This is a phase 2, prospective cohort clinical trial evaluating the utilization of CMV T Cell Immunity Panel (CMV-TCIP) assay to guide the duration of primary CMV prophylaxis in CMV-seropositive recipients of allogeneic stem cell transplant or recipients receiving a stem cell graft from a CMV serology positive donor.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Subjects will receive 14 weeks of letermovir prophylaxis at standard recommended dose follow by CMV-TCIP-directed extended prophylaxis.
Viracor CMV-TCIP assay to measure how a person's immune system responds to CMV. Viracor CMV-TCIP will be measured monthly, starting at week 14, until positive, then at week 30 and 52.
Plasma level of CMV DNA PCR will be measured at enrollment and at least weekly through week 30, then at least every 2 weeks through week 52 of transplant if no GVHD or CMV reactivation.
Chao Family Comprehensive Cancer Center, University of California Irvine
Orange, California, United States
RECRUITINGCumulative incidence of clinically significant cytomegalovirus infection (CS-CMVi) at 52 weeks after transplant
Number of patients who develop CS-CMVi within 52 weeks after receiving a transplant
Time frame: 1 year after transplant
Cumulative incidence of CMV disease at 52 weeks after transplant
Number of patients who develop CMV disease within 52 weeks after receiving a transplant
Time frame: 1 year after transplant
Cumulative incidence of CMV related death at 52 weeks
Number of patients who die from complications directly attributable to CMV infection within 52 weeks
Time frame: 1 year after transplant
Overall Survival at 1 year after transplant
Number of patients who survive beyond 1 year after transplant
Time frame: 1 year after transplant
Positive predictive value of CMV-TCIP assay after transplant in predicting CS-CMVi protection
Positive predictive value of CMV-TCIP assay at 14 weeks after transplant in predicting CS-CMVi protection through 1 year after transplant in patients who had letermovir discontinuation
Time frame: 1 year after transplant
Chao Family Comprehensive Cancer Center University of California, Irvine
CONTACT
University of California Irvine Medical
CONTACT
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