Homoharringtonine, venetoclax and azacitidine for new high-risk acute myeloid leukemia
Compares homoharringtonine-based treatment with standard options in high-risk acute myeloid leukemia.
Plain-language title generated from the registry record
Registry title: HVA vs IA/DA or VA in the Treatment of ND HR-AML
Key facts
- Where
- Guangzhou, ChinaSee the site
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with newly diagnosed high-risk acute myeloid leukemia (AML) who have not yet had treatment for it.
- Age
- 18 years or older.
- Sex
- All sexes can join.
- Disease stage
- Newly diagnosed AML with high risk: high risk under the ELN 2022 grouping, AML that developed from MDS, MPN or chronic myeloid leukemia, or AML linked to earlier cytotoxic treatment or radiation.
- Earlier treatment
- No earlier anti-AML treatment after diagnosis. Hydroxyurea or cytarabine under 1.0g/d for low white blood cell counts is allowed.
Main reasons for not taking part
- Acute promyelocytic leukemia
- Leukemia in the central nervous system (CNSL)
- HIV infection
- Uncontrolled or active infection, or hepatitis B or C needing treatment
- Pregnant or breastfeeding women
Read by machine on 12 November 2026.
Where in China
- Department of Hematology,Nanfang Hospital, Southern Medical UniversityGuangzhou, ChinaContact: Guopan YuTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Nanfang Hospital, Southern Medical University
- Trial code
- NCT06810791
- Record updated
- 6 February 2025
- Original description
The aim of this study is to evaluate the safety and efficacy of homohartonine combined with venetoclax and azacitidine (HVA) versus intensive chemotherapy (IA/DA) or venetoclax combined with azacitidine (VA) in newly diagnosed high-risk AML patients.Read full original descriptionShow less
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
The aim of this study is to evaluate the safety and efficacy of homohartonine combined with venetoclax and azacitidine (HVA) versus intensive chemotherapy (IA/DA) or venetoclax combined with azacitidine (VA) in newly diagnosed high-risk AML patients.
Inclusion: 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: 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; Acute promyelocytic leukemia; With central nervous system leukemia (CNSL) ; 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.