Comparing HVA regimen to standard chemotherapy for high-risk acute myeloid leukemia

The Efficacy and Safety of Homoharringtonine Combined With Venetoclax and Azacitidine Versus Standard Chemotherapy or VA in the Treatment of Acute Myeloid Leukemia With High-risk, a Multicenter, Prospective, Randomized Study

This study is testing a new treatment combining homohartonine with venetoclax and azacitidine to see if it works better than standard chemotherapy for people with high-risk acute myeloid leukemia.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 876 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Nanfang Hospital, Southern Medical University (Academic / other)
• Drugs / interventions: radiation, chemotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06810791 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety and efficacy of a new treatment regimen combining homohartonine with venetoclax and azacitidine (HVA) against standard intensive chemotherapy or a combination of venetoclax and azacitidine (VA) in patients with newly diagnosed high-risk acute myeloid leukemia (AML). The study will be conducted as a multi-center, randomized controlled trial, focusing on patients who are either fit or unfit for intensive chemotherapy. The HVA regimen is expected to provide a synergistic effect that may improve treatment outcomes compared to existing therapies. The trial will assess both the efficacy and safety of the HVA regimen in this patient population.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with newly diagnosed high-risk acute myeloid leukemia.

Not a fit: Patients who have previously received anti-AML therapy or those with severe comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a more effective option for patients with high-risk AML, potentially improving survival rates and quality of life.

How similar studies have performed: Other studies have shown promising results with similar combination therapies in treating acute myeloid leukemia, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* According to the world health organization (WHO) classification of newly diagnosed with AML patients;
* Age ≥18 years old;
* High-risk patients should meet any of the following criteria: ① High risk group according to the European Leukemia Risk stratification (ELN) 2022; (2) Secondary AML (sAML) which develops from myelodysplastic syndrome (MDS), bone marrow hyperplastic tumor (MPN) or chronic myeloid cell leukemia, et.; (3) Treatment-related AML (t-AML), Patients have a history of cytotoxic treatment record or ionizing radiation therapy.
* Patients did not receive anti-AML therapy (except leukopenia therapy, such as hydroxyurea or cytarabine \< 1.0g/d) after the diagnosis of AML;
* Expected survival ≥12 weeks;
* The eastern tumor cooperation group (ECOG) score 3 points or less;
* Kidney function: creatinine clearance acuity 30 ml/min;
* Liver function: ALT \< 5 times normal value, bilirubin \< 3 times normal value;
* Sign the informed consent form and understand and abide by the plan calls for process.

Exclusion Criteria:

* Acute promyelocytic leukemia;
* With central nervous system leukemia (CNSL) ;
* The cardiac function \> level 2;
* The AIDS virus (HIV) infection;
* Other clinical significance of uncontrolled condition, including but not limited to: (1) out of control, or active systemic infection (viruses, bacteria or fungi); (2) chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) requiring treatment; (3) need to actively deal with the merger of the second tumor;
* Can't take oral treatment or having a gastrointestinal disease impact ing the absorption;
* Being allergy to the experimental drugs;
* Pregnant and lactating women;
* Patients who could not understand or adhere to the study protocol;
* Patients deemed by the investigator to be ineligible for enrollment.

Where this trial is running

Guangzhou, Guangdong

• Department of Hematology,Nanfang Hospital, Southern Medical University — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: Guopan Yu — Nanfang Hospital, Southern Medical University
• Study coordinator: Guopan Yu

Conditions Newly Diagnosed Acute Myeloid Leukemia With High Risk; HVA regimen; Intensive chenmotherapy; Fit; randomized controlled trial; Phase 3; VEN combined with AZA; Unfit