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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

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions T-cell Type Acute Leukemia-Precursor
T-lymphoblastic Lymphoma/Leukaemia
Interventions Drug: Isatuximab SAR650984
Drug: dexamethasone
Drug: acetaminophen
Drug: ranitidine
Drug: diphenhydramine
Enrollment 14
Recruitment Details The study was conducted in 6 countries. A total of 16 participants were screened of those 2 participants failed screening: 1 participant for evidence of ongoing infection and 1 participant for not meeting the criterion for relapsed or refractory T-acute lymphoblastic leukemia (ALL)/T-lymphoblastic lymphoma (LBL).
Pre-assignment Details The first participant was enrolled on 14 March 2017. A total of 14 participants were enrolled to receive isatuximab. The study was early terminated on 08 Nov 2017 due to an unsatisfactory benefit/risk ratio.
Arm/Group Title Isatuximab
Hide Arm/Group Description 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).
Period Title: Overall Study
Started 14
Completed 0
Not Completed 14
Reason Not Completed
Adverse Event             2
Progressive disease             12
Arm/Group Title Isatuximab
Hide Arm/Group Description Participants received intravenous administration of isatuximab at a dose of 20 mg/kg at Day 1, 8, 15 and 22 of each Cycle (up to 2 treatment cycles, each cycle 28 days).
Overall Number of Baseline Participants 14
Hide Baseline Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of isatuximab.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants
41.36  (19.30)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Female
2
  14.3%
Male
12
  85.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
6
  42.9%
More than one race
0
   0.0%
Unknown or Not Reported
8
  57.1%
1.Primary Outcome
Title Percentage of Participants With Objective Response
Hide Description 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.
Time Frame Baseline until disease progression or death (maximum duration: 12.1 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of isatuximab.
Arm/Group Title Isatuximab
Hide Arm/Group Description:
Participants received intravenous administration of isatuximab at a dose of 20 mg/kg at Day 1, 8, 15 and 22 of each Cycle (up to 2 treatment cycles, each cycle 28 days).
Overall Number of Participants Analyzed 14
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0 to 23.2)
2.Secondary Outcome
Title Duration of Response (DOR)
Hide Description 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.
Time Frame Baseline until disease progression or death (maximum duration: 12.1 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The outcome measure was not analyzed due to lack of objective response. There was no specific additional data collected for the analysis of DOR as this outcome measure was to be derived using time point responses and death information that were collected and analyzed as part of primary and safety outcome measures, respectively.
Arm/Group Title Isatuximab
Hide Arm/Group Description:
Participants received intravenous administration of isatuximab at a dose of 20 mg/kg at Day 1, 8, 15 and 22 of each Cycle (up to 2 treatment cycles, each cycle 28 days).
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Progression Free Survival (PFS)
Hide Description 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.
Time Frame Baseline until disease progression or death (maximum duration: 12.1 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was not analyzed because disease progression data were not collected.
Arm/Group Title Isatuximab
Hide Arm/Group Description:
Participants received intravenous administration of isatuximab at a dose of 20 mg/kg at Day 1, 8, 15 and 22 of each Cycle (up to 2 treatment cycles, each cycle 28 days).
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Overall Survival (OS)
Hide Description 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.
Time Frame Baseline until death (maximum duration: 12.1 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was not analyzed because overall survival data were not collected.
Arm/Group Title Isatuximab
Hide Arm/Group Description:
Participants received intravenous administration of isatuximab at a dose of 20 mg/kg at Day 1, 8, 15 and 22 of each Cycle (up to 2 treatment cycles, each cycle 28 days).
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Number of Participants With Minimal Residual Disease (MRD)
Hide Description 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.
Time Frame Baseline until death or study cut-off (maximum duration: 12.1 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this outcome measure was not collected and analyzed because no participant achieved CR or CRi.
Arm/Group Title Isatuximab
Hide Arm/Group Description:
Participants received intravenous administration of isatuximab at a dose of 20 mg/kg at Day 1, 8, 15 and 22 of each Cycle (up to 2 treatment cycles, each cycle 28 days).
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Baseline up to 30 days after last dose of study drug administration (up to maximum of 12.1 weeks)
Adverse Event Reporting Description Reported Adverse events (AEs) are treatment emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from first study treatment administration until 30 days after the last administration of study treatment). Safety analysis set included all participants who received at least 1 dose of isatuximab.
 
Arm/Group Title Isatuximab
Hide Arm/Group Description Participants received intravenous administration of isatuximab at a dose of 20 mg/kg at Day 1, 8, 15 and 22 of each Cycle (up to 2 treatment cycles, each cycle 28 days).
All-Cause Mortality
Isatuximab
Affected / at Risk (%)
Total   6/14 (42.86%)    
Hide Serious Adverse Events
Isatuximab
Affected / at Risk (%) # Events
Total   10/14 (71.43%)    
Cardiac disorders   
Acute Myocardial Infarction  1  1/14 (7.14%)  1
Pericarditis Constrictive  1  1/14 (7.14%)  1
Gastrointestinal disorders   
Pancreatitis  1  1/14 (7.14%)  1
General disorders   
Disease Progression  1  4/14 (28.57%)  4
Infections and infestations   
Device Related Infection  1  1/14 (7.14%)  1
Fungal Infection  1  1/14 (7.14%)  1
Periorbital Cellulitis  1  1/14 (7.14%)  1
Pneumonia  1  1/14 (7.14%)  1
Sepsis  1  1/14 (7.14%)  1
Respiratory, thoracic and mediastinal disorders   
Acute Respiratory Failure  1  1/14 (7.14%)  1
Pleural Effusion  1  1/14 (7.14%)  1
Pulmonary Oedema  1  1/14 (7.14%)  1
Vascular disorders   
Pelvic Venous Thrombosis  1  1/14 (7.14%)  1
Vein Collapse  1  1/14 (7.14%)  1
1
Term from vocabulary, MedDra 20.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Isatuximab
Affected / at Risk (%) # Events
Total   12/14 (85.71%)    
Blood and lymphatic system disorders   
Anaemia  1  1/14 (7.14%)  1
Neutropenia  1  1/14 (7.14%)  1
Thrombocytopenia  1  1/14 (7.14%)  2
Cardiac disorders   
Tachycardia  1  2/14 (14.29%)  2
Gastrointestinal disorders   
Abdominal Pain Upper  1  1/14 (7.14%)  1
Constipation  1  2/14 (14.29%)  2
Diarrhoea  1  2/14 (14.29%)  2
Nausea  1  1/14 (7.14%)  1
Vomiting  1  1/14 (7.14%)  1
General disorders   
Asthenia  1  1/14 (7.14%)  1
Fatigue  1  1/14 (7.14%)  1
Pain  1  1/14 (7.14%)  1
Pyrexia  1  5/14 (35.71%)  6
Hepatobiliary disorders   
Cholangitis  1  1/14 (7.14%)  1
Cholecystitis  1  1/14 (7.14%)  1
Immune system disorders   
Cytokine Release Syndrome  1  1/14 (7.14%)  1
Infections and infestations   
Bronchiolitis  1  1/14 (7.14%)  1
Device Related Infection  1  1/14 (7.14%)  1
Nasopharyngitis  1  1/14 (7.14%)  1
Oral Herpes  1  1/14 (7.14%)  1
Pyelitis  1  1/14 (7.14%)  1
Rhinitis  1  1/14 (7.14%)  1
Injury, poisoning and procedural complications   
Infusion Related Reaction  1  8/14 (57.14%)  11
Investigations   
Body Temperature Increased  1  1/14 (7.14%)  1
Weight Decreased  1  1/14 (7.14%)  1
Musculoskeletal and connective tissue disorders   
Back Pain  1  2/14 (14.29%)  2
Bone Pain  1  2/14 (14.29%)  2
Flank Pain  1  1/14 (7.14%)  2
Muscle Oedema  1  1/14 (7.14%)  1
Musculoskeletal Pain  1  1/14 (7.14%)  1
Pain In Extremity  1  1/14 (7.14%)  1
Nervous system disorders   
Facial Paralysis  1  1/14 (7.14%)  1
Headache  1  1/14 (7.14%)  2
Peripheral Motor Neuropathy  1  1/14 (7.14%)  1
Sciatica  1  1/14 (7.14%)  1
Renal and urinary disorders   
Urinary Retention  1  1/14 (7.14%)  1
Respiratory, thoracic and mediastinal disorders   
Bronchitis Chronic  1  1/14 (7.14%)  1
Bronchostenosis  1  1/14 (7.14%)  1
Cough  1  2/14 (14.29%)  2
Dysphonia  1  1/14 (7.14%)  1
Dyspnoea  1  1/14 (7.14%)  1
Haemoptysis  1  1/14 (7.14%)  1
Hypoxia  1  1/14 (7.14%)  1
Pharyngeal Erythema  1  1/14 (7.14%)  1
Pleural Effusion  1  1/14 (7.14%)  1
Productive Cough  1  1/14 (7.14%)  1
Respiratory Failure  1  1/14 (7.14%)  1
Wheezing  1  1/14 (7.14%)  1
Vascular disorders   
Phlebitis  1  1/14 (7.14%)  1
1
Term from vocabulary, MedDra 20.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Trial Transparency Team
Organization: Sanofi
Phone: 800-633-1610 ext 1#
EMail: Contact-US@sanofi.com
Layout table for additonal information
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02999633    
Other Study ID Numbers: ACT14596
2016-002739-14 ( EudraCT Number )
U1111-1179-5294 ( Other Identifier: UTN )
First Submitted: December 19, 2016
First Posted: December 21, 2016
Results First Submitted: December 10, 2019
Results First Posted: January 18, 2020
Last Update Posted: January 18, 2020