This study intends to use a randomized controlled design to compare the MRD-negativw rate and related efficacy and safety of venetoclax combined with intermediate-dose cytarabine (IDAC) versus IDAC in the consolidation treatment of patients with AML after remission, providing high-quality evidence-based medical evidence for optimizing post-remission consolidation therapy for AML and improving patients' prognosis.
Studies have shown that venetoclax can significantly enhance the efficacy of intensive chemotherapy (IC) in the induction and salvage treatment of AML. However, there is still a lack of direct comparison of the efficacy and safety of venetoclax combined with intermediate-dose cytarabine (IDAC) with IDAC for consolidation in AML. In order to evaluate the benefit of venetoclax combined with IDAC, we plan to conduct a multicenter, prospective randomized controlled, phase 2 study to compare the efficacy and safety of venetoclax (d1-7, 400mg QD) combined with cytarabine (d1-3, 1.5g/㎡, q12h) versus cytarabine only for consolidation therapy in AML, aiming to fill the current evidence gap and provide scientific basis for improving deeper remission of AML and finally improve patients' long-term survival.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
232
Venetoclax 400mg per day from day 1 to day 7
Cytarabine 1.5g/m\^2 q12h from day 1 to day 3.
Department of Hematology, Guangdong Second Provincial General Hospital
Guangzhou, Guangdong, China
Rate of Measurable residual disease (MRD) negative
MRD is monitored using flow cytometric analysis with a positive MRD threshold of 0.1%.
Time frame: At the end of cycle 2 (28 days for a cycle)
Cumulative Incidence of Recurrence (CIR)
Assess the risk of leukemia recurrence after the consolidation
Time frame: 2 years
Overall survival (OS)
OS is calculated from enrollment to death or the last follow-up.
Time frame: 2 years
Disease Free Survival (DFS)
It refers to the time from the start of the consolidation to disease recurrence or death from any cause or the last follow-up.
Time frame: 2 years
Aderse events
Side effects of the consolidations including haematological and non-haematological toxicity.
Time frame: At the end of cycle 2 (28 days for a cycle)
The rate of being bridged to allogeneic hematopoietic stem cell transplantation
To assess how many patients are needed to accept allogeneic hematopoietic stem cell transplantation after the consolidation.
Time frame: 2 years
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