A Roll-over Study to Provide Continued Treatment With Lyophilized Pegaspargase (S95014) in Pediatric Patients With Acute Lymphoblastic Leukemia (ALL)

Phase 2

Completed

• Conditions: Acute Lymphoblastic Leukemia
• Interventions: Drug: Lyophilized S95014

• Registration Number: NCT04956666
• Lead Sponsor: Institut de Recherches Internationales Servier

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-15
• Study First Submitted: 2021-06-18
• Study First Submitted QC: 2021-06-29
• Study First Posted: 2021-07-09
• Primary Completion: 2023-01-23
• Study Completion: 2023-01-23
• Results First Submitted: 2023-11-07
• Status Verified: 2023-12
• Results First Submitted QC: 2023-12-12
• Last Update Submitted: 2023-12-12
• Results First Posted: 2023-12-29
• Last Update Posted: 2023-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lyophilized S95014	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.

Primary Outcome Measures

Name	Time	Method
Incidence of Adverse Events (AEs) (Safety and Tolerability)	Through study completion, approximately 19 months	All Adverse events (AEs) including Treatment Emergent Adverse Events (TEAEs) causality and severity based on NCI CTCAE 5.0.

Trial Locations

Locations (5)

Regional Children Clinical Hospital; 🇷🇺 Ekaterinburg, Russian Federation

Children Regional Clinical Hospital; 🇷🇺 Krasnodar, Russian Federation

Regional Children Hospital; 🇷🇺 Nizhny Novgorod, Russian Federation

V.A. Almazov National Medical Research Center; 🇷🇺 Saint Petersburg, Russian Federation

Russian Children Clinical Hospital; 🇷🇺 Moscow, Russian Federation