Comparison of VA and D/IA Induction Regimens in Elderly Fit Acute Myeloid Leukemia Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Daunorubicin/Idarubicin, Cytarabine, Azacitidine, Venetoclax.
- Who it may be relevant to
- Registry conditions: AML, Adult. Basic parameters: 55 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Multicenter, Randomized, Controlled Clinical Trial Comparing VA and D/IA Induction Regimens in Elderly Patients With Acute Myeloid Leukemia Suitable for Intensive Chemotherapy
Overview
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.
Interventions
- Drug Daunorubicin/Idarubicin
Daunorubicin/Idarubicin is used in Induction Therapy and Maintenance Therapy. - Drug Cytarabine
Cytarabine is used in Induction Therapy, Consolidation Therapy and Maintenance Therapy. - Drug Azacitidine
Azacitidine is used in VA regimen - Drug Venetoclax
Venetoclax is used in VA regimen
Primary outcome measures
- Overall Survival (OS) [Time frame: up to 1 years after completion of enrollment]
Secondary outcome measures (5)
- Composite Complete Remission Rate (CR/CRh/CRi) [Time frame: Six weeks after induction therapy]
- MRD Negativity Rate [Time frame: up to 1 years after completion of enrollment]
- Relapse-Free Survival (RFS) [Time frame: up to 1 years after completion of enrollment]
- Event-Free Survival (EFS) [Time frame: up to 1 years after completion of enrollment]
- 30-Day and 60-Day Mortality Rates [Time frame: within 30 and 60 days of starting treatment.]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Blood Diseases Hospital — Tianjin
Identifiers
NCT: NCT07132684 · IIT2025095