selinexor combined with azacitidine therapy in high-risk myeloid neoplasms patients

Conditions: Acute Myeloid Leukemia; Myelodysplastic Syndrome; Chronic Myelomonocytic Leukemia

Summary: efficacy and safety of selinexor combined with azacitidine as maintenance therapy in high-risk myeloid neoplasms patients post-transplantation: a single-center, single-arm, exploratory study

treatment period: from the time of transplantation, after screening by inclusion and exclusion criteria, patients who meet the criteria are enrolled and given maintenance therapy with selinexor in combination with azacitidine (selinexor: 40 mg/weekly, administered on d1; azacitidine: 50 mg/m2\*5d; every 28 days for a cycle of treatment, for at least one year of medication, or until progression of the disease, or until the development of intolerable toxicity, whichever comes first)

Eligibility criteria:
inclusion criteria: with pre-transplant mrd-positive aml, i.e., patients who meet one of the following criteria: 1. age≥ 16 years old; any gender; 2. high-risk mds (ipss-r or/and ipss-m high-risk and above); 3. 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 1. primary cases that have failed to respond to 2 courses of standard regimen chemotherapy; 2. cr was followed by consolidation and intensive treatment with no recurrence within 12 months; 3. it recurred 12 months later, but conventional chemotherapy was ineffective; 4. 2 or more relapses; 5. 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: 1. proportion of abnormal myeloid cells \>0.01% by pre-transplant flow assay; 2. 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. exclusion criteria: patients with any of the following are not eligible for enrollment in this study: 1. patients who relapsed within 3 months of transplantation or during maintenance therapy, including hematologic, molecular genetic, cytogenetic relapses, and extramedullary relapses. 2. known positive serology for hiv or active hepatitis b virus (hbv) and hepatitis c virus (hcv); 3. requirements for mental illness or other conditions that preclude cooperation with study treatment and monitoring; 4. patients who are pregnant or who are unable to use appropriate contraception during treatment; 5. suspected hypersensitivity to the experimental drug or any of its excipients; 6. 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.