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NCT02435849 · OUTCOME

Percentage of Participants With Best Overall Response (BOR) of CR or CRi With MRD Negative Bone Marrow by Flow Cytometry From All Manufacturing Facilities as Per IRC in the Main Cohort Only (Key Secondary)

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
3 months after tisagenlecleucel administration

What was measured

These are the percentage of participants who achieved Best Overall Response (BOR) of CR or CRi with an MRD-negative bone marrow by central analysis using flow cytometry among participants who received tisagenlecleucel from all manufacturing facilities by IRC assessment. MRD negative = MRD% \< 0.01%

Analysis population: FAS: The Full analysis set comprised all patients who received infusion of tisagenlecleucel from all manufacturing facilities.

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).

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

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Main Cohort: Single Dose of CTL01981.0Not reported70.689.0Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Ids
    1. OG000
    non Inferiority Comment
    testing the null hypothesis that ORR with MRD negative within 3 months is less than or equal to 15%
    non Inferiority Type
    OTHER
    p Value
    <.0001
    statistical Method
    Clopper-Pearson
Complete source fields
analyses
  1. group Ids
    1. OG000
    non Inferiority Comment
    testing the null hypothesis that ORR with MRD negative within 3 months is less than or equal to 15%
    non Inferiority Type
    OTHER
    p Value
    <.0001
    statistical Method
    Clopper-Pearson
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        70.6
        upper Limit
        89.0
        value
        81.0
denoms
  1. counts
    1. group Id
      OG000
      value
      79
    units
    Participants
description
These are the percentage of participants who achieved Best Overall Response (BOR) of CR or CRi with an MRD-negative bone marrow by central analysis using flow cytometry among participants who received tisagenlecleucel from all manufacturing facilities by IRC assessment. MRD negative = MRD% \< 0.01%
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
param Type
NUMBER
population Description
FAS: The Full analysis set comprised all patients who received infusion of tisagenlecleucel from all manufacturing facilities.
reporting Status
POSTED
time Frame
3 months after tisagenlecleucel administration
title
Percentage of Participants With Best Overall Response (BOR) of CR or CRi With MRD Negative Bone Marrow by Flow Cytometry From All Manufacturing Facilities as Per IRC in the Main Cohort Only (Key Secondary)
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice