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NCT03268954 · FLOW

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Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine as First-Line Treatment for Participants With Higher-Risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML), or Low-Blast Acute Myelogenous Leukemia (AML) · Source last updated 2025-10-29

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

groups
  1. description
    Participants were administered azacitidine 75 milligram per square meter (mg/m\^2) intravenous (IV) or subcutaneous (SC) injection on Days 1 to 5, Days 8 and 9, in 28-day treatment cycles until disease progression or unacceptable toxicity or up to a maximum of 63 cycles.
    id
    FG000
    title
    Azacitidine 75 mg/m^2
  2. description
    Participants were administered azacitidine 75 mg/m\^2 IV or SC injection on Days 1 to 5, Days 8 and 9 and pevonedistat 20 mg/m\^2 IV infusion, on Days 1, 3, and 5 in 28-day treatment cycles until disease progression or unacceptable toxicity or up to a maximum of 63 cycles.
    id
    FG001
    title
    Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        27
      2. group Id
        FG001
        num Subjects
        17
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        3
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        8
      type
      Reason Not Specified
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        227
      2. group Id
        FG001
        num Subjects
        227
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        220
      2. group Id
        FG001
        num Subjects
        223
      comment
      Safety Population included all enrolled participants who received at least 1 dose of azacitidine alone or pevonedistat + azacitidine.
      type
      Safety Population
    3. achievements
      1. group Id
        FG000
        num Subjects
        195
      2. group Id
        FG001
        num Subjects
        199
      comment
      Participants were considered to have completed the study if they were followed until death or until the sponsor terminated the study.
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        32
      2. group Id
        FG001
        num Subjects
        28
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Participants diagnosed with myelomonocytic, and myelogenous leukemia were randomized into two groups in 1:1 ratio to receive single-agent azacitidine or azacitidine + pevonedistat.
recruitment Details
Participants took part in the study at 130 investigative sites globally from 28 November 2017 to 14 October 2024.
Complete source fields
groups
  1. description
    Participants were administered azacitidine 75 milligram per square meter (mg/m\^2) intravenous (IV) or subcutaneous (SC) injection on Days 1 to 5, Days 8 and 9, in 28-day treatment cycles until disease progression or unacceptable toxicity or up to a maximum of 63 cycles.
    id
    FG000
    title
    Azacitidine 75 mg/m^2
  2. description
    Participants were administered azacitidine 75 mg/m\^2 IV or SC injection on Days 1 to 5, Days 8 and 9 and pevonedistat 20 mg/m\^2 IV infusion, on Days 1, 3, and 5 in 28-day treatment cycles until disease progression or unacceptable toxicity or up to a maximum of 63 cycles.
    id
    FG001
    title
    Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        27
      2. group Id
        FG001
        num Subjects
        17
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        3
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        8
      type
      Reason Not Specified
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        227
      2. group Id
        FG001
        num Subjects
        227
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        220
      2. group Id
        FG001
        num Subjects
        223
      comment
      Safety Population included all enrolled participants who received at least 1 dose of azacitidine alone or pevonedistat + azacitidine.
      type
      Safety Population
    3. achievements
      1. group Id
        FG000
        num Subjects
        195
      2. group Id
        FG001
        num Subjects
        199
      comment
      Participants were considered to have completed the study if they were followed until death or until the sponsor terminated the study.
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        32
      2. group Id
        FG001
        num Subjects
        28
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Participants diagnosed with myelomonocytic, and myelogenous leukemia were randomized into two groups in 1:1 ratio to receive single-agent azacitidine or azacitidine + pevonedistat.
recruitment Details
Participants took part in the study at 130 investigative sites globally from 28 November 2017 to 14 October 2024.

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Preserved source evidence · Not medical advice