NCT03860844 · OUTCOME

B-ALL and T-ALL: Area Under the Concentration Time Curve (AUC) 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: mg*hour (h)/Liter (L)
Interval / dispersion: Standard Deviation
Time frame: From Week 0 to Week 1, Week 0 to Week 5, and Week 0 to Week 10

What was measured

Plasma samples were collected at specified timepoints to determine the AUC of isatuximab.

Analysis population: The Pharmacokinetic (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)	12

Reported measurements

Week 0 to Week 1

Values in mg*hour (h)/Liter (L) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
B-cell Acute Lymphoblastic Leukemia (B-ALL)	31703	10048	Not reported	Not reported	Not reported
T-cell Acute Lymphoblastic Leukemia (T-ALL)	29057	8294	Not reported	Not reported	Not reported

Week 0 to Week 5

Values in mg*hour (h)/Liter (L) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
B-cell Acute Lymphoblastic Leukemia (B-ALL)	299071	127581	Not reported	Not reported	Not reported
T-cell Acute Lymphoblastic Leukemia (T-ALL)	289167	93095	Not reported	Not reported	Not reported

Week 0 to Week 10

Values in mg*hour (h)/Liter (L) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
B-cell Acute Lymphoblastic Leukemia (B-ALL)	582686	316749	Not reported	Not reported	Not reported
T-cell Acute Lymphoblastic Leukemia (T-ALL)	540375	233411	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
10048
value
31703
group Id
OG001
spread
8294
value
29057
title
Week 0 to Week 1
categories
measurements
group Id
OG000
spread
127581
value
299071
group Id
OG001
spread
93095
value
289167
title
Week 0 to Week 5
categories
measurements
group Id
OG000
spread
316749
value
582686
group Id
OG001
spread
233411
value
540375
title
Week 0 to Week 10

denoms

counts
group Id
OG000
value
27
group Id
OG001
value
12
units
Participants

description

Plasma samples were collected at specified timepoints to determine the AUC 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 Pharmacokinetic (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

From Week 0 to Week 1, Week 0 to Week 5, and Week 0 to Week 10

title

B-ALL and T-ALL: Area Under the Concentration Time Curve (AUC) of Isatuximab

type

SECONDARY

unit Of Measure

mg*hour (h)/Liter (L)

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Preserved source evidence · Not medical advice