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:

  1. To determine the relationship between individual concentration-time points achieved prior to engraftment and severe aGVHD (grade III and IV)
  2. To validate the previously developed LSS to determine cyclosporine AUC after IV administration at steady state and
  3. 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 ]

1)To determine the relationship between cyclosporine AUC achieved prior to engraftment and severe aGVHD (grade III and IV)


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