Comparing the Efficacy of LDA, LHAA, and LA Regimens in Young Adults With Intermediate- and High-Risk Acute Myeloid Leukemia Eligible for Intensive Chemotherapy

Enrolling by invitation · Phase 2/Phase 3

Conditions studied: Acute Myeloid Leukemia (AML), Lisaftoclax

In brief

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 OS rate of the LDA, LHAA, and LA regimens in newly diagnosed patients with intermediate- and high-risk acute myeloid leukemia who are eligible for intensive chemotherapy.

Key facts

Study ID

NCT07651163

Run by

First Affiliated Hospital of Zhejiang University

People needed

450

Starts

2026-03-01

Expected to finish

2029-12-01

Last updated by the study team

2026-06-16

Who can join

Age: 15 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Newly diagnosed acute myeloid leukemia (AML) confirmed according to the World Health Organization (WHO) classification;
• Classified as intermediate- or adverse-risk AML based on the European LeukemiaNet (ELN) 2022 genetic risk stratification (see Appendix Table 1);
• Age 15-65 years;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
• 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;
• Normal cardiac function, defined as left ventricular ejection fraction (LVEF) >50%;
• Life expectancy ≥3 months;
• Signed written informed consent by the patient or their legally authorized representative prior to study enrollment.

You may not qualify if…

• Acute promyelocytic leukemia;
• Central nervous system involvement by leukemia;
• History of other malignancies within the past 5 years;
• Positive for human immunodeficiency virus (HIV);
• Presence of any other serious medical condition that may limit study participation, including advanced infections, uncontrolled diabetes mellitus, severe cardiac insufficiency, or angina;
• Ineligible for intensive chemotherapy due to poor general condition;
• Pregnant or breastfeeding women;
• Inability to understand or comply with the study protocol;
• Inability to take oral medication or presence of malabsorption syndrome;
• Prior treatment with B-cell lymphoma 2 (BCL-2) inhibitors or hypomethylating agents, or current participation in any other investigational drug study;
• Inability or unwillingness to provide written informed consent.

Where it is running

• The First Affiliated Hospital of Zhejiang University — Hangzhou, Zhejiang, China

Full record on ClinicalTrials.gov

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