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

NCT02175615 — Completed, 105 participants, Lee Dupuis

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

Registry	NCT02175615
Status	Completed
Study type	Observational
Enrollment	105 (Actual)
Sponsor	Lee Dupuis (Other); collaborators: C17 Council
Conditions	Acute-graft-versus-host Disease
Dates	start 2010-10-01, primary completion 2015-12-01, completion 2015-12-01, first posted 2014-06-26, last updated 2021-08-19
Locations	1 site in Canada

-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

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+Outcome measures

Primary outcomes

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

Sex: All, ages: any to 18 Years

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)

Facility	City	Country	Status
Hospital for Sick Children	Toronto, Ontario	Canada

+Publications

Dupuis LL, Seto W, Teuffel O, Gibson P, Schultz KR, Doyle JD, Gassas A, Egeler RM, Sung L, Schechter T. Prediction of area under the cyclosporine concentration versus time curve in children undergoing hematopoietic stem cell transplantation. Biol Blood Marrow Transplant. 2013 Mar;19(3):418-23. doi: 10.1016/j.bbmt.2012.10.031. Epub 2012 Nov 2. PMID 23128321

+Investigators

Lee Dupuis, PhD, Principal investigator, SickKids Research Institute