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NCT01522976 · FLOW

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Azacitidine With or Without Lenalidomide or Vorinostat in Treating Patients With Higher-Risk Myelodysplastic Syndromes or Chronic Myelomonocytic Leukemia · Source last updated 2026-09-09

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

groups
  1. description
    Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Lenalidomide: Given PO
    id
    FG000
    title
    Arm 1: Azacitidine/Lenalidomide
  2. description
    Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV
    id
    FG001
    title
    Arm 2: Azacitidine
  3. description
    Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Vorinostat: Given PO
    id
    FG002
    title
    Arm 3: Azacitidine/Vorinostat
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Ineligible
    2. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        2
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        9
      3. group Id
        FG002
        num Subjects
        6
      type
      Still on treatment
    4. reasons
      1. group Id
        FG000
        num Subjects
        28
      2. group Id
        FG001
        num Subjects
        30
      3. group Id
        FG002
        num Subjects
        25
      type
      Disease progression
    5. reasons
      1. group Id
        FG000
        num Subjects
        17
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        18
      type
      Adverse Event
    6. reasons
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        13
      3. group Id
        FG002
        num Subjects
        14
      type
      Refusal unrelated to adverse event
    7. reasons
      1. group Id
        FG000
        num Subjects
        22
      2. group Id
        FG001
        num Subjects
        27
      3. group Id
        FG002
        num Subjects
        27
      type
      Not protocol specified
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        97
      2. group Id
        FG001
        num Subjects
        92
      3. group Id
        FG002
        num Subjects
        93
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        97
      2. group Id
        FG001
        num Subjects
        92
      3. group Id
        FG002
        num Subjects
        93
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
groups
  1. description
    Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Lenalidomide: Given PO
    id
    FG000
    title
    Arm 1: Azacitidine/Lenalidomide
  2. description
    Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV
    id
    FG001
    title
    Arm 2: Azacitidine
  3. description
    Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Vorinostat: Given PO
    id
    FG002
    title
    Arm 3: Azacitidine/Vorinostat
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Ineligible
    2. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        2
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        9
      3. group Id
        FG002
        num Subjects
        6
      type
      Still on treatment
    4. reasons
      1. group Id
        FG000
        num Subjects
        28
      2. group Id
        FG001
        num Subjects
        30
      3. group Id
        FG002
        num Subjects
        25
      type
      Disease progression
    5. reasons
      1. group Id
        FG000
        num Subjects
        17
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        18
      type
      Adverse Event
    6. reasons
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        13
      3. group Id
        FG002
        num Subjects
        14
      type
      Refusal unrelated to adverse event
    7. reasons
      1. group Id
        FG000
        num Subjects
        22
      2. group Id
        FG001
        num Subjects
        27
      3. group Id
        FG002
        num Subjects
        27
      type
      Not protocol specified
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        97
      2. group Id
        FG001
        num Subjects
        92
      3. group Id
        FG002
        num Subjects
        93
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        97
      2. group Id
        FG001
        num Subjects
        92
      3. group Id
        FG002
        num Subjects
        93
      type
      NOT COMPLETED
    title
    Overall Study

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Preserved source evidence · Not medical advice