Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Daunorubicin | Drug | Daunorubicin | ALIAS |
| Venetoclax Oral Tablet | Drug | Venetoclax | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- VA regimen
- description
- VA regimen: azacytidine and venetoclax
- interventionNames
- Drug: Venetoclax Oral Tablet
- type
- ACTIVE_COMPARATOR
- label
- DA regimen
- description
- DA regimen: daunorubicin and cytarabine
- interventionNames
- Drug: Daunorubicin
Primary outcomes (1)
- measure
- Composite complete remission (CRc) after one course of induction therapy
- timeFrame
- From randomization to the end of the first course of induction therapy (within 28 days)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 64 Years
Show eligibility criteria text
Inclusion Criteria: 1. Gender: female or male. 2. Age:18-64 years old. 3. Patients with newly diagnosed AML according to the WHO 2022 classification. 4. AML patients with adverse risk features according to the 2022 European Leukemia Net risk stratification. 5. Untreated AML (hydroxyurea, and low dose cytarabine with cummulative dose \<1.0g are permitted). 6. ECOG: 0-2. 7. 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) . 8. Adequate Renal function: Ccr (Creatinine Clearance Rate) ≥30 ml/min. 9. Be able to understand and be willing to participate in the study. Be able to provide written informed consent. Exclusion Criteria: 1. Patients with acute promyeloid leukemia. 2. AML with central nervous system infiltration. 3. Patients diagnosed with myeloid sarcoma. 4. Patients have AML secondary to MDS and previously been treated with hypomethylating agents. 5. Patients with active infection, which is considered as uncontrollable by the investigator. 6. Patients with active hepatitis B, hepatitis C and HIV infection. 7. Patients with heart failure (grade 3-4); 8. Patients who are pregnant or breastfeeding. 9. Patients who refused to be enrolled in the study. Patients who are considered as ineligible for the enrollment by the investigators.
References
Publications (0)
Data not yet available