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NCT01471782 · FLOW

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Clinical Study With Blinatumomab in Pediatric and Adolescent Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia · Source last updated 2017-02-08

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

groups
  1. description
    Dose Evaluation/Escalation: Blinatumomab was administered as a continuous intravenous (cIV) infusion at a constant daily flow rate of 5 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
    id
    FG000
    title
    Phase 1: Blinatumomab 5 µg/m²/Day
  2. description
    Dose Evaluation/Escalation: Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
    id
    FG001
    title
    Phase 1: Blinatumomab 15 µg/m²/Day
  3. description
    Dose Evaluation/Escalation: Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
    id
    FG002
    title
    Phase 1: Blinatumomab 30 µg/m²/Day
  4. description
    Dose Evaluation/Escalation: Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day for the first week of cycle 1 and then at 30 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 30 µg/m²/day for up to five cycles of treatment.
    id
    FG003
    title
    Phase 1: Blinatumomab 15/30 µg/m²/Day
  5. description
    PK Expansion: Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
    id
    FG004
    title
    Phase 1: Blinatumomab 5/15 µg/m²/Day
  6. description
    Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
    id
    FG005
    title
    Phase 2: Blinatumomab 5/15 µg/m²/Day
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        5
      6. group Id
        FG005
        num Subjects
        3
      type
      Hematopoietic Stem Cell Transplantation
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        5
      6. group Id
        FG005
        num Subjects
        18
      type
      Lack of Efficacy
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        1
      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
        1
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        6
      6. group Id
        FG005
        num Subjects
        5
      type
      Other
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        4
      type
      Change of Chemotherapy
    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
        1
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        1
      type
      Disease Relapse
    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
        3
      6. group Id
        FG005
        num Subjects
        8
      type
      Physician Decision
    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
        1
      6. group Id
        FG005
        num Subjects
        0
      type
      Withdrawal by Parent/Guardian
    9. 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
        0
      6. group Id
        FG005
        num Subjects
        1
      type
      Death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        26
      6. group Id
        FG005
        num Subjects
        44
      type
      STARTED
    2. achievements
      1. comment
        Completed 5 cycles
        group Id
        FG000
        num Subjects
        0
      2. comment
        Completed 5 cycles
        group Id
        FG001
        num Subjects
        1
      3. comment
        Completed 5 cycles
        group Id
        FG002
        num Subjects
        0
      4. comment
        Completed 5 cycles
        group Id
        FG003
        num Subjects
        1
      5. comment
        Completed 5 cycles
        group Id
        FG004
        num Subjects
        0
      6. comment
        Completed 5 cycles
        group Id
        FG005
        num Subjects
        3
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        5
      5. group Id
        FG004
        num Subjects
        26
      6. group Id
        FG005
        num Subjects
        41
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
The Phase 1 part of the study comprised 2 parts: * a dose evaluation/escalation part in patients aged 2 to 17 years to define the recommended phase 2 dose of blinatumomab (4 arms), * a pharmacokinetic (PK) expansion part in patients less than 18 years. The Phase 2 efficacy part enrolled patients at the recommended dose determined in phase 1.
recruitment Details
The study was conducted in 26 centers in Germany, France, Italy, the Netherlands, the United Kingdom, and the United States of America. Results are reported for the primary analysis with a data cut-off date of 12 January 2015.
Complete source fields
groups
  1. description
    Dose Evaluation/Escalation: Blinatumomab was administered as a continuous intravenous (cIV) infusion at a constant daily flow rate of 5 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
    id
    FG000
    title
    Phase 1: Blinatumomab 5 µg/m²/Day
  2. description
    Dose Evaluation/Escalation: Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
    id
    FG001
    title
    Phase 1: Blinatumomab 15 µg/m²/Day
  3. description
    Dose Evaluation/Escalation: Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
    id
    FG002
    title
    Phase 1: Blinatumomab 30 µg/m²/Day
  4. description
    Dose Evaluation/Escalation: Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day for the first week of cycle 1 and then at 30 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 30 µg/m²/day for up to five cycles of treatment.
    id
    FG003
    title
    Phase 1: Blinatumomab 15/30 µg/m²/Day
  5. description
    PK Expansion: Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
    id
    FG004
    title
    Phase 1: Blinatumomab 5/15 µg/m²/Day
  6. description
    Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
    id
    FG005
    title
    Phase 2: Blinatumomab 5/15 µg/m²/Day
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        5
      6. group Id
        FG005
        num Subjects
        3
      type
      Hematopoietic Stem Cell Transplantation
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        5
      6. group Id
        FG005
        num Subjects
        18
      type
      Lack of Efficacy
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        1
      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
        1
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        6
      6. group Id
        FG005
        num Subjects
        5
      type
      Other
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        4
      type
      Change of Chemotherapy
    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
        1
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        1
      type
      Disease Relapse
    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
        3
      6. group Id
        FG005
        num Subjects
        8
      type
      Physician Decision
    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
        1
      6. group Id
        FG005
        num Subjects
        0
      type
      Withdrawal by Parent/Guardian
    9. 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
        0
      6. group Id
        FG005
        num Subjects
        1
      type
      Death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        26
      6. group Id
        FG005
        num Subjects
        44
      type
      STARTED
    2. achievements
      1. comment
        Completed 5 cycles
        group Id
        FG000
        num Subjects
        0
      2. comment
        Completed 5 cycles
        group Id
        FG001
        num Subjects
        1
      3. comment
        Completed 5 cycles
        group Id
        FG002
        num Subjects
        0
      4. comment
        Completed 5 cycles
        group Id
        FG003
        num Subjects
        1
      5. comment
        Completed 5 cycles
        group Id
        FG004
        num Subjects
        0
      6. comment
        Completed 5 cycles
        group Id
        FG005
        num Subjects
        3
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        5
      5. group Id
        FG004
        num Subjects
        26
      6. group Id
        FG005
        num Subjects
        41
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
The Phase 1 part of the study comprised 2 parts: * a dose evaluation/escalation part in patients aged 2 to 17 years to define the recommended phase 2 dose of blinatumomab (4 arms), * a pharmacokinetic (PK) expansion part in patients less than 18 years. The Phase 2 efficacy part enrolled patients at the recommended dose determined in phase 1.
recruitment Details
The study was conducted in 26 centers in Germany, France, Italy, the Netherlands, the United Kingdom, and the United States of America. Results are reported for the primary analysis with a data cut-off date of 12 January 2015.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice