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

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

Completed

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Key information

Conditions

Acute-graft-versus-host Disease

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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)

Sponsors and collaborators

Lead sponsor

Lee Dupuis

Other

Collaborators

C17 Council

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2015
Study completion: 2015
First posted: Jun 26, 2014
Registry last updated: Aug 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed