A Roll-over Study to Provide Continued Treatment With Lyophilized Pegaspargase (S95014) in Pediatric Patients With Acute Lymphoblastic Leukemia (ALL)
NCT ID: NCT04956666
Last Updated: 2023-12-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
75 participants
INTERVENTIONAL
2021-06-15
2023-01-23
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Lyophilized S95014
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.
Lyophilized S95014
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.
Interventions
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Lyophilized S95014
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.
Eligibility Criteria
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Inclusion Criteria
* Patient currently receiving clinical benefit from previous treatment with S95014 as per investigator's judgment
* Signed informed consent and assent, when appropriate
* Highly effective contraception method
* Unlikely to cooperate in the study
* Pregnant and lactating women
* Participant already enrolled in the study (informed consent signed)
* Prior surgery or bone marrow transplant related to the studied disease
* History of sensitivity to polyethylene glycol (PEG) or PEG-based drugs
* Psychiatric illness/social situation that would limit compliance with study requirements
* Group "E" and "T-HR" patients according to ALL-MB 2015 protocol classification
* Major safety issue due to previous S95014 administration (e.g. non recovery of safety parameters, serious hypersensitivity, serious pancreatitis, serious haemorrhage, serious thromboembolic event)
* Significant laboratory abnormality or uncontrolled intercurrent illness (e.g. life-threatening acute tumor lysis syndrome, symptomatic congestive heart failure, cardiac arrhythmia, severe or uncontrolled active acute infection) likely to jeopardize the patients' safety or to interfere with the conduct of the study, in the investigator's opinion
1 Year
17 Years
ALL
No
Sponsors
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ADIR, a Servier Group company
INDUSTRY
Les Laboratoires Servier (L.L.S), Russia
INDUSTRY
Institut de Recherches Internationales Servier
OTHER
Responsible Party
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Principal Investigators
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Alexander Isaakovich Karachunskiy, PhD
Role: PRINCIPAL_INVESTIGATOR
Director of Institute of Oncology, Radiology and Nuclear Medicine. Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology
Locations
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Regional Children Clinical Hospital
Chelyabinsk, , Russia
Children Regional Clinical Hospital
Krasnodar, , Russia
Russian Children Clinical Hospital
Moscow, , Russia
Regional Children Hospital
Nizhny Novgorod, , Russia
V.A. Almazov National Medical Research Center
Saint Petersburg, , Russia
Regional Children Clinical Hospital
Yekaterinburg, , Russia
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Study Documents
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Document Type: Individual Participant Data Set
View DocumentDocument Type: Study Protocol
View DocumentDocument Type: Statistical Analysis Plan
View DocumentDocument Type: Informed Consent Form
View DocumentDocument Type: Clinical Study Report
View DocumentDocument Type: Study-level clinical trial data
View DocumentRelated Links
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Find results on Servier Clinical Trial Data website
Other Identifiers
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2020-004895-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CL2-95014-003
Identifier Type: -
Identifier Source: org_study_id