OncoMatch/Clinical Trials/NCT04687176
Frontline Oral Arsenic Trioxide for APL
Is NCT04687176 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Oral Arsenic Trioxide Formulation for acute promyelocytic leukemia.
Treatment: Oral Arsenic Trioxide Formulation — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Required: RARA translocation
t(15;17)(q24;q21) or AML with variant RARA translocation
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Lab requirements
Kidney function
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) [excluded]
Liver function
Significant liver function derangement (Bilirubin > 3 times upper limit normal and/or ALT > 5 times upper limit of normal) [excluded]
Cardiac function
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 [excluded]
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)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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