Studies of blinatumomab in initial treatment of Philadelphia chromosome-positive acute lymphoblastic leukemia
| Group (study) . | Phase . | Regimen . | Years . | N . | Age in years, median (range) . | CMR (%) . | alloHCT, CR1 (%) . | RFS/EFS (%) . | OS (%) . |
|---|---|---|---|---|---|---|---|---|---|
| SWOG(US) SWOG 1318 NCT02143414 | 2 | Ind: DAS, pred × 84 days Cons: DAS, blina x 3C CNS: 8 IT chemo | 2015-2021 | 24 | 73 (65-87) | 63 (12/19, anytime) | 3.8 | 77 (3-yr DFS) | 87 (3-yr) |
| GIMEMA(Italy) LAL2116 D-ALBA NCT02744768 | 2 | Ind: DAS, pred × 85 days Cons: DAS, blina x 5C CNS: 12 IT chemo | 2017-2019 | 63 | 54 (24-82) | 60 (blina C2) 82 (blina C4) | 38.1 | 75 (4-yr EFS) | 81 (4-yr) |
| MDACC(US) NCT03263572 | 2a | Ind/cons: PON + blina (C1-C5) CNS: 12 IT chemo | 2018- | 60 (39b) to date | 55 (20-83) | 83 (98 by NGS) | 3.3 | 77 (3-yr EFS) | 91 (3-yr) |
| DFCI(US) DF/HCC 18-170 NCT03595917 | 1a | Ind: DAS, ASC, pred x 1C Cons: DAS, ASC, blina x 5C CNS: 12 IT chemo | 2022- (blina cohort) | 15a | Eligibility: ≥18 | - | Per treating physician | - | - |
| ECOG-ACRIN(US) EA9181 NCT04530565 | 3a | Ind: DAS or PON + pred Cons: DAS or PON + hyper-CVAD vs blina (1:1) CNS: IT chemo + HD-MTX intensification x 1C | 2020- | 348a | Eligibility: 18-75 | - | Per treating physician | - | - |
| GIMEMA(Italy) ALL2820 NCT04722848 | 3a | Ind/cons: PON + blina vs IM + chemo (2:1) CNS: 15 IT chemo | 2021- | 236a | Eligibility: ≥18 | - | Based on IKZF1 plus and MRD | - | - |
| GRAALL(SAKK) GRAAPH-2024 | 3a | Ind: PON, blina, chemo Cons: alloHCT vs chemo/blina CNS: IT and systemic chemo | - | - | - | - | Randomize if in CMR (NGS) | - | - |
| Group (study) . | Phase . | Regimen . | Years . | N . | Age in years, median (range) . | CMR (%) . | alloHCT, CR1 (%) . | RFS/EFS (%) . | OS (%) . |
|---|---|---|---|---|---|---|---|---|---|
| SWOG(US) SWOG 1318 NCT02143414 | 2 | Ind: DAS, pred × 84 days Cons: DAS, blina x 3C CNS: 8 IT chemo | 2015-2021 | 24 | 73 (65-87) | 63 (12/19, anytime) | 3.8 | 77 (3-yr DFS) | 87 (3-yr) |
| GIMEMA(Italy) LAL2116 D-ALBA NCT02744768 | 2 | Ind: DAS, pred × 85 days Cons: DAS, blina x 5C CNS: 12 IT chemo | 2017-2019 | 63 | 54 (24-82) | 60 (blina C2) 82 (blina C4) | 38.1 | 75 (4-yr EFS) | 81 (4-yr) |
| MDACC(US) NCT03263572 | 2a | Ind/cons: PON + blina (C1-C5) CNS: 12 IT chemo | 2018- | 60 (39b) to date | 55 (20-83) | 83 (98 by NGS) | 3.3 | 77 (3-yr EFS) | 91 (3-yr) |
| DFCI(US) DF/HCC 18-170 NCT03595917 | 1a | Ind: DAS, ASC, pred x 1C Cons: DAS, ASC, blina x 5C CNS: 12 IT chemo | 2022- (blina cohort) | 15a | Eligibility: ≥18 | - | Per treating physician | - | - |
| ECOG-ACRIN(US) EA9181 NCT04530565 | 3a | Ind: DAS or PON + pred Cons: DAS or PON + hyper-CVAD vs blina (1:1) CNS: IT chemo + HD-MTX intensification x 1C | 2020- | 348a | Eligibility: 18-75 | - | Per treating physician | - | - |
| GIMEMA(Italy) ALL2820 NCT04722848 | 3a | Ind/cons: PON + blina vs IM + chemo (2:1) CNS: 15 IT chemo | 2021- | 236a | Eligibility: ≥18 | - | Based on IKZF1 plus and MRD | - | - |
| GRAALL(SAKK) GRAAPH-2024 | 3a | Ind: PON, blina, chemo Cons: alloHCT vs chemo/blina CNS: IT and systemic chemo | - | - | - | - | Randomize if in CMR (NGS) | - | - |
ongoing/planned.
previously untreated.
ara-C, cytarabine; ASC, asciminib; blina, blinatumomab; C, cycle; chemo, chemotherapy; CNS, central nervous system; cons, consolidation; DAS, dasatinib; EFS, event-free survival; HD-MTX; high-dose methotrexate; ind, induction; IT, intrathecal; NGS, next-generation sequencing; OS, overall survival; PON, ponatinib; pred, prednisone; RFS, relapse-free survival; SAKK (France, Belgium, and Switzerland); US, United States.