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)

Servier

Status and phase: Completed; Phase 2

Conditions: Acute Lymphoblastic Leukemia

Treatments: Drug: Lyophilized S95014; Drug: Liquid S95014

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04954326

CL2-95014-002

2020-004894-29 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 89 patients

Sex: All

Ages: 1 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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89 participants in 2 patient groups

S95014 lyophilizate

Experimental group

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.

Treatment:

Drug: Lyophilized S95014

S95014 liquid

Active Comparator group

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.

Treatment:

Drug: Liquid S95014