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

Launched by INSTITUTE OF HEMATOLOGY & BLOOD DISEASES HOSPITAL, CHINA · Mar 26, 2025

Keywords

ClinConnect Summary

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)

Gender

ALL

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.