A Roll-over Study to Provide Continued Treatment With Lyophilized Pegaspargase (S95014) in Pediatric Patients With Acute Lymphoblastic Leukemia (ALL)

PHASE2CompletedINTERVENTIONAL
Enrollment

75

Participants

Timeline

Start Date

June 15, 2021

Primary Completion Date

January 23, 2023

Study Completion Date

January 23, 2023

Conditions
Acute Lymphoblastic Leukemia
Interventions
DRUG

Lyophilized S95014

"Each patient was administrated, over 1 to 2 hours, every 2 weeks Lyophilized S95014 intravenously at the dose of 1000, 2000 or 2500U/m2, as per investigator's judgement.~In total, 9 infusions of lyophilized S95014 were administrated (at week 7, 9, 11, 15, 17, 19, 23, 25 and 27).Patients received other backbone chemotherapy agents as per ALL-MB 2015."

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