Oral arsenic trioxide treatment for acute promyelocytic leukemia
Frontline Oral Arsenic Trioxide-based Induction in Newly Diagnosed Acute Promyelocytic Leukaemia
This study is testing a new oral treatment using arsenic trioxide and vitamin A to see if it can help people with newly diagnosed acute promyelocytic leukemia while reducing the need for chemotherapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Sex | All |
| Sponsor | The University of Hong Kong Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Hong Kong and 1 other locations) |
| Trial ID | NCT04687176 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy of an oral formulation of arsenic trioxide combined with all-trans-retinoic acid in treating newly diagnosed acute promyelocytic leukemia (APL). Patients will undergo a 42-day induction phase followed by chemotherapy-free consolidation and maintenance phases. The study aims to monitor molecular responses and assess the overall survival and leukemia-free survival rates. The approach seeks to minimize chemotherapy exposure while maintaining high treatment efficacy.
Who should consider this trial
Good fit: Ideal candidates include individuals newly diagnosed with acute promyelocytic leukemia who meet specific genetic criteria.
Not a fit: Patients with significant comorbidities or advanced disease may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could provide a safer, chemotherapy-free option for patients with acute promyelocytic leukemia.
How similar studies have performed: Previous studies have shown promising results with similar approaches, indicating a potential for success in this novel treatment strategy.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 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 2. Ability and willingness to comply with the study procedures and restrictions 3. Voluntary written informed consent Exclusion Criteria: 1. ECOG performance score \>2 2. Decompensated heart failure with left-ventricular ejection fraction of less than 40% and global hypokinesia on echocardiogram. 3. Prolonged corrected QT interval (QTc) ≥ 500ms, in the absence of electrolyte disturbances and medications known to prolong QTc 4. Significant liver function derangement (Bilirubin \> 3 times upper limit normal and/or ALT \> 5 times upper limit of normal) 5. 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) 6. Female subject who is lactating or has positive pregnancy test result prior to the first dose of study drug
Where this trial is running
Hong Kong and 1 other locations
- The University of Hong Kong — Hong Kong, Hong Kong (Recruiting)
- National University Hospital Singapore — Singapore, Singapore (Recruiting)
Study contacts
- Principal investigator: Harry Gill, MD — The University of Hong Kong
- Study coordinator: Harry Gill, MD
- Email: gillhsh@hku.hk
- Phone: +852 22554542
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.