A 3-cohort Randomized Study Evaluating the Role of New Immunotherapeutic Agents and of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) in Frontline Therapy of Adults With Acute Lymphoblastic Leukemia

PHASE2/PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

1,200

Participants

Timeline

Start Date

March 15, 2025

Primary Completion Date

March 15, 2035

Study Completion Date

March 15, 2035

Conditions
Acute Lymphoblastic Leukemia
Interventions
DRUG

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)

OTHER

Randomization + Standard frontline T-ALL chemotherapy backbone

Rando 3 : standard of care

DRUG

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.

DRUG

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."

OTHER

Randomization 1 + Allo HSCT

Rando 1 : standard of care - Allogeneic Hematopoietic Stem Cell Transplantation

OTHER

Randomization 2 + Allo HSCT

Rando 2 : standard of care

All Listed Sponsors
lead

Assistance Publique - Hôpitaux de Paris

OTHER

NCT06860269 - A 3-cohort Randomized Study Evaluating the Role of New Immunotherapeutic Agents and of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) in Frontline Therapy of Adults With Acute Lymphoblastic Leukemia | Biotech Hunter | Biotech Hunter