Acute Myeloid Leukemia
Conditions
Interventions
SMD group:Selinexor 60 mg on days 1, 4, 8, 11,Decitabine 20mg/m2 on days 1-5, Mitoxantrone 5mg on days 4-6, Cytarabine 10 mg/m2 BID on days 4-14, G-CSF 300 µg on days 1-14(discontinue treatment if WBC
Sponsors
The Second Hospital of Hebei Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients diagnosed with acute myeloid leukemia (AML), excluding acute promyelocytic leukemia (APL), according to the World Health Organization diagnostic criteria (WHO 2022 standards). 2.Male or female, aged >18 years. 3. Meets the diagnostic criteria for relapsed or refractory acute myeloid leukemia (R/R AML): 1)Relapsed AML: Bone marrow blasts >=5% after achieving complete remission (CR), or reappearance of leukemic cells in the peripheral blood (excluding other causes such as bone marrow regeneration post-consolidation chemotherapy), or development of extramedullary disease. 2) Refractory AML: Defined by meeting any one of the following criteria: Failure to achieve CR after two cycles of standard induction therapy in newly diagnosed patients. Relapse within 12 months after achieving CR following consolidation/intensive therapy. Relapse after 12 months but refractory to conventional salvage chemotherapy. Two or more relapses. Persistent extramedullary disease. 4. Previously treated with Venetoclax. 5. Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score = 30 mL/min, calculated using the Cockcroft-Gault formula or measured via 24-hour urine collection. 7. Subjects of childbearing potential must have evidence of a negative pregnancy test within 72 hours prior to treatment initiation. Patients participating in the trial must use contraception during the trial treatment period and for 3 years after completion of treatment. 8. Life expectancy > 2 months. 9. Must provide written informed consent prior to the initiation of any study-specific procedures. Informed consent must be signed by the patient themselves or their first-degree relative. If, considering the patient's condition, signing by the patient themselves may be detrimental to treatment, the informed consent form shall be signed by the legal guardian or a first-degree relative of the patient.
Exclusion criteria
Exclusion criteria: 1. Newly diagnosed AML. 2. Patients who have not received Venetoclax-containing induction/salvage therapy. 3. Concurrent diagnosis of other hematological diseases (e.g., hemophilia, myelofibrosis, or other conditions deemed ineligible by the investigator; subjects with prior abnormal blood counts are allowed if previous bone marrow examination excluded myelodysplastic syndromes (MDS) or myeloproliferative disorders (MPD)). 4. Pregnant or lactating patients. 5. History of allergy to any drug involved in this study. 6. Concurrent active malignancy of other organs (requiring treatment). 7. Significant abnormal hepatic or renal function exceeding the inclusion criteria limits. 8. Active cardiac disease, defined as one or more of the following: 1) Myocardial infarction within 6 months prior to study enrollment. 2) History of clinically significant arrhythmia requiring medication. 3) Uncontrolled or symptomatic congestive heart failure (> New York Heart Association (NYHA) Class 2). 9. Active infectious diseases (e.g., untreated tuberculosis, pulmonary aspergillosis), or patients with known HIV infection or active hepatitis B or C (HBV-DNA or HCV-RNA levels exceeding the upper limit of detection at the enrolling center's laboratory). 10. Subjects with evidence of central nervous system (CNS) leukemia prior to treatment. 11. Subjects with epilepsy requiring medication, dementia, or other abnormal mental states that would impair understanding or compliance with the protocol. 12. Conditions limiting oral drug intake or gastrointestinal absorption. 13. Subjects deemed unsuitable for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the rate of CR/CRi/CRh/MLFs; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;safety; | — |
Countries
China
Contacts
Public ContactNie Ziyuan
The Second Hospital of Hebei Medical University
Outcome results
None listed