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A multicenter, prospective, randomized controlled clinical trial comparing the efficacy of LDA, LHAA, and LA regimens in young adults with intermediate-to-high risk acute myeloid leukemia eligible for intensive chemotherapy.

A multicenter, prospective, randomized controlled clinical trial comparing the efficacy of LDA, LHAA, and LA regimens in young adults with intermediate-to-high risk acute myeloid leukemia eligible for intensive chemotherapy.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600127904
Enrollment
Unknown
Registered
2026-07-09
Start date
2026-08-01
Completion date
Unknown
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Newly diagnosed intermediate-to-high risk acute myeloid leukemia

Interventions

Arm C:Lisaftoclax + Azacitidine
Arm B:Lisaftoclax+homoharringtonine+cytarabine+aclarubicin
Arm A:Lisaftoclax+Daunorubicin+Cytarabine

Sponsors

The FIrst Affiliated Hospital, College of Medicine, Zhejiang University
Lead Sponsor

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 intermediate- or adverse-risk AML based on the European LeukemiaNet (ELN) 2022 genetic risk stratification; 3. Age 15-65 years; 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; 5. Adequate hepatic and renal function: (1) 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

MeasureTime frame
2-year overall survival (OS) rate;—

Secondary

MeasureTime frame
Adverse event,AE Serious adverse event,SAE;2-year relapse-free survival (RFS) rate;2-year event-free survival (EFS) rate;Minimal residual disease (MRD) negativity rate after 1–2 cycles of induction chemotherapy;CRi+CR rate after 1–2 cycles of induction chemotherapy;—

Countries

China

Contacts

Public ContactJie Jin, Huafeng Wang

The FIrst Affiliated Hospital, College of Medicine, Zhejiang University

1509036@zju.edu.cn+86 571 8723 6898

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026