Acute-graft-versus-host DiseaseNCT02175615
Pharmacological Predictors of Successful Cyclosporine Acute GVHD Prophylaxis in Children Undergoing HSCT
An observational study of Acute-graft-versus-host Disease, run by Lee Dupuis at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Acute-graft-versus-host Disease
- How many people
- 105 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2010to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: ALLOGENEIC Hematopoietic stem cell transplant recipients
Who may be able to join
- 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.
Who cannot join
- -receipt of voriconazole or posaconazole within 14 days of the first cyclosporine dose or at any time until engraftment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
- To determine the relationship between individual concentration-time points achieved prior to engraftment and severe aGVHD (grade III and IV)
- To validate the previously developed LSS to determine cyclosporine AUC after IV administration at steady state and
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Weekly for 7 weeks or until engraftment and for 100 days after HSCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2014 (estimated)
- Study startOct 2010
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute-graft-versus-host DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lee Dupuis
- Sponsor type
- University, hospital or other
- Collaborators
- C17 Council
- Responsible party
- Sponsor-investigator, Lee Dupuis, The Hospital for Sick Children
- Investigators
- Lee Dupuis, PhD, Principal investigator, SickKids Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02175615
- Sponsor's protocol ID
- CSA Cyclosporine PK Study
- Status last verified
- Aug 2021
- First submitted
- 24 Jun 2014
- Last updated
- 19 Aug 2021
- Results posted
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PHARMACOLOGICAL PREDICTORS OF SUCCESSFUL CYCLOSPORINE ACUTE GRAFT VERSUS HOST DISEASE PROPHYLAXIS IN CHILDREN UNDERGOING HAEMATOPOIETIC STEM CELL TRANSPLANT
- ClinicalTrials.gov ID
- NCT02175615
- Acronym / sponsor ID
- CSA Cyclosporine PK Study
- Conditions
- Acute-graft-versus-host Disease
- Keywords
- CYCLOSPORINE, ACUTE GRAFT VERSUS HOST DISEASE, PROPHYLAXIS, CHILDREN, HAEMATOPOIETIC STEM CELL TRANSPLANT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Lee DupuisUniversity, hospital or other
- Collaborators
- C17 Council
- Study start
- Oct 2010
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 26 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To determine the relationship between individual concentration-time points achieved prior to engraftment and severe aGVHD (grade III and IV)
- To validate the previously developed LSS to determine cyclosporine AUC after IV administration at steady state and
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- ALLOGENEIC Hematopoietic stem cell transplant recipients
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- -receipt of voriconazole or posaconazole within 14 days of the first cyclosporine dose or at any time until engraftment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2021.
- Background: PubMed 23128321Dupuis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lee Dupuis, PhD principal investigator
SickKids Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute-graft-versus-host Disease, run by Lee Dupuis at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02175615, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2021.