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)

PHASE2CompletedINTERVENTIONAL
Enrollment

89

Participants

Timeline

Start Date

May 7, 2021

Primary Completion Date

May 20, 2022

Study Completion Date

May 20, 2022

Conditions
Acute Lymphoblastic Leukemia
Interventions
DRUG

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."

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."

Trial Locations (6)

119571

Russian Children Clinical Hospital, Moscow

197341

V.A. Almazov National Medical Research Center, Saint Petersburg

350007

Children Regional Clinical Hospital, Krasnodar

454087

Regional Children Clinical Hospital, Chelyabinsk

603136

Regional Children Hospital, Nizhny Novgorod

620149

Regional Children Clinical Hospital, Yekaterinburg

All Listed Sponsors
collaborator

ADIR, a Servier Group company

INDUSTRY

collaborator

Les Laboratoires Servier (L.L.S), Russia

INDUSTRY

lead

Institut de Recherches Internationales Servier

OTHER