NCT02445248 · OUTCOME

Pharmacokinetics (Pk): AUC0-28d and AUC0-84d

Study of Efficacy and Safety of CTL019 in Adult DLBCL Patients · Source last updated 2024-04-18

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 - 28 days after infusion for AUC0-28d, 0 - 84 days after infusion for AUC0-84d

What was measured

The AUC from time zero to day 28 and 84 or other disease assessment days, in peripheral blood. AUC0-28d and AUC0-84d, based on the transgene level data by qPCR, were summarized by Month 3 response, per Independent Review Committee assessment.

Analysis population: Full Analysis Set (FAS): Comprised all patients who received infusion of tisagenlecleucel with valid PK assessments.

Groups in this outcome

Tisagenlecleucel - CR/PR

Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US.

Tisagenlecleucel - Main Cohort: SD/PD/UNK

Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US

Tisagenlecleucel - Cohort A: CR/PR

Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.

Tisagenlecleucel - Cohort A: SD/PD/UNK

Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Tisagenlecleucel - CR/PR	40
Tisagenlecleucel - Main Cohort: SD/PD/UNK	59
Tisagenlecleucel - Cohort A: CR/PR	4
Tisagenlecleucel - Cohort A: SD/PD/UNK	12

Reported measurements

AUC0-28d

Analysis denominator · Participants

Group	Source count
Tisagenlecleucel - CR/PR	39
Tisagenlecleucel - Main Cohort: SD/PD/UNK	50
Tisagenlecleucel - Cohort A: CR/PR	4
Tisagenlecleucel - Cohort A: SD/PD/UNK	12

Values in copies/ug*days · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Tisagenlecleucel - CR/PR	58000	182.1	Not reported	Not reported	Not reported
Tisagenlecleucel - Main Cohort: SD/PD/UNK	49900	388.5	Not reported	Not reported	Not reported
Tisagenlecleucel - Cohort A: CR/PR	141000	78.2	Not reported	Not reported	Not reported
Tisagenlecleucel - Cohort A: SD/PD/UNK	63700	134.2	Not reported	Not reported	Not reported

AUC0-84d

Analysis denominator · Participants

Group	Source count
Tisagenlecleucel - CR/PR	39
Tisagenlecleucel - Main Cohort: SD/PD/UNK	24
Tisagenlecleucel - Cohort A: CR/PR	4
Tisagenlecleucel - Cohort A: SD/PD/UNK	5

Values in copies/ug*days · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Tisagenlecleucel - CR/PR	102000	171.7	Not reported	Not reported	Not reported
Tisagenlecleucel - Main Cohort: SD/PD/UNK	92900	165.4	Not reported	Not reported	Not reported
Tisagenlecleucel - Cohort A: CR/PR	206000	76.7	Not reported	Not reported	Not reported
Tisagenlecleucel - Cohort A: SD/PD/UNK	142000	61.3	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
182.1
value
58000
group Id
OG001
spread
388.5
value
49900
group Id
OG002
spread
78.2
value
141000
group Id
OG003
spread
134.2
value
63700
denoms
counts
group Id
OG000
value
39
group Id
OG001
value
50
group Id
OG002
value
4
group Id
OG003
value
12
units
Participants
title
AUC0-28d
categories
measurements
group Id
OG000
spread
171.7
value
102000
group Id
OG001
spread
165.4
value
92900
group Id
OG002
spread
76.7
value
206000
group Id
OG003
spread
61.3
value
142000
denoms
counts
group Id
OG000
value
39
group Id
OG001
value
24
group Id
OG002
value
4
group Id
OG003
value
5
units
Participants
title
AUC0-84d

denoms

counts
group Id
OG000
value
40
group Id
OG001
value
59
group Id
OG002
value
4
group Id
OG003
value
12
units
Participants

description

dispersion Type

Geometric Coefficient of Variation

groups

description
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US.
id
OG000
title
Tisagenlecleucel - CR/PR
description
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US
id
OG001
title
Tisagenlecleucel - Main Cohort: SD/PD/UNK
description
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
id
OG002
title
Tisagenlecleucel - Cohort A: CR/PR
description
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
id
OG003
title
Tisagenlecleucel - Cohort A: SD/PD/UNK

param Type

GEOMETRIC_MEAN

population Description

Full Analysis Set (FAS): Comprised all patients who received infusion of tisagenlecleucel with valid PK assessments.

reporting Status

POSTED

time Frame

0 - 28 days after infusion for AUC0-28d, 0 - 84 days after infusion for AUC0-84d

title

Pharmacokinetics (Pk): AUC0-28d and AUC0-84d

type

SECONDARY

unit Of Measure

copies/ug*days

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Preserved source evidence · Not medical advice