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Pivotal Open-label Phase 3 Clinical Study of QTX-2101 in Adult Patients With Acute Promyelocytic Leukemia
Trial Status: active
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.
Inclusion Criteria
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 must be willing and able to comply with the scheduled study visits, treatment plans, laboratory tests, contraception guidance, and other procedures
Exclusion Criteria
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
Participants who are unable to safely take study medication, including severe neuropathy, inability to swallow oral medication, malabsorption issues, or known allergy to ATO or ATRA
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07504458.
