Clinical trial · Interventional
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)
A Multicentre, Phase II Randomized Study, Open-label, With 2-arm Parallel Group, Comparing the Pharmacokinetics of the Liquid and the Lyophilized Formulations of Pegaspargase (S95014) in Treatment of Paediatric Patients With Newly-Diagnosed Acute Lymphoblastic Leukemia (ALL)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Liquid S95014 | Drug | — | UNRESOLVED |
| Lyophilized S95014 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- S95014 lyophilizate
- description
- Lyophilized S95014 reconstituted will provide 5 mL of extractable volume with the concentration of 750 U/mL. The vial of lyophilized powder (3.750 U/vial) is reconstituted with 5.2 mL of Sterile Water for Injection to obtain a 750 U/mL solution for single use.
- interventionNames
- Drug: Lyophilized S95014
- type
- ACTIVE_COMPARATOR
- label
- S95014 liquid
- description
- Liquid S95014 is provided as 3.750 U per 5 mL solution in a single use vial to obtain a 750 U/mL solution for single use.
- interventionNames
- Drug: Liquid S95014
Primary outcomes (2)
- measure
- Pharmacokinetics Measurement
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 17 Years
Show eligibility criteria text
Inclusion Criteria: * Patients aged 1 to \< 18 years * Patients with cytologically confirmed and documented newly diagnosed ALL according to National Comprehensive Cancer Network guidelines 2020 (see Appendix 2), excluding B-cell Burkitt ALL * Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2 (see Appendix 3) * Highly effective contraception method * Signed informed consent and assent, when appropriate Non-inclusion Criteria: * Unlikely to cooperate in the study * Pregnant and lactating women * Participation in another interventional study at the same time; participation in non-interventional registries or epidemiological studies is allowed * Participant already enrolled in the study (informed consent signed) * Women of childbearing potential tested positive in a serum pregnancy test within 7 days prior to the treatment period * Inadequate hepatic function (bilirubin \> 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
References
Publications (0)
Data not yet available