This Phase 3 study in adult participants with newly diagnosed low-risk APL will evaluate the efficacy, safety, and PK of an oral capsule formulation of ATO, in combination with ATRA.
Informed Consent
Participants must be between 18 and under 71 years of age
Participants must have a confirmed diagnosis of APL proven by standard genetic testing (t(15;17) or PML-RARA)
Participants must be classified as low- or intermediate-risk APL
Participants who have significant heart rhythm problems including long QT syndrome, serious arrhythmias, very slow heart rate, or prolonged QTc on ECG
Participants who have central nervous system leukemia
Participants having serious ongoing medical conditions or infections including uncontrolled infections, severe organ disease, or conditions that make study participation unsafe
Participants who are pregnant, breastfeeding, or unwilling to use contraception