Frontline Oral Arsenic Trioxide for APL

Launched by THE UNIVERSITY OF HONG KONG · Dec 23, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new oral form of arsenic trioxide (oral-ATO) for patients with Acute Promyelocytic Leukemia (APL), a type of blood cancer. The goal is to see how effective this oral medication is in helping patients achieve remission and to prevent the cancer from coming back. The researchers have previously shown that oral-ATO is effective and safe for treating APL, and they are now evaluating its use alongside another treatment called ATRA, with minimal use of chemotherapy.

To be eligible for this trial, participants must be newly diagnosed with APL and meet specific health criteria, such as being able to follow study procedures and providing written consent. Those with certain health issues, like severe heart problems or significant liver damage, may not qualify. If someone joins the study, they can expect regular monitoring and support throughout their treatment. This trial is currently recruiting participants of all ages and genders, aiming to find better ways to treat APL while reducing the need for intensive chemotherapy.

Gender

ALL

Eligibility 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