Actively Recruiting
AZA + Venetoclax as Maintenance Therapy in Younger Adults With AML in First Remission
Led by The First Affiliated Hospital of Soochow University · Updated on 2022-08-19
124
Participants Needed
2
Research Sites
414 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase III trial is conducted to evaluate if azacitidine in combination with venetoclax as maintenance therapy improves relapse-free survival (RFS) for younger adults with favorable-risk acute myeloid leukemia (AML) who remained in first complete remission (CR1) following intensive consolidation.
CONDITIONS
Official Title
AZA + Venetoclax as Maintenance Therapy in Younger Adults With AML in First Remission
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of favorable-risk acute myeloid leukemia (AML) as per 2017 European LeukemiaNet risk classification and not immediate candidates for stem cell transplant
- Age between 18 and 64 years
- Completed remission induction therapy and 3-4 cycles of HiDAC or medium-dose cytarabine consolidation and currently in first remission
- ECOG performance status of 3 or less
- Adequate organ function: total bilirubin ≤ 3 times upper limit of normal (ULN), AST and ALT ≤ 3 times ULN, creatinine clearance ≥ 60 ml/min, left ventricular ejection fraction ≥ 50%
- Negative pregnancy test within 10 to 14 days before enrollment for females of childbearing potential
- Males must use effective contraception during treatment and for 30 days after stopping treatment
- Ability to understand and sign informed consent
You will not qualify if you...
- Diagnosis of acute promyelocytic leukemia
- Active central nervous system (CNS) leukemia
- Prior diagnosis of myelodysplastic syndrome (MDS) or myeloproliferative neoplasm (MPN) that progressed to AML
- Presence of other progressive cancers
- Uncontrolled or active serious infections including viral, bacterial, or fungal
- Participation in other clinical trials within 30 days before consent
- Pregnant or breastfeeding females, or those planning pregnancy during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215000
Actively Recruiting
2
The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology
Suzhou, Jiangsu, China, 215000
Actively Recruiting
Research Team
S
Suning Chen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here