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Trial record 1 of 1 for:    NCT03860844
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Isatuximab in Combination With Chemotherapy in Pediatric Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia (ISAKIDS)

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ClinicalTrials.gov Identifier: NCT03860844
Recruitment Status : Terminated (Study was prematurely stopped due to sponsor decision (stage 2 efficacy criteria not met); not due to safety concerns.)
First Posted : March 4, 2019
Results First Posted : November 15, 2023
Last Update Posted : May 16, 2024
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Acute Lymphoblastic Leukemia
Acute Myeloid Leukemia
Interventions Drug: Isatuximab
Drug: Dexamethasone or equivalent
Drug: Fludarabine
Drug: Cytarabine
Drug: Liposomal daunorubicin
Drug: Daunorubicin (nonliposomal)
Drug: Idarubicin
Drug: Filgrastim or equivalent
Drug: Mitoxantrone
Drug: Doxorubicin
Drug: Vincristine
Drug: Pegaspargase (PEG) Asparaginase
Drug: Cyclophosphamide
Drug: Etoposide
Drug: Methotrexate
Drug: L - Asparginase
Drug: Hydroxyurea
Drug: L - Asparaginase (Erwinase)
Enrollment 67
Recruitment Details This Phase II, open-label, single-arm study was conducted in 3 separate cohorts at 41 investigational sites in 16 countries. A total of 67 participants were enrolled between 06 Aug 2019 and 08 Jun 2022.
Pre-assignment Details The study consisted of a screening period (up to 3 weeks prior to the first study treatment administration), treatment period [Day 1 to Day 57 for Acute Lymphoblastic Leukemia(ALL); Day 1 to Day 22 for Acute Myeloid Leukemia(AML)],a period of aplasia followed by recovery period;an end of treatment (EOT) visit within 30 days after hematological recovery and a follow-up period.The study was prematurely stopped due to sponsor decision (stage 2 efficacy criteria not met);not due to safety concerns.
Arm/Group Title B-cell Acute Lymphoblastic Leukemia (B-ALL) T-cell Acute Lymphoblastic Leukemia (T-ALL) Acute Myeloid Leukemia (AML)
Hide Arm/Group Description Participants with B-ALL received isatuximab 20 milligram per kilogram (mg/kg) intravenous (IV) infusion once every week (QW) for 4 weeks during the induction period (i.e., on Days 1, 8, 15, and 22) and every 2 weeks (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. 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. 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.
Period Title: Overall Study
Started 27 13 27
Completed 19 7 20
Not Completed 8 6 7
Reason Not Completed
Adverse event, not related to Coronavirus Disease-2019 (COVID-19)             3             2             3
Progressive disease             5             3             4
Other, Not related to COVID-19             0             1             0
Arm/Group Title B-cell Acute Lymphoblastic Leukemia (B-ALL) T-cell Acute Lymphoblastic Leukemia (T-ALL) Acute Myeloid Leukemia (AML) Total
Hide Arm/Group 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. 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 27 13 27 67
Hide Baseline Analysis Population Description
The All-treated (AT) population consisted of all participants who received at least 1 dose (even incomplete) of study treatment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants 13 participants 27 participants 67 participants
8.22  (3.92) 8.72  (4.15) 9.04  (5.41) 8.65  (4.56)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 13 participants 27 participants 67 participants
Female 10 4 12 26
Male 17 9 15 41
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 13 participants 27 participants 67 participants
American Indian or Alaska Native 3 0 0 3
Asian 1 1 4 6
Native Hawaiian or Other Pacific Islander 0 0 0 0
Black or African American 1 1 2 4
White 17 7 15 39
More than one race 1 0 0 1
Unknown or Not Reported 4 4 6 14
1.Primary Outcome
Title Percentage of Participants With Complete Response (CR) Rate
Hide Description The complete response rate (CR + CRi [complete response with incomplete peripheral recovery]) was defined as the percentage of participants achieving complete response (CR + CRi) assessed by the investigator per National Comprehensive Cancer Network (NCCN) guidelines version 1.2018 criteria. CR was defined as <5% blasts in a bone marrow aspirate (BMA) with spicules; no circulating blasts (ALL)/no blasts with Auer rods (AML) or extramedullary disease, no lymphadenopathy, splenomegaly, skin/gum infiltration/testicular mass/central nervous system involvement (ALL), trilineage hematopoiesis (ALL); Absolute neutrophil count (ANC) >=1000/microliter (mcL); platelets >100000/mcL; red blood cell transfusion independence. If the physician documented transfusion dependency related to study treatment and not to the participant's underlying disease, CRi was reported. CRi met the same criteria as for CR, except neutrophils and/or platelets recovery (ANC <1000/mcL or platelets <100000/mcL).
Time Frame From enrollment until the primary analysis completion date of 12 Sep 2022; the median duration of exposure was approximately 7 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The evaluable population consisted of evaluable participants from the AT population who received at least 1 full dose of isatuximab in Cycle 1 and who had at least 1 valid response value that was evaluable.
Arm/Group Title B-cell Acute Lymphoblastic Leukemia (B-ALL) T-cell Acute Lymphoblastic Leukemia (T-ALL) Acute Myeloid Leukemia (AML)
Hide Arm/Group 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.
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.
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.
Overall Number of Participants Analyzed 25 11 23
Measure Type: Number
Unit of Measure: percentage of participants
52.0 45.5 60.9
2.Secondary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Hide Description An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study treatment, whether or not considered related to the study treatment. SAEs were any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were defined as an AE which occurred after the first dose of study treatment administration until the last dose plus 30 days, or until the start of hematological recovery period or a new anti-leukemia/lymphoma therapy, whichever occurred first.
Time Frame From the time of the first treatment administration (Day 1) up to 30 days after the last treatment (maximum duration of exposure of 13.1 weeks for B-ALL cohort, 10.7 weeks for T-ALL cohort and 7.1 weeks for AML cohort)
Hide Outcome Measure Data
Hide Analysis Population Description
The AT population consisted of all participants who received at least 1 dose (even incomplete) of study treatment.
Arm/Group Title B-cell Acute Lymphoblastic Leukemia (B-ALL) T-cell Acute Lymphoblastic Leukemia (T-ALL) Acute Myeloid Leukemia (AML)
Hide Arm/Group 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.
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.
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.
Overall Number of Participants Analyzed 27 13 27
Measure Type: Count of Participants
Unit of Measure: Participants
Any TEAE 27 13 26
Any TESAE 19 12 17
3.Secondary Outcome
Title Number of Participants With Infusion Reactions (IRs)
Hide Description An IR was an AE related to isatuximab typically with onset within 24 hours from the start of the isatuximab infusion and was reported by the investigator.
Time Frame From the time of the first treatment administration (Day 1) up to 30 days after the last treatment (maximum duration of exposure of 13.1 weeks for B-ALL cohort, 10.7 weeks for T-ALL cohort and 7.1 weeks for AML cohort)
Hide Outcome Measure Data
Hide Analysis Population Description
The AT population consisted of all participants who received at least 1 dose (even incomplete) of study treatment.
Arm/Group Title B-cell Acute Lymphoblastic Leukemia (B-ALL) T-cell Acute Lymphoblastic Leukemia (T-ALL) Acute Myeloid Leukemia (AML)
Hide Arm/Group 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.
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.
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.
Overall Number of Participants Analyzed 27 13 27
Measure Type: Count of Participants
Unit of Measure: Participants
9 5 15
4.Secondary Outcome
Title B-ALL and T-ALL: Area Under the Concentration Time Curve (AUC) of Isatuximab
Hide Description Plasma samples were collected at specified timepoints to determine the AUC of isatuximab.
Time Frame From Week 0 to Week 1, Week 0 to Week 5, and Week 0 to Week 10
Hide Outcome Measure Data
Hide Analysis 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.
Arm/Group Title B-cell Acute Lymphoblastic Leukemia (B-ALL) T-cell Acute Lymphoblastic Leukemia (T-ALL)
Hide Arm/Group 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.
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.
Overall Number of Participants Analyzed 27 12
Mean (Standard Deviation)
Unit of Measure: mg*hour (h)/Liter (L)
Week 0 to Week 1 31703  (10048) 29057  (8294)
Week 0 to Week 5 299071  (127581) 289167  (93095)
Week 0 to Week 10 582686  (316749) 540375  (233411)
5.Secondary Outcome
Title AML: AUC of Isatuximab
Hide Description Plasma samples were collected at specified timepoints to determine the AUC of isatuximab.
Time Frame From Week 0 to Week 1, Week 0 to Week 3, and Week 0 to Week 8
Hide Outcome Measure Data
Hide Analysis 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.
Arm/Group Title Acute Myeloid Leukemia (AML)
Hide Arm/Group 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.
Overall Number of Participants Analyzed 26
Mean (Standard Deviation)
Unit of Measure: mg*h/L
Week 0 to Week 1 28592  (6858)
Week 0 to Week 3 130862  (40827)
Week 0 to Week 8 291962  (112222)
6.Secondary Outcome
Title B-ALL and T-ALL: Plasma Concentration Reached by Isatuximab Before Next Dose Administration (Ctrough)
Hide Description Plasma samples were collected at specified timepoints to determine the Ctrough of isatuximab.
Time Frame Cycle 1 Day 8, Cycle 1 Day 15, Cycle 1 Day 22, Cycle 1 Day 29, Cycle 2 Day 43, Cycle 2 Day 57
Hide Outcome Measure Data
Hide Analysis 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.
Arm/Group Title B-cell Acute Lymphoblastic Leukemia (B-ALL) T-cell Acute Lymphoblastic Leukemia (T-ALL)
Hide Arm/Group 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.
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.
Overall Number of Participants Analyzed 27 13
Mean (Standard Deviation)
Unit of Measure: microgram/milliliter (mcg/mL)
Cycle 1: Day 8 Number Analyzed 25 participants 11 participants
114  (45.7) 127  (49.9)
Cycle 1: Day 15 Number Analyzed 23 participants 11 participants
272  (118) 263  (103)
Cycle 1: Day 22 Number Analyzed 15 participants 8 participants
388  (163) 323  (206)
Cycle 1: Day 29 Number Analyzed 18 participants 9 participants
475  (174) 426  (209)
Cycle 2: Day 43 Number Analyzed 5 participants 1 participants
504  (296) 357 [1]   (NA)
Cycle 2: Day 57 Number Analyzed 8 participants 2 participants
531  (224) 478  (261)
[1]
Standard deviation (SD) could not be calculated for a single participant.
7.Secondary Outcome
Title AML: Plasma Concentration Reached by Isatuximab Before Next Dose Administration (Ctrough)
Hide Description Plasma samples were collected at specified timepoints to determine the Ctrough of isatuximab.
Time Frame Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1 and Cycle 2 Day 15
Hide Outcome Measure Data
Hide Analysis 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.
Arm/Group Title Acute Myeloid Leukemia (AML)
Hide Arm/Group 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.
Overall Number of Participants Analyzed 27
Mean (Standard Deviation)
Unit of Measure: mcg/mL
Cycle 1: Day 8 Number Analyzed 19 participants
126  (41.0)
Cycle 1: Day 15 Number Analyzed 24 participants
217  (60.6)
Cycle 2: Day 1 Number Analyzed 10 participants
115  (94.2)
Cycle 2: Day 15 Number Analyzed 8 participants
420  (205)
8.Secondary Outcome
Title B-ALL and T-ALL: Concentrations at the End of Infusion (Ceoi) of Isatuximab
Hide Description Ceoi is the plasma concentration observed at the end of intravenous infusion of isatuximab.
Time Frame At end of infusion on Cycle 1 Days 1 and 29
Hide Outcome Measure Data
Hide Analysis 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.
Arm/Group Title B-cell Acute Lymphoblastic Leukemia (B-ALL) T-cell Acute Lymphoblastic Leukemia (T-ALL)
Hide Arm/Group 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.
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.
Overall Number of Participants Analyzed 27 13
Mean (Standard Deviation)
Unit of Measure: mcg/mL
Cycle 1: Day 1 Number Analyzed 21 participants 8 participants
452  (344) 259  (120)
Cycle 1: Day 29 Number Analyzed 19 participants 7 participants
835  (366) 745  (330)
9.Secondary Outcome
Title AML: Ceoi of Isatuximab
Hide Description Ceoi is the plasma concentration observed at the end of intravenous infusion of isatuximab.
Time Frame At end of infusion on Cycle 1 Days 1 and 15
Hide Outcome Measure Data
Hide Analysis 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.
Arm/Group Title Acute Myeloid Leukemia (AML)
Hide Arm/Group 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.
Overall Number of Participants Analyzed 27
Mean (Standard Deviation)
Unit of Measure: mcg/mL
Cycle 1: Day 1 Number Analyzed 19 participants
363  (110)
Cycle 1: Day 15 Number Analyzed 20 participants
562  (176)
10.Secondary Outcome
Title Number of Participants With Negative Minimal Residual Disease (MRD)
Hide Description MRD assessment was performed centrally by next generation sequencing using clonoSEQ and T-cell receptor assays for B-ALL and T-ALL cohorts respectively. It was performed by flow cytometry for AML cohort. Number of participants with CR or CRi who achieved negative MRD in bone marrow and blood was analyzed. In AML indication, peripheral blood tissue is not representative of the tumor burden and cannot be used to assess MRD.
Time Frame From screening until the study completion date, approximately 45 months
Hide Outcome Measure Data
Hide Analysis Population Description
The evaluable population consisted of evaluable participants from the AT population who received at least 1 full dose of isatuximab in Cycle 1 and who had at least 1 valid response value that was evaluable. Only those participants who achieved CR/CRi were analyzed.
Arm/Group Title B-cell Acute Lymphoblastic Leukemia (B-ALL) T-cell Acute Lymphoblastic Leukemia (T-ALL) Acute Myeloid Leukemia (AML)
Hide Arm/Group 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.
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.
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.
Overall Number of Participants Analyzed 13 5 14
Measure Type: Count of Participants
Unit of Measure: Participants
Blood, 10^-6 Number Analyzed 13 participants 5 participants 0 participants
3 1
Bone marrow, 10^-6 Number Analyzed 13 participants 5 participants 14 participants
0 2 0
Bone marrow, 10^-3 Number Analyzed 0 participants 0 participants 14 participants
0
11.Secondary Outcome
Title Overall Response Rate (ORR)
Hide Description ORR:Percentage of participants with CR/CRi or partial response (PR) for blood and bone marrow disease based on NCCN guideline. CR: <5% blasts in BMA with spicules; no circulating blasts (ALL)/no blasts with Auer rods (AML) or extramedullary disease, no lymphadenopathy, splenomegaly, skin/gum infiltration/testicular mass/central nervous system involvement (ALL), trilineage hematopoiesis (ALL);ANC >=1000/mcL; platelets >100000/mcL; RBC transfusion independence. If the physician documented transfusion dependency related to study treatment;not to participant's underlying disease, CRi was reported. CRi met the same criteria as CR, except neutrophils and/or platelets recovery (ANC <1000/mcL or platelets <100000/mcL). PR: >50% decrease in the sum of the product of the greatest perpendicular diameters of the mediastinal enlargement. For participants with a previous positive positron emission tomography (PET) scan, a post-treatment PET was to be positive in at least 1 previously involved site.
Time Frame From enrollment until the primary analysis completion date of 12 Sep 2022; the median duration of exposure was approximately 7 weeks
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Hide Analysis Population Description
The evaluable population consisted of evaluable participants from the AT population who received at least 1 full dose of isatuximab in Cycle 1 and who had at least 1 valid response value that was evaluable.
Arm/Group Title B-cell Acute Lymphoblastic Leukemia (B-ALL) T-cell Acute Lymphoblastic Leukemia (T-ALL) Acute Myeloid Leukemia (AML)
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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.
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.
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.
Overall Number of Participants Analyzed 25 11 23
Measure Type: Number
Number (80% Confidence Interval)
Unit of Measure: percentage of participants
52.0
(37.5 to 66.2)
54.5
(31.8 to 75.9)
65.2
(49.7 to 78.6)
12.Secondary Outcome
Title Overall Survival (OS)
Hide Description Overall survival was defined as the time interval from the date of first study treatment administration to death from any cause. It was estimated using the Kaplan-Meier method. Confidence interval (CI) for Kaplan-Meier estimates were calculated with log-log transformation of survival function and methods of Brookmeyer and Crowley.
Time Frame From first study treatment administration up to death due to any cause, a maximum of 45 months
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Hide Analysis Population Description
The evaluable population consisted of evaluable participants from the AT population who received at least 1 full dose of isatuximab in Cycle 1 and who had at least 1 valid response value that was evaluable. Only those participants with data available were analyzed.
Arm/Group Title B-cell Acute Lymphoblastic Leukemia (B-ALL) T-cell Acute Lymphoblastic Leukemia (T-ALL) Acute Myeloid Leukemia (AML)
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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.
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.
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.
Overall Number of Participants Analyzed 25 11 23
Median (95% Confidence Interval)
Unit of Measure: months
12.09 [1] 
(3.975 to NA)
6.85 [1] 
(2.201 to NA)
9.40 [1] 
(5.947 to NA)
[1]
NA indicates that the upper limit of CI was not estimable due to insufficient number of participants with events at study closure.
13.Secondary Outcome
Title Event-Free Survival (EFS)
Hide Description EFS was defined as the time interval from the date of first study treatment administration to the date of the first of: completion or going off protocol induction/consolidation therapy without CR, relapse from CR, or death due to any cause, whichever occurred first. It was estimated using the Kaplan-Meier method. CI for Kaplan-Meier estimates are calculated with log-log transformation of survival function and methods of Brookmeyer and Crowley.
Time Frame From study treatment administration up to the date of first documented disease progression or death due to any cause, a maximum of 45 months
Hide Outcome Measure Data
Hide Analysis Population Description
The evaluable population consisted of evaluable participants from the AT population who received at least 1 full dose of isatuximab in Cycle 1 and who had at least 1 valid response value that was evaluable.
Arm/Group Title B-cell Acute Lymphoblastic Leukemia (B-ALL) T-cell Acute Lymphoblastic Leukemia (T-ALL) Acute Myeloid Leukemia (AML)
Hide Arm/Group 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.
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.
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.
Overall Number of Participants Analyzed 25 11 23
Median (95% Confidence Interval)
Unit of Measure: months
2.23 [1] 
(1.413 to NA)
2.14 [1] 
(1.347 to NA)
5.65 [1] 
(1.347 to NA)
[1]
NA indicates that upper limit of CI was not estimable due to insufficient number of participants with events at study closure.
14.Secondary Outcome
Title Duration of Response (DoR)
Hide Description Duration of response was defined as the time from the date of the first response to the date of first disease progression or death from any cause, whichever happens first. It was estimated using the Kaplan-Meier method. CI for Kaplan-Meier estimates are calculated with log-log transformation of survival function and methods of Brookmeyer and Crowley.
Time Frame From first documented response up to the date of first documented disease progression or death due to any cause, a maximum of 45 months
Hide Outcome Measure Data
Hide Analysis Population Description
The evaluable population consisted of evaluable participants from the AT population who received at least 1 full dose of isatuximab in Cycle 1 and who had at least 1 valid response value that was evaluable. Only responders were included in this analysis.
Arm/Group Title B-cell Acute Lymphoblastic Leukemia (B-ALL) T-cell Acute Lymphoblastic Leukemia (T-ALL) Acute Myeloid Leukemia (AML)
Hide Arm/Group 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.
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.
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.
Overall Number of Participants Analyzed 13 5 14
Median (95% Confidence Interval)
Unit of Measure: months
7.26 [1] 
(NA to NA)
1.18 [2] 
(0.887 to NA)
4.40 [1] 
(NA to NA)
[1]
Lower and upper limits of CI not estimable due to insufficient number of participants with events at study closure
[2]
Upper limit of CI not estimable due to insufficient number of participants with events at study closure
15.Secondary Outcome
Title Cluster of Differentiation (CD)38 Receptor Density
Hide Description Blood samples were collected to assess CD38 receptor density as a predictive biomarker. It was assessed across complete responders and non-complete responders. The Antibody Binding Capacity (ABC) was calculated using the following equation: ABC = 10^(Logarithm(Mean Fluorescence Intensity)*a+b) where "a" was the slope and "b" was the Y-intercept of the calibration curve equation. Specific and absolute quantitative values (specific antibody-binding capacity [sABC]) of binding of the selected antibodies were calculated after subtraction of the negative isotypic immunoglobulin G (IgG) control.
Time Frame Pre-dose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The evaluable population consisted of evaluable participants from the AT population who received at least 1 full dose of isatuximab in Cycle 1 and who had at least 1 valid response value that was evaluable. Only those participants with data available at specified timepoints were analyzed.
Arm/Group Title B-cell Acute Lymphoblastic Leukemia (B-ALL) T-cell Acute Lymphoblastic Leukemia (T-ALL) Acute Myeloid Leukemia (AML)
Hide Arm/Group 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.
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.
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.
Overall Number of Participants Analyzed 25 11 23
Mean (Standard Deviation)
Unit of Measure: sABC
Blood blast cells: CR/CRi Number Analyzed 5 participants 2 participants 3 participants
20345.6  (23439.7) 12780.0  (15559.2) 19502.0  (20919.7)
Blood blast cells: Non CR/CRi; Number Analyzed 2 participants 1 participants 2 participants
31080.0  (2397.1) 22952.0 [1]   (NA) 9815.0  (4203.0)
Blood immune cells (Natural Killer [NK] cells): CR/CRi Number Analyzed 5 participants 2 participants 3 participants
13506.2  (3018.6) 22639.0  (1796.1) 11220.3  (3764.6)
Blood immune cells (NK cells): Non CR/CRi Number Analyzed 2 participants 1 participants 2 participants
16650.0  (851.4) 33859.0 [1]   (NA) 22530.0  (685.9)
[1]
SD cannot be calculated for a single participant.
16.Secondary Outcome
Title CD38 Receptor Occupancy
Hide Description Blood samples were collected to assess CD38 receptor occupancy as a pharmacodynamics marker. It was assessed across complete responders and non-complete responders. Multicolor flow cytometry assay was validated for CD38 receptor occupancy (CD38RO) quantification, based on the use of two murine monoclonal antibodies (MAbs), one competing with SAR650984 to determine the number of free CD38 receptors (MAb1) and one recognizing a different binding epitope on CD38 to measure the total number of receptors (MAb2) at the cell surface of the cancer cells. Cells were tagged with either MAb1 (Tube #1) or MAb2 (Tube #2). The percentage RO was calculated using the following equation: % CD38RO = [(sABC MAb2 - sABC MAb1)/sABC MAb2] X 100.
Time Frame Pre-dose on Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
The evaluable population consisted of evaluable participants from the AT population who received at least 1 full dose of isatuximab in Cycle 1 and who had at least 1 valid response value that was evaluable. Only those participants with data available at specified timepoints were analyzed.
Arm/Group Title B-cell Acute Lymphoblastic Leukemia (B-ALL) T-cell Acute Lymphoblastic Leukemia (T-ALL) Acute Myeloid Leukemia (AML)
Hide Arm/Group 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.
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.
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.
Overall Number of Participants Analyzed 25 11 23
Mean (Standard Deviation)
Unit of Measure: percent receptor occupancy
Blood plasma cells: CR/CRi Number Analyzed 0 participants 2 participants 0 participants
40.5  (30.4)
Blood plasma cells: Non CR/CRi; Number Analyzed 1 participants 1 participants 0 participants
44.0 [1]   (NA) 55.0 [1]   (NA)
Blood NK cells: CR/CRi Number Analyzed 5 participants 3 participants 0 participants
55.6  (6.9) 66.7  (2.1)
Blood NK cells: Non CR/CRi Number Analyzed 3 participants 1 participants 0 participants
61.3  (3.5) 70.0 [1]   (NA)
[1]
SD cannot be calculated for a single participant.
Time Frame TEAEs were collected from the time of the first treatment administration (Day 1) up to 30 days after the last treatment (maximum duration of exposure of 13.1 weeks for B-ALL cohort, 10.7 weeks for T-ALL cohort and 7.1 weeks for AML cohort). All-cause mortality (Deaths) was collected for the entire study duration, a maximum of 45 months
Adverse Event Reporting Description Analysis was performed on the AT population.
 
Arm/Group Title B-cell Acute Lymphoblastic Leukemia (B-ALL) T-cell Acute Lymphoblastic Leukemia (T-ALL) Acute Myeloid Leukemia (AML) All Participants
Hide Arm/Group 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. 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. 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. All participants in the study were included in this cohort.
All-Cause Mortality
B-cell Acute Lymphoblastic Leukemia (B-ALL) T-cell Acute Lymphoblastic Leukemia (T-ALL) Acute Myeloid Leukemia (AML) All Participants
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   17/27 (62.96%)      8/13 (61.54%)      18/27 (66.67%)      43/67 (64.18%)    
Hide Serious Adverse Events
B-cell Acute Lymphoblastic Leukemia (B-ALL) T-cell Acute Lymphoblastic Leukemia (T-ALL) Acute Myeloid Leukemia (AML) All Participants
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   19/27 (70.37%)      12/13 (92.31%)      17/27 (62.96%)      48/67 (71.64%)    
Blood and lymphatic system disorders         
Febrile Bone Marrow Aplasia † 1  0/27 (0.00%)  0 0/13 (0.00%)  0 1/27 (3.70%)  1 1/67 (1.49%)  1
Febrile Neutropenia † 1  10/27 (37.04%)  12 5/13 (38.46%)  6 7/27 (25.93%)  11 22/67 (32.84%)  29
Neutropenia † 1  1/27 (3.70%)  1 0/13 (0.00%)  0 0/27 (0.00%)  0 1/67 (1.49%)  1
Pancytopenia † 1  0/27 (0.00%)  0 0/13 (0.00%)  0 1/27 (3.70%)  1 1/67 (1.49%)  1
Cardiac disorders         
Cardiac Failure † 1  1/27 (3.70%)  1 0/13 (0.00%)  0 0/27 (0.00%)  0 1/67 (1.49%)  1
Gastrointestinal disorders         
Anal Fissure † 1  1/27 (3.70%)  1 0/13 (0.00%)  0 0/27 (0.00%)  0 1/67 (1.49%)  1
Mouth Haemorrhage † 1  1/27 (3.70%)  1 0/13 (0.00%)  0 0/27 (0.00%)  0 1/67 (1.49%)  1
Neutropenic Colitis † 1  1/27 (3.70%)  1 1/13 (7.69%)  1 0/27 (0.00%)  0 2/67 (2.99%)  2
Pancreatitis Acute † 1  0/27 (0.00%)  0 1/13 (7.69%)  1 0/27 (0.00%)  0 1/67 (1.49%)  1
Stomatitis † 1  2/27 (7.41%)  2 0/13 (0.00%)  0 0/27 (0.00%)  0 2/67 (2.99%)  2
General disorders         
Pyrexia † 1  2/27 (7.41%)  2 1/13 (7.69%)  1 1/27 (3.70%)  1 4/67 (5.97%)  4
Hepatobiliary disorders         
Hepatic Failure † 1  0/27 (0.00%)  0 1/13 (7.69%)  1 0/27 (0.00%)  0 1/67 (1.49%)  1
Immune system disorders         
Anaphylactic Shock † 1  0/27 (0.00%)  0 1/13 (7.69%)  1 0/27 (0.00%)  0 1/67 (1.49%)  1
Cytokine Release Syndrome † 1  0/27 (0.00%)  0 0/13 (0.00%)  0 2/27 (7.41%)  2 2/67 (2.99%)  2
Haemophagocytic Lymphohistiocytosis † 1  0/27 (0.00%)  0 0/13 (0.00%)  0 1/27 (3.70%)  1 1/67 (1.49%)  1
Infections and infestations         
Appendicitis † 1  1/27 (3.70%)  1 0/13 (0.00%)  0 0/27 (0.00%)  0 1/67 (1.49%)  1
Bacterial Sepsis † 1  1/27 (3.70%)  1 0/13 (0.00%)  0 0/27 (0.00%)  0 1/67 (1.49%)  1
Catheter Site Infection † 1  1/27 (3.70%)  1 0/13 (0.00%)  0 0/27 (0.00%)  0 1/67 (1.49%)  1
Cellulitis † 1  0/27 (0.00%)  0 0/13 (0.00%)  0 1/27 (3.70%)  1 1/67 (1.49%)  1
Device Related Infection † 1  0/27 (0.00%)  0 1/13 (7.69%)  1 0/27 (0.00%)  0 1/67 (1.49%)  1
Disseminated Aspergillosis † 1  0/27 (0.00%)  0 1/13 (7.69%)  1 0/27 (0.00%)  0 1/67 (1.49%)  1
Encephalitis † 1  0/27 (0.00%)  0 0/13 (0.00%)  0 1/27 (3.70%)  1 1/67 (1.49%)  1
Escherichia Sepsis † 1  0/27 (0.00%)  0 1/13 (7.69%)  1 0/27 (0.00%)  0 1/67 (1.49%)  1
Fournier's Gangrene † 1  1/27 (3.70%)  1 0/13 (0.00%)  0 0/27 (0.00%)  0 1/67 (1.49%)  1
Fungal Infection † 1  1/27 (3.70%)  1 1/13 (7.69%)  1 0/27 (0.00%)  0 2/67 (2.99%)  2
Fungal Sepsis † 1  0/27 (0.00%)  0 0/13 (0.00%)  0 1/27 (3.70%)  1 1/67 (1.49%)  1
Genital Herpes Zoster † 1  0/27 (0.00%)  0 0/13 (0.00%)  0 1/27 (3.70%)  1 1/67 (1.49%)  1
Neutropenic Sepsis † 1  0/27 (0.00%)  0 1/13 (7.69%)  1 0/27 (0.00%)  0 1/67 (1.49%)  1
Otitis Externa † 1  1/27 (3.70%)  1 0/13 (0.00%)  0 0/27 (0.00%)  0 1/67 (1.49%)  1
Peritonitis † 1  0/27 (0.00%)  0 1/13 (7.69%)  1 0/27 (0.00%)  0 1/67 (1.49%)  1
Pneumocystis Jirovecii Pneumonia † 1  1/27 (3.70%)  1 0/13 (0.00%)  0 0/27 (0.00%)  0 1/67 (1.49%)  1
Pneumonia † 1  1/27 (3.70%)  1 0/13 (0.00%)  0 2/27 (7.41%)  2 3/67 (4.48%)  3
Pseudomonal Sepsis † 1  1/27 (3.70%)  1 0/13 (0.00%)  0 0/27 (0.00%)  0 1/67 (1.49%)  1
Rhinovirus Infection † 1  0/27 (0.00%)  0 1/13 (7.69%)  1 0/27 (0.00%)  0 1/67 (1.49%)  1
Sepsis † 1  1/27 (3.70%)  1 2/13 (15.38%)  2 1/27 (3.70%)  1 4/67 (5.97%)  4
Septic Shock † 1  3/27 (11.11%)  3 2/13 (15.38%)  2 3/27 (11.11%)  3 8/67 (11.94%)  8
Sinusitis Fungal † 1  1/27 (3.70%)  1 0/13 (0.00%)  0 0/27 (0.00%)  0 1/67 (1.49%)  1
Staphylococcal Bacteraemia † 1  0/27 (0.00%)  0 1/13 (7.69%)  1 1/27 (3.70%)  1 2/67 (2.99%)  2
Staphylococcal Infection † 1  1/27 (3.70%)  1 0/13 (0.00%)  0 0/27 (0.00%)  0 1/67 (1.49%)  1
Injury, poisoning and procedural complications         
Infusion Related Reaction † 1  1/27 (3.70%)  1 1/13 (7.69%)  1 1/27 (3.70%)  1 3/67 (4.48%)  3
Musculoskeletal and connective tissue disorders         
Bone Pain † 1  0/27 (0.00%)  0 1/13 (7.69%)  1 0/27 (0.00%)  0 1/67 (1.49%)  1
Nervous system disorders         
Generalised Tonic-Clonic Seizure † 1  1/27 (3.70%)  1 0/13 (0.00%)  0 0/27 (0.00%)  0 1/67 (1.49%)  1
Headache † 1  1/27 (3.70%)  1 0/13 (0.00%)  0 0/27 (0.00%)  0 1/67 (1.49%)  1
Leukoencephalopathy † 1  0/27 (0.00%)  0 1/13 (7.69%)  1 0/27 (0.00%)  0 1/67 (1.49%)  1
Seizure † 1  1/27 (3.70%)  1 0/13 (0.00%)  0 0/27 (0.00%)  0 1/67 (1.49%)  1
Respiratory, thoracic and mediastinal disorders         
Epistaxis † 1  0/27 (0.00%)  0 1/13 (7.69%)  1 0/27 (0.00%)  0 1/67 (1.49%)  1
Vascular disorders         
Aortic Aneurysm † 1  1/27 (3.70%)  1 0/13 (0.00%)  0 0/27 (0.00%)  0 1/67 (1.49%)  1
Hypotension † 1  0/27 (0.00%)  0 1/13 (7.69%)  1 1/27 (3.70%)  1 2/67 (2.99%)  2
1
Term from vocabulary, MedDra 26.0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
B-cell Acute Lymphoblastic Leukemia (B-ALL) T-cell Acute Lymphoblastic Leukemia (T-ALL) Acute Myeloid Leukemia (AML) All Participants
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   26/27 (96.30%)      12/13 (92.31%)      24/27 (88.89%)      62/67 (92.54%)    
Blood and lymphatic system disorders         
Anaemia † 1  1/27 (3.70%)  1 0/13 (0.00%)  0 2/27 (7.41%)  5 3/67 (4.48%)  6
Febrile Neutropenia † 1  4/27 (14.81%)  6 1/13 (7.69%)  1 5/27 (18.52%)  5 10/67 (14.93%)  12
Haemolysis † 1  0/27 (0.00%)  0 1/13 (7.69%)  1 0/27 (0.00%)  0 1/67 (1.49%)  1
Cardiac disorders         
Tachycardia † 1  2/27 (7.41%)  2 1/13 (7.69%)  1 2/27 (7.41%)  2 5/67 (7.46%)  5
Eye disorders         
Eyelid Oedema † 1  0/27 (0.00%)  0 1/13 (7.69%)  2 0/27 (0.00%)  0 1/67 (1.49%)  2
Periorbital Oedema † 1  2/27 (7.41%)  2 0/13 (0.00%)  0 0/27 (0.00%)  0 2/67 (2.99%)  2
Gastrointestinal disorders         
Abdominal Pain † 1  6/27 (22.22%)  6 1/13 (7.69%)  3 5/27 (18.52%)  8 12/67 (17.91%)  17
Abdominal Pain Upper † 1  1/27 (3.70%)  1 1/13 (7.69%)  1 2/27 (7.41%)  2 4/67 (5.97%)  4
Anal Fissure † 1  3/27 (11.11%)  5 0/13 (0.00%)  0 2/27 (7.41%)  2 5/67 (7.46%)  7
Anal Inflammation † 1  1/27 (3.70%)  1 2/13 (15.38%)  3 0/27 (0.00%)  0 3/67 (4.48%)  4
Colitis † 1  1/27 (3.70%)  1 2/13 (15.38%)  2 2/27 (7.41%)  2 5/67 (7.46%)  5
Constipation † 1  3/27 (11.11%)  3 2/13 (15.38%)  3 7/27 (25.93%)  7 12/67 (17.91%)  13
Diarrhoea † 1  4/27 (14.81%)  5 3/13 (23.08%)  3 8/27 (29.63%)  9 15/67 (22.39%)  17
Dyspepsia † 1  0/27 (0.00%)  0 1/13 (7.69%)  1 4/27 (14.81%)  6 5/67 (7.46%)  7
Gastritis † 1  0/27 (0.00%)  0 1/13 (7.69%)  1 1/27 (3.70%)  2 2/67 (2.99%)  3
Nausea † 1  9/27 (33.33%)  17 3/13 (23.08%)  5 6/27 (22.22%)  9 18/67 (26.87%)  31
Oral Pain † 1  0/27 (0.00%)  0 1/13 (7.69%)  1 1/27 (3.70%)  1 2/67 (2.99%)  2
Pancreatitis † 1  1/27 (3.70%)  1 1/13 (7.69%)  1 0/27 (0.00%)  0 2/67 (2.99%)  2
Stomatitis † 1  10/27 (37.04%)  10 4/13 (30.77%)  5 8/27 (29.63%)  8 22/67 (32.84%)  23
Vomiting † 1  6/27 (22.22%)  7 3/13 (23.08%)  3 10/27 (37.04%)  15 19/67 (28.36%)  25
General disorders         
Catheter Site Pain † 1  0/27 (0.00%)  0 1/13 (7.69%)  1 1/27 (3.70%)  2 2/67 (2.99%)  3
Chills † 1  0/27 (0.00%)  0 1/13 (7.69%)  1 1/27 (3.70%)  1 2/67 (2.99%)  2
Face Oedema † 1  2/27 (7.41%)  2 1/13 (7.69%)  1 0/27 (0.00%)  0 3/67 (4.48%)  3
Fatigue † 1  2/27 (7.41%)  2 1/13 (7.69%)  1 3/27 (11.11%)  5 6/67 (8.96%)  8
Oedema Peripheral † 1  0/27 (0.00%)  0 0/13 (0.00%)  0 2/27 (7.41%)  2 2/67 (2.99%)  2
Pyrexia † 1  10/27 (37.04%)  14 4/13 (30.77%)  6 12/27 (44.44%)  23 26/67 (38.81%)  43
Hepatobiliary disorders         
Hepatic Failure † 1  0/27 (0.00%)  0 1/13 (7.69%)  1 0/27 (0.00%)  0 1/67 (1.49%)  1
Hepatic Steatosis † 1  0/27 (0.00%)  0 1/13 (7.69%)  1 0/27 (0.00%)  0 1/67 (1.49%)  1
Immune system disorders         
Drug Hypersensitivity † 1  0/27 (0.00%)  0 1/13 (7.69%)  1 0/27 (0.00%)  0 1/67 (1.49%)  1
Food Allergy † 1  0/27 (0.00%)  0 1/13 (7.69%)  1 0/27 (0.00%)  0 1/67 (1.49%)  1
Infections and infestations         
Conjunctivitis † 1  1/27 (3.70%)  1 1/13 (7.69%)  1 2/27 (7.41%)  2 4/67 (5.97%)  4
Device Related Infection † 1  0/27 (0.00%)  0 1/13 (7.69%)  1 2/27 (7.41%)  2 3/67 (4.48%)  3
Lip Infection † 1  0/27 (0.00%)  0 1/13 (7.69%)  1 0/27 (0.00%)  0 1/67 (1.49%)  1
Oral Candidiasis † 1  0/27 (0.00%)  0 1/13 (7.69%)  1 0/27 (0.00%)  0 1/67 (1.49%)  1
Oral Herpes † 1  1/27 (3.70%)  1 1/13 (7.69%)  1 0/27 (0.00%)  0 2/67 (2.99%)  2
Respiratory Syncytial Virus Infection † 1  2/27 (7.41%)  2 0/13 (0.00%)  0 0/27 (0.00%)  0 2/67 (2.99%)  2
Skin Infection † 1  0/27 (0.00%)  0 1/13 (7.69%)  1 0/27 (0.00%)  0 1/67 (1.49%)  1
Upper Respiratory Tract Infection † 1  0/27 (0.00%)  0 0/13 (0.00%)  0 2/27 (7.41%)  2 2/67 (2.99%)  2
Viral Rhinitis † 1  0/27 (0.00%)  0 1/13 (7.69%)  1 0/27 (0.00%)  0 1/67 (1.49%)  1
Injury, poisoning and procedural complications         
Contusion † 1  0/27 (0.00%)  0 1/13 (7.69%)  1 0/27 (0.00%)  0 1/67 (1.49%)  1
Infusion Related Reaction † 1  8/27 (29.63%)  12 4/13 (30.77%)  5 14/27 (51.85%)  16 26/67 (38.81%)  33
Investigations         
Weight Decreased † 1  2/27 (7.41%)  2 1/13 (7.69%)  1 1/27 (3.70%)  1 4/67 (5.97%)  4
Metabolism and nutrition disorders         
Decreased Appetite † 1  1/27 (3.70%)  1 2/13 (15.38%)  2 8/27 (29.63%)  8 11/67 (16.42%)  11
Increased Appetite † 1  0/27 (0.00%)  0 1/13 (7.69%)  1 0/27 (0.00%)  0 1/67 (1.49%)  1
Musculoskeletal and connective tissue disorders         
Back Pain † 1  0/27 (0.00%)  0 1/13 (7.69%)  1 3/27 (11.11%)  3 4/67 (5.97%)  4
Bone Pain † 1  2/27 (7.41%)  2 0/13 (0.00%)  0 1/27 (3.70%)  1 3/67 (4.48%)  3
Neck Pain † 1  0/27 (0.00%)  0 0/13 (0.00%)  0 3/27 (11.11%)  3 3/67 (4.48%)  3
Pain In Extremity † 1  4/27 (14.81%)  6 2/13 (15.38%)  2 2/27 (7.41%)  5 8/67 (11.94%)  13
Nervous system disorders         
Dizziness † 1  1/27 (3.70%)  1 1/13 (7.69%)  1 1/27 (3.70%)  1 3/67 (4.48%)  3
Dysaesthesia † 1  1/27 (3.70%)  1 1/13 (7.69%)  1 0/27 (0.00%)  0 2/67 (2.99%)  2
Dysgeusia † 1  0/27 (0.00%)  0 0/13 (0.00%)  0 2/27 (7.41%)  2 2/67 (2.99%)  2
Facial Paralysis † 1  0/27 (0.00%)  0 1/13 (7.69%)  1 0/27 (0.00%)  0 1/67 (1.49%)  1
Headache † 1  3/27 (11.11%)  3 3/13 (23.08%)  4 9/27 (33.33%)  14 15/67 (22.39%)  21
Peripheral Sensory Neuropathy † 1  0/27 (0.00%)  0 1/13 (7.69%)  1 0/27 (0.00%)  0 1/67 (1.49%)  1
Seizure † 1  0/27 (0.00%)  0 1/13 (7.69%)  1 0/27 (0.00%)  0 1/67 (1.49%)  1
Tremor † 1  2/27 (7.41%)  2 1/13 (7.69%)  2 1/27 (3.70%)  1 4/67 (5.97%)  5
Psychiatric disorders         
Anxiety † 1  1/27 (3.70%)  1 1/13 (7.69%)  1 2/27 (7.41%)  2 4/67 (5.97%)  4
Depression † 1  0/27 (0.00%)  0 1/13 (7.69%)  1 0/27 (0.00%)  0 1/67 (1.49%)  1
Insomnia † 1  0/27 (0.00%)  0 1/13 (7.69%)  1 1/27 (3.70%)  1 2/67 (2.99%)  2
Irritability † 1  0/27 (0.00%)  0 1/13 (7.69%)  1 0/27 (0.00%)  0 1/67 (1.49%)  1
Renal and urinary disorders         
Nephropathy Toxic † 1  0/27 (0.00%)  0 1/13 (7.69%)  1 0/27 (0.00%)  0 1/67 (1.49%)  1
Renal Tubular Necrosis † 1  0/27 (0.00%)  0 1/13 (7.69%)  1 0/27 (0.00%)  0 1/67 (1.49%)  1
Urinary Retention † 1  2/27 (7.41%)  2 3/13 (23.08%)  4 1/27 (3.70%)  1 6/67 (8.96%)  7
Respiratory, thoracic and mediastinal disorders         
Cough † 1  6/27 (22.22%)  8 1/13 (7.69%)  1 1/27 (3.70%)  1 8/67 (11.94%)  10
Dyspnoea † 1  0/27 (0.00%)  0 0/13 (0.00%)  0 2/27 (7.41%)  2 2/67 (2.99%)  2
Epistaxis † 1  0/27 (0.00%)  0 0/13 (0.00%)  0 3/27 (11.11%)  5 3/67 (4.48%)  5
Hypoxia † 1  0/27 (0.00%)  0 0/13 (0.00%)  0 2/27 (7.41%)  3 2/67 (2.99%)  3
Oropharyngeal Pain † 1  2/27 (7.41%)  2 1/13 (7.69%)  1 2/27 (7.41%)  2 5/67 (7.46%)  5
Rhinorrhoea † 1  2/27 (7.41%)  2 0/13 (0.00%)  0 0/27 (0.00%)  0 2/67 (2.99%)  2
Skin and subcutaneous tissue disorders         
Alopecia † 1  2/27 (7.41%)  2 1/13 (7.69%)  1 0/27 (0.00%)  0 3/67 (4.48%)  3
Dry Skin † 1  0/27 (0.00%)  0 0/13 (0.00%)  0 2/27 (7.41%)  2 2/67 (2.99%)  2
Erythema † 1  1/27 (3.70%)  1 0/13 (0.00%)  0 2/27 (7.41%)  3 3/67 (4.48%)  4
Rash † 1  0/27 (0.00%)  0 0/13 (0.00%)  0 6/27 (22.22%)  7 6/67 (8.96%)  7
Rash Maculo-Papular † 1  1/27 (3.70%)  1 0/13 (0.00%)  0 2/27 (7.41%)  6 3/67 (4.48%)  7
Vascular disorders         
Flushing † 1  1/27 (3.70%)  1 1/13 (7.69%)  1 1/27 (3.70%)  1 3/67 (4.48%)  3
Hypertension † 1  0/27 (0.00%)  0 5/13 (38.46%)  7 3/27 (11.11%)  3 8/67 (11.94%)  10
Hypotension † 1  1/27 (3.70%)  1 0/13 (0.00%)  0 2/27 (7.41%)  2 3/67 (4.48%)  3
1
Term from vocabulary, MedDra 26.0
†
Indicates events were collected by systematic assessment
The study was prematurely stopped due to sponsor decision (stage 2 efficacy criteria not met) and not due to safety concerns.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Trial Transparency Team
Organization: Sanofi aventis recherche & développement
Phone: 800-633-1610 ext 6#
EMail: Contact-US@sanofi.com
Layout table for additonal information
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT03860844    
Other Study ID Numbers: ACT15378
PIP - 2018-002697-45
U1111-1202-1096 ( Other Identifier: UTN )
2018-002697-45 ( EudraCT Number )
First Submitted: February 21, 2019
First Posted: March 4, 2019
Results First Submitted: September 7, 2023
Results First Posted: November 15, 2023
Last Update Posted: May 16, 2024