The goal of this clinical research study is to learn if a drug called Letermovir can help to prevent CMV reactivation.
Primary Objective: Estimate the probabilities at days d = +28 and +98 following CAR T cell infusion, among patients alive at the day of evaluation, of CMV reactivation in CMV seropositive patients receiving letermovir for CMV prophylaxis after standard of care (SOC) axicabtagene ciloleucel (AXI-CEL) therapy, using the cutoff CMV DNA qPCR \> c for c = 400 and 1000 IU/mL to define CMV reactivation, for a total of four (d, c) combinations. Secondary Objectives: Estimate overall survival probabilities at days+28, +98, and +364 following CAR T cell infusion of CMV seropositive patients receiving letermovir for CMV prophylaxis after SOC AXI-CEL therapy. Describe the tolerability of letermovir during the period of CMV prophylaxis after SOC AXI-CEL therapy in CMV seropositive patients at high risk for CMV reactivation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
36
Given by mouth or intravenously
MD Anderson Cancer Center
Houston, Texas, United States
RECRUITINGSafety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Time frame: Through study completion; an average of 1 year
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