Single Arm Pilot Trial of Letermovir for CMV Prophy in CAR T Cell
The goal of this clinical research study is to learn if a drug called Letermovir can help to prevent CMV reactivation.
| Condition(s) | Cell Therapy |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | The goal of this clinical research study is to learn if a drug called Letermovir can help to prevent CMV reactivation. |
| Who can participate | 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 participating in this study, she should inform the treating physician immediately. 8. Participant must understand the investigational nature of this study and sign an Institutional Review Board approved wr |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | M.D. Anderson Cancer Center |
| Locations | Houston, Texas, United States |
| Start date | 2024-12-12 |
| NCT ID | NCT06575374 |
| Official listing | https://clinicaltrials.gov/study/NCT06575374 |