Status:
UNKNOWN
Polymorphisms and Busulfan Pharmacokinetic Study
Lead Sponsor:
University Hospital, Geneva
Collaborating Sponsors:
European Society for Blood and Marrow Transplantation
Conditions:
Children Who Receive a Stem Cell Transplantation With Busulfan IV
Eligibility:
All Genders
Up to 18 years
Brief Summary
Test the correlations between the pharmacogenetic and pharmacokinetic of Busulfan IV in children receiving hematopoietic stem cell transplantation.
Detailed Description
Most of the drugs used to treat cancer are metabolized by hepatic enzymes such as cytochrome P450 or Glutathion-S-Transferase (GST). These enzymatic pathways can be more or less active in the drug's m...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Patients must be ≤ than 18 years of age at study entry on this protocol
- The patient must receive iv Busulfan as part of his hematopoietic stem cell transplant conditioning regimen.
- Each participating center has to go through a PK cross validation
- All patients (or their legal guardians) must sign a document of informed consent that has been approved by the Institutional Human Review Committee.
- Each center has to do his own PK of BU
Exclusion
Key Trial Info
Start Date :
February 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01257854
Start Date
February 1 2008
End Date
December 1 2023
Last Update
April 28 2021
Active Locations (4)
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1
Alberta children's hospital
Calgary, Alberta, Canada
2
Chu St Justine
Montreal, Quebec, Canada, H3T1C5
3
Hopital Rebert Debré
Paris, France
4
Hopital Cantonal de Genève
Geneva, Switzerland, 1206