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NCT00211185 · FLOW

Participant flow

A Study of ONTAK and CHOP in Newly Diagnosed, Peripheral T-Cell Lymphoma · Source last updated 2020-03-18

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

groups
  1. description
    Unblinded denileukin diftitox at 18 micrograms/kilogram/day (ug/kg/d) was administered intravenously (IV) on Days 1 and 2 of each 21-day cycle. Cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) was administered on Day 3 of each 21-day cycle. On Day 4 of each 21-day cycle, pegfilgrastim (a granulocyte colony-stimulating factor (G-CSF)) was started as a prophylaxis to prevent neutropenia. After completion of two 21-day cycles, participants were evaluated for clinical response. Two 21-day cycles with denileukin and CHOP were repeated followed by response evaluations after each set of two 21-day cycles with intent to treat for 6 cycles, with a maximum of 8 cycles.
    id
    FG000
    title
    Denileukin Diftitox in Combination With CHOP
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        7
      type
      Disease progression
    3. reasons
      1. group Id
        FG000
        num Subjects
        6
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        5
      type
      Physician Decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        49
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        29
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        20
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
groups
  1. description
    Unblinded denileukin diftitox at 18 micrograms/kilogram/day (ug/kg/d) was administered intravenously (IV) on Days 1 and 2 of each 21-day cycle. Cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) was administered on Day 3 of each 21-day cycle. On Day 4 of each 21-day cycle, pegfilgrastim (a granulocyte colony-stimulating factor (G-CSF)) was started as a prophylaxis to prevent neutropenia. After completion of two 21-day cycles, participants were evaluated for clinical response. Two 21-day cycles with denileukin and CHOP were repeated followed by response evaluations after each set of two 21-day cycles with intent to treat for 6 cycles, with a maximum of 8 cycles.
    id
    FG000
    title
    Denileukin Diftitox in Combination With CHOP
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        7
      type
      Disease progression
    3. reasons
      1. group Id
        FG000
        num Subjects
        6
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        5
      type
      Physician Decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        49
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        29
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        20
      type
      NOT COMPLETED
    title
    Overall Study

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Preserved source evidence · Not medical advice