Table 1.
Clinical trials with blinatumomab currently recruiting
| Clinical trial identifier | Phase | Condition | Drugs | Primary end points |
|---|---|---|---|---|
| NCT 02412306 (Horai study) | I/II | R/R ALL, Ph− (all ages) | Blinatumomab | Phase I: DLT, Phase II: CR/CRh |
| NCT 02393859 | III | First relapse, Ph− (≤17 years) | Blinatumomab vs conventional chemo | EFS |
| NCT 02458014 | II | MRD-positive ALL | Blinatumomab | RFS |
| NCT 02143414 | II | Newly diagnosed ALL (Ph+ included) (≥65 years) | Blinatumomab plus chemo ± dasatinib | OS, DLT |
| NCT 02101853 | III | First relapse, Ph− (1–30 years) | Blinatumomab vs conventional chemo | DFS |
| NCT 02003222 | III | Newly diagnosed ALL, Ph− (adults) | Blinatumomab plus chemo vs chemo alone | OS |
| NCT 02187354 (RIALTO) | ND | R/R ALL (including after allo HSCT), Ph− (≤17 years) | Blinatumomab | AEs |
Abbreviations: AEs, adverse events; ALL, acute lymphoblastic leukemia; allo HSCT, allogeneic hematopoietic stem cell transplantation; chemo, chemotherapy; CR/CRh, complete response/complete remission with partial hematological recovery; DFS, disease-free survival; DLT, dose-limiting toxicity; EFS, event-free survival; MRD, minimal residual disease; ND, not done; OS, overall survival; Ph, Philadelphia chromosome; RFS, relapse-free survival; R/R, relapsed/refractory.