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NCT02003222 · FLOW

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Combination Chemotherapy With or Without Blinatumomab in Treating Patients With Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia · Source last updated 2026-08-04

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

groups
  1. description
    MRD negative patients received induction treatment and intensification treatment and then were randomized to receive blinatumomab plus chemotherapy.
    id
    FG000
    title
    MRD Negative - Blinatumomab + Chemotherapy
  2. description
    MRD negative patients received induction treatment and intensification treatment and then were randomized to receive chemotherapy.
    id
    FG001
    title
    MRD Negative - Chemotherapy
  3. description
    MRD positive patients received induction treatment and intensification treatment and then were randomized or assigned to receive blinatumomab plus chemotherapy.
    id
    FG002
    title
    MRD Positive - Blinatumomab + Chemotherapy
  4. description
    MRD positive patients received induction treatment and intensification treatment and then were randomized to receive chemotherapy.
    id
    FG003
    title
    MRD Positive - Chemotherapy
  5. description
    Patients were registered to receive induction treatment and intensification treatment but did not enter the randomization part of the study.
    id
    FG004
    title
    No Randomization/Registration
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        8
      type
      Never started treatment
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        67
      type
      Complete remission or complete remission incomplete not achieved
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        13
      type
      Adverse Event
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        12
      type
      Alternative therapy
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        22
      type
      Disease progression
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        3
      type
      Death
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        8
      type
      Withdrawal by Subject
    8. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        22
      type
      Other reasons
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        112
      2. group Id
        FG001
        num Subjects
        112
      3. group Id
        FG002
        num Subjects
        40
      4. group Id
        FG003
        num Subjects
        22
      5. group Id
        FG004
        num Subjects
        202
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        112
      2. group Id
        FG001
        num Subjects
        112
      3. group Id
        FG002
        num Subjects
        40
      4. group Id
        FG003
        num Subjects
        22
      5. group Id
        FG004
        num Subjects
        193
      type
      Received Treatment and Adverse Event Assessment Available
    3. achievements
      1. group Id
        FG000
        num Subjects
        112
      2. group Id
        FG001
        num Subjects
        112
      3. group Id
        FG002
        num Subjects
        40
      4. group Id
        FG003
        num Subjects
        22
      5. group Id
        FG004
        num Subjects
        47
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        155
      type
      NOT COMPLETED
    title
    Induction
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        2
      type
      Never started treatment
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        6
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        8
      type
      Alternative therapy
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        18
      type
      Disease progression
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        5
      type
      Withdrawal by Subject
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        8
      type
      Other reasons
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        112
      2. group Id
        FG001
        num Subjects
        112
      3. group Id
        FG002
        num Subjects
        40
      4. group Id
        FG003
        num Subjects
        22
      5. group Id
        FG004
        num Subjects
        47
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        112
      2. group Id
        FG001
        num Subjects
        112
      3. group Id
        FG002
        num Subjects
        40
      4. group Id
        FG003
        num Subjects
        22
      5. group Id
        FG004
        num Subjects
        30
      type
      Received Treatment and Adverse Event Assessment Available
    3. achievements
      1. group Id
        FG000
        num Subjects
        112
      2. group Id
        FG001
        num Subjects
        112
      3. group Id
        FG002
        num Subjects
        40
      4. group Id
        FG003
        num Subjects
        22
      5. group Id
        FG004
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        47
      type
      NOT COMPLETED
    title
    Intensification
  3. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        112
      2. group Id
        FG001
        num Subjects
        112
      3. group Id
        FG002
        num Subjects
        40
      4. group Id
        FG003
        num Subjects
        22
      5. group Id
        FG004
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        111
      2. group Id
        FG001
        num Subjects
        110
      3. group Id
        FG002
        num Subjects
        35
      4. group Id
        FG003
        num Subjects
        16
      5. group Id
        FG004
        num Subjects
        0
      type
      Received Treatment and Adverse Event Assessment Available
    3. achievements
      1. group Id
        FG000
        num Subjects
        112
      2. group Id
        FG001
        num Subjects
        112
      3. group Id
        FG002
        num Subjects
        40
      4. group Id
        FG003
        num Subjects
        22
      5. group Id
        FG004
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Randomization/Registration
  4. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        67
      2. group Id
        FG001
        num Subjects
        69
      3. group Id
        FG002
        num Subjects
        13
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        66
      2. group Id
        FG001
        num Subjects
        68
      3. group Id
        FG002
        num Subjects
        12
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        0
      type
      Received Treatment and Adverse Event Assessment Available
    3. achievements
      1. group Id
        FG000
        num Subjects
        67
      2. group Id
        FG001
        num Subjects
        69
      3. group Id
        FG002
        num Subjects
        13
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Maintenance
recruitment Details
This study was activated on December 17, 2013 and closed to accrual on October 15, 2019 after enrolling a total of 488 patients.
Complete source fields
groups
  1. description
    MRD negative patients received induction treatment and intensification treatment and then were randomized to receive blinatumomab plus chemotherapy.
    id
    FG000
    title
    MRD Negative - Blinatumomab + Chemotherapy
  2. description
    MRD negative patients received induction treatment and intensification treatment and then were randomized to receive chemotherapy.
    id
    FG001
    title
    MRD Negative - Chemotherapy
  3. description
    MRD positive patients received induction treatment and intensification treatment and then were randomized or assigned to receive blinatumomab plus chemotherapy.
    id
    FG002
    title
    MRD Positive - Blinatumomab + Chemotherapy
  4. description
    MRD positive patients received induction treatment and intensification treatment and then were randomized to receive chemotherapy.
    id
    FG003
    title
    MRD Positive - Chemotherapy
  5. description
    Patients were registered to receive induction treatment and intensification treatment but did not enter the randomization part of the study.
    id
    FG004
    title
    No Randomization/Registration
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        8
      type
      Never started treatment
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        67
      type
      Complete remission or complete remission incomplete not achieved
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        13
      type
      Adverse Event
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        12
      type
      Alternative therapy
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        22
      type
      Disease progression
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        3
      type
      Death
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        8
      type
      Withdrawal by Subject
    8. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        22
      type
      Other reasons
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        112
      2. group Id
        FG001
        num Subjects
        112
      3. group Id
        FG002
        num Subjects
        40
      4. group Id
        FG003
        num Subjects
        22
      5. group Id
        FG004
        num Subjects
        202
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        112
      2. group Id
        FG001
        num Subjects
        112
      3. group Id
        FG002
        num Subjects
        40
      4. group Id
        FG003
        num Subjects
        22
      5. group Id
        FG004
        num Subjects
        193
      type
      Received Treatment and Adverse Event Assessment Available
    3. achievements
      1. group Id
        FG000
        num Subjects
        112
      2. group Id
        FG001
        num Subjects
        112
      3. group Id
        FG002
        num Subjects
        40
      4. group Id
        FG003
        num Subjects
        22
      5. group Id
        FG004
        num Subjects
        47
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        155
      type
      NOT COMPLETED
    title
    Induction
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        2
      type
      Never started treatment
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        6
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        8
      type
      Alternative therapy
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        18
      type
      Disease progression
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        5
      type
      Withdrawal by Subject
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        8
      type
      Other reasons
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        112
      2. group Id
        FG001
        num Subjects
        112
      3. group Id
        FG002
        num Subjects
        40
      4. group Id
        FG003
        num Subjects
        22
      5. group Id
        FG004
        num Subjects
        47
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        112
      2. group Id
        FG001
        num Subjects
        112
      3. group Id
        FG002
        num Subjects
        40
      4. group Id
        FG003
        num Subjects
        22
      5. group Id
        FG004
        num Subjects
        30
      type
      Received Treatment and Adverse Event Assessment Available
    3. achievements
      1. group Id
        FG000
        num Subjects
        112
      2. group Id
        FG001
        num Subjects
        112
      3. group Id
        FG002
        num Subjects
        40
      4. group Id
        FG003
        num Subjects
        22
      5. group Id
        FG004
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        47
      type
      NOT COMPLETED
    title
    Intensification
  3. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        112
      2. group Id
        FG001
        num Subjects
        112
      3. group Id
        FG002
        num Subjects
        40
      4. group Id
        FG003
        num Subjects
        22
      5. group Id
        FG004
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        111
      2. group Id
        FG001
        num Subjects
        110
      3. group Id
        FG002
        num Subjects
        35
      4. group Id
        FG003
        num Subjects
        16
      5. group Id
        FG004
        num Subjects
        0
      type
      Received Treatment and Adverse Event Assessment Available
    3. achievements
      1. group Id
        FG000
        num Subjects
        112
      2. group Id
        FG001
        num Subjects
        112
      3. group Id
        FG002
        num Subjects
        40
      4. group Id
        FG003
        num Subjects
        22
      5. group Id
        FG004
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Randomization/Registration
  4. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        67
      2. group Id
        FG001
        num Subjects
        69
      3. group Id
        FG002
        num Subjects
        13
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        66
      2. group Id
        FG001
        num Subjects
        68
      3. group Id
        FG002
        num Subjects
        12
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        0
      type
      Received Treatment and Adverse Event Assessment Available
    3. achievements
      1. group Id
        FG000
        num Subjects
        67
      2. group Id
        FG001
        num Subjects
        69
      3. group Id
        FG002
        num Subjects
        13
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Maintenance
recruitment Details
This study was activated on December 17, 2013 and closed to accrual on October 15, 2019 after enrolling a total of 488 patients.

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Preserved source evidence · Not medical advice