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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02175615

Enrollment

105

Registered

2014-06-26

Start date

2010-10-31

Completion date

2015-12-31

Last updated

2021-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute-graft-versus-host Disease

Keywords

CYCLOSPORINE, ACUTE GRAFT VERSUS HOST DISEASE, PROPHYLAXIS, CHILDREN, 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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 18 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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)

Countries

Canada

Outcome results