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NCT04145531 · FLOW

Participant flow

An Open-Label Study of JZP-458 (RC-P) in Patients With Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LBL) · Source last updated 2023-11-18

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

groups
  1. description
    Participants who received an intramuscular (IM) dose of JZP-458 25 mg/m\^2 on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks based on available data from the Phase 1 (JZP458-101) healthy volunteer study.
    id
    FG000
    title
    Part A: JZP-458 IM 25 mg/m^2 (MWF)
  2. description
    Participants who received an intramuscular (IM) dose of JZP-458 37.5 mg/m\^2 on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.
    id
    FG001
    title
    Part A: JZP-458 IM 37.5 mg/m^2 (MWF)
  3. description
    Participants who received an intramuscular (IM) dose of JZP-458 25 mg/m\^2 on Mondays and Wednesdays and 50 mg/m\^2 on Fridays on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.
    id
    FG002
    title
    Part A: JZP-458 IM 25 (MW)/50 mg/m^2 (F)
  4. description
    Participants who received an intravenous (IV) dose of JZP-458 25 mg/m\^2 on Mondays and Wednesdays and 50 mg/m\^2 on Fridays on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.
    id
    FG003
    title
    Part B: JZP-458 IV 25 (MW)/50 mg/m^2 (F)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        12
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        0
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        0
      type
      Physician Decision
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      type
      Progressive disease
    5. 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
        0
      type
      Protocol deviation
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Withdrawal by parent or guardian
    7. 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
        0
      type
      Withdrawal by participant
    8. 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
        0
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        33
      2. group Id
        FG001
        num Subjects
        83
      3. group Id
        FG002
        num Subjects
        51
      4. group Id
        FG003
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        33
      2. group Id
        FG001
        num Subjects
        83
      3. group Id
        FG002
        num Subjects
        51
      4. group Id
        FG003
        num Subjects
        0
      type
      Safety Analysis Set
    3. achievements
      1. group Id
        FG000
        num Subjects
        32
      2. group Id
        FG001
        num Subjects
        83
      3. group Id
        FG002
        num Subjects
        50
      4. group Id
        FG003
        num Subjects
        0
      type
      Efficacy Analysis Set
    4. achievements
      1. group Id
        FG000
        num Subjects
        27
      2. group Id
        FG001
        num Subjects
        62
      3. group Id
        FG002
        num Subjects
        39
      4. group Id
        FG003
        num Subjects
        0
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        21
      3. group Id
        FG002
        num Subjects
        12
      4. group Id
        FG003
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Part A
  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
        21
      type
      Adverse Event
    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
        7
      type
      Physician Decision
    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
        1
      type
      Progressive disease
    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
        1
      type
      Recurrent disease
    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
        3
      type
      Withdrawal by parent or guardian
    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
      type
      Withdrawal by participant
    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
        1
      type
      Other
    milestones
    1. 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
        62
      type
      STARTED
    2. 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
        61
      type
      Safety Analysis Set
    3. 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
        59
      type
      Efficacy Analysis Set
    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
        27
      type
      COMPLETED
    5. 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
        35
      type
      NOT COMPLETED
    title
    Part B
recruitment Details
A total of 229 participants who met all inclusion and no exclusion criteria were enrolled in the study. One participant did not receive treatment; 228 participants were included in the Safety Analysis Set and 224 participants were included in the Efficacy Analysis Set. The data presented are based on the final database cut (22 November 2022).
Complete source fields
groups
  1. description
    Participants who received an intramuscular (IM) dose of JZP-458 25 mg/m\^2 on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks based on available data from the Phase 1 (JZP458-101) healthy volunteer study.
    id
    FG000
    title
    Part A: JZP-458 IM 25 mg/m^2 (MWF)
  2. description
    Participants who received an intramuscular (IM) dose of JZP-458 37.5 mg/m\^2 on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.
    id
    FG001
    title
    Part A: JZP-458 IM 37.5 mg/m^2 (MWF)
  3. description
    Participants who received an intramuscular (IM) dose of JZP-458 25 mg/m\^2 on Mondays and Wednesdays and 50 mg/m\^2 on Fridays on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.
    id
    FG002
    title
    Part A: JZP-458 IM 25 (MW)/50 mg/m^2 (F)
  4. description
    Participants who received an intravenous (IV) dose of JZP-458 25 mg/m\^2 on Mondays and Wednesdays and 50 mg/m\^2 on Fridays on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.
    id
    FG003
    title
    Part B: JZP-458 IV 25 (MW)/50 mg/m^2 (F)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        12
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        0
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        0
      type
      Physician Decision
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      type
      Progressive disease
    5. 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
        0
      type
      Protocol deviation
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Withdrawal by parent or guardian
    7. 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
        0
      type
      Withdrawal by participant
    8. 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
        0
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        33
      2. group Id
        FG001
        num Subjects
        83
      3. group Id
        FG002
        num Subjects
        51
      4. group Id
        FG003
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        33
      2. group Id
        FG001
        num Subjects
        83
      3. group Id
        FG002
        num Subjects
        51
      4. group Id
        FG003
        num Subjects
        0
      type
      Safety Analysis Set
    3. achievements
      1. group Id
        FG000
        num Subjects
        32
      2. group Id
        FG001
        num Subjects
        83
      3. group Id
        FG002
        num Subjects
        50
      4. group Id
        FG003
        num Subjects
        0
      type
      Efficacy Analysis Set
    4. achievements
      1. group Id
        FG000
        num Subjects
        27
      2. group Id
        FG001
        num Subjects
        62
      3. group Id
        FG002
        num Subjects
        39
      4. group Id
        FG003
        num Subjects
        0
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        21
      3. group Id
        FG002
        num Subjects
        12
      4. group Id
        FG003
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Part A
  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
        21
      type
      Adverse Event
    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
        7
      type
      Physician Decision
    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
        1
      type
      Progressive disease
    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
        1
      type
      Recurrent disease
    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
        3
      type
      Withdrawal by parent or guardian
    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
      type
      Withdrawal by participant
    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
        1
      type
      Other
    milestones
    1. 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
        62
      type
      STARTED
    2. 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
        61
      type
      Safety Analysis Set
    3. 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
        59
      type
      Efficacy Analysis Set
    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
        27
      type
      COMPLETED
    5. 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
        35
      type
      NOT COMPLETED
    title
    Part B
recruitment Details
A total of 229 participants who met all inclusion and no exclusion criteria were enrolled in the study. One participant did not receive treatment; 228 participants were included in the Safety Analysis Set and 224 participants were included in the Efficacy Analysis Set. The data presented are based on the final database cut (22 November 2022).

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

Preserved source evidence · Not medical advice