Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03568461 · OUTCOME

AUC0-28d and AUC0-84d; Cellular Kinetic Parameter for Tisagenlecleucel by Flow Cytometry, Based on Clinical Response by 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
GEOMETRIC_MEAN
Unit
percentage of cells*days
Interval / dispersion
Geometric Coefficient of Variation
Time frame
AUC0-28d: from time of infusion to 28 days post-dose; AUC0-84d: from time of infusion to 84 days post-infusion

What was measured

Exposure is summarized as area under the curve (AUC) from time 0 to 28 days (AUC0-28d) and from time to 84 days (AUC0-84d). The cellular kinetic parameters were estimated from the percentages of CD3+/CTL019+ cells obtained from flow cytometry. Flow cytometry measures the surface expression of chimeric antigen receptors (CARs) on T cells.

Analysis population: Participants in the Cellular kinetic set (CKAS) with an available value for the outcome measure. The CKAS consisted of patients in the Efficacy analysis set who provided an evaluable cellular kinetic profile (at least 1 cellular kinetic parameter).

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
CTL01993

Reported measurements

AUC 0-28d

Analysis denominator · Participants

GroupSource count
CTL01993
Values in percentage of cells*days · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
CTL01914.2114Not reportedNot reportedNot reported
AUC 0-84d

Analysis denominator · Participants

GroupSource count
CTL01991
Values in percentage of cells*days · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
CTL01932.689.1Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        114
        value
        14.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        93
      units
      Participants
    title
    AUC 0-28d
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        89.1
        value
        32.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        91
      units
      Participants
    title
    AUC 0-84d
denoms
  1. counts
    1. group Id
      OG000
      value
      93
    units
    Participants
description
Exposure is summarized as area under the curve (AUC) from time 0 to 28 days (AUC0-28d) and from time to 84 days (AUC0-84d). The cellular kinetic parameters were estimated from the percentages of CD3+/CTL019+ cells obtained from flow cytometry. Flow cytometry measures the surface expression of chimeric antigen receptors (CARs) on T cells.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    All participants who were enrolled in the study
    id
    OG000
    title
    CTL019
param Type
GEOMETRIC_MEAN
population Description
Participants in the Cellular kinetic set (CKAS) with an available value for the outcome measure. The CKAS consisted of patients in the Efficacy analysis set who provided an evaluable cellular kinetic profile (at least 1 cellular kinetic parameter).
reporting Status
POSTED
time Frame
AUC0-28d: from time of infusion to 28 days post-dose; AUC0-84d: from time of infusion to 84 days post-infusion
title
AUC0-28d and AUC0-84d; Cellular Kinetic Parameter for Tisagenlecleucel by Flow Cytometry, Based on Clinical Response by IRC Assessment
type
SECONDARY
unit Of Measure
percentage of cells*days

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

Preserved source evidence · Not medical advice