Although studies are ongoing to evaluate the efficiency and safety of venetoclax-based therapy, alone or in combination with hypomethylation agent or low-dose cytarabine, in relapsed/refractory acute myeloid leukemia, data are scarce and heterogenous. In this study, the investigators aimed to assess safety and response to a new venetoclax-based triple-drug combination regimen (venetoclax + hypomethylation agent + low-dose cytarabine) in acute myeloid leukemia patients who had relapsed/refractory disease or positive minimal residual disease.
Although the promising activity of venetoclax-based therapy is well demonstrated in the treatment of previously untreated elderly or unfit patients with acute myeloid leukemia, there are few data on the efficacy of venetoclax-based salvage therapy in relapsed/refractory patients, which can be difficult to treat. To date, data on venetoclax as monotherapy or in combination with hypomethylation agent or low-dose cytarabine as a salvage regimen in relapsed/refractory AML are scarce and heterogenous. In this study, the investigators aimed to assess safety and efficiency of a new triple-drug combination regimen, venetoclax + hypomethylation agent + low-dose cytarabine, in patients with relapsed/refractory acute myeloid leukemia or persistent positive minimal residual disease in the salvage setting.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
52
Venetoclax was given at a dose of 400 mg/day for 28 days per cycle. Decitabine was given at a dose of 20 mg/m2/day for 5 days (n=3) or azacytidine (n=8) was given at a dose of 75 mg/m2/day for 7 days at the discretion of the treating physician. Cytarabine was given at a dose of 10 mg/m2 twice daily for 7 days.
Complete remission rate
percentage of subjects with complete remission (CR) and incomplete hematologic recovery (CRi)
Time frame: At the end of Cycle 2 (each cycle is 28 days)
Complete minimal residual disease (MRD) Response Rate
Percentage of subjects with MRD negative or MRD \< 0.01%
Time frame: At the end of Cycle 2 (each cycle is 28 days)
MRD Response Rate
Percentage of subjects with MRD \< 0.1% detectable by multicolor flow cytometry
Time frame: At the end of Cycle 2 (each cycle is 28 days)
Relapse-Free Survival
Time interval from leukemia free state to the first recurrence or death
Time frame: 24 months
Overall Survival
Time interval from start of treatment until death or last follow-up
Time frame: 24 months
Duration of response
Time interval from morphologic/MRD response to loss of response or death
Time frame: 24 months
Adverse events
Number of subjects with adverse events
Time frame: start of treatment to 2 weeks after end of treatment
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