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)

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.

Study Overview

• Status: Completed
• Conditions: Acute Lymphoblastic Leukemia
• Intervention / Treatment: Drug: Lyophilized S95014

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Institut de Recherches Internationales Servier Clinical Studies Department; Phone Number: +33 1 55 72 43 66; Email: scientificinformation@servier.com

Study Locations

• Russian Federation
  • Chelyabinsk, Russian Federation, 454087
    • Regional Children Clinical Hospital
  • Ekaterinburg, Russian Federation, 620149
    • Regional Children Clinical Hospital
  • Krasnodar, Russian Federation, 350007
    • Children Regional Clinical Hospital
  • Moscow, Russian Federation, 119571
    • Russian Children Clinical Hospital
  • Nizhny Novgorod, Russian Federation, 603136
    • Regional Children Hospital
  • Saint Petersburg, Russian Federation, 197341
    • V.A. Almazov National Medical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Non-inclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Institut de Recherches Internationales Servier
• Collaborators: ADIR, a Servier Group company; Les Laboratoires Servier (L.L.S), Russia
• Investigators: 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

Publications and helpful links

Helpful Links

• Find Results on Servier Clinical Trial Data website

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2021
• Primary Completion (Actual): January 23, 2023
• Study Completion (Actual): January 23, 2023

Study Registration Dates

• First Submitted: June 18, 2021
• First Submitted That Met QC Criteria: June 29, 2021
• First Posted (Actual): July 9, 2021

Study Record Updates

• Last Update Posted (Actual): December 29, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Acute Lymphoblastic Leukemia; Phase II; Oncology / Haematology; Continued treatment; Pegaspargase; Lyophilized pegaspargase; Roll-over study / extension study
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
• Other Study ID Numbers: CL2-95014-003; 2020-004895-17 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing Time Frame: After Marketing Authorisation in EEA or US if the study is used for the approval.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Study Data/Documents

1. Individual Participant Data Set
2. Study Protocol
3. Statistical Analysis Plan
4. Informed Consent Form
5. Clinical Study Report
6. Study-level clinical trial data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes