1,200
Participants
Start Date
March 15, 2025
Primary Completion Date
March 15, 2035
Study Completion Date
March 15, 2035
Randomization + Blinatumomab + chemotherapy
Rando 1 : BLINA will be given at 28 µg/day IVC from D1 to D28 for 2 to 4 cycles (first cycle starts with 9 µg/day for 7 days)
Randomization + Standard frontline T-ALL chemotherapy backbone
Rando 3 : standard of care
Randomization + Isatuximab + Standard frontline T-ALL chemotherapy backbone
Rando 3 : ISA will be given at 10 mg/kg IV for a maximum of 28 infusions starting at induction up to maintenance phase.
Randomization + Blinatumomab + Ponatinib + chemotherapy
"Rando 2 :~* PONA will be given at 45 mg/day PO during 2 cycles, 30 mg/day during 2 additional cycles, and 15 mg/day during maintenance phase or after alloHSCT~* BLINA will be given at 28 µg/day IVC from D1 to D28 for 2 to 5 cycles (first cycle starts with 9 µg/day for 7 days). Patients allografted will receive two courses before transplant."
Randomization 1 + Allo HSCT
Rando 1 : standard of care - Allogeneic Hematopoietic Stem Cell Transplantation
Randomization 2 + Allo HSCT
Rando 2 : standard of care
Assistance Publique - Hôpitaux de Paris
OTHER