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Pharmacokinetics of Thymoglobulin in Paediatric Haematopoietic Stem-cell Transplants

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ClinicalTrials.gov Identifier: NCT01135537
Recruitment Status : Completed
First Posted : June 2, 2010
Last Update Posted : December 2, 2014
Sponsor:
Information provided by (Responsible Party):
Tal Schechter-Finkelstein, The Hospital for Sick Children

Brief Summary:
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 or disease Intervention/treatment Phase
Malignancy Metabolic Disease Genetic Disorder Biological: Thymoglobulin (rATG) Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
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
Study Start Date : November 2009
Primary Completion Date : January 2014
Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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)



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

Secondary Outcome Measures :
  1. Development of graft-versus-host disease [ Time Frame: 100 days ]
  2. 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.

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


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01135537


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

Responsible Party: Tal Schechter-Finkelstein, Staff Physician, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01135537     History of Changes
Other Study ID Numbers: 1000013834
First Posted: June 2, 2010    Key Record Dates
Last Update Posted: December 2, 2014
Last Verified: November 2014

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

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