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NCT03190915 · OUTCOME

Complete 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
NUMBER
Unit
Percentage of patients
Interval / dispersion
95% Confidence Interval
Time frame
12 cycles (1 cycle = 28 days)

What was measured

Complete Response rates will be calculated as the percent of evaluable patients who had an overall best response of Complete Response, and confidence intervals will be constructed accounting for the two-stage design.

Analysis population: All patients who met the evaluable for response criteria outlined in section 9.4 of the ADVL1521 protocol.

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)10

Reported measurements

Source class 1
Values in Percentage of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment (Trametinib)0.0Not reported0.030.8Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        30.8
        value
        0.0
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    units
    Participants
description
Complete Response rates will be calculated as the percent of evaluable patients who had an overall best response of Complete Response, and confidence intervals will be constructed accounting for the two-stage design.
dispersion Type
95% Confidence Interval
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
NUMBER
population Description
All patients who met the evaluable for response criteria outlined in section 9.4 of the ADVL1521 protocol.
reporting Status
POSTED
time Frame
12 cycles (1 cycle = 28 days)
title
Complete Response
type
SECONDARY
unit Of Measure
Percentage of patients

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

Preserved source evidence · Not medical advice