Evaluating the Clinical Utility of the T-SPOT.CMV Assay for the Prediction of CMV Reactivation Among Pediatric Patients Undergoing Hematopoietic Cell Transplant
- Conditions
- CMV
- Registration Number
- NCT03570411
- Lead Sponsor
- St. Jude Children's Research Hospital
- Brief Summary
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.
- Detailed Description
T-SPOT response will be measured using the results from the T-SPOT.CMV blood test in both HCT recipients and HCT donors.
A blood sample for the T-SPOT.CMV blood test will be collected from the HCT donor prior to transplant.
Blood specimens will be collected for the T-SPOT.CMV blood test from HCT recipients over the course of 6 months, starting weekly at Day +1, biweekly starting at Day +45, and monthly starting at day +120.
HCT recipient participant demographic and clinical characteristics will be collected at enrollment. Additional clinical information will be abstracted from the HCT recipient participants medical record during the study follow-up period. This will include information related to transplant history and outcome, infections, antimicrobial exposure, chemotherapy, and laboratory values related to infectious diseases and immunosuppression.
The feasibility of the T-SPOT.CMV spot count test will be evaluated once the first 30 participants enrolled on study reach day +90. If 75% of patients have at least 1 evaluable samples after engraftment (\> 75,000 per microtiter wells), we will proceed with enrollment. If more \>25% of patients have all their samples deemed not evaluable due to insufficient mononuclear cell count (\<75,000 per microtiter wells) the study will be stopped and concluded as not feasible.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 11
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of the first 30 participants with at least one evaluable sample Day +90 after transplant Percentage of the first 30 participants enrolled on study reach day +90 with at least one evaluable sample will be reported.
Odds ratio of subsequent reactivation Up to 180 days after enrollment. 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.
- Secondary Outcome Measures
Name Time Method Odds ratio of treatment outcomes Up to 180 days after enrollment. The odds ratio with 95% CI of treatment outcomes will be reported from multiple logistic regression.
Hazard ratio of morbidity Up to 180 days after enrollment. The hazard ratio with 95% CI of morbidity will be reported from Cox regression model.
Correlation coefficient of T-SPOT.CMV spot count in donors with subsequent recipient CMV spot count Up to 180 days after enrollment. 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.
Odds ratio of morbidity Up to 180 days after enrollment. The odds ratio with 95% CI of morbidity will be reported from multiple logistic regression.
Hazard ratio of treatment outcomes Up to 180 days after enrollment. The hazard ratio with 95% CI of treatment outcomes will be reported from Cox regression model.
Trial Locations
- Locations (1)
St. Jude Children's Research Hospital
🇺🇸Memphis, Tennessee, United States
St. Jude Children's Research Hospital🇺🇸Memphis, Tennessee, United States