Table 3.
Registration Number | Types | Phase | Status | Patient Number | Intervention | Main indicators |
---|---|---|---|---|---|---|
NCT04260022 | CP/AP/BP-CML and Ph+ ALL, Resistance or intolerance to at least two TKIs, BCP-ALL and LBP- CML, Resistance or intolerant to at least one second or later generation TKI |
I | Recruiting | 62 | Blinatumomab Olverembatinib. 30, 40, 50 mg QOD |
Phase 2 dose and PK/PD |
NCT05376852 | AP-CML and CML in lymphoid/myeloid blast crisis | II | Recruiting | 40 | Olverembatinib,40 mg QOD Combination with decitabine |
Overall response rate (end of cycle 2) |
NCT05311943 | CP-CML, Resistance or intolerance to at least two second generation TKIs | III | Recruiting | 40 | Olverembatinib, 40 mg QOD | MMR at 12 months |
NCT03883087 | CP-CML with T315I mutation | II | Active, Not recruiting | 41 | Olverembatinib,40 mg QOD | MCyR (by the end of cycle 24) |
NCT03883100 | AP-CML with T315I mutation | II | Active, Not recruiting | 23 | Olverembatinib,40 mg QOD | MaHR (by the end of cycle 24) |
NCT04126681 | CP-CML, Resistance or intolerance to first and second generation TKIs | II | Active, Not recruiting | 144 | Olverembatinib. Hydroxyurea or Interferon-based therapy. Homoharringtonine. Imatinib, Dasatinib or Nilotinib |
EFS (by the end of cycle 24) |
EFS, event-free survival; PK/PD, pharmacokinetic or pharmacodynamic; BCP-ALL, Ph+ B-cell precursor (BCP) ALL; LBP, lymphoid blast phase CML (CML LBP); AUC, area under the curve; MaHR, major hematologic response. Each cycle is 28 days.