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CompletedNCT02175615Updated Aug 19, 2021

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

An observational study in Acute-graft-versus-host Disease, sponsored by Lee Dupuis. Completed at 1 site in Canada. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2021-08-19.

Sponsored by Lee Dupuis · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
105
Ages
Up to 18 Years
Sex
All
01

Study 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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Conditions studied

  • Acute-graft-versus-host Disease

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Keywords

  • CYCLOSPORINE
  • ACUTE GRAFT VERSUS HOST DISEASE
  • PROPHYLAXIS
  • CHILDREN
  • HAEMATOPOIETIC STEM CELL TRANSPLANT
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In context

Graft vs Host Disease

806 studies on the registry are indexed under Graft vs Host Disease; 138 are open to participants now.

This study's enrollment of 105 is above the median of 94 across 102 observational studies indexed under Graft vs Host Disease.

Browse Graft vs Host Disease studies →

Lead sponsor

This is the only study on the registry with Lee Dupuis as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

ALLOGENEIC Hematopoietic stem cell transplant recipients

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

Exclusion Criteria:

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

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
105 participants (actual)
Patient registry
No
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What researchers measure

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)

    Time frame: Weekly for 7 weeks or until engraftment and for 100 days after HSCT

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Study locations

1 site
  • Hospital for Sick Children
    Toronto, Ontario M5G 1X8, Canada
08

References and documents

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. PubMed 23128321 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 19, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02175615
Lead sponsor
Lee Dupuis
Collaborators
C17 Council
Responsible party
Lee Dupuis (Dr. Lee Dupuis, The Hospital for Sick Children) — Sponsor-investigator
First posted
Jun 26, 2014
Start date
Oct 2010
Primary completion
Dec 2015
Completion
Dec 2015
Last update
Aug 19, 2021

Study contacts

Lee Dupuis, PhD
principal investigator · SickKids Research Institute
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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