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NCT02435849 · OUTCOME

Percentage Change From Baseline of Levels of B and T Cells (Blood and Bone Marrow) Prior to and Following CTL019 Infusion

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
MEAN
Unit
percentage change from baseline
Interval / dispersion
Standard Deviation
Time frame
Month 3, Month 12, Maximum post-baseline (approx. 60 months)

What was measured

Levels of B and T cells (blood and bone marrow) prior to and following CTL019 infusion for safety monitoring

Analysis population: Safety Set: The Safety set comprised all patients who received tisagenlecleucel infusion.

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

M3: % change from BL - (B cell) CR/CRi

Analysis denominator · Participants

GroupSource count
Main Cohort: Single Dose of CTL01957
Cohort 1: Single Dose of CTL0191
Values in percentage change from baseline · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Main Cohort: Single Dose of CTL019-25.3731.693Not reportedNot reportedNot reported
Cohort 1: Single Dose of CTL019-0.51NANot reportedNot reportedNA: not enough participants to analyze the Standard Deviation.
M3: % change from BL - (B cell) NR

Analysis denominator · Participants

GroupSource count
Main Cohort: Single Dose of CTL0193
Cohort 1: Single Dose of CTL0190
Values in percentage change from baseline · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Main Cohort: Single Dose of CTL019-37.9335.882Not reportedNot reportedNot reported
M3: % change from BL - (B cell) Unknown

Analysis denominator · Participants

GroupSource count
Main Cohort: Single Dose of CTL0198
Cohort 1: Single Dose of CTL0190
Values in percentage change from baseline · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Main Cohort: Single Dose of CTL019-11.016.649Not reportedNot reportedNot reported
M3: % change from BL - (B cell) All participants

Analysis denominator · Participants

GroupSource count
Main Cohort: Single Dose of CTL01968
Cohort 1: Single Dose of CTL0191
Values in percentage change from baseline · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Main Cohort: Single Dose of CTL019-24.2330.215Not reportedNot reportedNot reported
Cohort 1: Single Dose of CTL019-0.51NANot reportedNot reportedNA: not enough participants to analyze the Standard Deviation.
M12: % change from BL - (B cell) CR/CRi

Analysis denominator · Participants

GroupSource count
Main Cohort: Single Dose of CTL01934
Cohort 1: Single Dose of CTL0190
Values in percentage change from baseline · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Main Cohort: Single Dose of CTL019-18.5527.144Not reportedNot reportedNot reported
M12: % change from BL - (B cell) NR

Analysis denominator · Participants

GroupSource count
Main Cohort: Single Dose of CTL0191
Cohort 1: Single Dose of CTL0190
Values in percentage change from baseline · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Main Cohort: Single Dose of CTL019-55.21NANot reportedNot reportedNA: not enough participants to analyze the Standard Deviation.
M12: % change from BL - (B cell) Unknown

Analysis denominator · Participants

GroupSource count
Main Cohort: Single Dose of CTL0193
Cohort 1: Single Dose of CTL0190
Values in percentage change from baseline · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Main Cohort: Single Dose of CTL019-12.045.995Not reportedNot reportedNot reported
M12 % change from BL -: (B cell) All Participants

Analysis denominator · Participants

GroupSource count
Main Cohort: Single Dose of CTL01938
Cohort 1: Single Dose of CTL0190
Values in percentage change from baseline · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Main Cohort: Single Dose of CTL019-19.0026.432Not reportedNot reportedNot reported
Maximum post-BL: (B cell) CR/CRi

Analysis denominator · Participants

GroupSource count
Main Cohort: Single Dose of CTL01949
Cohort 1: Single Dose of CTL0191
Values in percentage change from baseline · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Main Cohort: Single Dose of CTL019-21.2537.618Not reportedNot reportedNot reported
Cohort 1: Single Dose of CTL0196.06NANot reportedNot reportedNA: not enough participants to analyze the Standard Deviation.
Maximum post-BL: (B cell) NR

Analysis denominator · Participants

GroupSource count
Main Cohort: Single Dose of CTL0195
Cohort 1: Single Dose of CTL0190
Values in percentage change from baseline · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Main Cohort: Single Dose of CTL0192.1066.398Not reportedNot reportedNot reported
Maximum post-BL: (B cell) Unknown

Analysis denominator · Participants

GroupSource count
Main Cohort: Single Dose of CTL0198
Cohort 1: Single Dose of CTL0190
Values in percentage change from baseline · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Main Cohort: Single Dose of CTL0197.9829.536Not reportedNot reportedNot reported
Maximum post-BL: (B cell) All participants

Analysis denominator · Participants

GroupSource count
Main Cohort: Single Dose of CTL01962
Cohort 1: Single Dose of CTL0191
Values in percentage change from baseline · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Main Cohort: Single Dose of CTL019-15.6040.336Not reportedNot reportedNot reported
Cohort 1: Single Dose of CTL0196.06NANot reportedNot reportedNA: not enough participants to analyze the Standard Deviation.
M3: % change from BL - (T cell) All participants

Analysis denominator · Participants

GroupSource count
Main Cohort: Single Dose of CTL01967
Cohort 1: Single Dose of CTL0190
Values in percentage change from baseline · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Main Cohort: Single Dose of CTL019-11.9132.333Not reportedNot reportedNot reported
M12: % change from BL - (T cell) All participants

Analysis denominator · Participants

GroupSource count
Main Cohort: Single Dose of CTL01938
Cohort 1: Single Dose of CTL0190
Values in percentage change from baseline · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Main Cohort: Single Dose of CTL019-1.6836.228Not reportedNot reportedNot reported
Maximum post-BL: (T cell) All participants

Analysis denominator · Participants

GroupSource count
Main Cohort: Single Dose of CTL01941
Cohort 1: Single Dose of CTL0190
Values in percentage change from baseline · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Main Cohort: Single Dose of CTL01934.1229.450Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        31.693
        value
        -25.37
      2. comment
        NA: not enough participants to analyze the Standard Deviation.
        group Id
        OG001
        spread
        NA
        value
        -0.51
    denoms
    1. counts
      1. group Id
        OG000
        value
        57
      2. group Id
        OG001
        value
        1
      units
      Participants
    title
    M3: % change from BL - (B cell) CR/CRi
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        35.882
        value
        -37.93
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    M3: % change from BL - (B cell) NR
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        6.649
        value
        -11.01
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    M3: % change from BL - (B cell) Unknown
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        30.215
        value
        -24.23
      2. comment
        NA: not enough participants to analyze the Standard Deviation.
        group Id
        OG001
        spread
        NA
        value
        -0.51
    denoms
    1. counts
      1. group Id
        OG000
        value
        68
      2. group Id
        OG001
        value
        1
      units
      Participants
    title
    M3: % change from BL - (B cell) All participants
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        27.144
        value
        -18.55
    denoms
    1. counts
      1. group Id
        OG000
        value
        34
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    M12: % change from BL - (B cell) CR/CRi
  6. categories
    1. measurements
      1. comment
        NA: not enough participants to analyze the Standard Deviation.
        group Id
        OG000
        spread
        NA
        value
        -55.21
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    M12: % change from BL - (B cell) NR
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.995
        value
        -12.04
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    M12: % change from BL - (B cell) Unknown
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        26.432
        value
        -19.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        38
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    M12 % change from BL -: (B cell) All Participants
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        37.618
        value
        -21.25
      2. comment
        NA: not enough participants to analyze the Standard Deviation.
        group Id
        OG001
        spread
        NA
        value
        6.06
    denoms
    1. counts
      1. group Id
        OG000
        value
        49
      2. group Id
        OG001
        value
        1
      units
      Participants
    title
    Maximum post-BL: (B cell) CR/CRi
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        66.398
        value
        2.10
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    Maximum post-BL: (B cell) NR
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        29.536
        value
        7.98
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    Maximum post-BL: (B cell) Unknown
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        40.336
        value
        -15.60
      2. comment
        NA: not enough participants to analyze the Standard Deviation.
        group Id
        OG001
        spread
        NA
        value
        6.06
    denoms
    1. counts
      1. group Id
        OG000
        value
        62
      2. group Id
        OG001
        value
        1
      units
      Participants
    title
    Maximum post-BL: (B cell) All participants
denoms
  1. counts
    1. group Id
      OG000
      value
      79
    2. group Id
      OG001
      value
      1
    units
    Participants
description
Levels of B and T cells (blood and bone marrow) prior to and following CTL019 infusion for safety monitoring
dispersion Type
Standard Deviation
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
MEAN
population Description
Safety Set: The Safety set comprised all patients who received tisagenlecleucel infusion.
reporting Status
POSTED
time Frame
Month 3, Month 12, Maximum post-baseline (approx. 60 months)
title
Percentage Change From Baseline of Levels of B and T Cells (Blood and Bone Marrow) Prior to and Following CTL019 Infusion
type
SECONDARY
unit Of Measure
percentage change from baseline

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Preserved source evidence · Not medical advice