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

PHASE3RecruitingINTERVENTIONAL
Enrollment

876

Participants

Timeline

Start Date

January 1, 2025

Primary Completion Date

June 30, 2026

Study Completion Date

December 31, 2026

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.

Trial Locations (1)

510515

RECRUITING

Department of Hematology,Nanfang Hospital, Southern Medical University, Guangzhou

All Listed Sponsors
collaborator

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

OTHER

collaborator

Guangzhou First People's Hospital

OTHER

collaborator

Guangdong Second Provincial General Hospital

OTHER

collaborator

Jiangmen Central Hospital

OTHER

collaborator

Shenzhen Second People's Hospital

OTHER

collaborator

First Affiliated Hospital of Guangxi Medical University

OTHER

collaborator

Dongguan People's Hospital

OTHER_GOV

collaborator

First People's Hospital of Foshan

OTHER

collaborator

Guangdong Provincial Hospital of Traditional Chinese Medicine

OTHER

collaborator

Huizhou Municipal Central Hospital

OTHER

collaborator

Shenzhen Hospital of Southern Medical University

OTHER

collaborator

Affiliated Hospital of Guangdong Medical University

OTHER

collaborator

People's Hospital of Guangxi Zhuang Autonomous Region

OTHER

collaborator

First People's Hospital of Chenzhou

OTHER

collaborator

Hunan Provincial People's Hospital

OTHER

collaborator

Ganzhou City People's Hospital

OTHER

collaborator

First Affiliated Hospital of Gannan Medical University

OTHER

lead

Nanfang Hospital, Southern Medical University

OTHER