Recruiting

Busulfan IV

Sponsor:

University Hospital, Geneva

Code:

NCT01257854

Conditions

Children Who Receive a Stem Cell Transplantation With Busulfan IV

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Study Details

Brief summary:

Test the correlations between the pharmacogenetic and pharmacokinetic of Busulfan IV in children receiving hematopoietic stem cell transplantation.

Conditions

Children Who Receive a Stem Cell Transplantation With Busulfan IV

Study ID

NCT01257854

Start date

Feb, 2008

Status verified date

Apr, 2021

Completion date

Dec, 2023

Anticipated

Primary completion date

Dec, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

Busulfan, pharmacogenetic, pharmacokinetic, children

Children who receive Busulfan IV and have a pharmacokinetic of Busulfan

Primary outcome measure

  • polymorphisms in genes involved in Busulfan pathways correlation with pharmacokinetic [ Time Frame: 1 year post hematopoietic stem cell transplantation ]

Central Contacts and Locations

Central contacts

Marc Ansari, MD, PhD

+41223824589marc.ansari@hcuge.ch

Michel Duval, MD

michel.duval@umontreal.ca

Locations

Chu St Justine

Recruiting

Montreal, Quebec, Canada, H3T1C5

Contacts

Henrique Bittencourt, MD, PhD

henrique.bittencourt.hsj@ssss.gouv.qc.ca

Principal Investigator:

Henrique Bittencourt, MD, PhD

More Information

Sponsor

University Hospital, Geneva

Last update posted

Apr 28, 2021

Last verified

Apr, 2021

Keywords

  • busulfan
  • pharmacogenetic
  • pharmacokinetic
  • toxicity
  • survival

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Hospital, Geneva on 2021-04-28.