Actively Recruiting
Frontline Oral Arsenic Trioxide for APL
Led by The University of Hong Kong · Updated on 2025-06-12
100
Participants Needed
2
Research Sites
286 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Frontline Oral Arsenic Trioxide for APL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed APL with t(15;17)(q24;q21) or AML with variant RARA translocation according to WHO Classification 2022
- Ability and willingness to comply with the study procedures and restrictions
- Voluntary written informed consent
You will not qualify if you...
- ECOG performance score greater than 2
- Decompensated heart failure with left-ventricular ejection fraction less than 40% and global hypokinesia on echocardiogram
- Prolonged corrected QT interval (QTc) of 500ms or more, without electrolyte disturbances or medications that prolong QTc
- Significant liver function derangement (Bilirubin more than 3 times upper limit normal and/or ALT more than 5 times upper limit normal)
- Glomerular filtration rate less than 30mL/min in adults or creatinine clearance less than 50ml/min/1.73m2 in pediatric and adolescent patients
- Female who is lactating or has a positive pregnancy test before the first dose of study drug
AI-Screening
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Trial Site Locations
Total: 2 locations
1
The University of Hong Kong
Hong Kong, Hong Kong
Actively Recruiting
2
National University Hospital Singapore
Singapore, Singapore
Actively Recruiting
Research Team
H
Harry Gill, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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