Selinexor Combined With Azacitidine Therapy in High-Risk Myeloid Neoplasms Patients

Prior treatment

• Patients who relapsed within 3 months of transplantation or during maintenance therapy, including hematologic, molecular genetic, cytogenetic relapses, and extramedullary relapses.

Other illness

• Known positive serology for HIV or active hepatitis B virus (HBV) and hepatitis C virus (HCV);
• Requirements for mental illness or other conditions that preclude cooperation with study treatment and monitoring;
• Suspected hypersensitivity to the experimental drug or any of its excipients;

Lab values

• Active heart disease, defined as one or more of the following:
  • （1）History of uncontrolled or symptomatic angina; （2）Myocardial infarction less than 6 months from study entry; （3）History of tardive dyskinesia requiring medication or clinically significant symptoms; （4）Uncontrolled or symptomatic congestive heart failure (\> NYHA class 2) （5）Ejection fraction is below the lower limit of the normal range. 7. Those deemed unsuitable for enrollment by the investigator.

Other

• Patients with any of the following are not eligible for enrollment in this study:
• Patients who are pregnant or who are unable to use appropriate contraception during treatment;

• with pre-transplant MRD-positive AML, i.e., patients who meet one of the following criteria:
• Age≥ 16 years old; any gender;
• High-risk MDS (IPSS-R or/and IPSS-M high-risk and above);
• High relapse risk AML, including relapsed refractory AML and patients with pre-transplant MRD-positive AML, i.e., patients who meet one of the following criteria:
  • (1)Refractory AML is defined as meeting one of the following conditions
• Primary cases that have failed to respond to 2 courses of standard regimen chemotherapy;
• CR was followed by consolidation and intensive treatment with no recurrence within 12 months;
• It recurred 12 months later, but conventional chemotherapy was ineffective;
• 2 or more relapses;
• Extramedullary leukemia persists. (2)Relapsed AML i.e., re-initialization of leukemic cells in the peripheral blood after complete remission (CR) or bone marrow primitive cells \>0.050 (except for other reasons such as bone marrow reconstitution after consolidation chemotherapy) or extramedullary infiltration of leukemic cells.
  • (3)Positive pre-transplant MRD, i.e., one of the following conditions is met:
• Proportion of abnormal myeloid cells \>0.01% by pre-transplant flow assay;
• Positive pre-transplantation molecular biology-related tests. (4)AML with poor prognosis (according to the Chinese Guidelines for the Diagnosis and Treatment of Adult Acute Myeloid Leukemia (Non-Acute Promyelocytic Leukemia) 2023 Edition) 4.Meets WHO diagnostic criteria for staging CMML; 5.MDS or CMML transforms AML.