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NCT03568461 · OUTCOME

Cmax; 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
Interval / dispersion
Geometric Coefficient of Variation
Time frame
From pre-dose until 60 months after infusion

What was measured

Cmax is the maximum (peak) observed in peripheral blood after single dose administration. Actual sampling times were taken into consideration for the calculation of cellular kinetic parameters 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
CTL01978

Reported measurements

Source class 1
Values in percentage of cells · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
CTL0191.48156Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        156
        value
        1.48
denoms
  1. counts
    1. group Id
      OG000
      value
      78
    units
    Participants
description
Cmax is the maximum (peak) observed in peripheral blood after single dose administration. Actual sampling times were taken into consideration for the calculation of cellular kinetic parameters 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
From pre-dose until 60 months after infusion
title
Cmax; Cellular Kinetic Parameter for Tisagenlecleucel by Flow Cytometry, Based on Clinical Response by IRC Assessment
type
SECONDARY
unit Of Measure
percentage of cells

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

Preserved source evidence · Not medical advice