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

Institute of Hematology & Blood Diseases Hospital, China

Status and phase

Not yet enrolling

Phase 2

Conditions

Myelodysplastic Syndrome

Acute Myeloid Leukemia

Chronic Myelomonocytic Leukemia

Treatments

Drug: Selinexor

Study type

Interventional

Funder types

Other

Identifiers

NCT06900088

IIT2024099

Details and patient eligibility

About

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

Full description

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)

Enrollment

20 estimated patients

Sex

All

Ages

16 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

Patients with any of the following are not eligible for enrollment in this study:

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;
Patients who are pregnant or who are unable to use appropriate contraception during treatment;
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.