The purpose of this study is to evaluate the ability of the T-SPOT.CMV assay to determine immune competence against CMV infection in stem cell transplantation. To determine the utility of the T-SPOT.CMV assay used before transplantation to determine immune competence against subsequent CMV reactivation and to determine the utility of the T-SPOT.CMV assay used after transplantation to determine immune competence against subsequent CMV reactivation.
In this prospective, non-randomized, observer-blind observational study, up to 200 patients who meet the study's eligibility criteria will be enrolled at up to 20 study centers. Enrollment will be actively managed by the sponsor. Blood samples will be collected up to 14 days before transplantation, and then at 2-week intervals for the 6 months after the transplant procedure. Study duration: 15 months: 9 months to enroll all patients, with 6 months (182 days) of participation for each patient.
Study Type
OBSERVATIONAL
Enrollment
250
City of Hope
Duarte, California, United States
UCLA Medical Center
Los Angeles, California, United States
The University of Chicago Medicine
Chicago, Illinois, United States
To evaluate the ability of the T SPOT.CMV assay to determine immune competence against CMV infection in stem cell transplantation.
change in T-SPOT counts from baseline to 182 days post transplant
Time frame: up to day 182
To determine the utility of the T SPOT.CMV assay used before transplantation to determine immune competence against subsequent CMV reactivation.
change in T-SPOT counts from baseline to 182 days post transplant
Time frame: up to day 182
To determine the utility of the T SPOT.CMV assay used after transplantation to determine immune competence against subsequent CMV reactivation.
Time frame: up to day 182
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Johns Hopkins Hospital
Baltimore, Maryland, United States
UMass Memorial Medical Center
Worcester, Massachusetts, United States
Wayne State University - School of Medicine
Detroit, Michigan, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Cleveland Clinic
Cleveland, Ohio, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
...and 2 more locations