Status:
RECRUITING
Frontline Oral Arsenic Trioxide for APL
Lead Sponsor:
The University of Hong Kong
Conditions:
Acute Promyelocytic Leukemia
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
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...
Detailed Description
After initial eligibility screening, patients will be recruited to oral arsenic trioxide, all-trans-retinoic acid, ascorbic acid (AAA) based-induction for 42 days. Daunorubicin or idarubicin will only...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04687176
Start Date
January 1 2021
End Date
June 30 2026
Last Update
June 12 2025
Active Locations (2)
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1
The University of Hong Kong
Hong Kong, Hong Kong
2
National University Hospital Singapore
Singapore, Singapore