"A Multicenter RCT of 3+7 vs Venetoclax + CACAG in Newly Diagnosed Mid/High-Risk AML Patients"

PHASE2RecruitingINTERVENTIONAL
Enrollment

160

Participants

Timeline

Start Date

April 18, 2024

Primary Completion Date

April 18, 2026

Study Completion Date

October 18, 2026

Conditions
Acute Myeloid LeukemiaFirst Line Therapy
Interventions
DRUG

Azacytidine;Cytarabine;Aclacinomycin;Chidamide;Venetoclax;Granulocyte colony-stimulating factor

"Azacytidine (75 mg/m2/day, days 1 to 7). Cytarabine (75-100 mg/m2 bid, days 1 to 5). Aclacinomycin(20 mg/day, days 1,3,5). Chidamide (30 mg/day , days 1,4,8,11). Venetoclax (400 mg/day, days 1 to 14,Combined with posaconazole reduced to 100 mg/day,Combined with voriconazole reduced to 200 mg/day ).~Granulocyte colony-stimulating factor (300 μg/day, day 0 until agranulocytosis recovery)"

DRUG

"3+7"

"IA regimen:~Idarubicin (8-10 mg/m2) for 3 days . Cytarabine (75-100mg/m2, every 12 hrs) for 7 days.~DA regimen:~Daunorubicin(60 mg/m2) for 3 days. Cytarabine (75-100mg/m2, every 12 hrs) for 7 days."

Trial Locations (1)

100853

RECRUITING

Chinese PLA General Hospital, Beijing

All Listed Sponsors
collaborator

First Affiliated Hospital of Harbin Medical University

OTHER

collaborator

Yantai Yuhuangding Hospital

OTHER

collaborator

Chinese People's Liberation Army Air Force General Hospital

UNKNOWN

collaborator

The General Hospital of Western Theater Command

OTHER

collaborator

940 Hospital of the People's Liberation Army Joint Logistic Support Force

OTHER

collaborator

The 960th Hospital of Joint Logistics Support Force of Chinese People's Liberation Army

UNKNOWN

collaborator

the First People's Hospital of Jining

UNKNOWN

lead

Chinese PLA General Hospital

OTHER