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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-002739-14 | EudraCT Number | ||
| U1111-1179-5294 | Other Identifier | UTN |
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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
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Primary Objective:
To evaluate the efficacy of isatuximab.
Secondary Objectives:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isatuximab SAR650984 | Drug | Pharmaceutical form:solution Route of administration: intravenous |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DOR) | 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) |
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Inclusion criteria :
Exclusion criteria:
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number 8400002 | Atlanta | Georgia | 30342 | United States | ||
| Investigational Site Number 8400003 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41331127 | Derived | 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. | |
| 34376579 | Derived | 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. |
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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
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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.
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).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 27, 2017 | Dec 10, 2019 |
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| dexamethasone |
| Drug |
Pharmaceutical form:pills Route of administration: oral |
|
| dexamethasone | Drug | Pharmaceutical form:solution Route of administration: intravenous |
|
| acetaminophen | Drug | Pharmaceutical form:pills Route of administration: oral |
|
| ranitidine | Drug | Pharmaceutical form:solution Route of administration: intravenous |
|
| diphenhydramine | Drug | Pharmaceutical form:solution Route of administration: intravenous |
|
| Progression Free Survival (PFS) | 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) | 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) | 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) |
| Hackensack |
| New Jersey |
| 07601 |
| United States |
| Investigational Site Number 8400001 | Houston | Texas | 77030 | United States |
| Investigational Site Number 2460001 | Helsinki | 00029 | Finland |
| Investigational Site Number 2500005 | Nantes | 44093 | France |
| Investigational Site Number 2500001 | Paris | 75475 | France |
| Investigational Site Number 2500004 | Pessac | 33600 | France |
| Investigational Site Number 2500002 | Pierre-Bénite | 69310 | France |
| Investigational Site Number 3480001 | Budapest | 1083 | Hungary |
| Investigational Site Number 3480003 | Budapest | 1097 | Hungary |
| Investigational Site Number 3480002 | Debrecen | 4032 | Hungary |
| Investigational Site Number 3800001 | Bergamo | 24127 | Italy |
| Investigational Site Number 3800004 | Brescia | 25123 | Italy |
| Investigational Site Number 4400001 | Vilnius | 08661 | Lithuania |
| Investigational Site Number 6430003 | Moscow | 117198 | Russia |
| Investigational Site Number 6430004 | Moscow | 125167 | Russia |
| Investigational Site Number 6430001 | Moscow | 129301 | Russia |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety analysis set included all participants who received at least 1 dose of isatuximab.
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| ID | Title | Description |
|---|---|---|
| BG000 | Isatuximab | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Safety analysis set included all participants who received at least 1 dose of isatuximab. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline until disease progression or death (maximum duration: 12.1 weeks) |
|
|
| |||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) | 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. | 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. | Posted | Baseline until disease progression or death (maximum duration: 12.1 weeks) |
|
| |||||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) | 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. | This outcome measure was not analyzed because disease progression data were not collected. | Posted | Baseline until disease progression or death (maximum duration: 12.1 weeks) |
|
| |||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | 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. | This outcome measure was not analyzed because overall survival data were not collected. | Posted | Baseline until death (maximum duration: 12.1 weeks) |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Minimal Residual Disease (MRD) | 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. | Data for this outcome measure was not collected and analyzed because no participant achieved CR or CRi. | Posted | Baseline until death or study cut-off (maximum duration: 12.1 weeks) |
|
|
Baseline up to 30 days after last dose of study drug administration (up to maximum of 12.1 weeks)
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Isatuximab | 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). | 6 | 14 | 10 | 14 | 12 | 14 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Myocardial Infarction | Cardiac disorders | MedDra 20.1 | Systematic Assessment |
| |
| Pericarditis Constrictive | Cardiac disorders | MedDra 20.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDra 20.1 | Systematic Assessment |
| |
| Disease Progression | General disorders | MedDra 20.1 | Systematic Assessment |
| |
| Device Related Infection | Infections and infestations | MedDra 20.1 | Systematic Assessment |
| |
| Fungal Infection | Infections and infestations | MedDra 20.1 | Systematic Assessment |
| |
| Periorbital Cellulitis | Infections and infestations | MedDra 20.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDra 20.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDra 20.1 | Systematic Assessment |
| |
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDra 20.1 | Systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDra 20.1 | Systematic Assessment |
| |
| Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDra 20.1 | Systematic Assessment |
| |
| Pelvic Venous Thrombosis | Vascular disorders | MedDra 20.1 | Systematic Assessment |
| |
| Vein Collapse | Vascular disorders | MedDra 20.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDra 20.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDra 20.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDra 20.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDra 20.1 | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDra 20.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDra 20.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDra 20.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDra 20.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDra 20.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDra 20.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDra 20.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDra 20.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDra 20.1 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDra 20.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDra 20.1 | Systematic Assessment |
| |
| Cytokine Release Syndrome | Immune system disorders | MedDra 20.1 | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDra 20.1 | Systematic Assessment |
| |
| Device Related Infection | Infections and infestations | MedDra 20.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDra 20.1 | Systematic Assessment |
| |
| Oral Herpes | Infections and infestations | MedDra 20.1 | Systematic Assessment |
| |
| Pyelitis | Infections and infestations | MedDra 20.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDra 20.1 | Systematic Assessment |
| |
| Infusion Related Reaction | Injury, poisoning and procedural complications | MedDra 20.1 | Systematic Assessment |
| |
| Body Temperature Increased | Investigations | MedDra 20.1 | Systematic Assessment |
| |
| Weight Decreased | Investigations | MedDra 20.1 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDra 20.1 | Systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDra 20.1 | Systematic Assessment |
| |
| Flank Pain | Musculoskeletal and connective tissue disorders | MedDra 20.1 | Systematic Assessment |
| |
| Muscle Oedema | Musculoskeletal and connective tissue disorders | MedDra 20.1 | Systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDra 20.1 | Systematic Assessment |
| |
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDra 20.1 | Systematic Assessment |
| |
| Facial Paralysis | Nervous system disorders | MedDra 20.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDra 20.1 | Systematic Assessment |
| |
| Peripheral Motor Neuropathy | Nervous system disorders | MedDra 20.1 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDra 20.1 | Systematic Assessment |
| |
| Urinary Retention | Renal and urinary disorders | MedDra 20.1 | Systematic Assessment |
| |
| Bronchitis Chronic | Respiratory, thoracic and mediastinal disorders | MedDra 20.1 | Systematic Assessment |
| |
| Bronchostenosis | Respiratory, thoracic and mediastinal disorders | MedDra 20.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDra 20.1 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDra 20.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDra 20.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDra 20.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDra 20.1 | Systematic Assessment |
| |
| Pharyngeal Erythema | Respiratory, thoracic and mediastinal disorders | MedDra 20.1 | Systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDra 20.1 | Systematic Assessment |
| |
| Productive Cough | Respiratory, thoracic and mediastinal disorders | MedDra 20.1 | Systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDra 20.1 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDra 20.1 | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDra 20.1 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi | 800-633-1610 | 1# | Contact-US@sanofi.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 13, 2017 | Dec 10, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D054218 | Precursor T-Cell Lymphoblastic Leukemia-Lymphoma |
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D007945 | Leukemia, Lymphoid |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
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| ID | Term |
|---|---|
| C000599209 | isatuximab |
| D003907 | Dexamethasone |
| D000082 | Acetaminophen |
| D011899 | Ranitidine |
| D004155 | Diphenhydramine |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D005663 | Furans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005021 | Ethylamines |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|