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NCT02421939 · FLOW

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A Study of ASP2215 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase (FLT3) Mutation · Source last updated 2025-12-04

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

groups
  1. description
    Participants received 120 mg dose (3 tablets of 40 mg) orally once a day in continuous 28-day cycles, at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants met one of the treatment discontinuation criteria. After the end of treatment period, participants were allowed to enter long-term follow up period for up to 3 years for collection of subsequent AML treatment, EuroQol Group-5 Dimension-5 Level Instrument (EQ-5D-5L), remission status and survival (cause of death and date of death). Participants continuing to derive clinical benefit from gilteritinib as assessed by the investigator were allowed to continue the study treatment until a discontinuation criterion was met or if they had completed more than 3 years of treatment.
    id
    FG000
    title
    Gilteritinib
  2. description
    Participants received chemotherapy in 28-day cycles. Participants on Low-Dose Cytarabine (LoDAC) received 20 mg of cytarabine twice daily by subcutaneous (SC) or intravenous (IV) injection for 10 days. Participants on azacitidine received 75 mg/m\^2 daily by SC or IV injection for 7 days. Participants on LoDAC or azacitidine treatment continued until they met discontinuation criteria. Participants on mitoxantrone, etoposide and intermediate-dose cytarabine (MEC) chemotherapy received mitoxantrone 8 mg/m\^2 daily by IV for 5 days, etoposide 100 mg/m\^2 daily by IV for 5 days and cytarabine 1000 mg/m\^2 daily by IV for 5 days (days 1-5). Participants on fludarabine, cytarabine and granulocyte colony-stimulating factor with idarubicin (FLAG-IDA) chemotherapy received granulocyte-colony stimulating factor (G-CSF) 300 μg/m\^2 daily by SC/IV for 5 days (days 1-5), fludarabine 30 mg/m\^2 daily by IV for 5 days (days 2-6), cytarabine 2000 mg/m\^2 daily by IV for 5 days (days 2-6) and idarubicin 10 mg/m\^2 daily by IV for 3 days (days 2-4). Participants receiving MEC or FLAG-IDA received 1 cycle of therapy and were assessed for response on or after day 15. After the end of treatment period, participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death).
    id
    FG001
    title
    Salvage Chemotherapy
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        76
      2. group Id
        FG001
        num Subjects
        16
      type
      Progressive disease
    2. reasons
      1. group Id
        FG000
        num Subjects
        21
      2. group Id
        FG001
        num Subjects
        31
      type
      Lack of Efficacy
    3. reasons
      1. group Id
        FG000
        num Subjects
        38
      2. group Id
        FG001
        num Subjects
        10
      type
      Death
    4. reasons
      1. group Id
        FG000
        num Subjects
        37
      2. group Id
        FG001
        num Subjects
        2
      type
      Disease relapse
    5. reasons
      1. group Id
        FG000
        num Subjects
        32
      2. group Id
        FG001
        num Subjects
        5
      type
      Adverse Event
    6. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        24
      type
      Withdrawal by Subject
    7. reasons
      1. group Id
        FG000
        num Subjects
        13
      2. group Id
        FG001
        num Subjects
        11
      type
      Physician Decision
    8. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      type
      Protocol deviation
    9. reasons
      1. group Id
        FG000
        num Subjects
        20
      2. group Id
        FG001
        num Subjects
        5
      type
      Miscellaneous
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        247
      2. group Id
        FG001
        num Subjects
        124
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        246
      2. group Id
        FG001
        num Subjects
        109
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        19
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        247
      2. group Id
        FG001
        num Subjects
        105
      type
      NOT COMPLETED
    title
    Randomization Period: Up to 3 Years
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        5
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        118
      2. group Id
        FG001
        num Subjects
        65
      type
      Death
    4. reasons
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        1
      type
      Miscellaneous
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        133
      2. group Id
        FG001
        num Subjects
        73
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        133
      2. group Id
        FG001
        num Subjects
        73
      type
      NOT COMPLETED
    title
    Long Term Follow up: up to 3 Years
pre Assignment Details
Participants entered the screening period up to 14 days prior to the start of treatment. Prior to randomization, the investigator preselected a salvage chemotherapy for each participant. The randomization was stratified by response to first-line AML therapy and preselected salvage chemotherapy. Treatment was given over continuous 28-day cycles.
recruitment Details
Participants were recruited from approximately 140 centers in North America, Europe, Asia and the rest of the world and randomized in a 2:1 ratio to receive gilteritinib or salvage chemotherapy. Participants had FMS-like tyrosine kinase 3 (FLT3) mutations and relapsed or refractory acute myeloid leukemia (AML) after first-line therapy.
Complete source fields
groups
  1. description
    Participants received 120 mg dose (3 tablets of 40 mg) orally once a day in continuous 28-day cycles, at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants met one of the treatment discontinuation criteria. After the end of treatment period, participants were allowed to enter long-term follow up period for up to 3 years for collection of subsequent AML treatment, EuroQol Group-5 Dimension-5 Level Instrument (EQ-5D-5L), remission status and survival (cause of death and date of death). Participants continuing to derive clinical benefit from gilteritinib as assessed by the investigator were allowed to continue the study treatment until a discontinuation criterion was met or if they had completed more than 3 years of treatment.
    id
    FG000
    title
    Gilteritinib
  2. description
    Participants received chemotherapy in 28-day cycles. Participants on Low-Dose Cytarabine (LoDAC) received 20 mg of cytarabine twice daily by subcutaneous (SC) or intravenous (IV) injection for 10 days. Participants on azacitidine received 75 mg/m\^2 daily by SC or IV injection for 7 days. Participants on LoDAC or azacitidine treatment continued until they met discontinuation criteria. Participants on mitoxantrone, etoposide and intermediate-dose cytarabine (MEC) chemotherapy received mitoxantrone 8 mg/m\^2 daily by IV for 5 days, etoposide 100 mg/m\^2 daily by IV for 5 days and cytarabine 1000 mg/m\^2 daily by IV for 5 days (days 1-5). Participants on fludarabine, cytarabine and granulocyte colony-stimulating factor with idarubicin (FLAG-IDA) chemotherapy received granulocyte-colony stimulating factor (G-CSF) 300 μg/m\^2 daily by SC/IV for 5 days (days 1-5), fludarabine 30 mg/m\^2 daily by IV for 5 days (days 2-6), cytarabine 2000 mg/m\^2 daily by IV for 5 days (days 2-6) and idarubicin 10 mg/m\^2 daily by IV for 3 days (days 2-4). Participants receiving MEC or FLAG-IDA received 1 cycle of therapy and were assessed for response on or after day 15. After the end of treatment period, participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death).
    id
    FG001
    title
    Salvage Chemotherapy
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        76
      2. group Id
        FG001
        num Subjects
        16
      type
      Progressive disease
    2. reasons
      1. group Id
        FG000
        num Subjects
        21
      2. group Id
        FG001
        num Subjects
        31
      type
      Lack of Efficacy
    3. reasons
      1. group Id
        FG000
        num Subjects
        38
      2. group Id
        FG001
        num Subjects
        10
      type
      Death
    4. reasons
      1. group Id
        FG000
        num Subjects
        37
      2. group Id
        FG001
        num Subjects
        2
      type
      Disease relapse
    5. reasons
      1. group Id
        FG000
        num Subjects
        32
      2. group Id
        FG001
        num Subjects
        5
      type
      Adverse Event
    6. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        24
      type
      Withdrawal by Subject
    7. reasons
      1. group Id
        FG000
        num Subjects
        13
      2. group Id
        FG001
        num Subjects
        11
      type
      Physician Decision
    8. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      type
      Protocol deviation
    9. reasons
      1. group Id
        FG000
        num Subjects
        20
      2. group Id
        FG001
        num Subjects
        5
      type
      Miscellaneous
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        247
      2. group Id
        FG001
        num Subjects
        124
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        246
      2. group Id
        FG001
        num Subjects
        109
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        19
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        247
      2. group Id
        FG001
        num Subjects
        105
      type
      NOT COMPLETED
    title
    Randomization Period: Up to 3 Years
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        5
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        118
      2. group Id
        FG001
        num Subjects
        65
      type
      Death
    4. reasons
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        1
      type
      Miscellaneous
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        133
      2. group Id
        FG001
        num Subjects
        73
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        133
      2. group Id
        FG001
        num Subjects
        73
      type
      NOT COMPLETED
    title
    Long Term Follow up: up to 3 Years
pre Assignment Details
Participants entered the screening period up to 14 days prior to the start of treatment. Prior to randomization, the investigator preselected a salvage chemotherapy for each participant. The randomization was stratified by response to first-line AML therapy and preselected salvage chemotherapy. Treatment was given over continuous 28-day cycles.
recruitment Details
Participants were recruited from approximately 140 centers in North America, Europe, Asia and the rest of the world and randomized in a 2:1 ratio to receive gilteritinib or salvage chemotherapy. Participants had FMS-like tyrosine kinase 3 (FLT3) mutations and relapsed or refractory acute myeloid leukemia (AML) after first-line therapy.

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Preserved source evidence · Not medical advice