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NCT02435849 · OUTCOME

Persistence of Tisagenlecleucel (CTL019) in Blood, Bone Marrow and CSF if Available, by qPCR, by Day 28 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

Persistence is defined as the time corresponding to last quantifiable transgene level in peripheral blood (Tlast), 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.

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 CTL01976
Cohort 1: Single Dose of CTL0191

Reported measurements

Tlast 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 CTL019232Not reported19.81860Not reported
Cohort 1: Single Dose of CTL01989.7Not reported89.789.7Not reported
Tlast NR

Analysis denominator · Participants

GroupSource count
Main Cohort: Single Dose of CTL0196
Cohort 1: Single Dose of CTL0190
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Main Cohort: Single Dose of CTL01948.5Not reported13.9888Not reported
Tlast 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 CTL019220Not reported64.01460Not reported
Tlast All Participants

Analysis denominator · Participants

GroupSource count
Main Cohort: Single Dose of CTL01976
Cohort 1: Single Dose of CTL0191
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Main Cohort: Single Dose of CTL019179Not reported13.91860Not reported
Cohort 1: Single Dose of CTL01989.7Not reported89.789.7Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        19.8
        upper Limit
        1860
        value
        232
      2. group Id
        OG001
        lower Limit
        89.7
        upper Limit
        89.7
        value
        89.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        62
      2. group Id
        OG001
        value
        1
      units
      Participants
    title
    Tlast CR/CRi
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        13.9
        upper Limit
        888
        value
        48.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    Tlast NR
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        64.0
        upper Limit
        1460
        value
        220
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    Tlast Unknown
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        13.9
        upper Limit
        1860
        value
        179
      2. group Id
        OG001
        lower Limit
        89.7
        upper Limit
        89.7
        value
        89.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        76
      2. group Id
        OG001
        value
        1
      units
      Participants
    title
    Tlast All Participants
denoms
  1. counts
    1. group Id
      OG000
      value
      76
    2. group Id
      OG001
      value
      1
    units
    Participants
description
Persistence is defined as the time corresponding to last quantifiable transgene level in peripheral blood (Tlast), 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.
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
Persistence of Tisagenlecleucel (CTL019) in Blood, Bone Marrow and CSF if Available, by qPCR, by Day 28 Response by IRC
type
SECONDARY
unit Of Measure
days

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

Preserved source evidence · Not medical advice