A Roll-over Study to Provide Continued Treatment With Lyophilized Pegaspargase (S95014) in Pediatric Patients With Acute Lymphoblastic Leukemia (ALL)
ALL
A Multicentre, Roll-over Study to Provide Continued Treatment With Lyophilized Pegaspargase (S95014) in Pediatric Patients With Acute Lymphoblastic Leukemia (ALL)
2 other identifiers
interventional
75
1 country
6
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2021
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 15, 2021
CompletedFirst Submitted
Initial submission to the registry
June 18, 2021
CompletedFirst Posted
Study publicly available on registry
July 9, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 23, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 23, 2023
CompletedResults Posted
Study results publicly available
December 29, 2023
CompletedDecember 29, 2023
December 1, 2023
1.6 years
June 18, 2021
November 7, 2023
December 12, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Lyophilized S95014
EXPERIMENTALLyophilized 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.
Interventions
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
You may qualify if:
- Patient who completed the CL2-95014-002 study
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Regional Children Clinical Hospital
Chelyabinsk, 454087, Russia
Children Regional Clinical Hospital
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
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Studies Department
- Organization
- Institut de Recherches Internationales Servier (I.R.I.S.)
Study Officials
- PRINCIPAL INVESTIGATOR
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
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2021
First Posted
July 9, 2021
Study Start
June 15, 2021
Primary Completion
January 23, 2023
Study Completion
January 23, 2023
Last Updated
December 29, 2023
Results First Posted
December 29, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- After Marketing Authorisation in EEA or US if the study is used for the approval.
- Access Criteria
- 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.
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: * used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US). * where Servier is the Marketing Authorization Holder (MAH).The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope. In addition, access can be requested for all interventional clinical studies in patients: * sponsored by Servier * with a first patient enrolled as of 1 January 2004 onwards * for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.