Actively Recruiting
VA vs DA for Newly Diagnosed Hig-risk AML
Led by The First Affiliated Hospital of Soochow University · Updated on 2024-04-09
116
Participants Needed
2
Research Sites
182 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open-label, multicenter, phase 2b, randomized study aiming to compare the efficacy and safety of venetoclax plus azacytidine Versus daunorubicin plus cytarabine (conventional 7+3 regimen) in adult acute myeloid leukemia (AML) patients with adverse risk featuress. Participants will be 1:1 randomly assigned to the VA and DA groups. Once remission was achieved, consolidated chemotherapy will be performed and allogeneic hematopoietic stem cell transplantation is strongly recommended. After completion of the study intervention, participants will be followed-up every 1 to 2 months for up to 2 years.
CONDITIONS
Official Title
VA vs DA for Newly Diagnosed Hig-risk AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female or male gender
- Age between 18 and 64 years old
- Newly diagnosed acute myeloid leukemia (AML) according to WHO 2022 classification
- AML with adverse risk features per 2022 European Leukemia Net risk stratification
- Untreated AML (prior hydroxyurea or low-dose cytarabine under 1.0g allowed)
- ECOG performance status of 0 to 2
- Adequate liver function: total bilirubin ≤ 1.5× upper limit of normal (ULN); AST and ALT ≤ 3× ULN (or ≤ 5× ULN if liver infiltration by leukemia)
- Adequate renal function: creatinine clearance rate ≥ 30 ml/min
- Ability to understand and willing to provide written informed consent
You will not qualify if you...
- Diagnosis of acute promyelocytic leukemia
- AML with central nervous system infiltration
- Diagnosis of myeloid sarcoma
- AML secondary to myelodysplastic syndrome previously treated with hypomethylating agents
- Uncontrollable active infection as judged by investigator
- Active hepatitis B, hepatitis C, or HIV infection
- Heart failure grade 3 or 4
- Pregnant or breastfeeding
- Refusal to participate or deemed ineligible by investigators
AI-Screening
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Trial Site Locations
Total: 2 locations
1
The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology
Suzhou, Jiangsu, China, 215000
Actively Recruiting
2
Ethical Committee of the First Affliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
Actively Recruiting
Research Team
S
Su-ning Chen
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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