Acute Myeloid Leukemia
Conditions
Interventions
Trial group:Maintenance Regimen After Pre-screening and Informed Consent
Venetoclax 400 mg orally once daily, continuously on days 1-28. The duration of administration per cycle may be adjusted based
Sponsors
Mianyang Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years, regardless of gender; 2. Patients diagnosed with acute myeloid leukemia other than acute promyelocytic leukemia by bone marrow cell morphology, immunology, and cytogenetics, with diagnosis based on the World Health Organization diagnostic criteria (WHO 2016 standard); 3. Patients who have completed prior standard intensive chemotherapy, including induction and at least 2 cycles of consolidation therapy, and have achieved CR/CRi for the first time; 4. Patients with intermediate-risk AML who achieve minimal residual disease (MRD) negativity and are unable to undergo autologous stem cell transplantation consolidation for various reasons, or whose consolidation therapy dose is insufficient; or patients with low- or intermediate-risk AML who fail to achieve MRD negativity, or patients with high-risk AML after induction and consolidation therapy who are unable to undergo allogeneic hematopoietic stem cell transplantation due to the following reasons: lack of a stem cell donor, unsuitability for transplantation, or refusal of transplantation. 5. Eastern Cooperative Oncology Group performance status (ECOG-PS) <= 3; 6. Informed consent must be signed before the study begins. Considering the patient's condition, if it is not conducive to the patient's treatment for the patient to sign personally, the informed consent shall be signed by a legal guardian or the patient's immediate relative.
Exclusion criteria
Exclusion criteria: 1. Patients who have previously received autologous or allogeneic hematopoietic stem cell transplantation. 2. Patients with active central nervous system (CNS) disease confirmed by cytology or pathology. 3. Patients with active symptomatic infections. 4. Patients unable to take oral medication or with malabsorption syndrome. 5. Patients with concurrent malignancies in other organs (except those cured for >=5 years, completely resected non-melanoma skin cancer, successfully treated carcinoma in situ, or controlled prostate cancer, as determined by the investigator not to affect the efficacy and safety evaluation of this study). 6. Patients known to be allergic to the components of the investigational drug or its analogs. 7. Female patients with a positive blood ß-HCG test, those who are pregnant or breastfeeding, or subjects planning to become pregnant during the study period. 8. Patients deemed unsuitable for participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete Remission (Bone marrow blasts = 1.0 × 10^9/L, platelets >= 100 × 10^9/L. No evidence of extramedullary leukemia.);Complete Remission with Partial Hematologic Recovery (Bone marrow blasts = 0.5 × 10^9/L, platelets >= 50 × 10^9/L.);Complete remission with incomplete hematologic recovery;Morphologic leukemia-free state;Measurable residual disease;Relapse-free survival;Partial Remission; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Duration of remission;Adverse Events (Adverse events occurring in subjects were monitored using the NCI-CTCAE Version 5.0.); | — |
Countries
China
Contacts
Public ContactXu Fang
Mianyang Central Hospital
Outcome results
None listed