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

This clinical trial is studying a combination of two treatments, Selinexor and Azacitidine, to see how well they work together as maintenance therapy for patients with high-risk myeloid neoplasms, which include conditions like Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), and Chronic Myelomonocytic Leukemia (CMML) after they have undergone a stem cell transplant. The goal is to find out if this combination can help prevent the cancer from coming back.

To participate in the trial, patients need to be at least 16 years old and have specific types of high-risk AML or MDS, particularly those who have tested positive for minimal residual disease (MRD) before their transplant. This means that even after treatment, there are still small amounts of cancer cells present. Unfortunately, patients who have relapsed shortly after their transplant, have certain active infections, or have severe heart conditions won't be eligible. Participants will receive the study treatments and will be monitored closely for their safety and how well the therapy works. It's important to know that this trial is not yet recruiting participants, so enrollment has not started.

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.