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

June 11, 2026 updated by: Huafeng Wang, First Affiliated Hospital of Zhejiang University

A Multicenter, Prospective, Randomized Controlled Clinical Study Comparing the Efficacy of the LDA, LHAA, and DA Regimens in Young Adults With Low-Risk Acute Myeloid Leukemia Eligible for Intensive Chemotherapy

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

267

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • The First Affiliated Hospital of Zhejiang University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A: Lisaftoclax+Daunorubicin+Cytarabine

Participants received induction chemotherapy with lisaftoclax, daunorubicin, and cytarabine.

Patients achieving partial response (PR) with a reduction in bone marrow blasts >60% were allowed to receive one additional cycle of the same regimen.

Patients who achieved complete response received consolidation therapy with lisaftoclax in combination with intermediate-dose cytarabine for 3 cycles.

After completion of consolidation therapy, next-generation sequencing (NGS) was performed. Patients with minimal residual disease (MRD) negativity did not receive maintenance therapy, whereas patients with MRD positivity proceeded to maintenance therapy.

Maintenance therapy consisted of lisaftoclax in combination with azacitidine, administered for up to 1 year or 10 cycles, whichever occurred first.
Drug: 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).
Other Names:
  • Induction chemotherapy
Drug: Lisaftoclax+cytarabine
Lisaftoclax (600 mg, orally, D1-7) + intermediate-dose cytarabine (2 g/m², q12h, D1-3) for 3 cycles
Other Names:
  • Consolidation treatment
Drug: 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.
Other Names:
  • Maintenance treatment
Experimental: Arm B: Lisaftoclax+homoharringtonine+cytarabine+aclarubicin

Participants received induction chemotherapy with lisaftoclax, homoharringtonine, cytarabine, and aclarubicin.

Patients achieving partial response (PR) with a reduction in bone marrow blasts >60% were allowed to receive one additional cycle of the same regimen.

Patients who achieved complete response received consolidation therapy with lisaftoclax in combination with intermediate-dose cytarabine for 3 cycles.

After completion of consolidation therapy, next-generation sequencing (NGS) was performed. Patients with minimal residual disease (MRD) negativity did not receive maintenance therapy, whereas patients with MRD positivity proceeded to maintenance therapy.

Maintenance therapy consisted of lisaftoclax in combination with azacitidine, administered for up to 1 year or 10 cycles, whichever occurred first.
Drug: Lisaftoclax+cytarabine
Lisaftoclax (600 mg, orally, D1-7) + intermediate-dose cytarabine (2 g/m², q12h, D1-3) for 3 cycles
Other Names:
  • Consolidation treatment
Drug: 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.
Other Names:
  • Maintenance treatment
Drug: 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).
Other Names:
  • Induction chemotherapy
Active Comparator: Arm C: Daunorubicin+cytarabine

Participants received induction chemotherapy with daunorubicin and cytarabine.

Patients achieving partial response (PR) with a reduction in bone marrow blasts >60% were allowed to receive one additional cycle of the same regimen.

Patients who achieved complete response received consolidation therapy with lisaftoclax in combination with intermediate-dose cytarabine for 3 cycles.

After completion of consolidation therapy, next-generation sequencing (NGS) was performed. Patients with minimal residual disease (MRD) negativity did not receive maintenance therapy, whereas patients with MRD positivity proceeded to maintenance therapy.

Maintenance therapy consisted of lisaftoclax in combination with azacitidine, administered for up to 1 year or 10 cycles, whichever occurred first.
Drug: Lisaftoclax+cytarabine
Lisaftoclax (600 mg, orally, D1-7) + intermediate-dose cytarabine (2 g/m², q12h, D1-3) for 3 cycles
Other Names:
  • Consolidation treatment
Drug: 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.
Other Names:
  • Maintenance treatment
Drug: Daunorubicin+cytarabine
Daunorubicin (60 mg/m², iv, qd, D1-3) + cytarabine (100 mg/m², q12h, subcutaneous injection or iv infusion, D1-7).
Other Names:
  • Induction chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2-year event-free survival (EFS) rate
Time Frame: 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.
from randomization up to 2 years after randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Response (CR) rate after 1/2 treatment cycles
Time Frame: At the end of Cycle 1 or Cycle 2 induction chemotherapy (each cycle is 28 days)
defined as the proportion of patients achieving complete response (CR) after the first or second cycle of induction chemotherapy.
At the end of Cycle 1 or Cycle 2 induction chemotherapy (each cycle is 28 days)
Composite Complete Response (CRc) rate after 1/2 treatment cycles
Time Frame: At the end of Cycle 1 or Cycle 2 induction chemotherapy (each cycle is 28 days)
defined as the proportion of patients achieving CRc after the first or second cycle of induction chemotherapy.
At the end of Cycle 1 or Cycle 2 induction chemotherapy (each cycle is 28 days)
Minimal residual disease (MRD) negativity rate after 1-2 cycles of induction chemotherapy
Time Frame: At the end of Cycle 1 or Cycle 2 induction chemotherapy (each cycle is 28 days)
defined as the the proportion of patients with negative minimal residual disease (MRD) among patients who achieve complete remission after 1-2 cycles of induction chemotherapy
At the end of Cycle 1 or Cycle 2 induction chemotherapy (each cycle is 28 days)
2-year overall survival rate (OS)
Time Frame: from randomization up to 2 years
defined as the proportion of patients who were still alive from the time of randomization for the last patient until 24 months later
from randomization up to 2 years
2-year relapse-free survival (RFS) rate
Time Frame: from the date of complete remission (CR/CRi) up to 2 years after achieving response
defined as the proportion of patients who achieved complete response (CR) or complete remission with incomplete hematologic recovery (CRi) and remained alive without disease relapse within 2 years after achieving response.
from the date of complete remission (CR/CRi) up to 2 years after achieving response
Safety and Tolerability
Time Frame: up to 24 months
defined as the number of participants with adverse events and serious adverse events as assessed by NCI CTCAE v5.0
up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital of Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2026

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

May 27, 2026

First Submitted That Met QC Criteria

June 11, 2026

First Posted (Actual)

June 16, 2026

Study Record Updates

Last Update Posted (Actual)

June 16, 2026

Last Update Submitted That Met QC Criteria

June 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CN-ZY-26-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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