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NCT02435849 · OUTCOME

Expression of Tisagenlecleucel (CTL019) Detected by Flow Cytometry in Peripheral Blood by Day 28 Disease Response Per IRC Assessment

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
GEOMETRIC_MEAN
Unit
Percentage of CD3+/CTL019+ cells
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Month 60

What was measured

This is the summary cellular kinetic concentrations for CTL019 by flow cytometry in peripheral blood. It evaluated the persistence of transduced CTL019 cells post-infusion. Observation was up to Month 60 for peripheral blood.

Analysis population: PAS: The PAS consisted of patients in the FAS who had at least one sample providing evaluable cellular kinetic data for tisagenlecleucel parameter under investigation. Analysis of this particular outcome included a subset of PAS who had evaluation data of the parameter at the specific timepoint. Therefore, no participants in Cohort 1 had at least one blood sample providing evaluable cellular kinetic data for tisagenlecleucel at tis 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 CTL01917
Cohort 1: Single Dose of CTL0190

Reported measurements

Source class 1
Values in Percentage of CD3+/CTL019+ cells · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Main Cohort: Single Dose of CTL0190.25367.4Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        67.4
        value
        0.253
denoms
  1. counts
    1. group Id
      OG000
      value
      17
    2. group Id
      OG001
      value
      0
    units
    Participants
description
This is the summary cellular kinetic concentrations for CTL019 by flow cytometry in peripheral blood. It evaluated the persistence of transduced CTL019 cells post-infusion. Observation was up to Month 60 for peripheral blood.
dispersion Type
Geometric Coefficient of Variation
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
GEOMETRIC_MEAN
population Description
PAS: The PAS consisted of patients in the FAS who had at least one sample providing evaluable cellular kinetic data for tisagenlecleucel parameter under investigation. Analysis of this particular outcome included a subset of PAS who had evaluation data of the parameter at the specific timepoint. Therefore, no participants in Cohort 1 had at least one blood sample providing evaluable cellular kinetic data for tisagenlecleucel at tis time point, so no data was collected for Cohort 1.
reporting Status
POSTED
time Frame
Month 60
title
Expression of Tisagenlecleucel (CTL019) Detected by Flow Cytometry in Peripheral Blood by Day 28 Disease Response Per IRC Assessment
type
SECONDARY
unit Of Measure
Percentage of CD3+/CTL019+ cells

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

Preserved source evidence · Not medical advice