Study of HQP1351 in Subjects With Refractory CML and Ph+ ALL

Inclusion criteria

• ✓. The definition of resistance to first-line TKI treatment refers to European Leukemia Net (ELN) recommendations. The definitions are the same for patients in CP, AP, BP, and Ph+ ALL, and apply also to second-line treatment, when first-line treatment was changed for intolerance. The patients must meet at least one criterion:
• ✓. Three months after the initiation of therapy: non-complete hematologic response (CHR) and/or Ph+ \>95%
• ✓. Six months after the initiation of therapy: BCR-ABL1\>10% and/or Ph+ \>35%
• ✓. Twelve months after the initiation of therapy: BCR-ABL1\>1% and/or Ph+ \>0%
• ✓. Then, and at any time after the initiation of therapy: Loss of CHR, or loss of complete cytogenetic response (CCyR), or confirmed loss of major molecular response (MMR) (In 2 consecutive tests, of which one with a BCR-ABL1 transcripts level ≥1%), mutations, clonal chromosome abnormalities in Ph+ cells (CCA/Ph+)
• ✓. The definition of resistance to second-line TKI treatment
• ✓. Intolerance to TKIs is defined as:
• ✓. Non-hematological AEs: patients with grade 3 or 4 toxicity during TKIs treatment, or with persistent grade 2 toxicity, unresponsive to optimal management, including dose adjustments in the absence of a CCyR for CP patients or MaHR for AP/BP or Ph+ ALL patients