The investigators have formulated an oral preparation of As2O3 (oral-As2O3), and shown that
it is efficacious for APL in R1, inducing CR2 in more than 90% of patients [8,9].
Furthermore, in an effort to prevent relapse, the investigators have moved oral-As2O3 forward
to the maintenance of CR1. This strategy results in favorable overall-survival (OS) and
leukemia-free-survival (LFS) [10], implying that prolonged treatment with oral-As2O3 may
prevent relapses.
Current protocols have incorporated i.v.-As2O3 in the treatment of newly-diagnosed APL
[11-15]. For regimens comprising As2O3, ATRA and chemotherapy, 5-year OS in excess of 90% is
achieved [11-15].
The investigators have also published long-term data showing the use of oral-As2O3 is highly
effective and safe in the relapsed and frontline settings [16,17].
In this study, the investigators evaluate the use of oral-As2O3 and ATRA based induction
regimens in newly diagnosed patients with APL with no of minimal chemotherapy in a
prospective multicentre phase 2 study.