A multicenter, prospective, randomized controlled clinical study comparing the efficacy of VHAA and DA regimens in the treatment of adult acute myeloid leukemia

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200059663

Enrollment

Unknown

Registered

2022-05-06

Start date

2022-05-01

Completion date

Unknown

Last updated

2024-03-25

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

Conditions

acute myeloid leukemia

Interventions

VHAA regimen:Homoharringtonine 2mg/m2/d, qd, intramuscular injection or intravenous drip, d1~d5

Cytarabine 100mg/m2/d, q12h, subcutaneous injection or intravenous drip, qd, d1~d5, Aclarubicin 12mg/m2/d, intravenous injection, d1~d5, venetoclax 100mg d2, 200mg d3, 300mg d4~d10, qd, oral

DA regimen:Daunorubicin 60mg/ m2/d, intravenous injection, qd, d1~3

Ara-C 100mg/ m2/d, intravenous injection, qd or subcutaneous injection, two times, 12 hours apart, d1~d7

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Newly diagnosed AML patients (excluding M3) by WHO classification; 2. Age 18-60 years; 3. When selected, the ECOG score is 0-2; 4. Liver and kidney function: blood bilirubin = 2mg/dL (35 µ Mol/L), AST/ALT is less than 2 times the upper limit of normal value, and blood inosine = 177 µ mol/L 5. Normal cardiac function: EF>50%; 6. Expected survival period = 3 months; 7. Obtain informed consent signed by the patient or family member.

Exclusion criteria

Exclusion criteria: 1. Acute promyelocytic leukemia; 2. Have a history of other malignant tumors in the past five years; 3. HIV positive; 4. Other serious diseases that may restrict patients from participating in this test (such as advanced infection, uncontrollable diabetes, severe cardiac insufficiency or angina pectoris); 5. General conditions are not suitable for chemotherapy; 6. Pregnant or lactating women; 7. Unable to understand or comply with the research protocol; 8. Patients who are unable to take drugs orally or with malabsorption syndrome; 9. Has received VEN treatment in the past and/or is currently involved in any other study of the investigational drug; 10. Unable to sign the informed consent form.

Design outcomes

Primary

Measure	Time frame
CR;	—

Secondary

Measure	Time frame
MRD;EFS;OS;safety;	—

Countries

China

Contacts

Public ContactJin jie

The First Affiliated Hospital of Medical College of Zhejiang University

Jiej0503@zju.edu.cn+86 57187236702

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026