About this trial
This is a single-center, prospective, single-arm, exploratory clinical study. To explore the efficacy and safety of avapritinib in patients with recurrent acute myeloid leukemia after allogeneic hematopoietic stem cell transplantation with C-KIT mutation RUNX1::RUNX1T1 or CBFB::MYH11.
Eligibility criteria
Qualifiers
Subjects met the criteria for recurrence after allogeneic transplantation: re-emergence of leukemia cells or bone marrow original cells in peripheral blood >5% (except for other causes such as bone marrow recovery period) or extramedullary leukemia cell infiltration or molecular or cytogenetic recurrence.
Bone marrow molecular biology detected C-KIT D816 or C-KIT N822 mutations
Patients with CBFB::MYH11 gene or RUNX1::RUNX1T1 fusion gene detected.
Eastern Cancer Collaboration Group (ECOG) physical status score 0-2 points.
Disqualifiers
Known allergy to KIT inhibitor drug analogues.
Patients who have received previous treatment with Midostaurin.
Patients who have previously been treated with mutation-specific C-KIT inhibitors and have developed disease progression during treatment.
FLT3-ITD mutation in patients with recurrent/refractory disease (except low gene ratio).
Trial design
Treatments tested in this trial
- Avapritinib, azacitidine, Venetoclax