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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
124
Given SC
Given PO
Patients will receive disease monitoring and supportive care for any complication.
First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
RECRUITINGThe First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology
Suzhou, Jiangsu, China
RECRUITINGRelapse-free survival (RFS)
RFS is defined as the number of days from CR/CRi to the date of relapse or the date of death from any cause, whichever comes first.
Time frame: From date of complete remission (CR) or complete remission with incomplete count recovery (CRi), to relapse or death from any cause, up to approximately 3 years
Percentage of Participants Who Achieve Minimal Minimal Residual Disease (MRD) Negative Conversion
The MRD conversion rate is defined as the percentage of participants deemed MRD positive (≥ 10\^-3) at study initiation who converted to MRD of \< 10\^-3 in the bone marrow after randomization or initiation of treatment.
Time frame: Measured From Baseline to approximately 3 years
Complete remission duration (CRd)
CRd is defined as time from CR/CRi until date of confirmed relapse
Time frame: From date of CR/CRi to approximately 3 years
Overall Survival (OS)
OS is defined as the number of days from the date of study treatment to the date of death.
Time frame: Time from treatment to death from any cause, up to approximately 3 years
Event free survival (EFS)
EFS is defined as time from the start of study treatment until date of first confirmed relapse, withdrawal from study due to adverse event, or death due to any cause,
Time frame: Time from treatment to relapse,withdrawal from study due to adverse event and death from any cause, up to approximately 3 years
Incidence of adverse events
The NCI Common Toxicity Criteria (CTCAE 5.0) is used to grade adverse events.
Time frame: Time from treatment to approximately 3 years
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