Safety and Efficacy of Isatuximab in Lymphoblastic Leukemia (ISLAY)

March 10, 2022 updated by: Sanofi

Phase 2, Safety and Efficacy Study of Isatuximab, an Anti-CD38 Monoclonal Antibody, Administered by Intravenous (IV) Infusion in Patients With Relapsed or Refractory T-acute Lymphoblastic Leukemia (T-ALL) or T-lymphoblastic Lymphoma (T-LBL)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The study duration per participant included a 3-week screening period, an approximately 1 year of treatment period or until disease progression or discontinuation for any other reason, and a follow-up period of at least 30 days after the last investigational medicinal product administration.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland, 00029
        • Investigational Site Number 2460001
  • France
      • Nantes Cedex 01, France, 44093
        • Investigational Site Number 2500005
      • Paris Cedex 10, France, 75475
        • Investigational Site Number 2500001
      • Pessac, France, 33600
        • Investigational Site Number 2500004
      • Pierre Benite, France, 69310
        • Investigational Site Number 2500002
  • Hungary
      • Budapest, Hungary, 1083
        • Investigational Site Number 3480001
      • Budapest, Hungary, 1097
        • Investigational Site Number 3480003
      • Debrecen, Hungary, 4032
        • Investigational Site Number 3480002
  • Italy
      • Bergamo, Italy, 24127
        • Investigational Site Number 3800001
      • Brescia, Italy, 25123
        • Investigational site number 3800004
  • Lithuania
      • Vilnius, Lithuania, 08661
        • Investigational Site Number 4400001
  • Russian Federation
      • Moscow, Russian Federation, 117198
        • Investigational Site Number 6430003
      • Moscow, Russian Federation, 125167
        • Investigational Site Number 6430004
      • Moscow, Russian Federation, 129301
        • Investigational Site Number 6430001
  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Investigational Site Number 8400002
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Investigational Site Number 8400003
    • Texas
      • Houston, Texas, United States, 77030
        • Investigational Site Number 8400001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria :

  • 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.

Exclusion criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Isatuximab
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 SAR650984
Pharmaceutical form:solution Route of administration: intravenous
Drug: dexamethasone
Pharmaceutical form:pills Route of administration: oral
Drug: dexamethasone
Pharmaceutical form:solution Route of administration: intravenous
Drug: acetaminophen
Pharmaceutical form:pills Route of administration: oral
Drug: ranitidine
Pharmaceutical form:solution Route of administration: intravenous
Drug: diphenhydramine
Pharmaceutical form:solution Route of administration: intravenous

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Objective Response
Time Frame: Baseline until disease progression or death (maximum duration: 12.1 weeks)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Response (DOR)
Time Frame: Baseline until disease progression or death (maximum duration: 12.1 weeks)
DOR defined as time (in days) from date of first response until date of first documented progressive disease (PD) or death (from any cause), whichever came first. Progressive disease as per NCCN guidelines was defined as increase of at least 25 percentage (%) in the absolute number of circulating or bone marrow blasts or development of extramedullary disease.
Baseline until disease progression or death (maximum duration: 12.1 weeks)
Progression Free Survival (PFS)
Time Frame: Baseline until disease progression or death (maximum duration: 12.1 weeks)
PFS was defined as the time interval (in days) from the date of first study drug administration to the date of first observation of PD or death due to any cause, whichever came first. PD as per NCCN guidelines was defined as increase of at least 25% in the absolute number of circulating or bone marrow blasts or development of extramedullary disease.
Baseline until disease progression or death (maximum duration: 12.1 weeks)
Overall Survival (OS)
Time Frame: Baseline until death (maximum duration: 12.1 weeks)
Overall Survival was defined as the time interval from the date of first study drug administration to the date of death due to any cause.
Baseline until death (maximum duration: 12.1 weeks)
Number of Participants With Minimal Residual Disease (MRD)
Time Frame: Baseline until death or study cut-off (maximum duration: 12.1 weeks)
Presence of MRD was measured by sequencing and/or flow cytometry in participants achieving CR and CRi. 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, ANC greater than 1000 per micro liter, platelets less than 100 000 per micro liter, no recurrence for 4 weeks. Complete response with incomplete blood count recovery meet all criteria for complete response except platelet count and/or ANC.
Baseline until death or study cut-off (maximum duration: 12.1 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2017

Primary Completion (Actual)

November 14, 2017

Study Completion (Actual)

November 14, 2017

Study Registration Dates

First Submitted

December 19, 2016

First Submitted That Met QC Criteria

December 19, 2016

First Posted (Estimate)

December 21, 2016

Study Record Updates

Last Update Posted (Actual)

March 21, 2022

Last Update Submitted That Met QC Criteria

March 10, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACT14596
  • 2016-002739-14 (EudraCT Number)
  • U1111-1179-5294 (Other Identifier: UTN)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on T-cell Type Acute Leukemia-Precursor

Clinical Trials on Isatuximab SAR650984

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Vietnam

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe