67
Participants
Start Date
August 6, 2019
Primary Completion Date
September 12, 2022
Study Completion Date
May 26, 2023
Isatuximab
Pharmaceutical form: Concentrate for solution for intravenous infusion Route of administration: Intravenous
Dexamethasone or equivalent
Pharmaceutical form: Solution for injection or tablet Route of administration: Intravenous or oral
Fludarabine
Pharmaceutical form: Solution for injection Route of administration: Intravenous
Cytarabine
Pharmaceutical form: Solution for injection Route of administration: Intravenous
Liposomal daunorubicin
Pharmaceutical form: Solution for injection Route of administration: Intravenous
Daunorubicin (nonliposomal)
Pharmaceutical form: Solution for injection Route of administration: Intravenous infusion
Idarubicin
Pharmaceutical form: Solution for injection Route of administration: Intravenous
Filgrastim or equivalent
Pharmaceutical form: Solution for injection Route of administration: Intravenous
Mitoxantrone
Pharmaceutical form: Solution for injection Route of administration: Intravenous
Doxorubicin
Pharmaceutical form: Solution for injection Route of administration: Intravenous
Vincristine
Pharmaceutical form: Solution for injection Route of administration: Intravenous
Pegaspargase (PEG) Asparaginase
Pharmaceutical form: Solution for injection Route of administration: Intravenous infusion
Cyclophosphamide
Pharmaceutical form: Solution for injection Route of administration: Intravenous
Etoposide
Pharmaceutical form: Solution for injection Route of administration: Intravenous infusion
Methotrexate
Pharmaceutical form: Solution for injection Route of administration: Intravenous infusion
L - Asparginase
Pharmaceutical form: Solution for injection Route of administration: Intramuscular
Hydroxyurea
Pharmaceutical form: Solution for injection Route of administration: PO
L - Asparaginase (Erwinase)
Pharmaceutical form: Solution for injection Route of administration: Intramuscular
Investigational Site Number :6040002, Lima
Investigational Site Number :3480002, Budapest
Investigational Site Number :2080001, Copenhagen
Investigational Site Number :5780001, Bergen
Investigational Site Number :3800003, Turin
Investigational Site Number :3800002, Genoa
Investigational Site Number :2760003, Hamburg
Investigational Site Number :3800001, Monza
Investigational Site Number :3800005, Verona
Sarah Cannon Research Institute-Site Number:8400001, Nashville
Investigational Site Number :2760006, Münster
Investigational Site Number :2500002, Lille
Investigational Site Number :4840001, Monterrey
Investigational Site Number :2500003, Lyon
Children's Medical Center of Dallas-Site Number:8400002, Dallas
Investigational Site Number :2500001, Paris
Investigational Site Number :2500004, Paris
Investigational Site Number :4840005, Col. Rancho Menchaca
Investigational Site Number :2760005, Erlangen
Investigational Site Number :0320002, CABA
Investigational Site Number :0320006, Capital Federal
Investigational Site Number :0320005, Buenos Aires
Investigational Site Number :0320004, Buenos Aires
Investigational Site Number :0760013, Curitiba
Investigational Site Number :0760006, Curitiba
Investigational Site Number :0760007, Porto Alegre
Investigational Site Number :0760010, Jaú
Investigational Site Number :0760009, Ribeirão Preto
Investigational Site Number :0760001, São Paulo
Investigational Site Number :0760004, São Paulo
Investigational Site Number :3000001, Athens
Investigational Site Number :5280001, Utrecht
Investigational Site Number :5780002, Oslo
Investigational Site Number :6040001, Arequipa
Investigational Site Number :6200002, Coimbra
Investigational Site Number :6200001, Lisbon
Investigational Site Number :6200003, Porto
Investigational Site Number :4100001, Seoul
Investigational Site Number :4100002, Seoul
Investigational Site Number :4100004, Seoul
Investigational Site Number :7520001, Gothenburg
Lead Sponsor
Sanofi
INDUSTRY