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)
1) Histologically confirmed acute myeloid leukemia (non-M3). Treatment-na?ve and unable to receive standard cytarabine and anthracycline induction regimens due to age or comorbidities or patient preference.
1)Acute promyelocytic leukemia (APL) and low risk cytogenetics such as t(8;21), inv(16) or t(16;16).
Single group
Venetoclax Combining Chidamide and Azacitidine (VCA) regimen followed by dicitabine combined with liposome mitoxantrone, cytarabine, and G-CSF (D-MAG) regimen
Drugvenetoclax 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
Complete remission (CR) rate
CR was \<5% marrow blasts by morphology
1 year leukemia free survival (LFS)
Leukemia-free survival (LFS) is defined as survival without evidence of relapse from treatment initiation
1 year overall survival (OS)
Overall survival（OS）is defined as the time from treatment initiation to death from any cause.
Adverse events
Adverse event is defined as any untoward medical occurrence associated with treatment
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.
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The First Affiliated Hospital of Xiamen University
Lead sponsor
Chipscreen Biosciences, Ltd.
Collaborator
CSPC Pharmaceutical Group Limited
Collaborator
Fujian Provincial Hospital
Collaborator
Fujian Cancer Hospital
Collaborator
Zhangzhou manicipal hospital of Fujian Province
Collaborator
Jieyang People's Hospital
Collaborator
Huizhou Municipal Central Hospital
Collaborator
