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NCT02445248 · OUTCOME

Overall Response Rate (ORR) Per Independent Review Committee (IRC) in Main Cohort

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
NUMBER
Unit
Percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
60 months

What was measured

ORR, which includes complete response (CR) and partial response (PR) in the Main cohort as determined by IRC assessment. ORR is the percentage of participants with a best overall disease response of CR or PR, where the best overall disease response is defined as the best disease response recorded from CTL019 infusion until progressive disease or start of new anticancer therapy (including ASCT), whichever comes first. Response was assessed according to Evaluation Criteria in diffuse large B cell lymphoma studies (based on Cheson Response criteria and the Lugano Classification (2014))

Analysis population: Full Analysis Set (FAS): Comprised of 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.

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

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Tisagenlecleucel - Main Cohort54.5Not reported44.264.6Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        44.2
        upper Limit
        64.6
        value
        54.5
denoms
  1. counts
    1. group Id
      OG000
      value
      99
    units
    Participants
description
ORR, which includes complete response (CR) and partial response (PR) in the Main cohort as determined by IRC assessment. ORR is the percentage of participants with a best overall disease response of CR or PR, where the best overall disease response is defined as the best disease response recorded from CTL019 infusion until progressive disease or start of new anticancer therapy (including ASCT), whichever comes first. Response was assessed according to Evaluation Criteria in diffuse large B cell lymphoma studies (based on Cheson Response criteria and the Lugano Classification (2014))
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
param Type
NUMBER
population Description
Full Analysis Set (FAS): Comprised of all patients in the Main cohort who received infusion of tisagenlecleucel.
reporting Status
POSTED
time Frame
60 months
title
Overall Response Rate (ORR) Per Independent Review Committee (IRC) in Main Cohort
type
PRIMARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice