NCT07132684RecruitingPhase 3
Comparison of VA and D/IA Induction Regimens in Elderly Fit Acute Myeloid Leukemia Patients
A Multicenter, Randomized, Controlled Clinical Trial Comparing VA and D/IA Induction Regimens in Elderly Patients With Acute Myeloid Leukemia Suitable for Intensive Chemotherapy
Source: ClinicalTrials.gov · Last updated 26 Oct 2026
Brief summary (registry, in English)
This study is a multicenter, randomized, controlled phase III clinical trial aimed at comparing the efficacy of two induction chemotherapy regimens-VA (Venetoclax + Azacitidine) and D/IA (Daunorubicin/Idarubicin + Cytarabine)-in elderly patients (aged 55-75) with acute myeloid leukemia (AML) who are fit for intensive chemotherapy.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 228 (estimated)
- First submitted
- 13 Aug 2025
- Start date
- 31 Aug 2025
- Primary completion date
- 30 Aug 2027
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT07132684
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 228
- From 31 Aug 2025 to the primary completion date, 30 Aug 2027
- 1 site 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
- Relapsed or refractory AML (previously treated with induction chemotherapy, but hydroxyurea is allowed).
- Concurrent other malignancies requiring treatment.
Other illness
- Severe infectious diseases (e.g., untreated tuberculosis, pulmonary aspergillosis).
- Other conditions deemed unsuitable by the investigator.
Lab values
- Active cardiac disease (e.g., uncontrolled angina, recent myocardial infarction, severe arrhythmias, uncontrolled heart failure, LVEF below normal).
Other
- Acute promyelocytic leukemia with PML-RARA fusion gene.
- AML with RUNX1-RUNX1T1 or CBFB-MYH11 fusion genes.
- AML with BCR-ABL fusion gene.
Who the study is looking for
- 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.
Age in the registry: 55 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Blood Diseases Hospital Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.