Novel approaches to Ph– ALL in older adults: published and ongoing trials*
| Reference . | Regimen . | Phase . | N . | Line . | Age, y . | Regimen-related deaths . | Response . | Survival . |
|---|---|---|---|---|---|---|---|---|
| Kantarjian et al (2018)22 Short et al (2020)23 NCT01371630 | IO + mini-hyper-CVD (Blina consolidation) | 2 | 70 | First | ≥60 | 0% early mortality 34% mortality in remission | 98% ORR 88% CR (96% MRD negative) | Continuous CR 3 years: 79% Median CCR NR OS 3 years: 56% Median OS 62 months |
| EWALL-INO NCT03249870 | IO + mild-intensity chemotherapy CC consolidation | 2 | — | First | ≥55 | — | — | — |
| Stelljes et al (2020)24 GMALL (INITIAL-1) NCT03460522 | IO induction CC consolidation | 2 | 36 | First | ≥56 | 0% early mortality | 100% CR/CRi (78% MRD negative) | EFS 1 year: 87% (95% CI, 70-100) OS 1 year: 87% (95% CI, 70-100) |
| Jain et al (2019)25 DFCI/MDACC IST NCT03319901 | Venetoclax + mini-hyper-CVD | 1b/2 | 19 | R/R (8) First (11) | All ages ≥60 | 0% early mortality | 91% CR (100% MRD negative) | — |
| Advani et al (2018)26 SWOG 1318 NCT02143414 | Blina induction Blina consolidation | 2 | 29 | First | ≥65 | 0% | 66% CR/CRi (92% MRD negative) | DFS 1 year: 56% (95% CI, 58-90) OS 1 year: 65% (95% CI, 43-80) |
| Alliance 041703 NCT03739814 | IO induction Blina consolidation | 2 | — | R/R First | All ages ≥60 | Results pending | Results pending | Results pending |
| Reference . | Regimen . | Phase . | N . | Line . | Age, y . | Regimen-related deaths . | Response . | Survival . |
|---|---|---|---|---|---|---|---|---|
| Kantarjian et al (2018)22 Short et al (2020)23 NCT01371630 | IO + mini-hyper-CVD (Blina consolidation) | 2 | 70 | First | ≥60 | 0% early mortality 34% mortality in remission | 98% ORR 88% CR (96% MRD negative) | Continuous CR 3 years: 79% Median CCR NR OS 3 years: 56% Median OS 62 months |
| EWALL-INO NCT03249870 | IO + mild-intensity chemotherapy CC consolidation | 2 | — | First | ≥55 | — | — | — |
| Stelljes et al (2020)24 GMALL (INITIAL-1) NCT03460522 | IO induction CC consolidation | 2 | 36 | First | ≥56 | 0% early mortality | 100% CR/CRi (78% MRD negative) | EFS 1 year: 87% (95% CI, 70-100) OS 1 year: 87% (95% CI, 70-100) |
| Jain et al (2019)25 DFCI/MDACC IST NCT03319901 | Venetoclax + mini-hyper-CVD | 1b/2 | 19 | R/R (8) First (11) | All ages ≥60 | 0% early mortality | 91% CR (100% MRD negative) | — |
| Advani et al (2018)26 SWOG 1318 NCT02143414 | Blina induction Blina consolidation | 2 | 29 | First | ≥65 | 0% | 66% CR/CRi (92% MRD negative) | DFS 1 year: 56% (95% CI, 58-90) OS 1 year: 65% (95% CI, 43-80) |
| Alliance 041703 NCT03739814 | IO induction Blina consolidation | 2 | — | R/R First | All ages ≥60 | Results pending | Results pending | Results pending |
Results at most recent publication.
Blina, blinatumomab; CCR, continuous complete remission; CRi, complete remission with incomplete count recovery; NR, not reached.