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

August 12, 2021 updated by: Lee Dupuis

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

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

105

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

ALLOGENEIC Hematopoietic stem cell transplant recipients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Weekly for 7 weeks or until engraftment and for 100 days after HSCT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lee Dupuis

Collaborators

C17 Council

Investigators

  • Principal Investigator: Lee Dupuis, PhD, SickKids Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

June 24, 2014

First Submitted That Met QC Criteria

June 25, 2014

First Posted (Estimate)

June 26, 2014

Study Record Updates

Last Update Posted (Actual)

August 19, 2021

Last Update Submitted That Met QC Criteria

August 12, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSA Cyclosporine PK Study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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