ALLG APML5 : A phase I pharmacokinetic evaluation of oral arsenic trioxide in previously untreated patients with acute promyelocytic leukaemia

Trial Identifiers

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• ACTRN12616001022459

Scientific Title

A phase I pharmacokinetic evaluation of oral arsenic trioxide in previously untreated patients with acute promyelocytic leukaemia

Cooperative Group

Australasian Leukaemia and Lymphoma Group (ALLG)

Summary

This trial has a randomised design, consisting of two parts. In part 1, patients will receive 7 cycles of All-Trans Retinoic Acid (ATRA, tretinoin) (45mg/m^2, in 2 divided doses) + 4 cycles of IV ATO (0.15mg/kg/day) with the exception of week one of ATO cycle #2, and week one of ATO cycle # 4, when oral tablet ATO (0.15mg/kg/day) will be used. In part 2 of the trial, patients will receive Patients will be given 7 cycles of ATRA (45mg/m^2, in 2 divided doses) + 4 cycles of IV ATO, with the exception of week one of either ATO cycle #1 or ATO cycle #2, and week one of either ATO cycle #3 or ATO cycle #4, when oral tablet ATO will be used (sequence will be determined by randomisation).