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Open Label Single Arm Pilot Trial of Letermovir for Cytomegalovirus Prophylaxis After Axicabtagene Ciloleucel Therapy
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
MD Anderson Cancer Center
Houston, Texas, United States
Start Date
December 12, 2024
Primary Completion Date
August 1, 2026
Completion Date
August 1, 2027
Last Updated
January 21, 2026
36
ESTIMATED participants
Letermovir
DRUG
Lead Sponsor
M.D. Anderson Cancer Center
NCT07198867
NCT06921980
Data Source & Attribution
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