RecruitingPhase 3NCT06810791

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

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

Sponsor

Nanfang Hospital, Southern Medical University

Enrollment

876 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

Newly Diagnosed Acute Myeloid Leukemia With High Risk

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing different chemotherapy combinations for people newly diagnosed with high-risk acute myeloid leukemia (AML), a fast-growing blood cancer. The goal is to find out which combination leads to better remission rates. **You may be eligible if...** - You are 18 or older and have been newly diagnosed with AML - Your AML is classified as high-risk (based on genetic testing or disease origin) - You have not yet received any AML treatment (minor exceptions apply) - Your expected survival is at least 12 weeks and you are well enough to tolerate intensive therapy **You may NOT be eligible if...** - You have already received AML-specific treatment - Your general health is too poor to handle intensive chemotherapy - You have other conditions that make the study drugs unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHVA

Homoharringtonine (HHT) is given by venous drip daily at 1 mg/m2 from day 1 to 7. Venetoclax (VEN) is given 100 mg on day 1, 200 mg on day 2, and 400 mg orally from day 3 to day 14. Azacitidine (AZA) is given 75 mg/m2 subcutaneously from day 1 to 7.

DRUGVA

VEN is given 100 mg on day 1, 200 mg on day 2, and 400 mg orally from day 3 to day 28, and AZA (75 mg/m2) is given subcutaneously from day 1 to 7.

DRUGStandard Chemotherapy

Standard Chemotherapy includes IA(Idarubicin combined with Cytarabine) or DA(Daunorubicin combined with Cytarabine). IDA is given by venous drip daily at 12mg/m2, or DNR is given by venous drip daily at 60mg/m2, from day 1-3, combined with Ara-C at 100mg/m2 by continuously venous drip from day 1-7.

Locations(1)

Department of Hematology,Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

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NCT06810791