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)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-07

Study Completion Date

2022-05-20

Brief Summary

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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

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Detailed Description

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Conditions

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Acute Lymphoblastic Leukemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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S95014 lyophilizate

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.

Group Type EXPERIMENTAL

Lyophilized S95014

Intervention Type DRUG

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.

S95014 liquid

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.

Group Type ACTIVE_COMPARATOR

Liquid S95014

Intervention Type DRUG

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.

Interventions

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Lyophilized S95014

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.

Intervention Type DRUG

Liquid S95014

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.

Intervention Type DRUG

Eligibility Criteria

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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

* 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

Minimum Eligible Age

1 Year

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexander Isaakovich Karachunskiy, PhD

Role: PRINCIPAL_INVESTIGATOR

Director of Institute of Oncology, Radiology and Nuclear Medicine. Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology.