Table 2.
Phase | Sponsor | Clinical trial identifier | Condition | Concomitant medication | Primary end point |
---|---|---|---|---|---|
I/II | Amgen | NCT02412306 | Japanese adults with R/R ALL | Phase I: DLT, II: CR | |
II | M.D. Anderson cancer center | NCT02877303 | Primary diagnosed Ph-neg. ALL ≥14 years | Sequentially with Hyper-CVAD | RFS |
II | M.D. Anderson cancer center | NCT02458014 | Adult patients in CR1 or CR2 with MRD nonresponse or relapse | None | RFS |
II | M.D. Anderson cancer center | NCT02807883 | Maintenance after allogeneic HSCT in adults | None | Toxicity, GvHD, graft failure |
II | National Cancer Institute | NCT02143414 | Primary diagnosed patients ≥65 years ± Ph+ | Combination chemotherapy or dasatinib + prednisone | DLT, OS |
III | Amgen | NCT02393859 | Pediatric patients with 1. High risk relapse | Comparison with standard combination chemotherapy | EFS |
III III |
National Cancer Institute National Cancer Institute |
NCT02101853 NCT02003222 |
Patients from 1 to 30 years with relapsed ALL Primary diagnosed Ph-neg. adults |
Comparison with standard combination chemotherapy ± HSCT ± standard combination chemotherapy | DFS OS |
Abbreviations: CR, complete remission; CVAD, course A: cyclophosphamide, vincristine, dexamethasone, course B: methotrexate, cytarabine; DLT, dose limiting toxicity; EFS, event-free survival; GvHD, graft vs host disease; HSCT, hematopoietic stem cell transplantation; MRD, minimal residual disease; OS, overall survival; Ph, Philadelphia chromosome; RFS, relapse-free survival; R/R ALL, relapsed or refractory acute lymphoblastic leukemia.