Alternating Regimen of VA and Low-dose CHA in the Treatment of Unfit Newly Diagnosed AML

PHASE2RecruitingINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

August 15, 2025

Primary Completion Date

July 31, 2027

Study Completion Date

July 31, 2029

Conditions
Age 60 and OlderIntensive Chemotherapy UnfitNewly Diagnosed Acute Myeloid Leukemia (AML)
Interventions
DRUG

Alternately treated with VA/low CHA regimen

"1. Induction Phase (4 alternating cycles):~ Participants will receive 4 cycles of alternating therapy:~ * VA Cycle:~ * Venetoclax 400 mg PO daily on Days 1-28~ * Azacitidine 75 mg/m² SC/IV daily on Days 1-7~ * Low-dose CHA Cycle:~ * Cladribine 5 mg/m² IV daily on Days 1-3~ * Homoharringtonine 1 mg/m² IV daily on Days 1-5~ * Cytarabine 20 mg SC every 12 hours on Days 1-10 Alternating sequence: VA → CHA → VA → CHA → VA → CHA → VA → CHA The interval between the VA to low-CHA is 2 weeks, and the interval between the two alternations (one alternation is VA plus low-CHA)is 4 weeks.~2. Maintenance Phase (24 months):~Following induction, participants will receive:~* Venetoclax 400 mg PO daily on Days 1-28~* Azacitidine 75 mg/m² SC/IV daily on Days 1-7 Repeated every 28 days for 24 cycles. The interval between the two cycles is 2 weeks."

Trial Locations (5)

Unknown

RECRUITING

Beijing Chao-Yang Hospital, Capital Medical University, Beijing

RECRUITING

Shenzhen University General Hospital, Shenzhen

RECRUITING

the First Affiliated Hospital of Soochow University, Suzhou

RECRUITING

the Second Affiliated Hospital of Nanchang University, Nanchang

RECRUITING

Bone Marrow Transplantation Center, the First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

AbbVie

INDUSTRY

lead

First Affiliated Hospital of Zhejiang University

OTHER