Status:
NOT_YET_RECRUITING
Selinexor Combined With Azacitidine Therapy in High-Risk Myeloid Neoplasms Patients
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Conditions:
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Eligibility:
All Genders
16-75 years
Phase:
PHASE2
Brief 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
Detailed 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 com...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06900088
Start Date
April 25 2025
End Date
October 30 2026
Last Update
March 28 2025
Active Locations (1)
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1
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin, China.
Tianjin, China