Actively Recruiting
Venetoclax and Azacitidine Combined With Chidamide (VAC) for the Treatment of Newly Diagnosed Acute Monocytic Leukemia
Led by The First Affiliated Hospital of Soochow University · Updated on 2025-11-21
92
Participants Needed
1
Research Sites
239 weeks
Total Duration
On this page
Sponsors
T
The First Affiliated Hospital of Soochow University
Lead Sponsor
J
Jining Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is to investigate the therapeutic efficacy and side effect of venetoclax, azacytidine combined with chidamide for newly diagnosed acute monocytic leukemia patients that are ineligible for intensive chemotherapy
CONDITIONS
Official Title
Venetoclax and Azacitidine Combined With Chidamide (VAC) for the Treatment of Newly Diagnosed Acute Monocytic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of acute monocytic leukemia (AML-M5) by FAB classification or specific markers
- Projected life expectancy of at least 12 weeks
- Previously untreated for AML-M5
- Ineligible for intensive chemotherapy due to age or health conditions
- Age 60 years or older, or age 18 to 59 with comorbidities such as ECOG status 2 or 3, heart failure, lung function impairment, kidney function limits, or moderate liver impairment
- Meet laboratory requirements specified by the study protocol
- Female participants must not be pregnant or breastfeeding and agree to use birth control during and for 90 days after the study
- Male participants with female partners of childbearing potential must agree to use contraception
- No radiotherapy, chemotherapy, targeted therapy, or stem cell transplantation within 4 weeks prior to enrollment
- Other comorbidities making intensive chemotherapy unsuitable
- Patient refusal of intensive chemotherapy
- Able to understand and willing to sign informed consent
You will not qualify if you...
- Allergy to study drugs or similar compounds
- Pregnant, breastfeeding, or unwilling to use effective contraception if of childbearing potential
- Active infection or active bleeding
- Recent thrombosis, embolism, cerebral hemorrhage, or related medical history within one year
- Mental disorders or inability to provide informed consent or follow study procedures
- Significant liver or kidney function abnormalities
- History of serious heart conditions including QTc prolongation, arrhythmias, heart attack within one year, heart failure, or coronary heart disease requiring treatment
- Surgery on major organs within the past six weeks
- Drug or long-term alcohol abuse affecting study evaluation
- History of organ transplants except bone marrow
- Investigator assessment deeming patient unsuitable for the study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Affliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
Actively Recruiting
Research Team
S
Sheng-Li Xue, M. D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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