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NCT03257631 · FLOW

Participant flow

A Study of Pomalidomide Monotherapy for Children and Young Adults With Recurrent or Progressive Primary Brain Tumors · Source last updated 2024-04-16

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

groups
  1. description
    Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
    id
    FG000
    title
    Diffuse Intrinsic Pontine Glioma
  2. description
    Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
    id
    FG001
    title
    Ependymoma
  3. description
    Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
    id
    FG002
    title
    High-grade Glioma
  4. description
    Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
    id
    FG003
    title
    Medulloblastoma
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        9
      3. group Id
        FG002
        num Subjects
        17
      4. group Id
        FG003
        num Subjects
        8
      type
      Progressive Disease
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        1
      type
      Withdrawal by Parent/Guardian
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        0
      type
      Adverse Event
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        11
      2. group Id
        FG001
        num Subjects
        9
      3. group Id
        FG002
        num Subjects
        23
      4. group Id
        FG003
        num Subjects
        10
      comment
      The intent-to-treat population includes all enrolled participants, regardless of whether they received any treatment or not
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        11
      2. group Id
        FG001
        num Subjects
        9
      3. group Id
        FG002
        num Subjects
        22
      4. group Id
        FG003
        num Subjects
        10
      comment
      The safety population included all participants who received at least 1 dose of study drug
      type
      Received Study Drug
    3. achievements
      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
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        11
      2. group Id
        FG001
        num Subjects
        9
      3. group Id
        FG002
        num Subjects
        22
      4. group Id
        FG003
        num Subjects
        10
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
In stage 1 approximately 9 participants were to be enrolled in parallel to each group. If two or more participants in a group achieved an objective response or long-term stable disease within the first 6 cycles of treatment (within the first 3 cycles for DIPG) an additional 11 participants were to be enrolled in that group.
recruitment Details
The study consisted of 4 groups, for each of the following primary brain tumor types: diffuse intrinsic pontine glioma (DIPG), ependymoma, high-grade glioma, and medulloblastoma.
Complete source fields
groups
  1. description
    Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
    id
    FG000
    title
    Diffuse Intrinsic Pontine Glioma
  2. description
    Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
    id
    FG001
    title
    Ependymoma
  3. description
    Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
    id
    FG002
    title
    High-grade Glioma
  4. description
    Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
    id
    FG003
    title
    Medulloblastoma
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        9
      3. group Id
        FG002
        num Subjects
        17
      4. group Id
        FG003
        num Subjects
        8
      type
      Progressive Disease
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        1
      type
      Withdrawal by Parent/Guardian
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        0
      type
      Adverse Event
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        11
      2. group Id
        FG001
        num Subjects
        9
      3. group Id
        FG002
        num Subjects
        23
      4. group Id
        FG003
        num Subjects
        10
      comment
      The intent-to-treat population includes all enrolled participants, regardless of whether they received any treatment or not
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        11
      2. group Id
        FG001
        num Subjects
        9
      3. group Id
        FG002
        num Subjects
        22
      4. group Id
        FG003
        num Subjects
        10
      comment
      The safety population included all participants who received at least 1 dose of study drug
      type
      Received Study Drug
    3. achievements
      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
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        11
      2. group Id
        FG001
        num Subjects
        9
      3. group Id
        FG002
        num Subjects
        22
      4. group Id
        FG003
        num Subjects
        10
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
In stage 1 approximately 9 participants were to be enrolled in parallel to each group. If two or more participants in a group achieved an objective response or long-term stable disease within the first 6 cycles of treatment (within the first 3 cycles for DIPG) an additional 11 participants were to be enrolled in that group.
recruitment Details
The study consisted of 4 groups, for each of the following primary brain tumor types: diffuse intrinsic pontine glioma (DIPG), ependymoma, high-grade glioma, and medulloblastoma.

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Preserved source evidence · Not medical advice