HVA vs IA/DA or VA in the Treatment of ND HR-AML

Recruiting now · Phase 3

Conditions studied: Newly Diagnosed Acute Myeloid Leukemia With High Risk

In brief

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.

Key facts

Study ID

NCT06810791

Run by

Nanfang Hospital, Southern Medical University

People needed

876

Starts

2025-01-01

Expected to finish

2026-12-31

Last updated by the study team

2025-02-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

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

Full record on ClinicalTrials.gov

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