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NCT03069352 · OUTCOME

Percentage of Participants With Complete Remission or Complete Remission With Partial Hematologic Recovery (CR + CRh) by Mutation Subgroup

A Study of Venetoclax in Combination With Low Dose Cytarabine Versus Low Dose Cytarabine Alone in Treatment Naive Patients With Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy · Source last updated 2025-09-30

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
Response was assessed at the end of Cycle 1 and every 3 cycles thereafter to the end of treatment. Median treatment duration at the 15 February 2019 cut-off date was 1.7 months (range: 0.1-14.2) and 3.9 months (range: 0.0-17.1) in each group respectively.

What was measured

The percentage of participants who achieved a complete remission or complete remission with partial hematologic recovery assessed by the investigator for participants with the following mutations: * Isocitrate dehydrogenase 1 and 2 (IDH1/2) mutation * FMS-like tyrosine kinase 3 (FLT3) mutation CR is defined according to the modified IWG criteria for AML as no morphologic evidence of AML, ANC ≥ 10³/μL, platelets ≥ 10⁵/μL, RBC transfusion independence, bone marrow with \< 5% blasts, absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease. CRh is achieved when the following criteria are met: * Bone marrow with \< 5% blasts and * Peripheral blood neutrophil count \> 0.5 × 10³/μL and * Peripheral blood platelet count \> 0.5 × 10⁵/μL and * A 1 week platelet transfusion-free period prior to hematology lab collection. Participants with no disease assessments were considered non-responders

Analysis population: Full analysis set participants in each mutation subgroup

Groups in this outcome

Placebo + Low Dose Cytarabine (LDAC)

Participants received matching placebo to venetoclax orally once a day (QD) plus cytarabine 20 mg/m² subcutaneously on Days 1 to 10 of each 28-day cycle.

Venetoclax + Low Dose Cytarabine (LDAC)

Participants received venetoclax 600 mg orally once a day plus cytarabine 20 mg/m² subcutaneously on Days 1 to 10 of each 28-day cycle.

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

Analysis denominator · Participants

GroupSource count
Placebo + Low Dose Cytarabine (LDAC)68
Venetoclax + Low Dose Cytarabine (LDAC)143

Reported measurements

IDH1/2 mutation

Analysis denominator · Participants

GroupSource count
Placebo + Low Dose Cytarabine (LDAC)12
Venetoclax + Low Dose Cytarabine (LDAC)21
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo + Low Dose Cytarabine (LDAC)33.3Not reportedNot reportedNot reportedNot reported
Venetoclax + Low Dose Cytarabine (LDAC)57.1Not reportedNot reportedNot reportedNot reported
FLT3 mutation

Analysis denominator · Participants

GroupSource count
Placebo + Low Dose Cytarabine (LDAC)9
Venetoclax + Low Dose Cytarabine (LDAC)20
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo + Low Dose Cytarabine (LDAC)44.4Not reportedNot reportedNot reportedNot reported
Venetoclax + Low Dose Cytarabine (LDAC)45.0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        33.3
      2. group Id
        OG001
        value
        57.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        21
      units
      Participants
    title
    IDH1/2 mutation
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        44.4
      2. group Id
        OG001
        value
        45.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        20
      units
      Participants
    title
    FLT3 mutation
denoms
  1. counts
    1. group Id
      OG000
      value
      68
    2. group Id
      OG001
      value
      143
    units
    Participants
description
The percentage of participants who achieved a complete remission or complete remission with partial hematologic recovery assessed by the investigator for participants with the following mutations: * Isocitrate dehydrogenase 1 and 2 (IDH1/2) mutation * FMS-like tyrosine kinase 3 (FLT3) mutation CR is defined according to the modified IWG criteria for AML as no morphologic evidence of AML, ANC ≥ 10³/μL, platelets ≥ 10⁵/μL, RBC transfusion independence, bone marrow with \< 5% blasts, absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease. CRh is achieved when the following criteria are met: * Bone marrow with \< 5% blasts and * Peripheral blood neutrophil count \> 0.5 × 10³/μL and * Peripheral blood platelet count \> 0.5 × 10⁵/μL and * A 1 week platelet transfusion-free period prior to hematology lab collection. Participants with no disease assessments were considered non-responders
groups
  1. description
    Participants received matching placebo to venetoclax orally once a day (QD) plus cytarabine 20 mg/m² subcutaneously on Days 1 to 10 of each 28-day cycle.
    id
    OG000
    title
    Placebo + Low Dose Cytarabine (LDAC)
  2. description
    Participants received venetoclax 600 mg orally once a day plus cytarabine 20 mg/m² subcutaneously on Days 1 to 10 of each 28-day cycle.
    id
    OG001
    title
    Venetoclax + Low Dose Cytarabine (LDAC)
param Type
NUMBER
population Description
Full analysis set participants in each mutation subgroup
reporting Status
POSTED
time Frame
Response was assessed at the end of Cycle 1 and every 3 cycles thereafter to the end of treatment. Median treatment duration at the 15 February 2019 cut-off date was 1.7 months (range: 0.1-14.2) and 3.9 months (range: 0.0-17.1) in each group respectively.
title
Percentage of Participants With Complete Remission or Complete Remission With Partial Hematologic Recovery (CR + CRh) by Mutation Subgroup
type
SECONDARY
unit Of Measure
percentage of participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice