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NCT03069352 · FLOW

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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.

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. Participants continued treatment until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation were met.
    id
    FG000
    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. Participants continued treatment until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation were met.
    id
    FG001
    title
    Venetoclax + Low Dose Cytarabine (LDAC)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        40
      type
      Ongoing
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        68
      2. group Id
        FG001
        num Subjects
        143
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        68
      2. group Id
        FG001
        num Subjects
        142
      type
      Received Treatment
    3. achievements
      1. group Id
        FG000
        num Subjects
        56
      2. group Id
        FG001
        num Subjects
        103
      comment
      As of 15 August 2019
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        40
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Participants with acute myeloid leukemia (AML) were randomized to one of two treatment arms in a 1:2 ratio (placebo + low-dose cytarabine \[LDAC\] or venetoclax + LDAC). Randomization was stratified by AML status (secondary, de novo), age (18 - \< 75, ≥ 75) and region (United States \[US\], European Union \[EU\], China, Japan, rest of world).
recruitment Details
Participants were enrolled at 76 sites globally. The study is currently ongoing; the results reported below include the primary analysis for efficacy which was conducted after 133 deaths occurred (data cut-off date of 15 February 2019), and an unplanned 6-month follow-up update for overall survival and safety (15 August 2019 cut-off date).
Complete source fields
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. Participants continued treatment until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation were met.
    id
    FG000
    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. Participants continued treatment until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation were met.
    id
    FG001
    title
    Venetoclax + Low Dose Cytarabine (LDAC)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        40
      type
      Ongoing
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        68
      2. group Id
        FG001
        num Subjects
        143
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        68
      2. group Id
        FG001
        num Subjects
        142
      type
      Received Treatment
    3. achievements
      1. group Id
        FG000
        num Subjects
        56
      2. group Id
        FG001
        num Subjects
        103
      comment
      As of 15 August 2019
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        40
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Participants with acute myeloid leukemia (AML) were randomized to one of two treatment arms in a 1:2 ratio (placebo + low-dose cytarabine \[LDAC\] or venetoclax + LDAC). Randomization was stratified by AML status (secondary, de novo), age (18 - \< 75, ≥ 75) and region (United States \[US\], European Union \[EU\], China, Japan, rest of world).
recruitment Details
Participants were enrolled at 76 sites globally. The study is currently ongoing; the results reported below include the primary analysis for efficacy which was conducted after 133 deaths occurred (data cut-off date of 15 February 2019), and an unplanned 6-month follow-up update for overall survival and safety (15 August 2019 cut-off date).

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Preserved source evidence · Not medical advice