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)
Condition: Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Intervention: Lyophilized S95014; Liquid S95014
Intervention description: Lyophilized S95014 will be intravenously administered over 1 hour at the dose of 2500 U/m2 at Day 3 of the induction phase.
Patients will receive other backbone chemotherapy agents as per ALL-MB 2015 protocol.; Liquid S95014 will be intravenously administered over 1 hour at the dose of 2500 U/m2 at Day 3 of the induction phase.
Patients will receive other backbone chemotherapy agents as per ALL-MB 2015 protocol.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 89.0
Sex: All
Minimum age: 1 Year
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Oncology / Haematology; Phase II; Acute Lymphoblastic Leukemia; Parallel group; Pegaspargase; Pharmacokinetics comparability; Lyophilized pegaspargase; Liquid pegaspargase; Pegaspargase formulation; Randomized, open-label

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
    

Eligibility criteria:

        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