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. 2022 Dec 8;12:1036437. doi: 10.3389/fonc.2022.1036437

Table 3.

Clinical studies of olverembatinib.

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.