Compares two drug combinations for newly diagnosed high-risk acute myeloid leukemia
Compares venetoclax with azacytidine against daunorubicin with cytarabine in adults with leukemia.
Plain-language title generated from the registry record
Registry title: VA vs DA for Newly Diagnosed Hig-risk AML
Key facts
- Where
- Suzhou, ChinaSee the 2 sites
- Phase
- Phase 2/3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Source: NCT05939180, who can take part
Where in China
- Ethical Committee of the First Affliated Hospital of Soochow UniversitySuzhou, ChinaTaking people
- The First Affiliated Hospital of Soochow University, Jiangsu Institute of HematologySuzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The First Affiliated Hospital of Soochow University
- Trial code
- NCT05939180
- Record updated
- 2 September 2026
- Original description
This is an open-label, multicenter, phase 2b, randomized study aiming to compare the efficacy and safety of venetoclax plus azacytidine Versus daunorubicin plus cytarabine (conventional 7+3 regimen) in adult acute myeloid leukemia (AML) patients with adverse risk featuress. Participants will be 1:1 randomly assigned to the VA and DA groups. Once remission was achieved, consolidated chemotherapy will be performed and allogeneic hematopoietic stem cell transplantation is strongly recommended. After completion of the study intervention, participants will be followed-up every 1 to 2 months for up to 2 years.Read full original descriptionShow less
Study of the Efficacy and Safety of Venetoclax Plus Azacytidine Versus Daunorubicin Plus Cytarabine in Adult Acute Myeloid Leukemia (AML) Patients With Adverse Risk Features
This is an open-label, multicenter, phase 2b, randomized study aiming to compare the efficacy and safety of venetoclax plus azacytidine Versus daunorubicin plus cytarabine (conventional 7+3 regimen) in adult acute myeloid leukemia (AML) patients with adverse risk featuress. Participants will be 1:1 randomly assigned to the VA and DA groups. Once remission was achieved, consolidated chemotherapy will be performed and allogeneic hematopoietic stem cell transplantation is strongly recommended. After completion of the study intervention, participants will be followed-up every 1 to 2 months for up to 2 years.
Inclusion: Gender: female or male; Age:18-64 years old; Patients with newly diagnosed AML according to the WHO 2022 classification; AML patients with adverse risk features according to the 2022 European Leukemia Net risk stratification; Untreated AML (hydroxyurea, and low dose cytarabine with cummulative dose <1.0g are permitted); ECOG: 0-2; Adequate liver function: Total bilirubin ≤ 1.5×upper limit of normal (ULN); aspartate aminotransferase (AST) ≤3×ULN (liver infiltration of leukemia: ≤5×ULN); alanine aminotransferase (ALT)≤3×ULN (liver infiltration of leukemia: ≤5×ULN) ; Adequate Renal function: Ccr (Creatinine Clearance Rate) ≥30 ml/min; Be able to understand and be willing to participate in the study. Be able to provide written informed consent.
Exclusion: Patients have AML secondary to MDS and previously been treated with hypomethylating agents; Patients with active infection, which is considered as uncontrollable by the investigator; Patients with active hepatitis B, hepatitis C and HIV infection; Patients with heart failure (grade 3-4); Patients with acute promyeloid leukemia; AML with central nervous system infiltration; Patients diagnosed with myeloid sarcoma; Patients who are pregnant or breastfeeding; Patients who refused to be enrolled in the study. Patients who are considered as ineligible for the enrollment by the investigators.