NCT05939180RecruitingPhase 2/3
VA vs DA for Newly Diagnosed Hig-risk AML
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
Source: ClinicalTrials.gov · Last updated 2 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 116 (estimated)
- First submitted
- 3 Jul 2023
- Start date
- 1 Apr 2024
- Primary completion date
- 13 Jun 2026
- Lead sponsor
- The First Affiliated Hospital of Soochow University
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT05939180
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 116
- From 1 Apr 2024 to the primary completion date, 13 Jun 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients have AML secondary to MDS and previously been treated with hypomethylating agents.
Other illness
- 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);
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
| Ethical Committee of the First Affliated Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.