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

RecruitingPhase 3Ages 55 Years - 75 YearsAllInstitute of Hematology & Blood Diseases Hospital…
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • Daunorubicin/Idarubicin
  • Cytarabine
  • Azacitidine
  • Venetoclax
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Where

1 site
Blood Diseases Hospital
Tianjin, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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