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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
89
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.
Regional Children Clinical Hospital
Chelyabinsk, Russia
Children Regional Clinical Hospital
Krasnodar, Russia
Russian Children Clinical Hospital
Moscow, Russia
Regional Children Hospital
Nizhny Novgorod, Russia
Pharmacokinetics Measurement
Area Under the Plasma Asparaginase activity - Time curve from Time zero to infinity (AUCinf)
Time frame: Predose up to 600 hours
Pharmacokinetics Measurement
Maximum observed plasma asparaginase activity (Cmax)
Time frame: Predose up to 600 hours
Pharmacokinetics Measurements
Observed Plasma Asparaginase Activity 14 days post-dose (Cday 14) of S95014
Time frame: 14 days post-dose
Activity Measurement
Plasma Asparaginase Activity (PAA) of ≥ 0.1 U/mL after the administration of either liquid or lyophilized S95014.
Time frame: Day 7, 14, 18 and 25 post-dose of either liquid or lyophilized S95014
Immunogenicity Measurements
Anti-drug antibodies (ADA) formation against S95014 and anti-PEG with the lyophilized or liquid formulations (positive patients).
Time frame: Pre-dose, post-dose (sum of 14 and 25 days post-dose)
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V.A. Almazov National Medical Research Center
Saint Petersburg, Russia
Regional Children Clinical Hospital
Yekaterinburg, Russia