Pivotal Open-label Phase 3 Clinical Study of QTX-2101 in Adult Patients With Acute Promyelocytic Leukemia
Recruiting now · Phase 3
Conditions studied: Acute Promyelocytic Leukemia (APL), Acute Promyelocytic Leukaemia, Acute Promyelocytic Leukemia With PML-RARA, Acute Promyelocytic Leukemia With t(15;17)(q24.1;q21.2); PML-RARA, Acute Promyelocytic Leukemia
In brief
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.
Key facts
- Study ID
- NCT07504458
- Run by
- Quetzal Therapeutics
- People needed
- 150
- Starts
- 2026-06-08
- Expected to finish
- 2030-12-01
- Last updated by the study team
- 2026-08-05
Who can join
Age: 18 and older, up to 71. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Quetzal Site 16 — Birmingham, Alabama, United States (enrolling)
- Quetzal Site 1 — Duarte, California, United States (enrolling)
- Quetzal Site 7 — Los Angeles, California, United States (enrolling)
- Quetzal Site 5 — Stanford, California, United States (enrolling)
- Quetzal Site 13 — Augusta, Georgia, United States (enrolling)
- Quetzal Site 4 — Buffalo, New York, United States (enrolling)
- Quetzal Site 2 — The Bronx, New York, United States (enrolling)
- Quetzal Site 8 — Columbus, Ohio, United States (enrolling)
- Quetzal Site 12 — Nashville, Tennessee, United States (enrolling)
- Quetzal Site 6 — Houston, Texas, United States (enrolling)
- Quetzal Site 3 — Charlottesville, Virginia, United States (enrolling)
- Quetzal Site 14 — Paris, France (enrolling)
- Quetzal Site 11 — Palma de Mallorca, Balearic Islands, Spain (enrolling)
- Quetzal Site 15 — Barcelona, Spain (enrolling)
- Quetzal Site 10 — Cáceres, Spain (enrolling)
- Quetzal Site 9 — Valencia, Spain (enrolling)
Full record on ClinicalTrials.gov
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