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

Acute-graft-versus-host Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02175615
• Other study ID #: CSA Cyclosporine PK Study
• Status: Completed
• Start date: October 2010
• Est. completion date: December 2015

Study information

• Verified date: August 2021
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute-graft-versus-host Disease
• Graft vs Host Disease

Locations

Country	Name	City	State
Canada	Hospital for Sick Children	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Lee Dupuis	C17 Council

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Weekly for 7 weeks or until engraftment and for 100 days after HSCT