Venetoclax plus Azacitidine versus Daunorubicin/Idarubicin plus Cytarabine induction for fit older adults with AML
A Multicenter, Randomized, Controlled Clinical Trial Comparing VA and D/IA Induction Regimens in Elderly Patients With Acute Myeloid Leukemia Suitable for Intensive Chemotherapy
This trial will test whether Venetoclax plus Azacitidine works as well as standard daunorubicin or idarubicin plus cytarabine induction in fit adults aged 55–75 with acute myeloid leukemia.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 55 Years to 75 Years |
| Sex | All |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Tianjin) |
| Trial ID | NCT07132684 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 55–75 with newly diagnosed AML who are fit for intensive therapy (ECOG 0–2), have adequate organ function, and do not have excluded genetic subtypes or prior induction treatment.
Not a fit: Patients with acute promyelocytic leukemia, AML with RUNX1‑RUNX1T1, CBFB‑MYH11, or BCR‑ABL fusions, relapsed/refractory disease, uncontrolled cardiac disease, severe infections, or major organ dysfunction are unlikely to be eligible or to benefit from the interventions tested here.
Why it matters
Potential benefit: If successful, the VA regimen could offer a less toxic induction option with similar or better remission and survival outcomes for fit older AML patients.
How similar studies have performed: Venetoclax combined with hypomethylating agents has shown strong responses in older or unfit AML patients, but direct randomized phase III comparisons against intensive anthracycline‑cytarabine induction in fit older adults are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Tianjin
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.