Starting soon
Phase 2
Selinexor Combined With Azacitidine Therapy in High-Risk Myeloid Neoplasms Patients
Condition(s) studied
Acute Myeloid LeukemiaMyelodysplastic SyndromeChronic Myelomonocytic Leukemia
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
| Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin, China. |
Tianjin |
China |
|
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