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NCT02000427 · FLOW

Participant flow

Blinatumomab in Adults With Relapsed/Refractory Philadelphia Positive B-precursor Acute Lymphoblastic Leukemia · Source last updated 2024-05-28

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

groups
  1. description
    Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for 2 cycles. Participants who achieved a complete remission or complete remission with partial or incomplete hematologic recovery within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab. The initial dose was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 and for all subsequent cycles of treatment.
    id
    FG000
    title
    Blinatumomab
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        22
      type
      Death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        45
      type
      STARTED
    2. achievements
      1. comment
        Indicates participants ongoing in study as of the data cut-off date of 20 May 2015.
        group Id
        FG000
        num Subjects
        23
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        22
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Results are reported as of the data cut-off date of 20 May 2015.
recruitment Details
This study was conducted at 19 centers in 4 European countries and the United States: 3 centers in France, 3 in Germany, 5 in Italy, 1 in the United Kingdom, and 7 in the United States. The first participant enrolled on 03 January 2014 and the last participant enrolled on 12 January 2015.
Complete source fields
groups
  1. description
    Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for 2 cycles. Participants who achieved a complete remission or complete remission with partial or incomplete hematologic recovery within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab. The initial dose was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 and for all subsequent cycles of treatment.
    id
    FG000
    title
    Blinatumomab
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        22
      type
      Death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        45
      type
      STARTED
    2. achievements
      1. comment
        Indicates participants ongoing in study as of the data cut-off date of 20 May 2015.
        group Id
        FG000
        num Subjects
        23
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        22
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Results are reported as of the data cut-off date of 20 May 2015.
recruitment Details
This study was conducted at 19 centers in 4 European countries and the United States: 3 centers in France, 3 in Germany, 5 in Italy, 1 in the United Kingdom, and 7 in the United States. The first participant enrolled on 03 January 2014 and the last participant enrolled on 12 January 2015.

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Preserved source evidence · Not medical advice