Actively Recruiting
Randomized Phase 3 Study of Azacitidine plus Venetoclax Maintenance Therapy in Younger Adults with Favorable-risk AML in First Remission After Chemotherapy
Led by The First Affiliated Hospital of Soochow University · Updated on 2022-08-19
124
Participants Needed
2
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether azacitidine combined with venetoclax as maintenance therapy can improve relapse-free survival for younger adults aged 18 to 64 with favorable-risk acute myeloid leukemia (AML) who have remained in their first complete remission after intensive consolidation chemotherapy. This phase III trial aims to compare the effects of this combination therapy against observation and supportive care during remission. The study is sponsored by The First Affiliated Hospital of Soochow University and includes participants who have completed remission induction and consolidation therapy and are not immediate candidates for stem cell transplant. Participants in the treatment group will receive azacitidine by subcutaneous injection once daily on days 1 through 5 and venetoclax by mouth once daily on days 1 through 14 of each 28-day cycle. This will continue for a total of 8 cycles. The comparison group will receive observation and supportive care to manage any complications during remission. There is no blinding, and participants are randomly assigned to one of the two groups. During the trial, researchers will monitor relapse-free survival from the date of complete remission to relapse or death for up to about three years. They will also assess secondary outcomes such as minimal residual disease negative conversion, duration of complete remission, overall survival, event-free survival, and the occurrence of adverse events. Participants will undergo disease monitoring and supportive care as needed. The study is expected to continue until June 2030, with regular follow-up visits to assess health and treatment outcomes.
CONDITIONS
Brief 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) based on 2017 European LeukemiaNet genetic risk stratification
- Age between 18 and 64 years
- In first remission after remission induction therapy and 3-4 cycles of HiDAC or medium-dose cytarabine consolidation
- Eastern Cooperative Oncology Group (ECOG) performance status of 3 or less
- Adequate organ function: serum 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 for females of childbearing age within 10 to 14 days before enrollment
- Effective contraception for males of childbearing age during treatment and for 30 days after
- Ability to understand and sign informed consent
You will not qualify if you...
- Diagnosis of acute promyelocytic leukemia
- Active central nervous system (CNS) leukemia
- History of myelodysplastic syndrome (MDS) or myeloproliferative neoplasm (MPN) progressing to AML
- Presence of other progressive cancers
- Clinically significant uncontrolled conditions, including active infections
- Participation in another clinical trial within 30 days before consent
- Females who are pregnant, breastfeeding, or planning pregnancy during the study
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 8 months (8 cycles of 28 days each)
Participants receive azacitidine and venetoclax in 28-day cycles for up to 8 cycles or receive observation and supportive care during remission.
Monthly visits for treatment administration and monitoring
Duration - Up to approximately 3 years
Participants are monitored for relapse and survival outcomes after treatment completion.
Periodic follow-up visits for disease monitoring
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
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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