Venetoclax plus Azacitidine versus Daunorubicin/Idarubicin plus Cytarabine induction for fit older adults with AML

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 is a multicenter, randomized, controlled phase III trial comparing two induction regimens—Venetoclax plus Azacitidine (VA) versus Daunorubicin or Idarubicin plus Cytarabine (D/IA)—in adults aged 55–75 with newly diagnosed AML who are fit for intensive chemotherapy. Participants are randomized to receive either the lower-intensity VA combination or standard anthracycline‑cytarabine induction, with planned follow-up to compare efficacy and safety outcomes including remission rates and survival. Key eligibility requires ECOG 0–2, adequate organ function, and exclusion of certain genetic subtypes (for example, APL, RUNX1‑RUNX1T1, CBFB‑MYH11, BCR‑ABL) or prior induction chemotherapy. The trial is led by the Institute of Hematology & Blood Diseases Hospital in Tianjin and enrolls patients at participating centers in China.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Diagnosis of AML according to WHO (2022) or ICC criteria.
* Age ≥55 and ≤75 years.
* ECOG performance status score of 0-2.
* Adequate organ function:

  * Total bilirubin ≤1.5× upper limit of normal (ULN)
  * AST and ALT ≤2.5× ULN
  * Serum creatinine \<2× ULN
  * Cardiac enzymes \<2× ULN
  * Left ventricular ejection fraction (LVEF, by echocardiogram) within normal range Signed informed consent by the patient or legal representative.

Exclusion Criteria:

* Acute promyelocytic leukemia with PML-RARA fusion gene.
* AML with RUNX1-RUNX1T1 or CBFB-MYH11 fusion genes.
* AML with BCR-ABL fusion gene.
* Relapsed or refractory AML (previously treated with induction chemotherapy, but hydroxyurea is allowed).
* Concurrent other malignancies requiring treatment.
* Active cardiac disease (e.g., uncontrolled angina, recent myocardial infarction, severe arrhythmias, uncontrolled heart failure, LVEF below normal).
* Severe infectious diseases (e.g., untreated tuberculosis, pulmonary aspergillosis).
* Other conditions deemed unsuitable by the investigator.

Where it's running

• Blood Diseases Hospital
  Tianjin, China Recruiting

Study contacts

• Principal investigator: Hui Wei, MD — Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
• Study coordinator: Hui Wei, MD
• Email: weihui@ihcams.ac.cn
• Phone: 13132507161

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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.