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Safety and Efficacy of Isatuximab in Lymphoblastic Leukemia (ISLAY)

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ClinicalTrials.gov Identifier: NCT02999633
Recruitment Status : Terminated (Due to an unsatisfactory benefit/risk ratio, as specified in & 14.8.1 of the protocol, Sanofi decided to stop enrollment and terminate ACT14596 prematurely)
First Posted : December 21, 2016
Results First Posted : January 18, 2020
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Description
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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.

Condition or disease Intervention/treatment Phase
T-cell Type Acute Leukemia-Precursor T-lymphoblastic Lymphoma/Leukaemia Drug: Isatuximab SAR650984 Drug: dexamethasone Drug: acetaminophen Drug: ranitidine Drug: diphenhydramine Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : March 8, 2017
Actual Primary Completion Date : November 14, 2017
Actual Study Completion Date : November 14, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia
Drug Information available for: Isatuximab

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02999633


Locations
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Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi
  Study Documents (Full-Text)

Documents provided by Sanofi:
Study Protocol  [PDF] February 27, 2017
Statistical Analysis Plan  [PDF] December 13, 2017

More Information
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02999633    
Other Study ID Numbers: ACT14596
2016-002739-14 ( EudraCT Number )
U1111-1179-5294 ( Other Identifier: UTN )
First Posted: December 21, 2016    Key Record Dates
Results First Posted: January 18, 2020
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data (IPD) and supporting clinical documents are available for request at clinicalstudydatarequest.com. While making information available Sanofi continues to protect the privacy of the participants in clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Acetaminophen
Diphenhydramine
Promethazine
Dexamethasone
 Dexamethasone acetate
Ranitidine
Ranitidine bismuth citrate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents