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NCT02445248 · OUTCOME

Pharmacokinetics (Pk): Cmax

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
GEOMETRIC_MEAN
Unit
copies/ug
Interval / dispersion
Geometric Coefficient of Variation
Time frame
60 months

What was measured

Cmax is the maximum (peak) observed in peripheral blood or other body fluid drug concentration after single dose administration. Cmax, based on the transgene level data by qPCR, was summarized by Month 3 response, per Independent Review Committee assessment. The reported Cmax is the summary of maximum level observed based on the data from each patient and based on all the data that's been collected for up to 60 months in a patient.

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 copies/ug · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Tisagenlecleucel - Main Cohort: CR/PR5570271.3Not reportedNot reportedNot reported
Tisagenlecleucel - Main Cohort: SD/PD/UNK4690481.1Not reportedNot reportedNot reported
Tisagenlecleucel - Cohort A: CR/PR1430067.5Not reportedNot reportedNot reported
Tisagenlecleucel - Cohort A: SD/PD/UNK6950109.3Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        271.3
        value
        5570
      2. group Id
        OG001
        spread
        481.1
        value
        4690
      3. group Id
        OG002
        spread
        67.5
        value
        14300
      4. group Id
        OG003
        spread
        109.3
        value
        6950
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
Cmax is the maximum (peak) observed in peripheral blood or other body fluid drug concentration after single dose administration. Cmax, based on the transgene level data by qPCR, was summarized by Month 3 response, per Independent Review Committee assessment. The reported Cmax is the summary of maximum level observed based on the data from each patient and based on all the data that's been collected for up to 60 months in a patient.
dispersion Type
Geometric Coefficient of Variation
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
GEOMETRIC_MEAN
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): Cmax
type
SECONDARY
unit Of Measure
copies/ug

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

Preserved source evidence · Not medical advice