Clinical trial NCT04954326: 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)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Lymphoblastic Leukemia
Keywords: Oncology / Haematology
Phase II
Acute Lymphoblastic Leukemia
Parallel group
Pegaspargase
Pharmacokinetics comparability
Lyophilized pegaspargase
Liquid pegaspargase
Pegaspargase formulation
Randomized, open-label
Lead sponsor: Servier
Sponsor class: INDUSTRY
Collaborators: name: ADIR, a Servier Group company
name: Les Laboratoires Servier (L.L.S), Russia
First posted: 2021-07-08
Enrollment: 89
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Pharmacokinetics Measurement
timeFrame: Predose up to 600 hours
measure: Pharmacokinetics Measurement
timeFrame: Predose up to 600 hours
Secondary outcomes:
measure: Pharmacokinetics Measurements
timeFrame: 14 days post-dose
measure: Activity Measurement
timeFrame: Day 7, 14, 18 and 25 post-dose of either liquid or lyophilized S95014
measure: Immunogenicity Measurements
timeFrame: Pre-dose, post-dose (sum of 14 and 25 days post-dose)
Other outcomes:
Locations:
city: Chelyabinsk
country: Russian Federation
facility: Regional Children Clinical Hospital
city: Ekaterinburg
country: Russian Federation
facility: Regional Children Clinical Hospital
city: Krasnodar
country: Russian Federation
facility: Children Regional Clinical Hospital
city: Moscow
country: Russian Federation
facility: Russian Children Clinical Hospital
city: Nizhny Novgorod
country: Russian Federation
facility: Regional Children Hospital
city: Saint Petersburg
country: Russian Federation
facility: V.A. Almazov National Medical Research Center
Study officials:
affiliation: Director of Institute of Oncology, Radiology and Nuclear Medicine. Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology.
name: Alexander Isaakovich Karachunskiy, PhD
role: PRINCIPAL_INVESTIGATOR
References: