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NCT03568461 · OUTCOME

Overall Response Rate (ORR) Per IRC Assessment

Efficacy and Safety of Tisagenlecleucel in Adult Patients With Refractory or Relapsed Follicular Lymphoma · Source last updated 2026-07-09

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

Measure
NUMBER
Unit
Percentage or participants
Interval / dispersion
95% Confidence Interval
Time frame
1 year

What was measured

Overall response rate is defined as the percentage of participants with a best overall disease response of complete response (CR) or partial response (PR). Response was evaluated per Lugano 2014 classification response criteria. The radiological response is first obtained from CT and PET studies according to the Lugano 2014 criteria. CT response is based on anatomical measurements of index/non-index/new lesions and spleen length. The possible response outcomes are complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD). PET response based on a 5-point scale (5PS) or Deauville score. The possible outcomes for PET response are complete metabolic response (CMR), partial metabolic response (PMR), no metabolic response (NMR), or progressive metabolic disease (PMD).

Analysis population: Efficacy analysis set (EAS): All the patients who received tisagenlecleucel, and had measurable disease at baseline per IRC. Non-measurable disease at baseline is defined as absence of index lesion at baseline disease evaluation (i.e. no disease at baseline).

Groups in this outcome

CTL019

All participants who were enrolled in the study

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

Analysis denominator · Participants

GroupSource count
CTL01994

Reported measurements

Source class 1
Values in Percentage or participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
CTL01986.2Not reported77.592.4Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        77.5
        upper Limit
        92.4
        value
        86.2
denoms
  1. counts
    1. group Id
      OG000
      value
      94
    units
    Participants
description
Overall response rate is defined as the percentage of participants with a best overall disease response of complete response (CR) or partial response (PR). Response was evaluated per Lugano 2014 classification response criteria. The radiological response is first obtained from CT and PET studies according to the Lugano 2014 criteria. CT response is based on anatomical measurements of index/non-index/new lesions and spleen length. The possible response outcomes are complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD). PET response based on a 5-point scale (5PS) or Deauville score. The possible outcomes for PET response are complete metabolic response (CMR), partial metabolic response (PMR), no metabolic response (NMR), or progressive metabolic disease (PMD).
dispersion Type
95% Confidence Interval
groups
  1. description
    All participants who were enrolled in the study
    id
    OG000
    title
    CTL019
param Type
NUMBER
population Description
Efficacy analysis set (EAS): All the patients who received tisagenlecleucel, and had measurable disease at baseline per IRC. Non-measurable disease at baseline is defined as absence of index lesion at baseline disease evaluation (i.e. no disease at baseline).
reporting Status
POSTED
time Frame
1 year
title
Overall Response Rate (ORR) Per IRC Assessment
type
SECONDARY
unit Of Measure
Percentage or participants

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

Preserved source evidence · Not medical advice