Research on Acute Promyelocytic Leukemia in Asia
The Acute Promyelocytic Leukaemia Asian Consortium (APL-AC) Project
This study is testing whether taking arsenic trioxide by mouth works as well as getting it through an IV for treating Acute Promyelocytic Leukemia in patients across Asia.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Sex | All |
| Sponsor | The University of Hong Kong Academic / other |
| Drugs / interventions | gemtuzumab, chemotherapy |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT04251754 on ClinicalTrials.gov |
What this trial studies
This project aims to gather collaborative data on the epidemiology, clinicopathologic features, and treatment outcomes of newly diagnosed and relapsed Acute Promyelocytic Leukemia (APL) in Asia. It will compare the efficacy of oral arsenic trioxide (oral-As2O3) with intravenous arsenic trioxide (i.v.-As2O3) in treating APL, leveraging both retrospective and prospective data from various Asian countries. The study seeks to establish the long-term benefits of oral-As2O3, which has shown promising results in Hong Kong, and to facilitate its broader application across Asia.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 or older diagnosed with Acute Promyelocytic Leukemia with the PML/RARA fusion gene.
Not a fit: Patients with Acute Myeloid Leukemia that do not have the PML/RARA fusion gene or variant RARA translocation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment protocols for APL, enhancing patient outcomes across Asia.
How similar studies have performed: Other studies have shown success with arsenic trioxide treatments for APL, but this specific approach of oral-As2O3 in a broader Asian context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * Patients aged 18 or above * Acute promyelocytic leukaemia with PML/RARA * Acute myeloid leukaemia with variant RARA translocation Exclusion criteria: -Acute myeloid leukaemia without PML/RARA or variant RARA translocation
Where this trial is running
Hong Kong
- Department of Medicine, the University of Hong Kong, Queen Mary Hospital — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Harinder Gill, MD — The University of Hong Kong
- Study coordinator: Harinder Singh 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.