Phase 2 Completed N=75 Treatment

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

Acute Lymphoblastic Leukemia

Source: ClinicalTrials.gov NCT04956666 ↗

Enrolled (actual)

Serious AEs

36.5%

Results posted

Dec 2023

Primary outcomePrimary: Incidence of Adverse Events (AEs) (Safety and Tolerability) — 74; 74; 72; 27 Participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Incidence of Adverse Events (AEs) (Safety and Tolerability)	74; 74; 72; 27	—

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04956666). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.