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

Clinical Study Protocol for the Treatment of Newly Diagnosed and Relapsed/Refractory Acute Myeloid Leukemia With KMT2A Gene Abnormalities Using VHEA（Venetoclax With Homoharringtonine，Etoposide，Cytarabine）

This study is testing a new combination of medications to see if it can help people with acute myeloid leukemia that has KMT2A gene abnormalities feel better and improve their chances of recovery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 34 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Huai'an First People's Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Huai'an, Jiangsu)
• Trial ID: NCT06328179 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 60 years with newly diagnosed or relapsed/refractory acute myeloid leukemia exhibiting KMT2A gene abnormalities.

Not a fit: Patients with other malignancies or significant comorbidities affecting their ability to tolerate chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve remission rates and overall outcomes for patients with acute myeloid leukemia and KMT2A gene abnormalities.

How similar studies have performed: While there is limited data on the specific VHEA regimen, similar approaches targeting MLL-related leukemia have shown promise, indicating potential for success.

Eligibility criteria

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 this trial is running

Huai'an, Jiangsu

• 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

Conditions Acute Myeloid Leukemia