dupuis, Pharmacy         
Sub-Investigator: Adam Gassas, MD         
Sub-Investigator: John Doyle, MD         
Sub-Investigator: Yaron Finkelstein, MD         
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Tal Schechter-Finkelstein, MD The Hospital for Sick Children
  More Information

No publications provided

Responsible Party: Tal Schechter-Finkelstein, Staff Physician, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01135537     History of Changes
Other Study ID Numbers: 1000013834
Study First Received: March 26, 2010
Last Updated: December 2, 2013
Health Authority: Canada: Health Canada

Keywords provided by The Hospital for Sick Children:
allogeneic hematopoietic stem cell transplantation
pharmacokinetics
pediatrics

Additional relevant MeSH terms:
Neoplasms
Genetic Diseases, Inborn
Metabolic Diseases
Antilymphocyte Serum
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 20, 2014