Lisaftoclax+daunorubicin+cytarabine: Lisaftoclax (200 mg on D2, 400 mg on D3, and 600 mg qd on D4-8, orally) + daunorubicin (60 mg/m², iv, qd, D1-3) + cytarabine (100 mg/m², q12h, subcutaneous injection or iv infusion, D1-7).
Lisaftoclax+homoharringtonine+cytarabine+aclarubicin: Lisaftoclax (200 mg on D2, 400 mg on D3, and 600 mg qd on D4-8, orally) + homoharringtonine (2 mg/m², qd, intramuscular injection or iv infusion, D1-5) + cytarabine (100 mg/m², q12h, subcutaneous injection or iv infusion, D1-5) + aclarubicin (12 mg/m², maximum 20 mg, iv, D1-5).
Daunorubicin+cytarabine: Daunorubicin (60 mg/m², iv, qd, D1-3) + cytarabine (100 mg/m², q12h, subcutaneous injection or iv infusion, D1-7).
Lisaftoclax+azacitidine: Lisaftoclax (400 mg, orally, D1-7) + azacitidine (50 mg/m², D1-7) for up to 1 year or 10 cycles, whichever occurred first.
Study summary
This is a phase II/III, multicenter, randomized, three-arm, open-label, parallel controlled trial. The primary objective of this study is to compare the 2-years EFS rate of the LDA, LHAA, and DA regimens in newly diagnosed patients with low-risk acute myeloid leukemia who are eligible for intensive chemotherapy.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria:
1. Newly diagnosed acute myeloid leukemia (AML) confirmed according to the World Health Organization (WHO) classification;
2. Classified as intermediate- or adverse-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 ≤2 mg/dL (35 μmol/L); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2× the upper limit of normal; serum creatinine ≤177 μmol/L;
6. Normal cardiac function, defined as left ventricular ejection fraction (LVEF) \>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:
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.
Primary outcome measure(s)
2-year event-free survival (EFS) rate — from randomization up to 2 years after randomization defined as the proportion of patients remaining free of treatment failure, hematologic relapse, MRD relapse, or death within 2 years after randomization.
Trial sites (1)
Facility
City
Region
Status
The First Affiliated Hospital of Zhejiang University
Hangzhou
Zhejiang
More First Affiliated Hospital of Zhejiang University trials in China
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.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.