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NCT04312841 · OUTCOME

Genotyping of Mutations in CMV Terminase Complex Genes

Letermovir for the Prevention of Cytomegalovirus Reactivation in Patients With Hematological Malignancies Treated With Alemtuzumab · Source last updated 2025-02-28

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
Up to 2 years

What was measured

CMV DNA sequence analysis to be performed only in subjects with CMV reactivation. Resistance to letermovir will be monitored by retrospective genotypic analysis of the CMV terminase genes in CMV DNA extracts from selected plasma samples collected at the time of diagnosed CMV reactivation. Samples will be analyzed by standard population sequencing technology through an established contract laboratory with validated protocols in place.

Analysis population: Data for this outcome was not collected

Groups in this outcome

Treatment (Letermovir)

Beginning within 7 days of the first administration of standard alemtuzumab, patients receive letermovir PO (or IV over 1 hour if patient is unable to take PO for an extended period of time) daily on days 1-28. Cycles repeat every 28 days for up to 3 months after the last dose of alemtuzumab in the absence of unacceptable toxicity. Letermovir: Given PO

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Treatment (Letermovir)0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    units
    Participants
description
CMV DNA sequence analysis to be performed only in subjects with CMV reactivation. Resistance to letermovir will be monitored by retrospective genotypic analysis of the CMV terminase genes in CMV DNA extracts from selected plasma samples collected at the time of diagnosed CMV reactivation. Samples will be analyzed by standard population sequencing technology through an established contract laboratory with validated protocols in place.
groups
  1. description
    Beginning within 7 days of the first administration of standard alemtuzumab, patients receive letermovir PO (or IV over 1 hour if patient is unable to take PO for an extended period of time) daily on days 1-28. Cycles repeat every 28 days for up to 3 months after the last dose of alemtuzumab in the absence of unacceptable toxicity. Letermovir: Given PO
    id
    OG000
    title
    Treatment (Letermovir)
population Description
Data for this outcome was not collected
reporting Status
POSTED
time Frame
Up to 2 years
title
Genotyping of Mutations in CMV Terminase Complex Genes
type
OTHER_PRE_SPECIFIED

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice