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NCT02435849 · OUTCOME

Relapse-free Survival 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
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
60 months

What was measured

RFS is the time from achievement of CR or CRi at any time post-infusion, whichever occurs first, to relapse or death due to any cause during CR or CRi.

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 CTL01966
Cohort 1: Single Dose of CTL0191

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Main Cohort: Single Dose of CTL01946.8Not reported17.8NANA: more than 50% were either censored or in remission at time of analysis.
Cohort 1: Single Dose of CTL019NANot reportedNANANA: The patient did not relapse at the time of discontinuation.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        NA: more than 50% were either censored or in remission at time of analysis.
        group Id
        OG000
        lower Limit
        17.8
        upper Limit
        NA
        value
        46.8
      2. comment
        NA: The patient did not relapse at the time of discontinuation.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      66
    2. group Id
      OG001
      value
      1
    units
    Participants
description
RFS is the time from achievement of CR or CRi at any time post-infusion, whichever occurs first, to relapse or death due to any cause during CR or CRi.
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
MEDIAN
population Description
FAS: The Full analysis set comprised all patients who received infusion of tisagenlecleucel.
reporting Status
POSTED
time Frame
60 months
title
Relapse-free Survival Per IRC Assessment
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice