Chidamide in combination with venetoclax and azacitidine (VAC) were expected to improve remission rate of patients following to VA regimen treatment failure.
Venetoclax and azacitidine has become the standard first-line treatment for elderly/unsuitable AML patients who can't tolerate for intense chemotherapy. However, a proportion of patients who were not able to achieve remission after failing to VA regimen and then were given the second cycle, and their rate of achieving remission was even lower. Chidamide down-regulates the expression of MCL and is expected to improve the remission rate further in combination with VA regimen.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Enrolled patients were given chidamide 10 mg every day on days 1-14, azacitidine 75mg/m2 every day on days 1-7, and oral venetoclax began at 100mg on day 1 and increased stepwise over 3 days to reach the target dose of 400mg (100mg, 200mg, and 400mg) on days 1-28. Dose adjustments for concomitant venetoclax with CYP3A4 inhibitors were made according to the literature.
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
RECRUITINGORR(overall response rate)
ORR was calculated as the sum of CR, CRi, MLFS and PR.
Time frame: 1 month
OS (Overall survival)
OS was defined as the time from enrollment to this study to the date of death from any cause; patients not known to have died at last follow-up are censored on the date they were last known to be alive.
Time frame: 2 years
EFS (Event-free survival)
EFS was defined as the time from the initiation of CAV to treatment failure, relapse, death from any cause or the last follow-up.
Time frame: 2 years
Adverse events (AEs)
It is evaluated and graded according to CTCAE 5.0.
Time frame: 2 months
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