The purpose of this study is to evaluate the safety and efficacy of Venetoclax Combining Chidamide and Azacitidine (VCA) Followed by D-MAG Regimen on the Treatment of Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
Elderly Patients with AML have inferior outcomes due to poor physical condition, and intolerant to conventional chemotherapy. The regimen of Venetoclax and Azacitidine has been widely used in these patients and has proved to achieve higher CR rate than low intensity therapy. 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. The Venetoclax Combining Chidamide and Azacitidine (VCA) regimen was applied to one 62-year-old male patient with AML who achieved CR. Meanwhile, Liposome mitoxantrone has better safety and tolerance than mitoxantrone in elderly patients. Thus, this study is intended to use 2 cycles of VCA regimens followed by 2 cycles of D-MAG regimens, and then repeat the above four courses of treatment once to improve the median event free survival of elderly AML patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
66
venetoclax combining chidamide and azacitidine (VCA) 28 days per cycle × 2 cycles; 1) chidamide 30mg biw × 2weeks;2) venetoclax 200mg/d × 2 weeks 3) azacitidine 100mg/d d1-7 dicitabine combined with liposome mitoxantrone, cytarabine, and G-CSF (D-MAG) regimen 28 days per cycle ×2 cycles; 1)dicitabine 25mg d1-3,2)liposome mitoxantrone 20mg d4,3)cytarabine 10mg/m2 Q12h d1-7 4)G-CSF 300ug d-1 until WBC \> 20×109/L
Bing Xu
Xiamen, Fujian, China
RECRUITINGComplete remission (CR) rate
CR was \<5% marrow blasts by morphology
Time frame: 6 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
1 year 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: 6 months
objective response rate (ORR)
ORR is defined as CR, CRi and PR. Partial remission (PR) is defined as a decrease of at least 50% in the percentage of blasts to 5 to 25% in the bone marrow aspirate and the normalization of blood counts.
Time frame: 6 months
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