Evaluating the Clinical Utility of the T-SPOT.CMV Assay for the Prediction of CMV Reactivation Among Pediatric Patients Undergoing Hematopoietic Cell Transplant

Stopped early

Conditions studied: CMV

In brief

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.

Key facts

Study ID
NCT03570411
Run by
St. Jude Children's Research Hospital
People needed
11
Starts
2018-07-16
Expected to finish
2019-04-22
Last updated by the study team
2019-06-11

Who can join

Age: any. Sex: any. Healthy volunteers: accepted.

Where it is running

Full record on ClinicalTrials.gov

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