Pharmacological Predictors of Successful Cyclosporine Acute GVHD Prophylaxis in Children Undergoing HSCT

Sponsor

Lee Dupuis (Other)

Overall Status

Completed

CT.gov ID

NCT02175615

Collaborator

C17 Council (Other)

105

Enrollment

Location

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Acute-graft-versus-host Disease

Study Design

Study Type:

Observational

Actual Enrollment :

105 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

PHARMACOLOGICAL PREDICTORS OF SUCCESSFUL CYCLOSPORINE ACUTE GRAFT VERSUS HOST DISEASE PROPHYLAXIS IN CHILDREN UNDERGOING HAEMATOPOIETIC STEM CELL TRANSPLANT

Study Start Date :

Oct 1, 2010

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Dec 1, 2015

Outcome Measures

Primary Outcome Measures

Relationship between CSA area-under-the-curve (AUC) prior to ENGRAFTMENT and severe aGVHD [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

less than 18 years of age
undergoing allogeneic myeloablative HSCT at one of the participating centres and
scheduled to receive cyclosporine for aGVHD prophylaxis
minimum patient weight:
6.4kg if < 6 months old or 7.2kg if > 6 months old

All patients or guardians will provide informed consent or assent as appropriate. Initial contact will be made by a member of the patient's current care team. Consent will be obtained by a co-investigator or the CTSU personnel.