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)

• Status: Recruiting
• Trial end date: 2022-04-22
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut de Recherches Internationales Servier
• Collaborators: ADIR, a Servier Group company; Les Laboratoires Servier (L.L.S), Russia

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