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

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.

Conditions

• Newly Diagnosed Acute Myeloid Leukemia With High Risk

Interventions

DRUG

HVA

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.

DRUG

VA

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.

DRUG

Standard 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.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  collaborator OTHER

• Guangzhou First People's Hospital

  collaborator OTHER

• Guangdong Second Provincial General Hospital

  collaborator OTHER

• Jiangmen Central Hospital

  collaborator OTHER

• Shenzhen Second People's Hospital

  collaborator OTHER

• First Affiliated Hospital of Guangxi Medical University

  collaborator OTHER

• Dongguan People's Hospital

  collaborator OTHER_GOV

• First People's Hospital of Foshan

  collaborator OTHER

• Guangdong Provincial Hospital of Traditional Chinese Medicine

  collaborator OTHER

• Huizhou Municipal Central Hospital

  collaborator OTHER

• Shenzhen Hospital of Southern Medical University

  collaborator OTHER

• Affiliated Hospital of Guangdong Medical University

  collaborator OTHER

• People's Hospital of Guangxi Zhuang Autonomous Region

  collaborator OTHER

• First People's Hospital of Chenzhou

  collaborator OTHER

• Hunan Provincial People's Hospital

  collaborator OTHER

• Ganzhou City People's Hospital

  collaborator OTHER

• First Affiliated Hospital of Gannan Medical University

  collaborator OTHER

• Nanfang Hospital, Southern Medical University

  lead OTHER

Principal Investigators

• Guopan Yu · Nanfang Hospital, Southern Medical University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-01-01

Primary Completion

2026-06-30

Completion

2026-12-31

Countries

• China

Study Locations