NCT02435849 · OUTCOME

Frequent Monitoring of Concentrations of Soluble Immune Factors in Blood (C Reactive Protein & Ferritin)

Study of Efficacy and Safety of CTL019 in Pediatric ALL Patients · Source last updated 2024-02-13

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: GEOMETRIC_MEAN
Unit: fold-change from baseline
Interval / dispersion: Geometric Coefficient of Variation
Time frame: Maximum post-baseline (approx. 60 months)

What was measured

Profile of soluble immune factors of key inflammatory markers and cytokine parameters in blood by maximum CRS grade that may be key to cytokine release syndrome (CRS).

Analysis population: Safety Set: The Safety set comprised all patients who received tisagenlecleucel infusion with evaluable data. This analysis included a subset of Safety set who had any data of the particular biomarker at the specific timepoint. Therefore, no participants in Cohort 1 had biomarker data at this time point, so no data was collected for Cohort 1.

Groups in this outcome

Main Cohort: Single Dose of CTL019

Pediatric patients with relapsed or refractory B-cell ALL who were treated with single dose of tisagenlecleucel (CTL019).

Cohort 1: Single Dose of CTL019

Pediatric B-ALL patients who are very high risk at first relapse.

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
Main Cohort: Single Dose of CTL019	21
Cohort 1: Single Dose of CTL019	0

Reported measurements

C Reactive Protein: Fold-change from BL Grade 4 CRS

Values in fold-change from baseline · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Main Cohort: Single Dose of CTL019	9.33	303.9	Not reported	Not reported	Not reported

Ferritin: Fold-change from BL Grade 4 CRS

Values in fold-change from baseline · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Main Cohort: Single Dose of CTL019	36.62	164.6	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
303.9
value
9.33
title
C Reactive Protein: Fold-change from BL Grade 4 CRS
categories
measurements
group Id
OG000
spread
164.6
value
36.62
title
Ferritin: Fold-change from BL Grade 4 CRS

denoms

counts
group Id
OG000
value
21
group Id
OG001
value
0
units
Participants

description

Profile of soluble immune factors of key inflammatory markers and cytokine parameters in blood by maximum CRS grade that may be key to cytokine release syndrome (CRS).

dispersion Type

Geometric Coefficient of Variation

groups

description
Pediatric patients with relapsed or refractory B-cell ALL who were treated with single dose of tisagenlecleucel (CTL019).
id
OG000
title
Main Cohort: Single Dose of CTL019
description
Pediatric B-ALL patients who are very high risk at first relapse.
id
OG001
title
Cohort 1: Single Dose of CTL019

param Type

GEOMETRIC_MEAN

population Description

Safety Set: The Safety set comprised all patients who received tisagenlecleucel infusion with evaluable data. This analysis included a subset of Safety set who had any data of the particular biomarker at the specific timepoint. Therefore, no participants in Cohort 1 had biomarker data at this time point, so no data was collected for Cohort 1.

reporting Status

POSTED

time Frame

Maximum post-baseline (approx. 60 months)

title

Frequent Monitoring of Concentrations of Soluble Immune Factors in Blood (C Reactive Protein & Ferritin)

type

SECONDARY

unit Of Measure

fold-change from baseline

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

Preserved source evidence · Not medical advice