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Starting soon Phase 2

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

NCT06900088 · tracked via the Priya Life Science China tracker
Phase
Phase 2
Started
2025-04-25
Last updated
2025-03-28

Condition(s) studied

Acute Myeloid LeukemiaMyelodysplastic SyndromeChronic Myelomonocytic Leukemia

Investigational drug(s) / intervention(s)

Selinexor →

Selinexor: maintenance therapy with Selinexor combined with Azacitidine in patients with high-risk myeloid neoplasms after transplantation

Study 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

Eligibility

Sex
ALL
Min age
16 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 2-year recurrence free survival rate (RFS) — 2 years
    the rate at which a patient has been on the drug for at least 1 year without morphological relapse or death of the subject from the transplantation date (whichever comes first)

Trial sites (1)

FacilityCityRegionStatus
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin, China. Tianjin China
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06900088 on ClinicalTrials.gov ↗ ← All trials in China