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NCT03568461 · OUTCOME

Progression Free Survival (PFS) 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
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
up to 61.7 months

What was measured

Progression free survival is the time from tisagenlecleucel infusion to first documented disease progression or death due to any cause. PFS was estimated using the Kaplan-Meier method.

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 months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
CTL01953.2Not reported18.2NANA: The upper confidence interval for median PFS was not estimable because the number of progression or death events was insufficient to estimate the upper CI boundary at the time of analysis.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        NA: The upper confidence interval for median PFS was not estimable because the number of progression or death events was insufficient to estimate the upper CI boundary at the time of analysis.
        group Id
        OG000
        lower Limit
        18.2
        upper Limit
        NA
        value
        53.2
denoms
  1. counts
    1. group Id
      OG000
      value
      94
    units
    Participants
description
Progression free survival is the time from tisagenlecleucel infusion to first documented disease progression or death due to any cause. PFS was estimated using the Kaplan-Meier method.
dispersion Type
95% Confidence Interval
groups
  1. description
    All participants who were enrolled in the study
    id
    OG000
    title
    CTL019
param Type
MEDIAN
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
up to 61.7 months
title
Progression Free Survival (PFS) Per IRC Assessment
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice