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

Lee Dupuis105 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

105

Conditions

Acute-graft-versus-host Disease

Eligibility

Sex: ALLMax age: 18 Years

Medical Language ↔ Plain English

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. Exclusion Criteria: -receipt of voriconazole or posaconazole within 14 days of the first cyclosporine dose or at any time until engraftment

Locations (1)

Outcomes

Primary Outcomes

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

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

Time frame: Weekly for 7 weeks or until engraftment and for 100 days after HSCT