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NCT02445248 · OUTCOME

Time to Response (TTR) as Assessed by Independent Review Committee (Main Cohort & All Patients)

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
Months
Interval / dispersion
95% Confidence Interval
Time frame
up to approx. 3.3 months

What was measured

TTR is the time between date of CTL019 infusion until first documented response (CR or PR).

Analysis population: Full Analysis Set (FAS): Comprised all patients in the Main cohort who received infusion of tisagenlecleucel.

Groups in this outcome

Tisagenlecleucel - Main Cohort

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 - All Patients

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 and 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 Cohort99
Tisagenlecleucel - All Patients115

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Tisagenlecleucel - Main Cohort1.0Not reported0.91.0Not reported
Tisagenlecleucel - All Patients1.0Not reported0.91.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.9
        upper Limit
        1.0
        value
        1.0
      2. group Id
        OG001
        lower Limit
        0.9
        upper Limit
        1.0
        value
        1.0
denoms
  1. counts
    1. group Id
      OG000
      value
      99
    2. group Id
      OG001
      value
      115
    units
    Participants
description
TTR is the time between date of CTL019 infusion until first documented response (CR or PR).
dispersion Type
95% Confidence Interval
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
  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 and at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
    id
    OG001
    title
    Tisagenlecleucel - All Patients
param Type
MEDIAN
population Description
Full Analysis Set (FAS): Comprised all patients in the Main cohort who received infusion of tisagenlecleucel.
reporting Status
POSTED
time Frame
up to approx. 3.3 months
title
Time to Response (TTR) as Assessed by Independent Review Committee (Main Cohort & All Patients)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice