Frontline Oral Arsenic Trioxide for APL
Recruiting now · Phase 2
Conditions studied: Acute Promyelocytic Leukemia
In brief
The investigators have formulated an oral preparation of arsenic trioxide (oral-ATO), 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-ATO 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-ATO may prevent relapses. Current protocols have incorporated i.v.-ATO in the treatment of newly-diagnosed APL \[11-15\]. For regimens comprising oral-ATO, 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-ATO is highly effective and safe in the relapsed and frontline settings \[16,17\]. In this study, the investigators evaluate the use of oral-ATO and ATRA based induction regimens in newly diagnosed patients with APL with no of minimal chemotherapy in a prospective multicentre phase 2 study.
Key facts
- Study ID
- NCT04687176
- Run by
- The University of Hong Kong
- People needed
- 100
- Starts
- 2021-01-01
- Expected to finish
- 2026-06-30
- Last updated by the study team
- 2025-06-12
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Newly diagnosed APL with t(15;17)(q24;q21) or acute myeloid leukaemia (AML) with variant RARA translocation according to the World Health Organization (WHO) Classification 2022
- Ability and willingness to comply with the study procedures and restrictions
- Voluntary written informed consent
You may not qualify if…
- ECOG performance score >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)
- Glomerular filtration rate (GRF) by Cockcroft-Gault formula or eGFR (MDRD) of less than 30mL/min in adults (aged ≥ 18) or Creatinine clearance < 50ml/min/1.73m2 in paediatric and adolescent patients (Age ≤ 17)
- Female subject who is lactating or has positive pregnancy test result prior to the first dose of study drug
Where it is running
- The University of Hong Kong — Hong Kong, Hong Kong (enrolling)
- National University Hospital Singapore — Singapore, Singapore (enrolling)
Full record on ClinicalTrials.gov
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