NCT02999633

Brief Summary

Primary Objective: To evaluate the efficacy of isatuximab. Secondary Objectives:

  • To evaluate the safety profile of isatuximab.
  • To evaluate the duration of response (DOR).
  • To evaluate progression free survival (PFS) and overall survival (OS).
  • To evaluate the pharmacokinetics (PK) of isatuximab in participants with T-ALL or T-LBL.
  • To evaluate immunogenicity of isatuximab in participants with T-ALL or T-LBL.
  • To assess minimal residual disease (MRD) and correlate it with clinical outcome.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2017

Shorter than P25 for phase_2

Geographic Reach
7 countries

17 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

First Submitted

Initial submission to the registry

December 19, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 21, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

March 8, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2017

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

January 18, 2020

Completed
Last Updated

March 21, 2022

Status Verified

March 1, 2022

Enrollment Period

8 months

First QC Date

December 19, 2016

Results QC Date

December 10, 2019

Last Update Submit

March 10, 2022

Conditions

T-cell Type Acute Leukemia-PrecursorT-lymphoblastic Lymphoma/Leukaemia

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With Objective Response

    Objective response was defined as percentage of participants with complete response (CR) or with complete response with incomplete peripheral recovery (CRi) as per National Comprehensive Cancer Network (NCCN) guidelines. CR was defined as no circulating blasts or extramedullary disease, no lymphadenopathy, splenomegaly, skin/gum infiltration/testicular mass/central nervous system involvement, trilineage hematopoiesis and less than 5 percentage blasts, absolute neutrophil count (ANC) greater than 1000 per micro liter, platelets less than 100 000 per micro liter, no recurrence for 4 weeks. CRi meet all criteria for complete response except platelet count and/or ANC.

    Baseline until disease progression or death (maximum duration: 12.1 weeks)

Secondary Outcomes (4)

  • Duration of Response (DOR)

    Baseline until disease progression or death (maximum duration: 12.1 weeks)

  • Progression Free Survival (PFS)

    Baseline until disease progression or death (maximum duration: 12.1 weeks)

  • Overall Survival (OS)

    Baseline until death (maximum duration: 12.1 weeks)

  • Number of Participants With Minimal Residual Disease (MRD)

    Baseline until death or study cut-off (maximum duration: 12.1 weeks)

Study Arms (1)

Isatuximab

EXPERIMENTAL

Participants received intravenous administration of isatuximab at a dose of 20 milligrams/kilogram (mg/kg) at Day 1, 8, 15 and 22 of each Cycle (up to 2 treatment cycles, each cycle 28 days).

Drug: Isatuximab SAR650984Drug: dexamethasoneDrug: acetaminophenDrug: ranitidineDrug: diphenhydramine

Interventions

Isatuximab SAR650984DRUG

Pharmaceutical form:solution Route of administration: intravenous

Isatuximab
dexamethasoneDRUG

Pharmaceutical form:pills Route of administration: oral

Isatuximab
acetaminophenDRUG

Pharmaceutical form:pills Route of administration: oral

Isatuximab
ranitidineDRUG

Pharmaceutical form:solution Route of administration: intravenous

Isatuximab
diphenhydramineDRUG

Pharmaceutical form:solution Route of administration: intravenous

Isatuximab

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Participants must had a known diagnosis of acute lymphoblastic leukemia (ALL) of T cell origin, including T-LBL and T-ALL with extramedullary involvement at relapse confirmed by biopsy.
  • Participants must be previously treated for T-ALL or T-LBL and have relapsed or are refractory to most recent treatment. Participants in first relapse were be eligible regardless of the first remission duration.
  • Participants must had been previously exposed to nelarabine in countries where this drug is available (unless due to a contraindication to its use or administrative issue).
  • No more than 3 prior salvage therapies.

You may not qualify if:

  • Prior treatment with immunotherapy/investigational agents within 3 weeks, chemotherapy within 2 weeks of study treatment. Must have recovered from acute toxicity before first study treatment administration.
  • Prior stem cell transplant within 4 months and/or evidence of active systemic Graft versus Host Disease and/or immunosuppressive therapy for Graft versus Host Disease within 1 week before the first study treatment administration.
  • Clinical evidence of active central nervous system (CNS) leukemia.
  • T-ALL with testicular involvement alone.
  • The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Investigational Site Number 8400002

Atlanta, Georgia, 30342, United States

Location

Investigational Site Number 8400003

Hackensack, New Jersey, 07601, United States

Location

Investigational Site Number 8400001

Houston, Texas, 77030, United States

Location

Investigational Site Number 2460001

Helsinki, 00029, Finland

Location

Investigational Site Number 2500005

Nantes, 44093, France

Location

Investigational Site Number 2500001

Paris, 75475, France

Location

Investigational Site Number 2500004

Pessac, 33600, France

Location

Investigational Site Number 2500002

Pierre-Bénite, 69310, France

Location

Investigational Site Number 3480001

Budapest, 1083, Hungary

Location

Investigational Site Number 3480003

Budapest, 1097, Hungary

Location

Investigational Site Number 3480002

Debrecen, 4032, Hungary

Location

Investigational Site Number 3800001

Bergamo, 24127, Italy

Location

Investigational Site Number 3800004

Brescia, 25123, Italy

Location

Investigational Site Number 4400001

Vilnius, 08661, Lithuania

Location

Investigational Site Number 6430003

Moscow, 117198, Russia

Location

Investigational Site Number 6430004

Moscow, 125167, Russia

Location

Investigational Site Number 6430001

Moscow, 129301, Russia

Location

Related Publications (2)

  • Brillac C, Semiond D, Oprea C, Baruchel A, Zwaan CM, Nguyen L. Selection of isatuximab dosing regimen in pediatric patients with leukemia using population pharmacokinetics. Cancer Chemother Pharmacol. 2025 Dec 3;95(1):116. doi: 10.1007/s00280-025-04832-2.

    PMID: 41331127DERIVED

  • Wang A, Song Z, Zheng G, Nicolazzi C, Fromm JR, Shehu E, Srinivasan S, Chen X, Zhu C, Blondel MC, Adrian FJ. Evaluation of Preclinical Activity of Isatuximab in Patients with Acute Lymphoblastic Leukemia. Mol Cancer Ther. 2021 Oct;20(10):1916-1925. doi: 10.1158/1535-7163.MCT-21-0058. Epub 2021 Aug 10.

    PMID: 34376579DERIVED

MeSH Terms

Conditions

Precursor T-Cell Lymphoblastic Leukemia-LymphomaLeukemia

Interventions

isatuximabDexamethasoneAcetaminophenRanitidineDiphenhydramine

Condition Hierarchy (Ancestors)

Precursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, LymphoidNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesFuransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsEthylaminesBenzhydryl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Results Point of Contact

Title
Trial Transparency Team
Organization
Sanofi
Contact-US@sanofi.com
800-633-1610

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2016

First Posted

December 21, 2016

Study Start

March 8, 2017

Primary Completion

November 14, 2017

Study Completion

November 14, 2017

Last Updated

March 21, 2022

Results First Posted

January 18, 2020

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will share

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Locations

US(3)FI(1)FR(4)HU(3)LI(1)RU(3)IT(2)