Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02435849 · OUTCOME

Pharmacokinetics (PK) Parameter: AUCs by qPCR in Peripheral Blood, by Day 28 Disease Response by IRC

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
GEOMETRIC_MEAN
Unit
copies/ug*days
Interval / dispersion
Geometric Coefficient of Variation
Time frame
0 to 84 days after infusion

What was measured

AUC (area under curve) from day of infusion to day 28 or other disease assessment days, in peripheral blood (% or copies/μg x days), reported by CR/CRi, no response (NR), Unknown and by All participants. D28 refers to the timepoint for definition of responder populations, whereas 84 days is the actual timepoint for endpoint assessment. : AUC is defined based on the time window i.e., AUC from 0 to 84 days after infusion. Therefore, the time frame specifies the maximum time for up to which the data are used for estimation of AUC (84 days for AUC84d).

Analysis population: PAS: The PAS consisted of patients in the FAS who had at least one sample providing evaluable cellular kinetic data for 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 CTL01975
Cohort 1: Single Dose of CTL0191

Reported measurements

AUC0-28d: CR/CRi

Analysis denominator · Participants

GroupSource count
Main Cohort: Single Dose of CTL01962
Cohort 1: Single Dose of CTL0191
Values in copies/ug*days · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Main Cohort: Single Dose of CTL019310000192.2Not reportedNot reportedNot reported
Cohort 1: Single Dose of CTL01931500NANot reportedNot reportedNA: Geo-CV could not be calculated for 1 participant.
AUC0-28d: NR

Analysis denominator · Participants

GroupSource count
Main Cohort: Single Dose of CTL0195
Cohort 1: Single Dose of CTL0190
Values in copies/ug*days · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Main Cohort: Single Dose of CTL019301000116.9Not reportedNot reportedNot reported
AUC0-28d: Unknown

Analysis denominator · Participants

GroupSource count
Main Cohort: Single Dose of CTL0198
Cohort 1: Single Dose of CTL0190
Values in copies/ug*days · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Main Cohort: Single Dose of CTL019768000177.4Not reportedNot reportedNot reported
AUC0-28d: All Participants

Analysis denominator · Participants

GroupSource count
Main Cohort: Single Dose of CTL01975
Cohort 1: Single Dose of CTL0191
Values in copies/ug*days · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Main Cohort: Single Dose of CTL019341000190.9Not reportedNot reportedNot reported
Cohort 1: Single Dose of CTL01931500NANot reportedNot reportedNA: Geo-CV could not be calculated for 1 participant.
AUC 0-84d: CR/CRi

Analysis denominator · Participants

GroupSource count
Main Cohort: Single Dose of CTL01956
Cohort 1: Single Dose of CTL0191
Values in copies/ug*days · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Main Cohort: Single Dose of CTL019462000230.1Not reportedNot reportedNot reported
Cohort 1: Single Dose of CTL01974700NANot reportedNot reportedNA: Geo-CV could not be calculated for 1 participant.
AUC 0-84d: NR

Analysis denominator · Participants

GroupSource count
Main Cohort: Single Dose of CTL0193
Cohort 1: Single Dose of CTL0190
Values in copies/ug*days · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Main Cohort: Single Dose of CTL019113000075.5Not reportedNot reportedNot reported
AUC 0-84d: Unknown

Analysis denominator · Participants

GroupSource count
Main Cohort: Single Dose of CTL0197
Cohort 1: Single Dose of CTL0190
Values in copies/ug*days · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Main Cohort: Single Dose of CTL019984000202.4Not reportedNot reportedNot reported
AUC 0-84d: All Participants

Analysis denominator · Participants

GroupSource count
Main Cohort: Single Dose of CTL01966
Cohort 1: Single Dose of CTL0191
Values in copies/ug*days · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Main Cohort: Single Dose of CTL019521000225.3Not reportedNot reportedNot reported
Cohort 1: Single Dose of CTL01974700NANot reportedNot reportedNA: Geo-CV could not be calculated for 1 participant.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        192.2
        value
        310000
      2. comment
        NA: Geo-CV could not be calculated for 1 participant.
        group Id
        OG001
        spread
        NA
        value
        31500
    denoms
    1. counts
      1. group Id
        OG000
        value
        62
      2. group Id
        OG001
        value
        1
      units
      Participants
    title
    AUC0-28d: CR/CRi
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        116.9
        value
        301000
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    AUC0-28d: NR
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        177.4
        value
        768000
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    AUC0-28d: Unknown
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        190.9
        value
        341000
      2. comment
        NA: Geo-CV could not be calculated for 1 participant.
        group Id
        OG001
        spread
        NA
        value
        31500
    denoms
    1. counts
      1. group Id
        OG000
        value
        75
      2. group Id
        OG001
        value
        1
      units
      Participants
    title
    AUC0-28d: All Participants
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        230.1
        value
        462000
      2. comment
        NA: Geo-CV could not be calculated for 1 participant.
        group Id
        OG001
        spread
        NA
        value
        74700
    denoms
    1. counts
      1. group Id
        OG000
        value
        56
      2. group Id
        OG001
        value
        1
      units
      Participants
    title
    AUC 0-84d: CR/CRi
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        75.5
        value
        1130000
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    AUC 0-84d: NR
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        202.4
        value
        984000
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    AUC 0-84d: Unknown
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        225.3
        value
        521000
      2. comment
        NA: Geo-CV could not be calculated for 1 participant.
        group Id
        OG001
        spread
        NA
        value
        74700
    denoms
    1. counts
      1. group Id
        OG000
        value
        66
      2. group Id
        OG001
        value
        1
      units
      Participants
    title
    AUC 0-84d: All Participants
denoms
  1. counts
    1. group Id
      OG000
      value
      75
    2. group Id
      OG001
      value
      1
    units
    Participants
description
AUC (area under curve) from day of infusion to day 28 or other disease assessment days, in peripheral blood (% or copies/μg x days), reported by CR/CRi, no response (NR), Unknown and by All participants. D28 refers to the timepoint for definition of responder populations, whereas 84 days is the actual timepoint for endpoint assessment. : AUC is defined based on the time window i.e., AUC from 0 to 84 days after infusion. Therefore, the time frame specifies the maximum time for up to which the data are used for estimation of AUC (84 days for AUC84d).
dispersion Type
Geometric Coefficient of Variation
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
GEOMETRIC_MEAN
population Description
PAS: The PAS consisted of patients in the FAS who had at least one sample providing evaluable cellular kinetic data for tisagenlecleucel.
reporting Status
POSTED
time Frame
0 to 84 days after infusion
title
Pharmacokinetics (PK) Parameter: AUCs by qPCR in Peripheral Blood, by Day 28 Disease Response by IRC
type
SECONDARY
unit Of Measure
copies/ug*days

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

Preserved source evidence · Not medical advice