The purpose of this study is to evaluate the safety and efficacy of Venetoclax Combining Chidamide and Azacitidine (VCA) in the Treatment of relapsed and/or refractory AML
Patients with relapsed and/or refractory AML have inferior outcomes. The regimen of Venetoclax and Azacitidine has been widely used in the treatment of RR AML and has proved to achieve CR rate of 30% \~ 40%. However, the median duration of response (DOR) of this regimen is about one year. Chidamide is a histone deacetylase (HDAC) inhibitor and preclinical data showed adding low-dose Chidamide to venetoclax could significantly promoted apoptosis of leukemia cell lines. Meanwhile, the Venetoclax Combining Chidamide and Azacitidine (VCA) regimen was applied to 2 patients with refractory AML. This regimen was well tolerated and both patients achieved CR after one cycle. Thus, we register this clinical trial and evaluate the safety and efficacy of VCA regimen.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
information already included in arm/group descriptions
Bing Xu
Xiamen, Fujian, China
RECRUITINGComplete remission (CR) rate
CR was \<5% marrow blasts by morphology
Time frame: 2 months
Overall response rate (ORR)
ORR is defined as CR, CRi and PR.
Time frame: 2 months
1 year leukemia free survival (LFS)
Leukemia-free survival (LFS) is defined as survival without evidence of relapse from treatment initiation
Time frame: 1 year from treatment initiation
1year overall survival (OS)
Overall survival(OS)is defined as the time from treatment initiation to death from any cause.
Time frame: 1 year from treatment initiation
Adverse events
Adverse event is defined as any untoward medical occurrence associated with treatment
Time frame: 2 months
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