Phase 2 Completed N=89 Randomized Treatment

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)

Acute Lymphoblastic Leukemia

Source: ClinicalTrials.gov NCT04954326 ↗

Enrolled (actual)

Serious AEs

42.1%

Results posted

Jul 2023

Primary outcomePrimary: Pharmacokinetics Measurement — 362028.656; 352248.907 mU*day/mL — p=0.05

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Pharmacokinetics Measurement	1563.115; 1672.136	0.05
SECONDARY Pharmacokinetics Measurements	496.599; 408.655	0.05
SECONDARY Activity Measurement	43; 43; 43; 41; 41; 39	—
SECONDARY Immunogenicity Measurements	38; 38; 2; 4; 3; 1	—

Eligibility Criteria

Inclusion Criteria

Patients aged 1 to 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
Psychiatric illness/social situation that would limit compliance with study requirements
Known history of pancreatitis
Known history of significant liver disease
Known carriers of HIV antibodies
Significant laboratory abnormality likely to jeopardize the patients' safety or to interfere with the conduct of the study, in the investigator's opinion
Pre-existing known coagulopathy (e.g. haemophilia and known protein S deficiency)
History of previous or concurrent malignancy
History of sensitivity to polyethylene glycol (PEG) or PEG-based drugs
Severe or uncontrolled active acute or chronic infection
Uncontrolled intercurrent illness including life-threatening acute tumor lysis syndrome (e.g. with renal failure), symptomatic congestive heart failure, cardiac arrhythmia

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04954326). 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.