Tests selinexor with azacitidine after transplant in high-risk blood cancers

Trial details

Who runs it

Institute of Hematology & Blood Diseases Hospital, China

Trial code

NCT06900088

Record updated

28 March 2025

Original description

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 StudyRead full original descriptionShow less

Efficacy and Safety of Selinexor Combined With Azacitidine as Maintenance Therapy in High-Risk Myeloid Neoplasms Patients Post-Transplantation: A Single-Center, Single-Arm, Explorato

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

Inclusion: 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.

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

ClinicalTrials.gov NCT06900088