Oral Arsenic Trioxide for Newly Diagnosed Acute Promyelocytic Leukaemia
Status:
Recruiting
Trial end date:
2023-12-31
Target enrollment:
Participant gender:
Summary
Acute promyelocytic leukemia (APL) is characterized by t(15;17)(q24;21) and the fusion gene
PML-RARA. We 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. Furthermore, in an
effort to prevent relapse, we have moved oral-As2O3 forward to the maintenance of CR1. This
strategy results in favorable overall-survival (OS) and leukemia-free-survival (LFS),
implying that prolonged treatment with oral-As2O3 may prevent relapses. Current protocols
have incorporated i.v.-As2O3 in the treatment of newly-diagnosed APL. In regimens comprising
i.v.-As2O3, ATRA and chemotherapy, 5-year overall survivals in excess of 90% is achieved. In
this study, we evaluate the use of oral-As2O3 and ATRA based induction regimens in newly
diagnosed patients with APL. In this study, we evaluate the efficacy and tolerability of
frontline oral arsenic trioxide-based regimen in newly diagnosed patients with acute
promyelocytic leukaemia