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Clinical Study Protocol for the Treatment of ND-AML and RR-AML With KMT2A Gene Abnormalities Using VHEA.

RecruitingNAAges 18 Years - 60 YearsAllHuai'an First People's Hospital
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In plain words

What the trial is, and whether it could suit you

This study is a clinical trial aimed at evaluating the efficacy and safety of the VHEA(Venetoclax with Homoharringtonine,Etoposide,Cytarabine)regimen in the treatment of newly diagnosed and relapsed/refractory acute myeloid leukemia (AML) with MLL gene abnormalities. This study includes the induction and consolidation phases of AML treatment.

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

📋 Eligibility rules (as published)
Inclusion Criteria: * Age between 18 and 60 years old;Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. * Expected survival time of at least 3 months. * Does not meet any of the following criteria for severe heart, lung, liver, or kidney disease:A) History of congestive heart failure requiring treatment, or ejection fraction ≤ 50%, or presence of chronic stable angina;B) Lung diffusing capacity for carbon monoxide (DLCO) ≤ 65%, or forced expiratory volume in one second (FEV1) ≤ 65%;C) Moderate liver dysfunction, total bilirubin \> 1.5 to ≤ 3.0 × upper limit of normal (ULN);D) Creatinine clearance ≥ 30 mL/min to \< 45 mL/min. * No other significant contraindications to chemotherapy as determined by the physician; * Capable of understanding and willing to sign the informed consent form for this study. Exclusion Criteria: * Presence of other malignancies; * Underwent cardiac vascular intervention or stent placement within 12 months prior to signing the informed consent, or history of myocardial infarction, unstable angina, or other clinically significant cardiac disease; * Uncontrolled active infection (including bacterial, fungal, or viral infection) and visceral bleeding; * Pregnant or lactating women; * Participation in any other clinical study within 3 months prior to signing the informed consent; * Any other condition deemed unsuitable for participation in this study by the investigator.
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What it tests

  • Venetoclax 100 mg d1,200 mg d2,400 mg d3-14;
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Where

1 site
The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University(Huai'an First People's Hospital)
Huai'an, 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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