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

NCT02175615 | Completed

• 1 other identifier: CSA Cyclosporine PK Study
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

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. 1.To determine the relationship between individual concentration-time points achieved prior to engraftment and severe aGVHD (grade III and IV)
2. 2.To validate the previously developed LSS to determine cyclosporine AUC after IV administration at steady state and
3. 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

Conditions

Acute-graft-versus-host Disease

Keywords

CYCLOSPORINE; ACUTE GRAFT VERSUS HOST DISEASE; PROPHYLAXIS; CHILDREN; HAEMATOPOIETIC STEM CELL TRANSPLANT

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

ALLOGENEIC Hematopoietic stem cell transplant recipients

You may qualify if:

• 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:
• kg 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.

You may not qualify if:

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

Sponsors & Collaborators

• Lee Dupuis: lead
• C17 Council: collaborator

Study Sites (1)

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related 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.

  PMID: 23128321 BACKGROUND

Study Officials

• Lee Dupuis, PhD

  SickKids Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. Lee Dupuis

Study Record Dates

• First Submitted: June 24, 2014
• First Posted: June 26, 2014
• Study Start: October 1, 2010
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: August 19, 2021

Record last verified: 2021-08

Locations

CA (1)