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NCT03568461 · OUTCOME

Duration of Response (DOR) for Complete Response (CR) Only 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
approx. 60 months

What was measured

Duration of response (DOR) applied only to participants whose best overall disease response was complete response (CR) only. It is defined as the time from the date of first documented disease response (CR only) to the date of first documented progression or death due to follicular lymphoma (FL). DOR 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). Analysis was on participants who achieved a complete response only.

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
CTL01964

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
CTL019NANot reportedNANANA: Median DOR is not estimable due to insufficient number of participants with events.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        NA: Median DOR is not estimable due to insufficient number of participants with events.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      64
    units
    Participants
description
Duration of response (DOR) applied only to participants whose best overall disease response was complete response (CR) only. It is defined as the time from the date of first documented disease response (CR only) to the date of first documented progression or death due to follicular lymphoma (FL). DOR 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). Analysis was on participants who achieved a complete response only.
reporting Status
POSTED
time Frame
approx. 60 months
title
Duration of Response (DOR) for Complete Response (CR) Only Per IRC Assessment
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice