CMV Clinical Trial
Official title:
Evaluating the Clinical Utility of the T-SPOT.CMV Assay for the Prediction of CMV Reactivation Among Pediatric Patients Undergoing Hematopoietic Cell Transplant
Verified date | June 2019 |
Source | St. Jude Children's Research Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The ability to distinguish allogeneic hematopoietic cell transplantation (allo-HCT)
recipients at risk for cytomegalovirus (CMV) reactivation from those who are not is central
for optimal CMV management strategies. Measuring this cell mediated immunity has been
proposed as a potent tool to predict those patients at highest risk of CMV reactivation and
disease. This study will evaluate the ability of the T-SPOT.CMV test to predict
Cytomegalovirus (CMV) reactivation in allogeneic hematopoietic cell transplantation
(allo-HCT) pediatric recipients.
Primary Objectives:
To evaluate feasibility of T-SPOT.CMV spot count test in allo-HCT pediatric recipients.
To evaluate association of T-SPOT.CMV spot count in the first sample collected after patient
has engrafted with subsequent CMV reactivation in allo-HCT pediatric recipients.
Secondary Objectives:
To evaluate the correlation between T-SPOT.CMV spot count in donors with subsequent recipient
CMV spot count.
To explore the relationship between recipient T-SPOT.CMV spot counts and subsequent CMV
infection related morbidity and treatment outcomes among pediatric all-HCT recipients.
Status | Terminated |
Enrollment | 11 |
Est. completion date | April 22, 2019 |
Est. primary completion date | April 22, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility |
HCT Recipient Inclusion Criteria - Less than 18 years old at the time of study enrollment - Scheduled to receive allogeneic HCT at St Jude Children's Research Hospital - HCT recipient has a documented seropositive CMV result prior to enrollment OR The HCT recipient is seronegative, but the HCT donor has a seropositive CMV result as documented in the recipient's medical record. HCT Recipient Exclusion Criteria - Any condition or therapy that would, in the opinion of the investigator, place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the study, or impact the outcome of the study. - Inability or unwillingness of research participant or legal guardian/representative to give written informed consent. HCT Donor Inclusion Criteria • Approved allogeneic HCT donor for a HCT recipient enrolled on the SPOTCMV protocol HCT Donor Exclusion Criteria • Inability or unwillingness of research participant or legal guardian/representative to give written informed consent. |
Country | Name | City | State |
---|---|---|---|
United States | St. Jude Children's Research Hospital | Memphis | Tennessee |
Lead Sponsor | Collaborator |
---|---|
St. Jude Children's Research Hospital | Oxford Immunotec |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of the first 30 participants with at least one evaluable sample | Percentage of the first 30 participants enrolled on study reach day +90 with at least one evaluable sample will be reported. | Day +90 after transplant | |
Primary | Odds ratio of subsequent reactivation | We define the primary endpoint to the T-SPOT CMV count in the first sample collected after patient has engrafted, which is the time point when one establishes his/her post-transplant immunity. If the count in this sample is less than or equal to 100, the participant will be noted as "low response", while an individual with a spot count greater than 100 will be noted as "high response". Odds ratio of having subsequent CMV reactivation between "low response" and "high response" groups will be estimated. | Up to 180 days after enrollment. | |
Secondary | Correlation coefficient of T-SPOT.CMV spot count in donors with subsequent recipient CMV spot count | The correlation coefficient between T-SPOT.CMV spot count in donors (one-time measure) and maximal recipient's CMV spot count will be calculated with Pearson's or Spearman's correlation coefficient. | Up to 180 days after enrollment. | |
Secondary | Odds ratio of morbidity | The odds ratio with 95% CI of morbidity will be reported from multiple logistic regression. | Up to 180 days after enrollment. | |
Secondary | Odds ratio of treatment outcomes | The odds ratio with 95% CI of treatment outcomes will be reported from multiple logistic regression. | Up to 180 days after enrollment. | |
Secondary | Hazard ratio of morbidity | The hazard ratio with 95% CI of morbidity will be reported from Cox regression model. | Up to 180 days after enrollment. | |
Secondary | Hazard ratio of treatment outcomes | The hazard ratio with 95% CI of treatment outcomes will be reported from Cox regression model. | Up to 180 days after enrollment. |
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