Prospect Eval of Efficacy of CMV-TCIP Direct Letermovir Prophylax After Allogen Hemato Cell Transpla

Eligibility 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 IgG seropositivity) before AHCT.
• * Eligible for AHCT from an HLA-matched related, matched unrelated, mismatched unrelated or haploidentical donor using either bone marrow or peripheral blood stem cells.
• * Have undetectable CMV DNA from a plasma sample collected within 5 days prior to enrollment.
• * Be within 28 days post-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 for hemoglobin.
• * Has a history of CMV end-organ disease or CS-CMVi within 6 months prior to enrollment.
• * Received within 7 days prior to screening or plans to receive during the study any of 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 any of the following drugs: cidofovir, CMV hyper-immune globulin, any investigational CMV antiviral agent/biologic therapy.
• * Has suspected or known hypersensitivity to active or inactive ingredients of letermovir formulations.
• * Has an uncontrolled infection on the day of randomization.
• * Requires mechanical ventilation or is hemodynamically unstable at the time of randomization.