Pharmacokinetics of Thymoglobulin in Paediatric Haematopoietic Stem-cell Transplants

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents

ClinicalTrials.gov processed this record on August 28, 2014