Evaluate the Pharmacokinetics of Oral Arsenic Trioxide Solution Under Fasting and Fed Conditions, to Compare Intravenous Arsenic Trioxide, in Acute Promyelocytic Leukemia

Launched by SDK THERAPEUTICS, INC. · Mar 14, 2025

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ClinConnect Summary

This clinical trial is studying a new oral form of arsenic trioxide, a medication used to treat Acute Promyelocytic Leukemia (APL), a type of blood cancer. The trial aims to understand how the body processes this new oral medication when taken on an empty stomach compared to after eating, and how it compares to the traditional intravenous (IV) form of arsenic trioxide. This research is important because it could help improve treatment options for patients with APL.

To participate in this trial, individuals need to be diagnosed with APL, specifically those who have a genetic change known as the t(15;17) translocation. Unfortunately, those who have had a relapse or who do not respond to treatment for APL cannot join. Participants in the trial will take the oral medication and may be required to follow specific guidelines about eating before their doses. This study is currently looking for volunteers aged 65 to 74, and it welcomes both men and women. Being part of this trial could help advance our understanding of APL treatments and potentially benefit future patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • -Diagnosis of APL characterized by the presence of the t(15;17) translocation or promyelocytic leukemia/retinoic acid receptor alpha gene expression
• Exclusion Criteria:
• • Relapsed or refractory APL