Clinical Study of Venetoclax Combined With CACAG Regimen in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia

PHASE2RecruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

August 1, 2023

Primary Completion Date

January 31, 2026

Study Completion Date

January 31, 2026

Conditions
Relapsed/Refractory Acute Myeloid Leukemia
Interventions
DRUG

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

"1. Azacytidine (75mg/m2/day, days 1 to 7).~2. Cytarabine (75-100mg/m2 q12h, days 1 to 5).~3. Aclacinomycin(20mg/day, days 1,3,5).~4. Chidamide(30mg/day , days 1,4,8,11).~5. Venetoclax (100mg on day 1,200mg on day 2,400mg on days 3-14).~6. Granulocyte colony stimulating factor (300 μg/day, day 0 until agranulocytosis recovery)"

DRUG

Best-Available Therapy(BAT) Regimen

"1. FLAG regimen:Fludarabine(30mg/m2,days 1-5)+Cytarabine (1-2g/m2 applied 4h after fludarabine, days 1 to 5)+Granulocyte colony-stimulating factor(300ug/day,days 0 to 5)~2. CLAG regimen:Cladribine(5mg/2,days 1-5)+Cytarabine (1-2g/m2 applied 4h after fludarabine, days 1 to 5)+Granulocyte colony-stimulating factor(300ug/day,days 0 to 5)~3. MAE regimen:Mitox(10mg/m2,days 1 to 5)+VP-16(100mg/m2,days 1 to 5)+Cytarabine (100-150mg/m2,days 1 to 7)~4. DCAG regimen:Decitabine(20mg/m2,days 1 to 5)+Aclacinomycin(20mg/day on days 1,3,5)+Cytarabine (100mg q12h,days 1 to 5)+Granulocyte colony-stimulating factor(300 ug/day,day 0 until agranulocytosi recovery)~5. HAA regimen:HHT(2mg/m2,days 1 to 7)+Aclacinomycin(20mg/day,days 1 to 7) and Cytarabine (100-200 mg/m2, days 1 to 5);~6. HAD regimen:HHT(2mg/m2,days 1 to 7)+Daunorubicin(45mg/m2/day,days 1 to 3)+Cytarabine (100-200 mg/m2,days 1 to 5)."

Trial Locations (1)

100853

RECRUITING

Chinese PLA General Hospital, Beijing

All Listed Sponsors
collaborator

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

OTHER

collaborator

The General Hospital of Western Theater Command

OTHER

collaborator

The General Hospital of Northern Theater Command

OTHER

collaborator

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

UNKNOWN

collaborator

Air Force Military Medical University, China

OTHER

collaborator

Yantai Yuhuangding Hospital

OTHER

collaborator

People's Liberation Army (PLA) Strategic Support Force Characteristic Medical Center

UNKNOWN

collaborator

First Hospital of China Medical University

OTHER

lead

Chinese PLA General Hospital

OTHER