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NCT02445248 · OUTCOME

Pharmacokinetics (Pk): Tmax

Study of Efficacy and Safety of CTL019 in Adult DLBCL Patients · Source last updated 2024-04-18

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
days
Interval / dispersion
Full Range
Time frame
60 months

What was measured

Tmax is the time to reach maximum (peak) peripheral blood or other body fluid drug concentration after single dose administration (days). Tmax, based on the transgene level data by qPCR, was summarized by Month 3 response, per Independent Review Committee assessment. The time frame of 60 months refers to the duration for which the data were reviewed to identify the time of Cmax for this measure.

Analysis population: Full Analysis Set (FAS): Comprised all patients who received infusion of tisagenlecleucel with valid PK assessments.

Groups in this outcome

Tisagenlecleucel - Main Cohort: CR/PR

Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US

Tisagenlecleucel - Main Cohort: SD/PD/UNK

Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US

Tisagenlecleucel - Cohort A: CR/PR

Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.

Tisagenlecleucel - Cohort A: SD/PD/UNK

Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Tisagenlecleucel - Main Cohort: CR/PR40
Tisagenlecleucel - Main Cohort: SD/PD/UNK56
Tisagenlecleucel - Cohort A: CR/PR4
Tisagenlecleucel - Cohort A: SD/PD/UNK11

Reported measurements

Source class 1
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Tisagenlecleucel - Main Cohort: CR/PR9.84Not reported5.7827.7Not reported
Tisagenlecleucel - Main Cohort: SD/PD/UNK8.95Not reported0.99426.7Not reported
Tisagenlecleucel - Cohort A: CR/PR6.95Not reported5.948.96Not reported
Tisagenlecleucel - Cohort A: SD/PD/UNK6.93Not reported6.6710.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.78
        upper Limit
        27.7
        value
        9.84
      2. group Id
        OG001
        lower Limit
        0.994
        upper Limit
        26.7
        value
        8.95
      3. group Id
        OG002
        lower Limit
        5.94
        upper Limit
        8.96
        value
        6.95
      4. group Id
        OG003
        lower Limit
        6.67
        upper Limit
        10.9
        value
        6.93
denoms
  1. counts
    1. group Id
      OG000
      value
      40
    2. group Id
      OG001
      value
      56
    3. group Id
      OG002
      value
      4
    4. group Id
      OG003
      value
      11
    units
    Participants
description
Tmax is the time to reach maximum (peak) peripheral blood or other body fluid drug concentration after single dose administration (days). Tmax, based on the transgene level data by qPCR, was summarized by Month 3 response, per Independent Review Committee assessment. The time frame of 60 months refers to the duration for which the data were reviewed to identify the time of Cmax for this measure.
dispersion Type
Full Range
groups
  1. description
    Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US
    id
    OG000
    title
    Tisagenlecleucel - Main Cohort: CR/PR
  2. description
    Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US
    id
    OG001
    title
    Tisagenlecleucel - Main Cohort: SD/PD/UNK
  3. description
    Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
    id
    OG002
    title
    Tisagenlecleucel - Cohort A: CR/PR
  4. description
    Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
    id
    OG003
    title
    Tisagenlecleucel - Cohort A: SD/PD/UNK
param Type
MEDIAN
population Description
Full Analysis Set (FAS): Comprised all patients who received infusion of tisagenlecleucel with valid PK assessments.
reporting Status
POSTED
time Frame
60 months
title
Pharmacokinetics (Pk): Tmax
type
SECONDARY
unit Of Measure
days

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Preserved source evidence · Not medical advice