Letermovir for CMV prevention post allogenic hematopoietic stem cell transplant

Single Center Phase II study to determine safety and efficacy of Letermovir for the Prevention of Clinically Significant Cytomegalovirus (CMV) Infection in Adult, CMV-Seropositive Allogeneic Hematopoietic Stem Cell Transplant Recipients - NIL

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/06/089192

Enrollment

Registered

2025-06-20

Start date

Unknown

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: D759- Disease of blood and blood-formingorgans, unspecified

Interventions

Intervention1: Letermovir: Oral formulation of Letermovir either 240 mg per day, if receiving concomitant Cyclosporine (CsA), or 480 mg per day, if not on CsA after allogenic graft infusion (day 0) a

Eligibility

Inclusion criteria

Inclusion criteria: Male or Female patient who has documented CMV seropositivity before allogenic stem cell transplantation

Exclusion criteria

Exclusion criteria: Has a history of CMV end-organ disease within 6 months prior to randomization or has evidence of CMV viremia from a central or local laboratory at any time prior to randomization

Design outcomes

Primary

Measure	Time frame
1. Clinically significant CMV titer 2. CMV diseaseTimepoint: Twice weekly week 1 to week 4 Once weekly week 5 to week 28	—

Secondary

Measure	Time frame
1) To evaluate the efficacy of Letermovir in reduction of 6 months non-relapse mortality (NRM). 2) To evaluate the safety and tolerability of Letermovir.Timepoint: 6 months	—

Countries

India

Contacts

Public ContactDr. Saswata Saha

Tata Medical Center

saswata.saha@tmckolkata.com8777016375

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026