Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02435849 · OUTCOME

Prevalence and Incidence of Immunogenicity to Tisagenlecleucel (CTL019)

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
At any time post-baseline, up to a max. of 60 months

What was measured

This is defined as the percentage of participants who tested positive for anti-mCAR19 antibodies at any time post-baseline, reported by CR/CRi, no response (NR), Unknown and by All participants. .

Analysis population: Safety Set: The Safety set comprised all patients who received tisagenlecleucel infusion in the Main Cohort. No participants in Cohort 1 had immunogenicity data providing evaluable cellular kinetic data for tisagenlecleucel at this time point, so no data was collected for Cohort 1.

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 CTL01979
Cohort 1: Single Dose of CTL0190

Reported measurements

CR/CRi positive

Analysis denominator · Participants

GroupSource count
Main Cohort: Single Dose of CTL01962
Cohort 1: Single Dose of CTL0190
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Cohort: Single Dose of CTL01961Not reportedNot reportedNot reportedNot reported
NR positive

Analysis denominator · Participants

GroupSource count
Main Cohort: Single Dose of CTL0196
Cohort 1: Single Dose of CTL0190
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Cohort: Single Dose of CTL0196Not reportedNot reportedNot reportedNot reported
Unknown positive

Analysis denominator · Participants

GroupSource count
Main Cohort: Single Dose of CTL01911
Cohort 1: Single Dose of CTL0190
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Cohort: Single Dose of CTL01911Not reportedNot reportedNot reportedNot reported
All Patients positive

Analysis denominator · Participants

GroupSource count
Main Cohort: Single Dose of CTL01979
Cohort 1: Single Dose of CTL0190
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Cohort: Single Dose of CTL01978Not reportedNot reportedNot reportedNot reported
Complete source fields
calculate Pct
false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        61
    denoms
    1. counts
      1. group Id
        OG000
        value
        62
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    CR/CRi positive
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        6
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    NR positive
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        11
    denoms
    1. counts
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    Unknown positive
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        78
    denoms
    1. counts
      1. group Id
        OG000
        value
        79
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    All Patients positive
denoms
  1. counts
    1. group Id
      OG000
      value
      79
    2. group Id
      OG001
      value
      0
    units
    Participants
description
This is defined as the percentage of participants who tested positive for anti-mCAR19 antibodies at any time post-baseline, reported by CR/CRi, no response (NR), Unknown and by All participants. .
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
COUNT_OF_PARTICIPANTS
population Description
Safety Set: The Safety set comprised all patients who received tisagenlecleucel infusion in the Main Cohort. No participants in Cohort 1 had immunogenicity data providing evaluable cellular kinetic data for tisagenlecleucel at this time point, so no data was collected for Cohort 1.
reporting Status
POSTED
time Frame
At any time post-baseline, up to a max. of 60 months
title
Prevalence and Incidence of Immunogenicity to Tisagenlecleucel (CTL019)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice