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Trial record 3 of 3 for:    isatuximab | Child

Safety and Efficacy of Isatuximab in Lymphoblastic Leukemia (ISLAY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE December 19, 2016
First Posted Date  ICMJE December 21, 2016
Results First Submitted Date  ICMJE December 10, 2019
Results First Posted Date  ICMJE January 18, 2020
Last Update Posted Date January 18, 2020
Actual Study Start Date  ICMJE March 8, 2017
Actual Primary Completion Date November 14, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 8, 2020)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 19, 2016)
Objective response rate [ Time Frame: 6 months after last patient 1st administration (Day 1), 12 months after last patient 1st administration (Day 1) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 8, 2020)
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2016)
  • Duration of response - time [ Time Frame: 6 months after last patient 1st administration (Day 1), 12 months after last patient 1st administration (Day 1) ]
  • Progression free survival - time [ Time Frame: 6 months after last patient 1st administration (Day 1), 12 months after last patient 1st administration (Day 1) ]
  • Overall survival - time [ Time Frame: 6 months after last patient 1st administration (Day 1), 12 months after last patient 1st administration (Day 1) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Isatuximab in Lymphoblastic Leukemia
Official Title  ICMJE 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)
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • T-cell Type Acute Leukemia-Precursor
  • T-lymphoblastic Lymphoma/Leukaemia
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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).
Interventions:
  • Drug: Isatuximab SAR650984
  • Drug: dexamethasone
  • Drug: dexamethasone
  • Drug: acetaminophen
  • Drug: ranitidine
  • Drug: diphenhydramine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 8, 2018)
14
Original Estimated Enrollment  ICMJE
 (submitted: December 19, 2016)
39
Actual Study Completion Date  ICMJE November 14, 2017
Actual Primary Completion Date November 14, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland,   France,   Hungary,   Italy,   Lithuania,   Russian Federation,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02999633
Other Study ID Numbers  ICMJE ACT14596
2016-002739-14 ( EudraCT Number )
U1111-1179-5294 ( Other Identifier: UTN )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Sciences & Operations Sanofi
PRS Account Sanofi
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP