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NCT03860844 · OUTCOME

AML: Plasma Concentration Reached by Isatuximab Before Next Dose Administration (Ctrough)

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
Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1 and Cycle 2 Day 15

What was measured

Plasma samples were collected at specified timepoints to determine the Ctrough 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

Acute Myeloid Leukemia (AML)

Participants with AML received isatuximab 20 mg/kg IV infusion on Days 1, 8, and 15 of each Cycle (up to 2 treatment cycles, each cycle 28 days). 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

GroupSource count
Acute Myeloid Leukemia (AML)27

Reported measurements

Cycle 1: Day 8

Analysis denominator · Participants

GroupSource count
Acute Myeloid Leukemia (AML)19
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Acute Myeloid Leukemia (AML)12641.0Not reportedNot reportedNot reported
Cycle 1: Day 15

Analysis denominator · Participants

GroupSource count
Acute Myeloid Leukemia (AML)24
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Acute Myeloid Leukemia (AML)21760.6Not reportedNot reportedNot reported
Cycle 2: Day 1

Analysis denominator · Participants

GroupSource count
Acute Myeloid Leukemia (AML)10
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Acute Myeloid Leukemia (AML)11594.2Not reportedNot reportedNot reported
Cycle 2: Day 15

Analysis denominator · Participants

GroupSource count
Acute Myeloid Leukemia (AML)8
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Acute Myeloid Leukemia (AML)420205Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        41.0
        value
        126
    denoms
    1. counts
      1. group Id
        OG000
        value
        19
      units
      Participants
    title
    Cycle 1: Day 8
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        60.6
        value
        217
    denoms
    1. counts
      1. group Id
        OG000
        value
        24
      units
      Participants
    title
    Cycle 1: Day 15
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        94.2
        value
        115
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      units
      Participants
    title
    Cycle 2: Day 1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        205
        value
        420
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      units
      Participants
    title
    Cycle 2: Day 15
denoms
  1. counts
    1. group Id
      OG000
      value
      27
    units
    Participants
description
Plasma samples were collected at specified timepoints to determine the Ctrough of isatuximab.
dispersion Type
Standard Deviation
groups
  1. description
    Participants with AML received isatuximab 20 mg/kg IV infusion on Days 1, 8, and 15 of each Cycle (up to 2 treatment cycles, each cycle 28 days). 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
    Acute Myeloid Leukemia (AML)
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
Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1 and Cycle 2 Day 15
title
AML: Plasma Concentration Reached by Isatuximab Before Next Dose Administration (Ctrough)
type
SECONDARY
unit Of Measure
mcg/mL

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

Preserved source evidence · Not medical advice