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NCT03190915 · OUTCOME

Duration of Response

Trametinib in Treating Patients With Relapsed or Refractory Juvenile Myelomonocytic Leukemia · Source last updated 2026-07-20

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

Measure
MEDIAN
Unit
years
Interval / dispersion
Full Range
Time frame
Up to 5 years

What was measured

Duration of response (Aim 1.2.5) will be defined as the time from first occurrence of PR or CR until the first occurrence of PD, death, or going off study. Patients who progress will be considered to have had an event, patients who die prior to progressing will be considered to have a competing event, and patients who go off study prior to progressing will be censored at time of last contact. The analysis will be done using the method of Gray.

Analysis population: All patients who achieved an overall best response of Partial Response or Complete Response.

Groups in this outcome

Treatment (Trametinib)

Patients receive trametinib PO QD on days 1-28 of each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo a bone marrow aspiration or biopsy at baseline, on day 28 of cycles 1 and 2, at all subsequent odd numbered cycles, and at end of treatment.

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 (Trametinib)5

Reported measurements

Source class 1
Values in years · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Treatment (Trametinib)2.26Not reported0.872.78Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.87
        upper Limit
        2.78
        value
        2.26
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    units
    Participants
description
Duration of response (Aim 1.2.5) will be defined as the time from first occurrence of PR or CR until the first occurrence of PD, death, or going off study. Patients who progress will be considered to have had an event, patients who die prior to progressing will be considered to have a competing event, and patients who go off study prior to progressing will be censored at time of last contact. The analysis will be done using the method of Gray.
dispersion Type
Full Range
groups
  1. description
    Patients receive trametinib PO QD on days 1-28 of each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo a bone marrow aspiration or biopsy at baseline, on day 28 of cycles 1 and 2, at all subsequent odd numbered cycles, and at end of treatment.
    id
    OG000
    title
    Treatment (Trametinib)
param Type
MEDIAN
population Description
All patients who achieved an overall best response of Partial Response or Complete Response.
reporting Status
POSTED
time Frame
Up to 5 years
title
Duration of Response
type
SECONDARY
unit Of Measure
years

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

Preserved source evidence · Not medical advice