NCT03860844|TerminatedPhase 2ResultsDMCFDA Drug

Study Stopped

Study was prematurely stopped due to sponsor decision (stage 2 efficacy criteria not met); not due to safety concerns.

Isatuximab in Combination With Chemotherapy in Pediatric Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia

ISAKIDS

Open-label, Single-arm Trial to Evaluate Antitumor Activity, Safety, and Pharmacokinetics of Isatuximab Used in Combination With Chemotherapy in Pediatric Patients From 28 Days to Less Than 18 Years of Age With Relapsed/Refractory B or T Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia in First or Second Relapse

Sanofi ClinicalTrials.gov

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4 other identifiers

ACT15378PIP - 2018-002697-45U1111-1202-10962018-002697-45

Study Type

interventional

Target

Locations

16 countries

Sites

Timeline

RegisteredMar 2019

StartedAug 2019

CompletionMay 2023

Brief Summary

Primary Objective: Evaluate the anti-leukemic activity of isatuximab in combination with standard chemotherapies in pediatric participants of ages 28 days to less than 18 years with Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) or Acute Myeloid Leukemia (AML) Secondary Objectives:

Safety and tolerability assessments
Assessment of infusion reactions (IRs)
Pharmacokinetics (PK) of isatuximab
Minimal residual disease
Overall response rate
Overall survival
Event free survival
Duration of response
Relationship between clinical effects and CD38 receptor density and occupancy

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_2

Timeline

Completed

Started Aug 2019

Typical duration for phase_2

Geographic Reach

16 countries

41 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.8 years study duration

First Submitted

Initial submission to the registry

February 21, 2019

Completed

11 days until next milestone

First Posted

Study publicly available on registry

March 4, 2019

Completed

5 months until next milestone

Study Start

First participant enrolled

August 6, 2019

Completed

3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2022

Completed

9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 26, 2023

Completed

6 months until next milestone

Results Posted

Study results publicly available

November 15, 2023

Completed

Last Updated

September 9, 2025

Status Verified

September 1, 2025

Enrollment Period

3.1 years

First QC Date

February 21, 2019

Results QC Date

September 7, 2023

Last Update Submit

September 8, 2025

Conditions

Acute Lymphoblastic Leukemia Acute Myeloid Leukemia

Keywords

Anti-CD38 monoclonal antibody

Outcome Measures

Primary Outcomes (1)

Percentage of Participants With Complete Response (CR) Rate
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).
From enrollment until the primary analysis completion date of 12 Sep 2022; the median duration of exposure was approximately 7 weeks

Secondary Outcomes (15)

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
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)
Number of Participants With Infusion Reactions (IRs)
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)
B-ALL and T-ALL: Area Under the Concentration Time Curve (AUC) of Isatuximab
From Week 0 to Week 1, Week 0 to Week 5, and Week 0 to Week 10
AML: AUC of Isatuximab
From Week 0 to Week 1, Week 0 to Week 3, and Week 0 to Week 8
B-ALL and T-ALL: Plasma Concentration Reached by Isatuximab Before Next Dose Administration (Ctrough)
Cycle 1 Day 8, Cycle 1 Day 15, Cycle 1 Day 22, Cycle 1 Day 29, Cycle 2 Day 43, Cycle 2 Day 57
+10 more secondary outcomes

Study Arms (1)

Acute Myeloid Leukemia (AML) and Acute Lymphoblastic Leukemia

EXPERIMENTAL

This arm includes participants from 3 cohorts: AML, T-ALL and B-ALL.; AML: Weekly dosing of isatuximab with induction chemotherapy. The therapy may be repeated one more cycle; ALL: (Includes T-ALL and B-ALL) Weekly dosing of isatuximab with induction chemotherapy, then biweekly dosing of isatuximab with consolidation chemotherapy.

Drug: IsatuximabDrug: Dexamethasone or equivalentDrug: FludarabineDrug: CytarabineDrug: Liposomal daunorubicinDrug: Daunorubicin (nonliposomal)Drug: IdarubicinDrug: Filgrastim or equivalentDrug: MitoxantroneDrug: DoxorubicinDrug: VincristineDrug: Pegaspargase (PEG) AsparaginaseDrug: CyclophosphamideDrug: EtoposideDrug: MethotrexateDrug: L - AsparginaseDrug: HydroxyureaDrug: L - Asparaginase (Erwinase)

Interventions

IsatuximabDRUG

Pharmaceutical form: Concentrate for solution for intravenous infusion Route of administration: Intravenous

Also known as: SAR650984, Sarclisa