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.
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.
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).
Single group
Avapritinib, azacitidine, Venetoclax
DrugA: Induction therapy period: After patients were screened and enrolled, they began to receive 1-2 cycles of induction therapy, and the specific administration regimen was as follows: Avapritinib 100mg po qd D1-D14, azacitidine 35mg/m2 ih D1-D5, Venetoclax 100mg po qd D1-D14. The 28-day cycle was followed by curative effect evaluation at the end of each cycle. Patients who achieved complete remission entered the consolidation treatment stage. B: Consolidation therapy period: Patients who achieved complete remission after 1-2 cycles of induction therapy continued to receive avapritinib 100mg/d po. monotherapy for consolidation therapy, with a cycle of 28 days and a total of 4 cycles
2-month ORR after induction therapy
2-month objective remission rate after induction therapy
CR rate after induction therapy
CR rate after 2 months
MRD negative rate after induction therapy
MRD negative rate after 2 months
Response rate after Consolidation treatment
Response rate after 6 months
Safety
Types of adverse events (AE), AE severity, Relevance to study drugs
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