A Study Comparing the Blood Levels of Both Pegaspargase (S95014) Formulations (Liquid vs Lyophilized) in the Treatment of Paediatric Patients With Acute Lymphoblastic Leukemia (ALL)
ALL
A Multicentre, Phase II Randomized Study, Open-label, With 2-arm Parallel Group, Comparing the Pharmacokinetics of the Liquid and the Lyophilized Formulations of Pegaspargase (S95014) in Treatment of Paediatric Patients With Newly-Diagnosed Acute Lymphoblastic Leukemia (ALL)
2 other identifiers
interventional
89
1 country
6
Brief Summary
The purpose of this study is to compare the pharmacokinetics (PK) of both lyophilized and liquid S95014 formulations during the induction phase after a single IV dose in newly diagnosed paediatric patients with ALL
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 May 2021
Shorter than P25 for phase_2
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
May 7, 2021
CompletedFirst Submitted
Initial submission to the registry
June 18, 2021
CompletedFirst Posted
Study publicly available on registry
July 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 20, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 20, 2022
CompletedResults Posted
Study results publicly available
July 5, 2023
CompletedJuly 12, 2023
July 1, 2023
1 year
June 18, 2021
May 17, 2023
July 10, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Pharmacokinetics Measurement
Area Under the Plasma Asparaginase activity - Time curve from Time zero to infinity (AUCinf)
Predose up to 600 hours
Pharmacokinetics Measurement
Maximum observed plasma asparaginase activity (Cmax)
Predose up to 600 hours
Secondary Outcomes (3)
Pharmacokinetics Measurements
14 days post-dose
Activity Measurement
Day 7, 14, 18 and 25 post-dose of either liquid or lyophilized S95014
Immunogenicity Measurements
Pre-dose, post-dose (sum of 14 and 25 days post-dose)
Study Arms (2)
S95014 lyophilizate
EXPERIMENTALLyophilized S95014 reconstituted will provide 5 mL of extractable volume with the concentration of 750 U/mL. The vial of lyophilized powder (3.750 U/vial) is reconstituted with 5.2 mL of Sterile Water for Injection to obtain a 750 U/mL solution for single use.
S95014 liquid
ACTIVE COMPARATORLiquid S95014 is provided as 3.750 U per 5 mL solution in a single use vial to obtain a 750 U/mL solution for single use.
Interventions
Lyophilized S95014 will be intravenously administered over 1 hour at the dose of 2500 U/m2 at Day 3 of the induction phase. Patients will receive other backbone chemotherapy agents as per ALL-MB 2015 protocol.
Liquid S95014 will be intravenously administered over 1 hour at the dose of 2500 U/m2 at Day 3 of the induction phase. Patients will receive other backbone chemotherapy agents as per ALL-MB 2015 protocol.
Eligibility Criteria
You may qualify if:
- Patients aged 1 to \< 18 years
- Patients with cytologically confirmed and documented newly diagnosed ALL according to National Comprehensive Cancer Network guidelines 2020 (see Appendix 2), excluding B-cell Burkitt ALL
- Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2 (see Appendix 3)
- Highly effective contraception method
- Signed informed consent and assent, when appropriate
- Unlikely to cooperate in the study
- Pregnant and lactating women
- Participation in another interventional study at the same time; participation in non-interventional registries or epidemiological studies is allowed
- Participant already enrolled in the study (informed consent signed)
- Women of childbearing potential tested positive in a serum pregnancy test within 7 days prior to the treatment period
- Inadequate hepatic function (bilirubin \> 1.5 times upper limit of normal (ULN), transaminases \> 5x ULN)
- Inadequate renal function defined as serum creatinine \> 1.5 x ULN
- Prior treatment with chemotherapy or radiotherapy (except steroids and intrathecal therapy)
- Prior surgery or bone marrow transplant related to the studied disease
- Down Syndrome
- +10 more criteria
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
- Therapeutic Area in Oncology
- Organization
- Institut de Recherches Internationales Servier
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
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2021
First Posted
July 8, 2021
Study Start
May 7, 2021
Primary Completion
May 20, 2022
Study Completion
May 20, 2022
Last Updated
July 12, 2023
Results First Posted
July 5, 2023
Record last verified: 2023-07
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.