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

NCT07651176 | Enrolling By Invitation Phase 2 DMC

• 1 other identifier: CN-ZY-26-01
• Study Type: interventional
• Target: 267
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Acute Myeloid Leukemia; Lisaftoclax

Keywords

Acute myeloid leukemia; Lisaftoclax

Outcome Measures

Primary Outcomes (1)

• 2-year event-free survival (EFS) rate

  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 Outcomes (6)

• Complete Response (CR) rate after 1/2 treatment cycles

  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

  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

  At the end of Cycle 1 or Cycle 2 induction chemotherapy (each cycle is 28 days)

• 2-year overall survival rate (OS)

  from randomization up to 2 years

• 2-year relapse-free survival (RFS) rate

  from the date of complete remission (CR/CRi) up to 2 years after achieving response

Study Arms (3)

Arm A: Lisaftoclax+Daunorubicin+Cytarabine

EXPERIMENTAL

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; Drug: Lisaftoclax+cytarabine; Drug: Lisaftoclax+azacitidine

Arm B: Lisaftoclax+homoharringtonine+cytarabine+aclarubicin

EXPERIMENTAL

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+homoharringtonine+cytarabine+aclarubicin; Drug: Lisaftoclax+cytarabine; Drug: Lisaftoclax+azacitidine

Arm C: Daunorubicin+cytarabine

ACTIVE COMPARATOR

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: Daunorubicin+cytarabine; Drug: Lisaftoclax+cytarabine; Drug: Lisaftoclax+azacitidine

Interventions

Lisaftoclax+daunorubicin+cytarabine DRUG

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).

Also known as: Induction chemotherapy

Arm A: Lisaftoclax+Daunorubicin+Cytarabine

Lisaftoclax+homoharringtonine+cytarabine+aclarubicin DRUG

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).

Also known as: Induction chemotherapy

Arm B: Lisaftoclax+homoharringtonine+cytarabine+aclarubicin

Daunorubicin+cytarabine DRUG

Daunorubicin (60 mg/m², iv, qd, D1-3) + cytarabine (100 mg/m², q12h, subcutaneous injection or iv infusion, D1-7).

Also known as: Induction chemotherapy

Arm C: Daunorubicin+cytarabine

Lisaftoclax+cytarabine DRUG

Lisaftoclax (600 mg, orally, D1-7) + intermediate-dose cytarabine (2 g/m², q12h, D1-3) for 3 cycles

Also known as: Consolidation treatment

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

Lisaftoclax+azacitidine DRUG

Lisaftoclax (400 mg, orally, D1-7) + azacitidine (50 mg/m², D1-7) for up to 1 year or 10 cycles, whichever occurred first.

Also known as: Maintenance treatment

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (1)

The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Induction Chemotherapy; Opiate Substitution Treatment

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Remission Induction

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: June 16, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: June 16, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)