NCT05969743

Brief Summary

Explore the tolerability and efficacy of letermovir in the prevention of CMV reactivation in patients with acute and chronic graft-versus-host disease (GVHD) beyond day 100.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 1, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

August 1, 2023

Status Verified

July 1, 2023

Enrollment Period

1.6 years

First QC Date

July 23, 2023

Last Update Submit

July 23, 2023

Conditions

Graft-versus-host-diseaseCMV

Outcome Measures

Primary Outcomes (1)

  • Incidence of CMV infection

    The proportion of patients with clinically significant CMV infection through week 14 after enrollment or until prednisone dose is reduced below 0.2 mg / kg / day, whichever comes earlier.

    14 weeks

Study Arms (1)

Letermovir

EXPERIMENTAL

Patients meeting the inclusion criteria will receive letermovir 480 mg per day. Patients receiving concomitant cyclosporine will receive 240 mg of letermovir. Letermovir will be given during 14 weeks or until prednisone dose is reduced below 0.2 mg / kg / day, whichever comes earlier.

Drug: Letermovir

Interventions

LetermovirDRUG

Patients meeting the inclusion criteria will receive letermovir 480 mg per day. Patients receiving concomitant cyclosporine will receive 240 mg of letermovir. Letermovir will be given during 14 weeks or until prednisone dose is reduced below 0.2 mg / kg / day, whichever comes earlier.

Letermovir

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients
  • After allogeneic transplantation
  • Seropositive for CMV
  • Who already received letermovir prophylaxis until day 100 without CMV reactivation
  • Beyond day 100 after transplantation at enrollment
  • With acute or chronic GVHD
  • Daily prednisone dose ≥ 0.5 mg/kg (or equivalent dose of another glucocorticoid) at enrollment.
  • Negative polymerase chain reaction (PCR) for CMV at enrollment
  • Provided informed consent

You may not qualify if:

  • Seronegative for CMV
  • Positive PCR for CMV at enrollment
  • Patient has previously had CMV reactivation under letermovir.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

letermovir

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

  • Moshe Yeshurun, MD

    Institution of Hematology, Rabin Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Moshe Yeshurun, MD

CONTACT

0526015543moshe.yeshurun@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2023

First Posted

August 1, 2023

Study Start

October 1, 2023

Primary Completion

April 30, 2025

Study Completion

July 31, 2025

Last Updated

August 1, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share