Treatment for acute myeloid leukemia with KMT2A gene abnormalities using VHEA.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the efficacy and safety of the VHEA regimen, which combines Venetoclax, Homoharringtonine, Etoposide, and Cytarabine, for treating newly diagnosed and relapsed/refractory acute myeloid leukemia (AML) with KMT2A gene abnormalities. The study is multicenter, single-arm, and open-label, focusing on both induction and consolidation phases of AML treatment. Given the poor prognosis associated with MLL-related leukemia, this trial aims to provide a more effective treatment option compared to conventional chemotherapy regimens.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Study coordinator: Shandong Tao
• Email: TSD8884@126.com
• Phone: 15252393900

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.