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NCT02435849 · OUTCOME

Pharmacokinetics (PK) Parameter: Tmax by qPCR in Peripheral Blood, by Day 28 Disease Response by IRC

Study of Efficacy and Safety of CTL019 in Pediatric ALL Patients · Source last updated 2024-02-13

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

Measure
MEDIAN
Unit
days
Interval / dispersion
Full Range
Time frame
60 months

What was measured

Tmax is the time to reach maximum (peak) peripheral blood drug concentration after single dose administration (days)", reported by CR/CRi, no response (NR), Unknown and by All participants. D28 refers to the timepoint for definition of responder populations, whereas M60 is the actual timepoint for endpoint assessment. The time frame of 60 months refers to the duration for which the data were reviewed to identify the time of Cmax for this measure.

Analysis population: PAS: The PAS consisted of patients in the FAS who had at least one sample providing evaluable cellular kinetic data for tisagenlecleucel.

Groups in this outcome

Main Cohort: Single Dose of CTL019

Pediatric patients with relapsed or refractory B-cell ALL who were treated with single dose of tisagenlecleucel (CTL019).

Cohort 1: Single Dose of CTL019

Pediatric B-ALL patients who are very high risk at first relapse.

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

Analysis denominator · Participants

GroupSource count
Main Cohort: Single Dose of CTL01975
Cohort 1: Single Dose of CTL0191

Reported measurements

CR/CRi

Analysis denominator · Participants

GroupSource count
Main Cohort: Single Dose of CTL01962
Cohort 1: Single Dose of CTL0191
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Main Cohort: Single Dose of CTL0199.87Not reported5.7027.8Not reported
Cohort 1: Single Dose of CTL0198.55Not reported8.558.55Not reported
NR

Analysis denominator · Participants

GroupSource count
Main Cohort: Single Dose of CTL0195
Cohort 1: Single Dose of CTL0190
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Main Cohort: Single Dose of CTL01920.9Not reported12.662.7Not reported
Unknown

Analysis denominator · Participants

GroupSource count
Main Cohort: Single Dose of CTL0198
Cohort 1: Single Dose of CTL0190
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Main Cohort: Single Dose of CTL01913.4Not reported8.7319.9Not reported
All Participants

Analysis denominator · Participants

GroupSource count
Main Cohort: Single Dose of CTL01975
Cohort 1: Single Dose of CTL0191
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Main Cohort: Single Dose of CTL0199.98Not reported5.7062.7Not reported
Cohort 1: Single Dose of CTL0198.55Not reported8.558.55Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.70
        upper Limit
        27.8
        value
        9.87
      2. group Id
        OG001
        lower Limit
        8.55
        upper Limit
        8.55
        value
        8.55
    denoms
    1. counts
      1. group Id
        OG000
        value
        62
      2. group Id
        OG001
        value
        1
      units
      Participants
    title
    CR/CRi
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        12.6
        upper Limit
        62.7
        value
        20.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    NR
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8.73
        upper Limit
        19.9
        value
        13.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    Unknown
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.70
        upper Limit
        62.7
        value
        9.98
      2. group Id
        OG001
        lower Limit
        8.55
        upper Limit
        8.55
        value
        8.55
    denoms
    1. counts
      1. group Id
        OG000
        value
        75
      2. group Id
        OG001
        value
        1
      units
      Participants
    title
    All Participants
denoms
  1. counts
    1. group Id
      OG000
      value
      75
    2. group Id
      OG001
      value
      1
    units
    Participants
description
Tmax is the time to reach maximum (peak) peripheral blood drug concentration after single dose administration (days)", reported by CR/CRi, no response (NR), Unknown and by All participants. D28 refers to the timepoint for definition of responder populations, whereas M60 is the actual timepoint for endpoint assessment. The time frame of 60 months refers to the duration for which the data were reviewed to identify the time of Cmax for this measure.
dispersion Type
Full Range
groups
  1. description
    Pediatric patients with relapsed or refractory B-cell ALL who were treated with single dose of tisagenlecleucel (CTL019).
    id
    OG000
    title
    Main Cohort: Single Dose of CTL019
  2. description
    Pediatric B-ALL patients who are very high risk at first relapse.
    id
    OG001
    title
    Cohort 1: Single Dose of CTL019
param Type
MEDIAN
population Description
PAS: The PAS consisted of patients in the FAS who had at least one sample providing evaluable cellular kinetic data for tisagenlecleucel.
reporting Status
POSTED
time Frame
60 months
title
Pharmacokinetics (PK) Parameter: Tmax by qPCR in Peripheral Blood, by Day 28 Disease Response by IRC
type
SECONDARY
unit Of Measure
days

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

Preserved source evidence · Not medical advice