Lisaftoclax (A Novel BCL2 Inhibitor) Combined with Daunorubicin and Cytarabine in the Treatment of Newly Diagnosed Fit Acute Myeloid Leukemia Patients: A Clinical Study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2600128940

Enrollment

Unknown

Registered

2026-07-28

Start date

2026-07-28

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia

Interventions

Treatment Group:Lisaftoclax + Daunorubicin + Cytarabine

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age 18–75 years, male or female; 2. Clinically confirmed diagnosis of acute myeloid leukemia (AML) according to the WHO 2016 classification of tumors of hematopoietic and lymphoid tissues, with no prior chemotherapy for AML; 3. Eastern Cooperative Oncology Group (ECOG) performance status score = 50%; 5. Adequate hepatic and renal function, with total bilirubin (TBIL) <= 1.5 × upper limit of normal (ULN), ALT and AST <= 2.0 × ULN, and serum creatinine <= 1.5 × ULN; 6. Voluntarily participate in the study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with acute promyelocytic leukemia (APL); 2. Active tuberculosis or other malignant tumors; 3. Human immunodeficiency virus (HIV) infection, or active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, or other uncontrolled severe infections; 4. New York Heart Association (NYHA) functional class > 2; 5. Significant history of renal, hepatic, cardiovascular, neurological, psychiatric, endocrine, metabolic, or immune system diseases, or chronic respiratory diseases requiring continuous oxygen therapy; 6. Intolerance or allergy to any drug in the treatment regimen; 7. Pregnant or breastfeeding women (women of childbearing potential must undergo HCG testing to exclude pregnancy); 8. Any other conditions deemed by the investigator to make the patient unsuitable for participation in this trial.

Design outcomes

Primary

Measure	Time frame
The percentage of blasts detected by flow cytometric immunophenotyping;The percentage of myeloblasts assessed by bone marrow morphological examination;	—

Secondary

Measure	Time frame
Platelet;Absolute Neutrophil Count;Hemoglobin;	—

Countries

China

Contacts

Public ContactYuPingGong

West China Hospital of Sichuan University

gongyuping@hotmail.com+86 10 85423046

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026