Clinical Trial: Pharmacological Predictors of Successful Cyclosporine Acute GVHD Prophylaxis in Children Undergoing HSCT
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: PHARMACOLOGICAL PREDICTORS OF SUCCESSFUL CYCLOSPORINE ACUTE GRAFT VERSUS HOST DISEASE PROPHYLAXIS IN CHILDREN UNDERGOING HAEMATOPOIETIC STEM CELL TRANSPLANT
Brief Summary:
The specific objectives of this study are:
Primary:
1)To determine the relationship between cyclosporine AUC achieved prior to engraftment and severe aGVHD (grade III and IV)
Secondary:
- To determine the relationship between individual concentration-time points achieved prior to engraftment and severe aGVHD (grade III and IV)
- To validate the previously developed LSS to determine cyclosporine AUC after IV administration at steady state and
- To describe the relationship between cyclosporine AUC and individual concentration-time points achieved prior to engraftment and other HSCT outcomes (clinically significant aGVHD (grade II to IV), hypertension, engraftment failure, relapse
Detailed Summary:
Sponsor: Lee Dupuis
Current Primary Outcome: Relationship between CSA area-under-the-curve (AUC) prior to ENGRAFTMENT and severe aGVHD [ Time Frame: Weekly for 7 weeks or until engraftment and for 100 days after HSCT ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: The Hospital for Sick Children
Dates:
Date Received: June 24, 2014
Date Started: October 2010
Date Completion:
Last Updated: January 19, 2016
Last Verified: January 2016