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NCT02435849 · OUTCOME

Site of Involvement of Subsequent Relapse

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
60 months

What was measured

Anatomical location of relapse in participants who achieved prior CR/CRi subsequent to tisagenlecleucel infusion.

Analysis population: FAS: The Full analysis set comprised all patients who received infusion of tisagenlecleucel and who achieved CR or CRi. Achieving CR or CRi" requireb confirmation but for this analysis, all patients with one CR/CRi, regardless of confirmation were included.

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 CTL01971
Cohort 1: Single Dose of CTL0190

Reported measurements

BM and/or blood relapse
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Cohort: Single Dose of CTL01923Not reportedNot reportedNot reportedNot reported
Extramedullary only
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Cohort: Single Dose of CTL0192Not reportedNot reportedNot reportedNot reported
Unknown
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Cohort: Single Dose of CTL0194Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        23
    title
    BM and/or blood relapse
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Extramedullary only
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    Unknown
denoms
  1. counts
    1. group Id
      OG000
      value
      71
    2. group Id
      OG001
      value
      0
    units
    Participants
description
Anatomical location of relapse in participants who achieved prior CR/CRi subsequent to tisagenlecleucel infusion.
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
FAS: The Full analysis set comprised all patients who received infusion of tisagenlecleucel and who achieved CR or CRi. Achieving CR or CRi" requireb confirmation but for this analysis, all patients with one CR/CRi, regardless of confirmation were included.
reporting Status
POSTED
time Frame
60 months
title
Site of Involvement of Subsequent Relapse
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice