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NCT02669017 · FLOW

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Study of ADCT-402 in Patients With Relapsed or Refractory B-cell Lineage Non Hodgkin Lymphoma (B-NHL) · Source last updated 2021-05-19

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

groups
  1. description
    Participants received an intravenous (IV) infusion of ADCT-402 (15 μg/kg) on Day 1 of each 3 week cycle (Q3W).
    id
    FG000
    title
    Part 1: 15 μg/kg Q3W
  2. description
    Participants received an intravenous (IV) infusion of ADCT-402 (30 μg/kg) on Day 1 of each 3 week cycle (Q3W).
    id
    FG001
    title
    Part 1: 30 μg/kg Q3W
  3. description
    Participants received an intravenous (IV) infusion of ADCT-402 (60 μg/kg) on Day 1 of each 3 week cycle (Q3W).
    id
    FG002
    title
    Part 1: 60 μg/kg Q3W
  4. description
    Participants received an intravenous (IV) infusion of ADCT-402 (90 μg/kg) on Day 1 of each 3 week cycle (Q3W).
    id
    FG003
    title
    Part 1: 90 μg/kg Q3W
  5. description
    Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W).
    id
    FG004
    title
    Part 1: 120 μg/kg Q3W
  6. description
    Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W).
    id
    FG005
    title
    Part 2: 120 μg/kg Q3W
  7. description
    Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W).
    id
    FG006
    title
    Part 1: 150 μg/kg Q3W
  8. description
    Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W).
    id
    FG007
    title
    Part 2: 150 μg/kg Q3W
  9. description
    Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 3 week cycle (Q3W). Following protocol amendment 5, treatment cycle length was increased to 6 weeks (Q6W).
    id
    FG008
    title
    Part 1: 200 μg/kg Q3W and Q6W
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        8
      6. group Id
        FG005
        num Subjects
        18
      7. group Id
        FG006
        num Subjects
        10
      8. group Id
        FG007
        num Subjects
        47
      9. group Id
        FG008
        num Subjects
        20
      type
      Death
    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
        1
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        2
      9. group Id
        FG008
        num Subjects
        2
      type
      Withdrawal by Subject
    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
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        1
      type
      Lost to Follow-up
    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
        2
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        13
      9. group Id
        FG008
        num Subjects
        2
      type
      Miscellaneous
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        5
      5. group Id
        FG004
        num Subjects
        16
      6. group Id
        FG005
        num Subjects
        26
      7. group Id
        FG006
        num Subjects
        19
      8. group Id
        FG007
        num Subjects
        69
      9. group Id
        FG008
        num Subjects
        36
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        4
      6. group Id
        FG005
        num Subjects
        7
      7. group Id
        FG006
        num Subjects
        8
      8. group Id
        FG007
        num Subjects
        7
      9. group Id
        FG008
        num Subjects
        11
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        4
      5. group Id
        FG004
        num Subjects
        12
      6. group Id
        FG005
        num Subjects
        19
      7. group Id
        FG006
        num Subjects
        11
      8. group Id
        FG007
        num Subjects
        62
      9. group Id
        FG008
        num Subjects
        25
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Participants were screened at 11 sites in 3 countries.
Complete source fields
groups
  1. description
    Participants received an intravenous (IV) infusion of ADCT-402 (15 μg/kg) on Day 1 of each 3 week cycle (Q3W).
    id
    FG000
    title
    Part 1: 15 μg/kg Q3W
  2. description
    Participants received an intravenous (IV) infusion of ADCT-402 (30 μg/kg) on Day 1 of each 3 week cycle (Q3W).
    id
    FG001
    title
    Part 1: 30 μg/kg Q3W
  3. description
    Participants received an intravenous (IV) infusion of ADCT-402 (60 μg/kg) on Day 1 of each 3 week cycle (Q3W).
    id
    FG002
    title
    Part 1: 60 μg/kg Q3W
  4. description
    Participants received an intravenous (IV) infusion of ADCT-402 (90 μg/kg) on Day 1 of each 3 week cycle (Q3W).
    id
    FG003
    title
    Part 1: 90 μg/kg Q3W
  5. description
    Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W).
    id
    FG004
    title
    Part 1: 120 μg/kg Q3W
  6. description
    Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W).
    id
    FG005
    title
    Part 2: 120 μg/kg Q3W
  7. description
    Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W).
    id
    FG006
    title
    Part 1: 150 μg/kg Q3W
  8. description
    Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W).
    id
    FG007
    title
    Part 2: 150 μg/kg Q3W
  9. description
    Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 3 week cycle (Q3W). Following protocol amendment 5, treatment cycle length was increased to 6 weeks (Q6W).
    id
    FG008
    title
    Part 1: 200 μg/kg Q3W and Q6W
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        8
      6. group Id
        FG005
        num Subjects
        18
      7. group Id
        FG006
        num Subjects
        10
      8. group Id
        FG007
        num Subjects
        47
      9. group Id
        FG008
        num Subjects
        20
      type
      Death
    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
        1
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        2
      9. group Id
        FG008
        num Subjects
        2
      type
      Withdrawal by Subject
    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
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        1
      type
      Lost to Follow-up
    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
        2
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        13
      9. group Id
        FG008
        num Subjects
        2
      type
      Miscellaneous
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        5
      5. group Id
        FG004
        num Subjects
        16
      6. group Id
        FG005
        num Subjects
        26
      7. group Id
        FG006
        num Subjects
        19
      8. group Id
        FG007
        num Subjects
        69
      9. group Id
        FG008
        num Subjects
        36
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        4
      6. group Id
        FG005
        num Subjects
        7
      7. group Id
        FG006
        num Subjects
        8
      8. group Id
        FG007
        num Subjects
        7
      9. group Id
        FG008
        num Subjects
        11
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        4
      5. group Id
        FG004
        num Subjects
        12
      6. group Id
        FG005
        num Subjects
        19
      7. group Id
        FG006
        num Subjects
        11
      8. group Id
        FG007
        num Subjects
        62
      9. group Id
        FG008
        num Subjects
        25
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Participants were screened at 11 sites in 3 countries.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice