Efficacy and Safety of HVA Regimens as Salvage Treatment in rrAML
Efficacy and Safety of HVA Regimens as Salvage Treatment in rrAML
Up Until now, there is not well acepted treatment for relapsed/refractory (rr) acute myeloid
 luekemia (AML), which has low complete response and poor survival. According to different
 guildlines, clinical trial is the first choice for the treatment of rrAML. High expression of
 BCL-2 and hypermethylation are very important factors for drug resistance in AML. Lots of
 studies have reported combination of BCL-2 inhibitor with hypomethylating agents (HMA) showed
 a promising efficacy in elder or unfit patients with newly diagnosed AML, however, presented
 not that exciting curing effect in rrAML. It is known that overexpression of MCL-1 and BCL-XL
 is the main reason for leukemia cells being resistant to BCL2 inhibitors. Since
 Homoharringtonine (HHT) could downregulate MCL-1 and BCL-XL in leukemia cells, there might be
 a synergic effect for combination of BCL-2 inhibitors with HHT, which has been proven in the
 treatment of lymphoma. Yet, there is not a report for the use of this combination in AML. In
 this single arm multi-centers prospective study, adult patients with rrAML are included and
 treated with BCL-2 inhibitor venetoclax at a dose of 400mg per day for 14 days, combined with
 azacitidine (AZA) at a dose of 75mg/m2 per day for 7 days, and HHT 1mg/m2 per day for 7 days,
 and then the eficacy and safety of HVA regimens as salvage treatment in rrAML are assessed.
Inclusion Criteria:

 Patients with rrAML Patients with the age of 18-80 years old

 Exclusion Criteria:

 -  Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood
 pressure)

 -  Patients with any conditions not suitable for the trial (investigators' decision)