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Clinical Trials in China / NCT07132684
Recruiting Phase 3

Comparison of VA and D/IA Induction Regimens in Elderly Fit Acute Myeloid Leukemia Patients

NCT07132684 · tracked via the Priya Life Science China tracker
Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Phase
Phase 3
Started
2025-08-31
Last updated
2026-03-02

Condition(s) studied

AML, Adult

Investigational drug(s) / intervention(s)

Daunorubicin/IdarubicinCytarabineAzacitidineVenetoclax

Daunorubicin/Idarubicin: Daunorubicin/Idarubicin is used in Induction Therapy and Maintenance Therapy.

Cytarabine: Cytarabine is used in Induction Therapy, Consolidation Therapy and Maintenance Therapy.

Azacitidine: Azacitidine is used in VA regimen

Venetoclax: Venetoclax is used in VA regimen

Study summary

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.

Eligibility

Sex
ALL
Min age
55 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Blood Diseases Hospital Tianjin China Recruiting

On this site

📄 Venclexta (venetoclax) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07132684 on ClinicalTrials.gov ↗ ← All trials in China