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NCT00313586 · FLOW

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Azacitidine With or Without Entinostat in Treating Patients With Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Acute Myeloid Leukemia · Source last updated 2017-02-02

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

groups
  1. description
    Non-treatment-induced patients receive azacitidine (50 mg/m2) subcutaneously once daily on days 1-10 in a 28-day cycle.
    id
    FG000
    title
    Arm A (Azacitidine; Non-treatment-induced Cohort)
  2. description
    Non-treatment-induced patients receive azacitidine as in arm A and oral entinostat (4 mg/m2) on days 3 and 10 of each 28-day cycle.
    id
    FG001
    title
    Arm B (Azacitidine + Entinostat; Non-treatment-induced Cohort)
  3. description
    Treatment-induced patients receive azacitidine (50 mg/m2) subcutaneously once daily on days 1-10 in a 28-day cycle.
    id
    FG002
    title
    Arm A (Azacitidine; Treatment-induced Cohort)
  4. description
    Treatment-induced patients receive azacitidine as in arm A and oral entinostat (4 mg/m2) on days 3 and 10 of each 28-day cycle.
    id
    FG003
    title
    Arm B (Azacitidine + Entinostat; Treatment-induced Cohort)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        14
      2. group Id
        FG001
        num Subjects
        19
      3. group Id
        FG002
        num Subjects
        10
      4. group Id
        FG003
        num Subjects
        3
      type
      Disease progression
    2. reasons
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        18
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        10
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        11
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        7
      type
      Death
    4. reasons
      1. group Id
        FG000
        num Subjects
        13
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        2
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        0
      type
      Alternative therapy
    6. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Other complicating disease
    7. reasons
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        1
      type
      Did not achieve HI-major/better response
    8. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Physician Decision
    9. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Absolute neutrophil count not recovered
    10. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Lost insurance
    11. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Moved
    12. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Death before starting treatment
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        75
      2. group Id
        FG001
        num Subjects
        75
      3. group Id
        FG002
        num Subjects
        24
      4. group Id
        FG003
        num Subjects
        23
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        74
      2. group Id
        FG001
        num Subjects
        75
      3. group Id
        FG002
        num Subjects
        24
      4. group Id
        FG003
        num Subjects
        23
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        70
      2. group Id
        FG001
        num Subjects
        70
      3. group Id
        FG002
        num Subjects
        24
      4. group Id
        FG003
        num Subjects
        23
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
Participants were recruited from ECOG member institutions between August 18, 2006 and April 29, 2011. One hundred and fifty non-treatment-induced patients and forty-seven treatment-induced patients were enrolled.
Complete source fields
groups
  1. description
    Non-treatment-induced patients receive azacitidine (50 mg/m2) subcutaneously once daily on days 1-10 in a 28-day cycle.
    id
    FG000
    title
    Arm A (Azacitidine; Non-treatment-induced Cohort)
  2. description
    Non-treatment-induced patients receive azacitidine as in arm A and oral entinostat (4 mg/m2) on days 3 and 10 of each 28-day cycle.
    id
    FG001
    title
    Arm B (Azacitidine + Entinostat; Non-treatment-induced Cohort)
  3. description
    Treatment-induced patients receive azacitidine (50 mg/m2) subcutaneously once daily on days 1-10 in a 28-day cycle.
    id
    FG002
    title
    Arm A (Azacitidine; Treatment-induced Cohort)
  4. description
    Treatment-induced patients receive azacitidine as in arm A and oral entinostat (4 mg/m2) on days 3 and 10 of each 28-day cycle.
    id
    FG003
    title
    Arm B (Azacitidine + Entinostat; Treatment-induced Cohort)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        14
      2. group Id
        FG001
        num Subjects
        19
      3. group Id
        FG002
        num Subjects
        10
      4. group Id
        FG003
        num Subjects
        3
      type
      Disease progression
    2. reasons
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        18
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        10
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        11
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        7
      type
      Death
    4. reasons
      1. group Id
        FG000
        num Subjects
        13
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        2
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        0
      type
      Alternative therapy
    6. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Other complicating disease
    7. reasons
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        1
      type
      Did not achieve HI-major/better response
    8. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Physician Decision
    9. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Absolute neutrophil count not recovered
    10. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Lost insurance
    11. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Moved
    12. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Death before starting treatment
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        75
      2. group Id
        FG001
        num Subjects
        75
      3. group Id
        FG002
        num Subjects
        24
      4. group Id
        FG003
        num Subjects
        23
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        74
      2. group Id
        FG001
        num Subjects
        75
      3. group Id
        FG002
        num Subjects
        24
      4. group Id
        FG003
        num Subjects
        23
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        70
      2. group Id
        FG001
        num Subjects
        70
      3. group Id
        FG002
        num Subjects
        24
      4. group Id
        FG003
        num Subjects
        23
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
Participants were recruited from ECOG member institutions between August 18, 2006 and April 29, 2011. One hundred and fifty non-treatment-induced patients and forty-seven treatment-induced patients were enrolled.

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

Preserved source evidence · Not medical advice