Newly diagnosed patients with low-risk acute myeloid leukemia
Conditions
Interventions
Arm C:Daunorubicin+cytarabine
Sponsors
The FIrst Affiliated Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Newly diagnosed acute myeloid leukemia (AML) confirmed according to the World Health Organization (WHO) classification; 2. Classified as favorable prognosis-risk AML based on the European LeukemiaNet (ELN) 2022 genetic risk stratification; 3. Age 18–65 years; 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0–2; 5. Adequate hepatic and renal function: total bilirubin 50%; 7. Life expectancy >=3 months; 8. Signed written informed consent by the patient or their legally authorized representative prior to study enrollment.
Exclusion criteria
Exclusion criteria: 1. Acute promyelocytic leukemia; 2. Central nervous system involvement by leukemia; 3. History of other malignancies within the past 5 years; 4. Positive for human immunodeficiency virus (HIV); 5. Presence of any other serious medical condition that may limit study participation, including advanced infections, uncontrolled diabetes mellitus, severe cardiac insufficiency, or angina; 6. Ineligible for intensive chemotherapy due to poor general condition; 7. Pregnant or breastfeeding women; 8. Inability to understand or comply with the study protocol; 9. Inability to take oral medication or presence of malabsorption syndrome; 10. Prior treatment with B-cell lymphoma 2 (BCL-2) inhibitors or hypomethylating agents, or current participation in any other investigational drug study; 11. Inability or unwillingness to provide written informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year event-free survival (EFS) rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Composite Complete Response (CRc) rate after 1/2 treatment cycles;Safety;2-year relapse-free survival (RFS) rate;Complete Response (CR) rate after 1/2 treatment cycles;2-year overall survival (OS) rate;Minimal residual disease (MRD) negativity rate after 1–2 cycles of induction chemotherapy; | — |
Countries
China
Contacts
Public ContactJin Jie, Wang Huafeng
The FIrst Affiliated Hospital, College of Medicine, Zhejiang University
Outcome results
None listed