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
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.
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.
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