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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-004895-17 | EudraCT Number |
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| Name | Class |
|---|---|
| ADIR, a Servier Group company | INDUSTRY |
| Les Laboratoires Servier (L.L.S), Russia | INDUSTRY |
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The purpose of this study is to provide treatment with lyophilized S95014 in pediatric patients with ALL who completed the CL2-95014-002 study during the induction phase and who are clinically benefitting from S95014 without major toxicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lyophilized S95014 | Experimental | Lyophilized S95014 reconstituted was provided 5 mL of extractable volume with the concentration of 750 U/mL. The vial of lyophilized powder (3.750 U/vial) was reconstituted with 5.2 mL of Sterile Water For Injection to obtain a 750 U/mL solution for single use. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lyophilized S95014 | Drug | Each patient was administrated, over 1 to 2 hours, every 2 weeks Lyophilized S95014 intravenously at the dose of 1000, 2000 or 2500U/m2, as per investigator's judgement. In total, 9 infusions of lyophilized S95014 were administrated (at week 7, 9, 11, 15, 17, 19, 23, 25 and 27).Patients received other backbone chemotherapy agents as per ALL-MB 2015. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events (AEs) (Safety and Tolerability) | All Adverse events (AEs) including Treatment Emergent Adverse Events (TEAEs) causality and severity based on NCI CTCAE 5.0. | Through study completion, approximately 19 months |
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Inclusion Criteria:
Non-inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexander Isaakovich Karachunskiy, PhD | Director of Institute of Oncology, Radiology and Nuclear Medicine. Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regional Children Clinical Hospital | Chelyabinsk | 454087 | Russia | |||
| Children Regional Clinical Hospital |
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| Label | URL |
|---|---|
| Find results on Servier Clinical Trial Data website | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| Individual Participant Data Set | View IPD |
Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.
Access can be requested for all interventional clinical studies:
In addition, access can be requested for all interventional clinical studies in patients:
After Marketing Authorisation in EEA or US if the study is used for the approval.
Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lyophilized S95014 | Lyophilized S95014 reconstituted provided 5 mL of extractable volume with the concentration of 750 U/mL. |
| 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 | Dec 2, 2020 | Aug 10, 2023 |
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|
| Krasnodar |
| 350007 |
| Russia |
| Russian Children Clinical Hospital | Moscow | 119571 | Russia |
| Regional Children Hospital | Nizhny Novgorod | 603136 | Russia |
| V.A. Almazov National Medical Research Center | Saint Petersburg | 197341 | Russia |
| Regional Children Clinical Hospital | Yekaterinburg | 620149 | Russia |
| Study Protocol | View IPD |
| Statistical Analysis Plan | View IPD |
| Informed Consent Form | View IPD |
| Clinical Study Report | View IPD |
| Study-level clinical trial data | View IPD |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Lyophilized S95014 | Lyophilized S95014 reconstituted was provided 5 mL of extractable volume with the concentration of 750 U/mL. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| ECOG Performance Status | Eastern Cooperative Oncology Group (ECOG) performance status scores range from 0 to 5, with 0 being fully active and 5 being dead, and are graded by the investigator during the participants clinical examination. | Count of Participants | Participants |
| |||||||||||||||||
| Body Mass Index (kg/m^2) | Mean | Standard Deviation | kg/m^2 |
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| Body Surface Area (m^2) | Mean | Standard Deviation | m^2 |
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| 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 | Incidence of Adverse Events (AEs) (Safety and Tolerability) | All Adverse events (AEs) including Treatment Emergent Adverse Events (TEAEs) causality and severity based on NCI CTCAE 5.0. | Posted | Count of Participants | Participants | Through study completion, approximately 19 months |
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Through study completion, approximately 19 months
Throughout the study multiple safety visits were conducted and patients underwent physical examinations, electrocardiograms, hematology, blood biochemistry, coagulation parameters, urinalysis, hepatitis serology, cardiac imaging, and vital sign measurements. During these assessments any abnormal values, test or exam results constituted an adverse event if they meet criteria or were deemed clinically significant by the investigator.
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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 | Lyophilized S95014 | Lyophilized S95014 reconstituted provided 5 mL of extractable volume with the concentration of 750 U/mL. | 0 | 74 | 27 | 74 | 68 | 74 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypersensitivity | Immune system disorders | MedDRA (25.0) | Non-systematic Assessment |
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| Anaphylactic reaction | Immune system disorders | MedDRA (25.0) | Systematic Assessment |
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| Drug hypersensitivity | Immune system disorders | MedDRA (25.0) | Systematic Assessment |
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| Haemophagocytic lymphohistiocytosis | Immune system disorders | MedDRA (25.0) | Non-systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA (25.0) | Non-systematic Assessment |
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| COVID-19 pneumonia | Infections and infestations | MedDRA (25.0) | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA (25.0) | Non-systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
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| Neutropenic sepsis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA (25.0) | Non-systematic Assessment |
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| Cellulitis gangrenous | Infections and infestations | MedDRA (25.0) | Non-systematic Assessment |
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| Device related bacteraemia | Infections and infestations | MedDRA (25.0) | Non-systematic Assessment |
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| Device related infection | Infections and infestations | MedDRA (25.0) | Non-systematic Assessment |
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| Laryngitis | Infections and infestations | MedDRA (25.0) | Non-systematic Assessment |
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| Pneumonia fungal | Infections and infestations | MedDRA (25.0) | Non-systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA (25.0) | Systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (25.0) | Systematic Assessment |
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| Agranulocytosis | Blood and lymphatic system disorders | MedDRA (25.0) | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA (25.0) | Systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | MedDRA (25.0) | Systematic Assessment |
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| Enterocolitis haemorrhagic | Gastrointestinal disorders | MedDRA (25.0) | Non-systematic Assessment |
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| Oedematous pancreatitis | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
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| Ejection fraction decreased | Investigations | MedDRA (25.0) | Systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA (25.0) | Systematic Assessment |
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| General physical health deterioration | General disorders | MedDRA (25.0) | Non-systematic Assessment |
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| Hepatomegaly | Hepatobiliary disorders | MedDRA (25.0) | Systematic Assessment |
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| Hepatotoxicity | Hepatobiliary disorders | MedDRA (25.0) | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Antithrombin III decreased | Investigations | MedDRA (25.0) | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA (25.0) | Systematic Assessment |
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| Blood fibrinogen decreased | Investigations | MedDRA (25.0) | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA (25.0) | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA (25.0) | Systematic Assessment |
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| Gamma-glutamyltransferase increased | Investigations | MedDRA (25.0) | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA (25.0) | Systematic Assessment |
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| Hypersensitivity | Immune system disorders | MedDRA (25.0) | Non-systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | MedDRA (25.0) | Systematic Assessment |
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| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
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| Protein S decreased | Investigations | MedDRA (25.0) | Systematic Assessment |
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| Blood bilirubin increased | Investigations | MedDRA (25.0) | Systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA (25.0) | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (25.0) | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA (25.0) | Non-systematic Assessment |
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| White blood cell count decreased | Investigations | MedDRA (25.0) | Systematic Assessment |
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| Activated partial thromboplastin time prolonged | Investigations | MedDRA (25.0) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (25.0) | Systematic Assessment |
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| Drug hypersensitivity | Immune system disorders | MedDRA (25.0) | Systematic Assessment |
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| Lipase increased | Investigations | MedDRA (25.0) | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
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| Toxic neuropathy | Nervous system disorders | MedDRA (25.0) | Non-systematic Assessment |
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| Blood albumin decreased | Investigations | MedDRA (25.0) | Systematic Assessment |
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| Haemoglobin decreased | Investigations | MedDRA (25.0) | Systematic Assessment |
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| Hypofibrinogenaemia | Blood and lymphatic system disorders | MedDRA (25.0) | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (25.0) | Non-systematic Assessment |
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| Ammonia increased | Investigations | MedDRA (25.0) | Systematic Assessment |
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| Amylase increased | Investigations | MedDRA (25.0) | Systematic Assessment |
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| Hyperammonaemia | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
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| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
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| Lymphocyte count decreased | Investigations | MedDRA (25.0) | Systematic Assessment |
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| Lymphopenia | Blood and lymphatic system disorders | MedDRA (25.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (25.0) | Non-systematic Assessment |
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| Platelet count decreased | Investigations | MedDRA (25.0) | Systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA (25.0) | Non-systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | MedDRA (25.0) | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Studies Department | Institut de Recherches Internationales Servier (I.R.I.S.) | +33 1 55 72 60 00 | scientificinformation@servier.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 2, 2023 | Aug 8, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ≥ 16 years |
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| Unknown or Not Reported |
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| Multiple |
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| ECOG Performance Status: 2 |
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| Number of Participants with a Serious Treatment Emergent Adverse Event |
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