Open Label Single Arm Pilot Trial of Letermovir for Cytomegalovirus Prophylaxis After Axicabtagene Ciloleucel Therapy
M.D. Anderson Cancer Center
Summary
The goal of this clinical research study is to learn if a drug called Letermovir can help to prevent CMV reactivation.
Description
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age ≥ 18 years of age. 2. Have an ECOG performance status of 0 or 1. 3. The participant must be scheduled for SOC AXI-CEL. 4. The participant must be seropositive for CMV (defined as having anti-CMV IgG antibodies) 5. Creatinine clearance \> 10 mL/min 6. Child Pugh class A or B if liver disease is present. 7. Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is part…
Interventions
- DrugLetermovir
Given by mouth or intravenously
Location
- MD Anderson Cancer CenterHouston, Texas