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NCT04487106 · OUTCOME

Overall Survival

Azacitidine, Venetoclax, and Trametinib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia or Higher-Risk Myelodysplastic Syndrome · Source last updated 2025-04-22

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

Measure
MEDIAN
Unit
Months
Interval / dispersion
Full Range
Time frame
From the first day of treatment to time of death from any cause, assessed until study completion

What was measured

Overall survival is defined as the time from the first day of treatment to time of death from any cause.

Groups in this outcome

Cohort A (Newly Diagnosed AML Patients)

INDUCTION (CYCLE 1): Patients receive azacitidine IV over 30-60 minutes or SC on days 1-7, venetoclax PO QD on days 1-28, and trametinib PO QD on days 1-28 in the absence of disease progression or unacceptable toxicity. CONSOLIDATION (CYCLES 2-24): Patients receive azacitidine IV over 30-60 minutes or SC on days 1-7, venetoclax PO QD on days 1-21, and trametinib PO QD on days 1-28. Treatment repeats every 28 days for up to 23 cycles in the absence of disease progression or unacceptable toxicity. Azacitidine: Given IV or SC Trametinib: Given PO Venetoclax: Given PO

Cohort B (Relapsed/Refractory AML or Higher-risk MDS or CMML Patients)

INDUCTION (CYCLE 1): Patients receive azacitidine IV over 30-60 minutes or SC on days 1-7, venetoclax PO QD on days 1-28, and trametinib PO QD on days 1-28 in the absence of disease progression or unacceptable toxicity. CONSOLIDATION (CYCLES 2-24): Patients receive azacitidine IV over 30-60 minutes or SC on days 1-7, venetoclax PO QD on days 1-21, and trametinib PO QD on days 1-28. Treatment repeats every 28 days for up to 23 cycles in the absence of disease progression or unacceptable toxicity. Azacitidine: Given IV or SC Trametinib: Given PO Venetoclax: 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
Cohort A (Newly Diagnosed AML Patients)3
Cohort B (Relapsed/Refractory AML or Higher-risk MDS or CMML Patients)13

Reported measurements

Source class 1
Values in Months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Cohort A (Newly Diagnosed AML Patients)2.5Not reported0.536.4Not reported
Cohort B (Relapsed/Refractory AML or Higher-risk MDS or CMML Patients)2.4Not reported0.538.6Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.5
        upper Limit
        36.4
        value
        2.5
      2. group Id
        OG001
        lower Limit
        0.5
        upper Limit
        38.6
        value
        2.4
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      13
    units
    Participants
description
Overall survival is defined as the time from the first day of treatment to time of death from any cause.
dispersion Type
Full Range
groups
  1. description
    INDUCTION (CYCLE 1): Patients receive azacitidine IV over 30-60 minutes or SC on days 1-7, venetoclax PO QD on days 1-28, and trametinib PO QD on days 1-28 in the absence of disease progression or unacceptable toxicity. CONSOLIDATION (CYCLES 2-24): Patients receive azacitidine IV over 30-60 minutes or SC on days 1-7, venetoclax PO QD on days 1-21, and trametinib PO QD on days 1-28. Treatment repeats every 28 days for up to 23 cycles in the absence of disease progression or unacceptable toxicity. Azacitidine: Given IV or SC Trametinib: Given PO Venetoclax: Given PO
    id
    OG000
    title
    Cohort A (Newly Diagnosed AML Patients)
  2. description
    INDUCTION (CYCLE 1): Patients receive azacitidine IV over 30-60 minutes or SC on days 1-7, venetoclax PO QD on days 1-28, and trametinib PO QD on days 1-28 in the absence of disease progression or unacceptable toxicity. CONSOLIDATION (CYCLES 2-24): Patients receive azacitidine IV over 30-60 minutes or SC on days 1-7, venetoclax PO QD on days 1-21, and trametinib PO QD on days 1-28. Treatment repeats every 28 days for up to 23 cycles in the absence of disease progression or unacceptable toxicity. Azacitidine: Given IV or SC Trametinib: Given PO Venetoclax: Given PO
    id
    OG001
    title
    Cohort B (Relapsed/Refractory AML or Higher-risk MDS or CMML Patients)
param Type
MEDIAN
reporting Status
POSTED
time Frame
From the first day of treatment to time of death from any cause, assessed until study completion
title
Overall Survival
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice