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NCT02435849 · OUTCOME

Bone Marrow MRD Status by Flow Cytometry 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
NUMBER
Unit
Percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
28 days

What was measured

Percentage of participants who achieved CR or CRi response with bone marrow MRD negative (MRD \< 0.01%) after tisagenlecleucel infusion by flow cytometry.

Analysis population: FAS: The Full analysis set comprised all patients who received infusion of 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 CTL01979
Cohort 1: Single Dose of CTL0191

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Main Cohort: Single Dose of CTL01975.9Not reported65.084.9Not reported
Cohort 1: Single Dose of CTL019100.0Not reportedNANANA: Confidence Interval could not be calculated for only1 participant.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        65.0
        upper Limit
        84.9
        value
        75.9
      2. comment
        NA: Confidence Interval could not be calculated for only1 participant.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        100.0
denoms
  1. counts
    1. group Id
      OG000
      value
      79
    2. group Id
      OG001
      value
      1
    units
    Participants
description
Percentage of participants who achieved CR or CRi response with bone marrow MRD negative (MRD \< 0.01%) after tisagenlecleucel infusion by flow cytometry.
dispersion Type
95% Confidence Interval
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
NUMBER
population Description
FAS: The Full analysis set comprised all patients who received infusion of tisagenlecleucel
reporting Status
POSTED
time Frame
28 days
title
Bone Marrow MRD Status by Flow Cytometry Per IRC Assessment
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice