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

Lee Dupuis

Status: Completed

Conditions: Acute-graft-versus-host Disease

Study type: Observational

Funder types: Other

Identifiers

NCT02175615

CSA Cyclosporine PK Study

Details and patient eligibility

About

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

Enrollment: 105 patients

Sex: All

Ages: Under 18 years old

Volunteers: No 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.

Exclusion criteria

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