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NCT03257631 · OUTCOME

Duration of Response (DoR)

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.

Measure
MEDIAN
Unit
weeks
Interval / dispersion
95% Confidence Interval
Time frame
From the first dose of pomalidomide to the date of the first documented tumor progression or death due to any cause, whichever occurs first (Up to 71 months)

What was measured

DoR is defined as the time from the date of the first objective response (complete response \[CR\] or partial response \[PR\]) to disease progression. Participants who did not have disease progression or had not died were censored at the time of their last disease assessment or at the time of start of new anticancer therapy, whichever occurred first. Progressive disease (PD): ≥ 25% increase in the size of the measurable lesions taking as a reference the smallest disease measurement recorded since the start of protocol therapy (nadir), or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions, or if spine MRI and/or lumbar cerebrospinal fluid (CSF) cytology were previously negative and became positive. CR: Disappearance of all lesions and no new lesions. PR: A reduction of ≥ 50% in the size of measurable lesions compared to baseline, and/or the persistence of non-target lesions with no progression or decrease in size.

Analysis population: All enrolled participants with response (PR or CR), regardless of whether they received any treatment or not

Groups in this outcome

Diffuse Intrinsic Pontine Glioma

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.

Ependymoma

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.

High-grade Glioma

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.

Medulloblastoma

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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Diffuse Intrinsic Pontine Glioma1
Ependymoma0
High-grade Glioma1
Medulloblastoma0

Reported measurements

Source class 1
Values in weeks · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Diffuse Intrinsic Pontine Glioma12.29Not reportedNANA95% CI was not estimable due to insufficient number of events
High-grade GliomaNANot reportedNANAMedian and 95% CI were not estimable due to insufficient number of events
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        95% CI was not estimable due to insufficient number of events
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        12.29
      2. comment
        Median and 95% CI were not estimable due to insufficient number of events
        group Id
        OG002
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      1
    4. group Id
      OG003
      value
      0
    units
    Participants
description
DoR is defined as the time from the date of the first objective response (complete response \[CR\] or partial response \[PR\]) to disease progression. Participants who did not have disease progression or had not died were censored at the time of their last disease assessment or at the time of start of new anticancer therapy, whichever occurred first. Progressive disease (PD): ≥ 25% increase in the size of the measurable lesions taking as a reference the smallest disease measurement recorded since the start of protocol therapy (nadir), or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions, or if spine MRI and/or lumbar cerebrospinal fluid (CSF) cytology were previously negative and became positive. CR: Disappearance of all lesions and no new lesions. PR: A reduction of ≥ 50% in the size of measurable lesions compared to baseline, and/or the persistence of non-target lesions with no progression or decrease in size.
dispersion Type
95% Confidence Interval
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
    OG000
    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
    OG001
    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
    OG002
    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
    OG003
    title
    Medulloblastoma
param Type
MEDIAN
population Description
All enrolled participants with response (PR or CR), regardless of whether they received any treatment or not
reporting Status
POSTED
time Frame
From the first dose of pomalidomide to the date of the first documented tumor progression or death due to any cause, whichever occurs first (Up to 71 months)
title
Duration of Response (DoR)
type
SECONDARY
unit Of Measure
weeks

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Preserved source evidence · Not medical advice