To evaluate the feasibility, effectiveness and safety of chidamide combined with venetoclax and azacitidine in the treatment of newly diagnosed acute myeloid leukemia (AML) who are not suitable for intensive chemotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
184
30 mg/d orally twice-weekly
100 mg d1 200 mg d 2 400 mg d3-d28 Orally
75 mg/m 2 /d subcutaneous injection or IV d1-d7
Blood Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGComposite complete remission rate
Composite complete remission rate after 2 cycles of treatment \[Complete remission, CR) + complete remission with incomplete blood count (CR with incomplete blood count recovery, CRi); CR + CRi \]
Time frame: 2 months
Overall response rate (ORR)
Overall response rate (ORR), including complete remission (Complete remission (CR), complete remission with incomplete blood count (CR with incomplete blood count recovery (CRi), morphological leukemia free state (MLFS), and partial remission (PR) as a percentage of the total number of patients participating in the efficacy analysis.
Time frame: 24months
Overall survival (OS)
Overall survival (OS): defined as the number of days from the date of randomization to the date of death. Subjects who have not died will be censored on the last date they are known to be alive .
Time frame: 24months
MRD response rate
Minimal residual disease (MRD)rate: defined as less than 0.1% remaining blasts per white blood cell, as measured by bone marrow examination. Other thresholds can also be explored and correlated with efficacy results. Subjects who are randomized but not assessed for MRD will be considered MRD response rate non-responders. The proportion of subjects achieving an MRD response (CR + CRi) was calculated.
Time frame: 24months
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