A multicenter, open-label, prospective, randomized controlled study to optimize the treatment of patients with acute myeloid leukemia based on early peripheral blood minimal residual disease
This study is a randomized controlled, prospective clinical trial, with the leading unit being the First Hospital of Jilin University. It aims to screen patients with a suboptimal response to chemotherapy based on early peripheral blood minimal residual disease (MRD) levels, and explore the efficacy and safety of adding venetoclax. A total of 70 subjects are expected to be enrolled, with 35 subjects each in the experimental group and the control group. The study will collect data on subjects' demographics, other baseline characteristics, medication usage, prognosis, etc. Statistical analysis will be performed on the collected data to compare efficacy indicators.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Patients identified with a suboptimal response to chemotherapy based on minimal residual disease (MRD) levels in peripheral blood on Day 6 will initiate venetoclax therapy added on Day 8, administered for 7 days.
The First Hospital of Jilin University
Changchun, Jilin, China
RECRUITINGModified Composite Complete Response Rate(mCRc)
Complete Response(CR) + Complete Response with Incomplete Hematologic Recovery(CRi)+Morphologic Leukemia Free State(MLFS)
Time frame: Through study completion, an average of 1 year
Overall Survival (OS)
Defined as the time from enrollment in this study to death from any cause. If the exact date of death is unknown, the time of death is defined as the last contact date. If the patient is still alive, the last observed time will be used, and the patient's OS will be considered for analysis.
Time frame: From date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 48 months.
MRD Negative Conversion Rate
Defined as the proportion of patients who convert to MRD negative among all evaluable patients for efficacy.
Time frame: Through study completion, an average of 1 year
Relapse-Free Survival(RFS)
Defined as the time from enrollment in this study to the occurrence of relapse. For patients without relapse, the time is calculated until death from any cause or the time of the last follow-up
Time frame: From date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 48 months.
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