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NCT02445248 · OUTCOME

Pharmacokinetics (Pk): Tlast

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

Tlast is the time of last observed quantifiable concentration in peripheral blood. Tlast, based on the transgene level data by qPCR, was summarized by Month 3 response, per Independent Review Committee assessment. This time frame reflects maximum duration of 60 months up to which the transgene levels were collected.

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/UNK55
Tisagenlecleucel - Cohort A: CR/PR4
Tisagenlecleucel - Cohort A: SD/PD/UNK12

Reported measurements

Source class 1
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Tisagenlecleucel - Main Cohort: CR/PR930Not reported18.01830Not reported
Tisagenlecleucel - Main Cohort: SD/PD/UNK41.9Not reported0.9941480Not reported
Tisagenlecleucel - Cohort A: CR/PR1040Not reported17.11830Not reported
Tisagenlecleucel - Cohort A: SD/PD/UNK59.4Not reported26.8126Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        18.0
        upper Limit
        1830
        value
        930
      2. group Id
        OG001
        lower Limit
        0.994
        upper Limit
        1480
        value
        41.9
      3. group Id
        OG002
        lower Limit
        17.1
        upper Limit
        1830
        value
        1040
      4. group Id
        OG003
        lower Limit
        26.8
        upper Limit
        126
        value
        59.4
denoms
  1. counts
    1. group Id
      OG000
      value
      40
    2. group Id
      OG001
      value
      55
    3. group Id
      OG002
      value
      4
    4. group Id
      OG003
      value
      12
    units
    Participants
description
Tlast is the time of last observed quantifiable concentration in peripheral blood. Tlast, based on the transgene level data by qPCR, was summarized by Month 3 response, per Independent Review Committee assessment. This time frame reflects maximum duration of 60 months up to which the transgene levels were collected.
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): Tlast
type
SECONDARY
unit Of Measure
days

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

Preserved source evidence · Not medical advice