CMV-TCIP Directed Letermovir Prophylaxis After Allo-SCT

Inclusion Criteria:

• ≥ 18 years of age on the day of signing informed consent.

• Karnofsky performance >70%

• Have documented seropositivity for CMV (either donor or recipient CMV IgGseropositivity) before AHCT.

• Eligible for AHCT from an HLA-matched related, matched unrelated, mismatchedunrelated or haploidentical donor using either bone marrow or peripheral blood stemcells.

• Have undetectable CMV DNA from a plasma sample collected within 5 days prior toenrollment.

• Must be within Day-10 thru Day+28 days of planned HSCT at the time of enrollment.

• Be able to comply with medical recommendations or follow-up.

• Has adequate organ functions determined by

1. Serum creatinine clearance ≥50 ml/min (calculated with Cockroft-Gault formula).

2. Bilirubin ≤1.5 mg/dl except for Gilbert's disease.

3. ALT or AST ≤200 IU/ml for adults.

4. Conjugated (direct) bilirubin < 2x upper limit of normal.

5. Left ventricular ejection fraction ≥40%.

6. Diffusing capacity for carbon monoxide (DLCO) ≥ 50% predicted corrected forhemoglobin.

Exclusion Criteria:

• Has a history of CMV end-organ disease or CS-CMVi within 6 months prior toenrollment.

• Received within 7 days prior to screening or plans to receive during the study anyof the following:

1. Ganciclovir

2. Valganciclovir

3. Foscarnet

4. Acyclovir (> 3200 mg PO per day or > 25 mg/kg IV per day)

5. Valacyclovir (> 3000 mg/day)

6. Famciclovir (> 1500 mg/day)

• Received within 30 days prior to screening or plans to receive during the study anyof the following drugs: cidofovir, CMV hyper-immune globulin, any investigationalCMV antiviral agent/biologic therapy.

• Has suspected or known hypersensitivity to active or inactive ingredients ofletermovir formulations.

• Has an uncontrolled infection

• Requires mechanical ventilation or is hemodynamically unstable