Inotuzumab-ozogamicin in frontline or MRD-positive trials for AYA with Ph-negative ALL
| Group . | Phase . | Condition . | Age . | Disease . | End point . | N . | CT . |
|---|---|---|---|---|---|---|---|
| GIMEMA (ALL2418) | 2 | INO in MRD+ patients before allo-HSCT | 18 y+ | Ph+/− | MRD | 76 | NCT03610438 |
| MDACC | 2 | INO in MRD+ patients | 18 y+ | Ph+/− | RFS | 40 | NCT03441061 |
| MDACC | 2 | INO + BLINA + chemotherapy | 14 y+ | Ph− | RFS | 80 | NCT02877303 |
| ALLIANCE | 3 | INO (2 cycles) randomized after induction if M0/M2 bone marrow | 18-39 | Ph− | EFS | 310 | NCT03150693 |
| COG | 3 | INO postinduction in HR-BCP-ALL (2 cycles) | 1-24 y | Ph− | DFS | 4772 | NCT03959085 |
| ALLTogether | 3 | INO postinduction in IR-high BCP-ALL (2 cycles) | 0-45 y | Ph− | DFS | 6430 | NCT04307576 |
| GRAALL (B-2022) | 3 | INO during delayed intensification (1 cycle) | 18-65 y | Ph− | DFS | 600 | Pending |
| Cleveland Medical Center | 1/2 | INO post transplant (CR1 and MRD+ before D45, Ph-like, RIC) | 16-75 y | Ph+/− | Safety/DFS | 44 | NCT03104491 |
| MDACC | 2 | INO before and after allo-HSCT (RIC) | 18-70 y | Ph− | Safety | 44 | NCT03856216 |
| Group . | Phase . | Condition . | Age . | Disease . | End point . | N . | CT . |
|---|---|---|---|---|---|---|---|
| GIMEMA (ALL2418) | 2 | INO in MRD+ patients before allo-HSCT | 18 y+ | Ph+/− | MRD | 76 | NCT03610438 |
| MDACC | 2 | INO in MRD+ patients | 18 y+ | Ph+/− | RFS | 40 | NCT03441061 |
| MDACC | 2 | INO + BLINA + chemotherapy | 14 y+ | Ph− | RFS | 80 | NCT02877303 |
| ALLIANCE | 3 | INO (2 cycles) randomized after induction if M0/M2 bone marrow | 18-39 | Ph− | EFS | 310 | NCT03150693 |
| COG | 3 | INO postinduction in HR-BCP-ALL (2 cycles) | 1-24 y | Ph− | DFS | 4772 | NCT03959085 |
| ALLTogether | 3 | INO postinduction in IR-high BCP-ALL (2 cycles) | 0-45 y | Ph− | DFS | 6430 | NCT04307576 |
| GRAALL (B-2022) | 3 | INO during delayed intensification (1 cycle) | 18-65 y | Ph− | DFS | 600 | Pending |
| Cleveland Medical Center | 1/2 | INO post transplant (CR1 and MRD+ before D45, Ph-like, RIC) | 16-75 y | Ph+/− | Safety/DFS | 44 | NCT03104491 |
| MDACC | 2 | INO before and after allo-HSCT (RIC) | 18-70 y | Ph− | Safety | 44 | NCT03856216 |
BLIN, blinatumomab; DFS, disease-free survival; INO, inotuzumab-ozogamicin, HR, high risk; IR, intermediate risk; RIC, reduced intensity regimen; RFS: relapse-free survival.