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NCT03568461 · OUTCOME

AUC0-28d and AUC0-84d; Cellular Kinetic Parameter of Tisagenlecleucel Transgene Levels by qPCR, 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
Copies/ug*days
Interval / dispersion
Geometric Coefficient of Variation
Time frame
0 to 28 days after infusion, 0 to 84 days after infusion

What was measured

AUC0-28 is the area under curve (AUC) from time zero to day 28 in peripheral blood. AUC0-84d is the AUC from time zero to day 84 in peripheral blood. Actual sampling times were taken into consideration for the calculation of cellular kinetic parameters.

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
CTL01974

Reported measurements

AUC 0 - 28d

Analysis denominator · Participants

GroupSource count
CTL01974
Values in Copies/ug*days · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
CTL01948700449Not reportedNot reportedNot reported
AUC 0 - 84d

Analysis denominator · Participants

GroupSource count
CTL01966
Values in Copies/ug*days · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
CTL01993700281Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        449
        value
        48700
    denoms
    1. counts
      1. group Id
        OG000
        value
        74
      units
      Participants
    title
    AUC 0 - 28d
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        281
        value
        93700
    denoms
    1. counts
      1. group Id
        OG000
        value
        66
      units
      Participants
    title
    AUC 0 - 84d
denoms
  1. counts
    1. group Id
      OG000
      value
      74
    units
    Participants
description
AUC0-28 is the area under curve (AUC) from time zero to day 28 in peripheral blood. AUC0-84d is the AUC from time zero to day 84 in peripheral blood. Actual sampling times were taken into consideration for the calculation of cellular kinetic parameters.
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
0 to 28 days after infusion, 0 to 84 days after infusion
title
AUC0-28d and AUC0-84d; Cellular Kinetic Parameter of Tisagenlecleucel Transgene Levels by qPCR, Based on Clinical Response by IRC Assessment
type
SECONDARY
unit Of Measure
Copies/ug*days

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

Preserved source evidence · Not medical advice