Comparing two treatments for newly diagnosed high-risk acute myeloid leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, multicenter study aims to compare the efficacy and safety of venetoclax plus azacytidine against the conventional daunorubicin plus cytarabine regimen in adults with newly diagnosed acute myeloid leukemia (AML) exhibiting adverse risk features. Participants will be randomly assigned to one of the two treatment groups and will receive induction therapy followed by consolidation chemotherapy and potential stem cell transplantation upon achieving remission. The study also incorporates a novel targeted sequencing panel for rapid screening of adverse mutations. Follow-up will occur every 1 to 2 months for up to 2 years post-treatment.

Why it matters

Who can join: the full rules

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.

Where it's running

• The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology
  Suzhou, Jiangsu, China Recruiting
• Ethical Committee of the First Affliated Hospital of Soochow University
  Suzhou, Jiangsu, China Recruiting

Study contacts

• Principal investigator: Su-ning Chen — The First Affiliated Hospital of Soochow University
• Study coordinator: Su-ning Chen
• Email: chensuning@sina.com
• Phone: 008613814881746

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.