Comparing the Efficacy of the LDA, LHAA, and DA Regimens in Young Adults With Low-Risk Acute Myeloid Leukemia Eligible for Intensive Chemotherapy
Enrolling by invitation · Phase 2/Phase 3
Conditions studied: Acute Myeloid Leukemia, 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 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.
Key facts
- Study ID
- NCT07651176
- Run by
- First Affiliated Hospital of Zhejiang University
- People needed
- 267
- Starts
- 2026-03-01
- Expected to finish
- 2029-12-01
- Last updated by the study team
- 2026-06-16
Who can join
Age: 18 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;
- Age 18-65 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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