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Multicenter randomized controlled superiority trial of lisaftoclax + idarubicin + cytarabine versus idarubicin + cytarabine in the treatment of newly diagnosed acute myeloid leukemia

Multicenter randomized controlled superiority trial of lisaftoclax + idarubicin + cytarabine versus idarubicin + cytarabine in the treatment of newly diagnosed acute myeloid leukemia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600123725
Enrollment
Unknown
Registered
2026-04-29
Start date
2026-04-30
Completion date
Unknown
Last updated
2026-05-04

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

Conditions

Acute myeloid leukemia

Interventions

Trial Group:Idarubicin 10-12 mg/m^2/day intravenous injection on days 1-3
Cytarabine 100 mg/m^2/day intravenous injection on days 1-7
Lissatocla 400 mg/day oral administration on days 4-11
Control Group:Idarubicin 10-12 mg/m^2/day intravenous injection on days 1-3

Sponsors

The First Affiliated Hospital of Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-75 years, any gender 2. Clinically diagnosed with AML (diagnostic criteria per WHO 2022 classification of hematopoietic and lymphoid tissue tumors), no prior AML-related chemotherapy 3. ECOG performance status =50% 5. Normal hepatic and renal function, TBIL <=1.5×ULN, ALT/AST <=2.0×ULN, Cr <=1.5×ULN 6. Voluntary participation with signed informed consent

Exclusion criteria

Exclusion criteria: 1. patients with acute promyelocytic leukemia (APL); 2. suffering from tuberculosis or other malignant tumors; 3. Human immunodeficiency virus (HIV) infection or hepatitis B virus (HBV), hepatitis C virus (HCV) active infection, or other uncontrolled severe infection; 4. New York Heart Association (NYHA) cardiac function classification > 2; 5. have obvious kidney, liver, cardiovascular, nervous system, mental illness, endocrine, metabolic, immune system disease history, or suffering from chronic respiratory diseases requiring continuous oxygen; 6. Intolerance or allergy to drugs in the treatment plan; 7. pregnant or lactating women (women of childbearing age need to be tested for HCG to exclude pregnancy); 8. The researchers believe that patients should not participate in any other circumstances of this trial.

Design outcomes

Primary

MeasureTime frame
Complete remission rate;

Secondary

MeasureTime frame
Negative remission rate of minimal residual disease;Adverse Event;Overall survival;Recurrence free survival;

Countries

China

Contacts

Public ContactXu Shuangnian

The First Affiliated Hospital of Army Medical University

xushuangnian1985@163.com+86 13650596553

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026