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NCT Number: NCT07651163

Comparing the Efficacy of LDA, LHAA, and LA Regimens in Young Adults With Intermediate- and High-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 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.

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Key information

Conditions

Acute Myeloid Leukemia (AML) Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Lisaftoclax Neoplasms Neoplasms by Histologic Type

Age range

15 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%;
  • Life expectancy ≥3 months;
  • 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;
  • 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.

Treatment and study plan

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).

Other names: Induction chemotherapy

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).

Other names: Induction chemotherapy

Lisaftoclax+azacitidine

Drug

Lisaftoclax (200 mg, orally, D1; 400 mg, orally, D2; 600 mg, orally, qd, D3-28) + azacitidine (75 mg/m², D1-7)

Other names: Induction chemotherapy

Lisaftoclax+ cytarabine

Drug

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

Other names: Consolidation treatment

Lisaftoclax+azacitidine or azacitidine

Drug

Post-transplant maintenance therapy: patients were randomized 1:1 to receive either combination therapy or azacitidine monotherapy. The combination regimen consisted of lisaftoclax (400 mg, orally, D1-7) in combination with azacitidine (50 mg/m², D1-7) for up to 1 year or 10 cycles, whichever occurred first. Azacitidine monotherapy consisted of azacitidine (50 mg/m², D1-7) for up to 1 year or 10 cycles, whichever occurred first. Non-transplant maintenance therapy: lisaftoclax (400 mg, orally, D1-7) in combination with azacitidine (50 mg/m², D1-7) for up to 1 year or 10 cycles, whichever occurred first.

Other names: Maintenance treatment

Primary outcomes

  1. 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

Secondary outcomes

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

    Time frame: At the end of Cycle 1 or Cycle 2 of 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.

  2. Composite Complete Response (CRc) rate after 1/2 treatment cycles

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

    defined as the proportion of patients achieving CRc after the first or second cycle of induction chemotherapy.

  3. Minimal residual disease (MRD) negativity rate after 1-2 cycles of induction chemotherapy

    Time frame: At the end of Cycle 1 or Cycle 2 of 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

  4. 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.

  5. 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.

  6. 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

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jun 16, 2026
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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