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Clinical Trials/NCT04956666
NCT04956666CompletedPhase 2

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

Institut de Recherches Internationales Servier5 sites in 1 country75 target enrollmentStarted: June 15, 2021Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
75
Locations
5
Primary Endpoint
Incidence of Adverse Events (AEs) (Safety and Tolerability)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
1 Year to 17 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Exclusion Criteria

  • Not provided

Arms & Interventions

Lyophilized S95014

Experimental

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.

Intervention: Lyophilized S95014 (Drug)

Outcomes

Primary Outcomes

Incidence of Adverse Events (AEs) (Safety and Tolerability)

Time Frame: 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (5)

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