Comparing the Efficacy of LDA, LHAA, and LA Regimens in Young Adults With Intermediate- and High-… (NCT07651163) | Clinical Trial Compass
By InvitationPhase 2/3
Comparing the Efficacy of LDA, LHAA, and LA Regimens in Young Adults With Intermediate- and High-Risk Acute Myeloid Leukemia Eligible for Intensive Chemotherapy
China450 participantsStarted 2026-03-01
Plain-language 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 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.
Who can participate
Age range
15 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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%;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compares three different chemotherapy regimens — LDA, LHAA, and LA — for intermediate- and high-risk AML in young adults; can you explain what each of those regimens involves and which one, if any, you'd expect me to be assigned to?
2The trial is 'enrolling by invitation only' — what criteria would make someone eligible to be invited, and is that something you could look into on my behalf?
3Since this is a Phase 2/3 trial, what do we already know about the safety and effectiveness of these regimens, particularly the one that includes lisaftoclax, which appears to be a newer drug?
4The trial's main goal is measuring 2-year overall survival — how does that compare to what I might expect from standard intensive chemotherapy treatment for intermediate- or high-risk AML right now?
5Given my specific AML risk category and overall health, do you think participating in a trial like this would be a reasonable path to consider, or would starting with an established standard-of-care regimen first make more sense for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
2-year overall survival rate (OS)
Timeframe: from randomization up to 2 years
Trial details
NCT IDNCT07651163
SponsorFirst Affiliated Hospital of Zhejiang University
. Signed written informed consent by the patient or their legally authorized representative prior to study enrollment.
Exclusion criteria
. 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;