NCT03190915 · OUTCOME

Mutant Allele Burden

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: MEAN
Unit: Percent Change In Mutant Allele Burden
Interval / dispersion: Standard Deviation
Time frame: Up to cycle 12 (1 cycle = 28 days)

What was measured

Will be measured by next-generation sequencing. The percent change in mutant allele burden will be analyzed descriptively. Values will be summarized with means and standard deviations.

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

Group	Source count
Treatment (Trametinib)	10

Reported measurements

Source class 1

Values in Percent Change In Mutant Allele Burden · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment (Trametinib)	0.0	0	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
0
value
0.0

denoms

counts
group Id
OG000
value
10
units
Participants

description

Will be measured by next-generation sequencing. The percent change in mutant allele burden will be analyzed descriptively. Values will be summarized with means and standard deviations.

dispersion Type

Standard Deviation

groups

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

MEAN

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

Up to cycle 12 (1 cycle = 28 days)

title

Mutant Allele Burden

type

SECONDARY

unit Of Measure

Percent Change In Mutant Allele Burden

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

Preserved source evidence · Not medical advice