Actively Recruiting
HVA vs IA/DA or VA in the Treatment of ND HR-AML
Led by Nanfang Hospital, Southern Medical University · Updated on 2025-02-06
876
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
N
Nanfang Hospital, Southern Medical University
Lead Sponsor
S
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborating Sponsor
AI-Summary
What this Trial Is About
The aim of this study is to evaluate the safety and efficacy of homohartonine combined with venetoclax and azacitidine (HVA) versus intensive chemotherapy (IA/DA) or venetoclax combined with azacitidine (VA) in newly diagnosed high-risk AML patients.
CONDITIONS
Official Title
HVA vs IA/DA or VA in the Treatment of ND HR-AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with acute myeloid leukemia according to WHO classification
- Age 18 years or older
- High-risk AML as defined by European Leukemia Risk stratification (ELN) 2022 or secondary AML from MDS, MPN, or chronic myeloid leukemia, or treatment-related AML with prior cytotoxic or radiation therapy
- No prior anti-AML therapy except leukopenia treatment like hydroxyurea or low-dose cytarabine (<1.0g/day) after AML diagnosis
- Expected survival of at least 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status of 3 or less
- Kidney function with creatinine clearance of at least 30 ml/min
- Liver function with ALT less than 5 times normal and bilirubin less than 3 times normal
- Signed informed consent and willingness to follow study procedures
You will not qualify if you...
- Acute promyelocytic leukemia
- Central nervous system leukemia (CNSL)
- Cardiac function worse than level 2
- HIV infection
- Uncontrolled or active systemic infections including viral, bacterial, or fungal
- Chronic hepatitis B or C requiring treatment
- Active second tumors needing treatment
- Unable to take oral medications or have gastrointestinal conditions affecting absorption
- Allergy to study drugs
- Pregnant or breastfeeding women
- Unable to understand or follow the study protocol
- Investigator judgment deems patient ineligible
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Hematology,Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China, 510515
Actively Recruiting
Research Team
G
Guopan Yu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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