Oral Arsenic Trioxide for Newly Diagnosed Acute Promyelocytic Leukaemia
Acute Promyelocytic Leukemia
About this trial
This is an interventional treatment trial for Acute Promyelocytic Leukemia focused on measuring Acute promyelocytic leukaemia, Oral arsenic trioxide
Eligibility Criteria
Inclusion Criteria:
- Newly diagnosed patients with acute promyelocytic leukaemia (APL) with t(15;17) (q24;q21)according to the World Health Organization (WHO) Classification 2016
- Patients aged ≥18 years
- Able and willing to comply with the study procedures and restrictions
- Having given voluntary written informed consent
Exclusion Criteria:
- ECOG performance status above 2
- Decompensated heart failure with left-ventricular ejection fraction of less than 40% and global hypokinesia on echocardiogram.
- Prolonged corrected QT interval (QTc) > 500ms, in the absence of electrolyte disturbances and medications known to prolong QTc
- Significant liver function derangement (Bilirubin > 3 times upper limit normal and/or ALT > 5 times upper limit of normal)
- Acute myeloid leukaemia with variant RARA translocation
Sites / Locations
- Department of Medicine, the University of Hong Kong, Queen Mary HospitalRecruiting
Arms of the Study
Arm 1
Experimental
Frontline oral arsenic trioxide, ATRA and ascorbic acid (AAA)
Induction: Oral arsenic trioxide 10mg daily, all-trans retinoic acid (ATRA) (45mg/m2 per day in divided doses) and Ascorbic acid 1g daily for 42 days Daunorubicin at 50mg/m2 daily for 3 days (omitted if WBC at diagnosis < 10 x 10^9/L; or age ≥ 65 years; or cardiac function impairment) Hydroxyurea 2-4g per day if WBC > 5 x 10^9/L during the first 7 days of induction. Consolidation (for all patients): - Oral arsenic trioxide 10mg daily, all-trans retinoic acid (ATRA) (45mg/m2 per day in divided doses) and ascorbic acid 1g daily for 14 days every 28 days for 2 cycles Maintenance (for all patients): - Oral Arsenic trioxide 10mg daily, ATRA (45mg/m2 per day in divided doses) and ascorbic acid 1g daily for 2 weeks every 2 months for 24 months.