NCT03860844 · OUTCOME

B-ALL and T-ALL: Concentrations at the End of Infusion (Ceoi) of Isatuximab

Isatuximab in Combination With Chemotherapy in Pediatric Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia · Source last updated 2025-09-09

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

Measure: MEAN
Unit: mcg/mL
Interval / dispersion: Standard Deviation
Time frame: At end of infusion on Cycle 1 Days 1 and 29

What was measured

Ceoi is the plasma concentration observed at the end of intravenous infusion of isatuximab.

Analysis population: The PK population consisted of all participants from the AT population with at least 1 PK parameter available (isatuximab concentration). Only those participants with data available at specified timepoints were analyzed.

Groups in this outcome

B-cell Acute Lymphoblastic Leukemia (B-ALL)

Participants with B-ALL received isatuximab 20 mg/kg IV infusion QW for 4 weeks during the induction period (i.e., on Days 1, 8, 15, and 22) and Q2W during the consolidation period (i.e., on Days 29, 43, and 57. Participants received recommended isatuximab premedication as per protocol. Starting on Day 8, combination chemotherapies were added. Participants without documented disease progression at EOT visit who had not started treatment with another anticancer therapy received follow-up visits every 2 months until initiation of another anticancer therapy, disease progression, death, or final analysis cut-off date, whichever occurred first. Participants with documented disease progression/initiation of new anticancer treatment were followed for survival every 4 months until death or final analysis cut-off date, whichever occurred first.

T-cell Acute Lymphoblastic Leukemia (T-ALL)

Participants with T-ALL received isatuximab 20 mg/kg IV infusion QW for 4 weeks during the induction period (i.e., on Days 1, 8, 15, and 22) and Q2W during the consolidation period (i.e., on Days 29, 43, and 57. Participants received recommended isatuximab premedication as per protocol. Starting on Day 8, combination chemotherapies were added. Participants without documented disease progression at EOT visit who had not started treatment with another anticancer therapy received follow-up visits every 2 months until initiation of another anticancer therapy, disease progression, death, or final analysis cut-off date, whichever occurred first. Participants with documented disease progression/initiation of new anticancer treatment were followed for survival every 4 months until death or final analysis cut-off date, whichever occurred first.

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
B-cell Acute Lymphoblastic Leukemia (B-ALL)	27
T-cell Acute Lymphoblastic Leukemia (T-ALL)	13

Reported measurements

Cycle 1: Day 1

Analysis denominator · Participants

Group	Source count
B-cell Acute Lymphoblastic Leukemia (B-ALL)	21
T-cell Acute Lymphoblastic Leukemia (T-ALL)	8

Values in mcg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
B-cell Acute Lymphoblastic Leukemia (B-ALL)	452	344	Not reported	Not reported	Not reported
T-cell Acute Lymphoblastic Leukemia (T-ALL)	259	120	Not reported	Not reported	Not reported

Cycle 1: Day 29

Analysis denominator · Participants

Group	Source count
B-cell Acute Lymphoblastic Leukemia (B-ALL)	19
T-cell Acute Lymphoblastic Leukemia (T-ALL)	7

Values in mcg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
B-cell Acute Lymphoblastic Leukemia (B-ALL)	835	366	Not reported	Not reported	Not reported
T-cell Acute Lymphoblastic Leukemia (T-ALL)	745	330	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
344
value
452
group Id
OG001
spread
120
value
259
denoms
counts
group Id
OG000
value
21
group Id
OG001
value
8
units
Participants
title
Cycle 1: Day 1
categories
measurements
group Id
OG000
spread
366
value
835
group Id
OG001
spread
330
value
745
denoms
counts
group Id
OG000
value
19
group Id
OG001
value
7
units
Participants
title
Cycle 1: Day 29

denoms

counts
group Id
OG000
value
27
group Id
OG001
value
13
units
Participants

description

Ceoi is the plasma concentration observed at the end of intravenous infusion of isatuximab.

dispersion Type

Standard Deviation

groups

description
Participants with B-ALL received isatuximab 20 mg/kg IV infusion QW for 4 weeks during the induction period (i.e., on Days 1, 8, 15, and 22) and Q2W during the consolidation period (i.e., on Days 29, 43, and 57. Participants received recommended isatuximab premedication as per protocol. Starting on Day 8, combination chemotherapies were added. Participants without documented disease progression at EOT visit who had not started treatment with another anticancer therapy received follow-up visits every 2 months until initiation of another anticancer therapy, disease progression, death, or final analysis cut-off date, whichever occurred first. Participants with documented disease progression/initiation of new anticancer treatment were followed for survival every 4 months until death or final analysis cut-off date, whichever occurred first.
id
OG000
title
B-cell Acute Lymphoblastic Leukemia (B-ALL)
description
Participants with T-ALL received isatuximab 20 mg/kg IV infusion QW for 4 weeks during the induction period (i.e., on Days 1, 8, 15, and 22) and Q2W during the consolidation period (i.e., on Days 29, 43, and 57. Participants received recommended isatuximab premedication as per protocol. Starting on Day 8, combination chemotherapies were added. Participants without documented disease progression at EOT visit who had not started treatment with another anticancer therapy received follow-up visits every 2 months until initiation of another anticancer therapy, disease progression, death, or final analysis cut-off date, whichever occurred first. Participants with documented disease progression/initiation of new anticancer treatment were followed for survival every 4 months until death or final analysis cut-off date, whichever occurred first.
id
OG001
title
T-cell Acute Lymphoblastic Leukemia (T-ALL)

param Type

MEAN

population Description

The PK population consisted of all participants from the AT population with at least 1 PK parameter available (isatuximab concentration). Only those participants with data available at specified timepoints were analyzed.

reporting Status

POSTED

time Frame

At end of infusion on Cycle 1 Days 1 and 29

title

B-ALL and T-ALL: Concentrations at the End of Infusion (Ceoi) of Isatuximab

type

SECONDARY

unit Of Measure

mcg/mL

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Preserved source evidence · Not medical advice