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NCT Number: NCT07132684

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

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.

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Key information

Conditions

AML, Adult Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

55 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Daunorubicin/Idarubicin

Drug

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

Cytarabine

Drug

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

Azacitidine

Drug

Azacitidine is used in VA regimen

Venetoclax

Drug

Venetoclax is used in VA regimen

Primary outcomes

  1. Overall Survival (OS)

    Time frame: up to 1 years after completion of enrollment

    Time from randomization to death from any cause.

Secondary outcomes

  1. Composite Complete Remission Rate (CR/CRh/CRi)

    Time frame: Six weeks after induction therapy

    Proportion of patients achieving CR, CRh, or CRi after induction.

  2. MRD Negativity Rate

    Time frame: up to 1 years after completion of enrollment

    Proportion of patients achieving MRD negativity after induction and overall treatment.

  3. Relapse-Free Survival (RFS)

    Time frame: up to 1 years after completion of enrollment

    Time from achieving CR/CRh/CRi to relapse or death.

  4. Event-Free Survival (EFS)

    Time frame: up to 1 years after completion of enrollment

    Time from randomization to treatment failure, relapse, or death.

  5. 30-Day and 60-Day Mortality Rates

    Time frame: within 30 and 60 days of starting treatment.

    Proportion of patients who die within 30 and 60 days of starting treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Hui Wei, MD

CONTACT

[email protected]

13132507161

Sponsors and collaborators

Lead sponsor

Institute of Hematology & Blood Diseases Hospital, China

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Aug 20, 2025
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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