ALLG APML5: This phase I trial is evaluating an oral anti-cancer drug (arsenic trioxide) as a consolidation therapy for acute promyelocytic leukaemia (APML)A phase I pharmacokinetic evaluation of oral arsenic trioxide in previously untreated patients with acute promyelocytic leukaemia

Inclusion

1. Patient has consented to and registered with the National Blood Cancer Registry (NBCR).
2. Morphological diagnosis of APL, either classical FAB-M3 or variant FAB-M3v.
3. Diagnosis of APL has been confirmed by the presence of PML-RARA fusion transcripts in pre-treatment blood or bone marrow.
4. Age greater than or equal to 18 years
5. In haematological complete remission (hCR or hCRi) following induction with ATRA + ATO (standard-risk as per APL0406) or ATRA + ATO + idarubicin (high-risk as per APML4).
6. An ECOG performance status score of 3 or less.
7. Absence of previous history of serious cardiac, pulmonary, hepatic or renal disease.
8. Serum creatinine less than or equal to 200µmol/L (unless medically correctable).
9. Serum bilirubin less than or equal to 50µmol/L (unless medically correctable).
10. ECG showing sinus rhythm and QTc interval (Framingham) < 450msec. Prolongation of QTc due to medication or electrolyte disturbance must be corrected before registration.
11. No contra-indication to use of any of the study drugs.
12. Has provided written informed consent.
13. Females of childbearing potential must have a negative pregnancy test at registration for APML5.
14. Females of childbearing potential and males must use an effective method of contraception or practice absolute abstinence during treatment and for 2 months after treatment discontinuation.
15. Participants must agree not to donate blood, semen or sperm whilst on study treatment and for 2 months after treatment discontinuation.