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NCT03069352 · OUTCOME

Percentage of Participants With Complete Remission or Complete Remission With Incomplete Blood Count Recovery (CR + CRi) by Initiation of Cycle 2

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
95% Confidence Interval
Time frame
Cycle 1, 28 days

What was measured

The composite complete remission rate is defined as the percentage of participants with complete remission (CR) or complete remission with incomplete blood count recovery (CRi) before initiation of Cycle 2, assessed by the investigator. Response was based on physical examination, bone marrow results and hematology values according to the revised guidelines by the IWG for AML: CR: No morphologic evidence of AML and absolute neutrophil count ≥ 10³/μL, platelets ≥ 10⁵/μL, red cell transfusion independence, and bone marrow with \< 5% blasts, absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease. CRi: All criteria as CR except for residual neutropenia \< 10³/μL or thrombocytopenia \< 10⁵/μL. If all criteria for CR are met except for RBC transfusion independence, CRi criteria are met. Participants who had no IWG disease assessments were considered to be non-responders.

Analysis population: Full analysis set

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

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Placebo + Low Dose Cytarabine (LDAC)2.9Not reported0.410.2Not reported
Venetoclax + Low Dose Cytarabine (LDAC)34.3Not reported26.542.7Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.001
    statistical Comment
    Cochran-Mantel-Haenszel test stratified by age (18 - \< 75, ≥ 75) and AML status (de novo, secondary).
    statistical Method
    Cochran-Mantel-Haenszel
  2. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.001
    statistical Method
    Fisher Exact
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.001
    statistical Comment
    Cochran-Mantel-Haenszel test stratified by age (18 - \< 75, ≥ 75) and AML status (de novo, secondary).
    statistical Method
    Cochran-Mantel-Haenszel
  2. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.001
    statistical Method
    Fisher Exact
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.4
        upper Limit
        10.2
        value
        2.9
      2. group Id
        OG001
        lower Limit
        26.5
        upper Limit
        42.7
        value
        34.3
denoms
  1. counts
    1. group Id
      OG000
      value
      68
    2. group Id
      OG001
      value
      143
    units
    Participants
description
The composite complete remission rate is defined as the percentage of participants with complete remission (CR) or complete remission with incomplete blood count recovery (CRi) before initiation of Cycle 2, assessed by the investigator. Response was based on physical examination, bone marrow results and hematology values according to the revised guidelines by the IWG for AML: CR: No morphologic evidence of AML and absolute neutrophil count ≥ 10³/μL, platelets ≥ 10⁵/μL, red cell transfusion independence, and bone marrow with \< 5% blasts, absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease. CRi: All criteria as CR except for residual neutropenia \< 10³/μL or thrombocytopenia \< 10⁵/μL. If all criteria for CR are met except for RBC transfusion independence, CRi criteria are met. Participants who had no IWG disease assessments were considered to be non-responders.
dispersion Type
95% Confidence Interval
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
reporting Status
POSTED
time Frame
Cycle 1, 28 days
title
Percentage of Participants With Complete Remission or Complete Remission With Incomplete Blood Count Recovery (CR + CRi) by Initiation of Cycle 2
type
SECONDARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice