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Pivotal Open-label Phase 3 Clinical Study of QTX-2101 in Adult Patients With Acute Promyelocytic Leukemia
RecruitingPhase 3
A Pivotal Open-label Phase 3 Clinical Study Evaluating the Efficacy and Safety of QTX-2101 in Combination With All-trans Retinoic Acid in Newly Diagnosed, Low-risk Acute Promyelocytic Leukemia
Who can join
Ages 18 to 71 · All sexes
Full eligibility criteria
Inclusion Criteria: 1. Informed Consent 2. Participants must be between 18 and under 71 years of age 3. Participants must have a confirmed diagnosis of APL proven by standard genetic testing (t(15;17) or PML-RARA) 4. Participants must be classified as low- or intermediate-risk APL 5. Participants must be willing and able to comply with the scheduled study visits, treatment plans, laboratory tests, contraception guidance, and other procedures Exclusion Criteria 1. Participants who have significant heart rhythm problems including long QT syndrome, serious arrhythmias, very slow heart rate, or prolonged QTc on ECG 2. Participants who have central nervous system leukemia 3. Participants having serious ongoing medical conditions or infections including uncontrolled infections, severe organ disease, or conditions that make study participation unsafe 4. Participants who are pregnant, breastfeeding, or unwilling to use contraception 5. 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
About the study
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.
What is being tested
- QTX-2101 + ATRA (drug)
- IV arsenic trioxide (ATO) + ATRA (drug)
Sponsor: Quetzal Therapeutics · Participants: 150 · Started: Jun 8, 2026
Contact the study team
Official record on ClinicalTrials.gov — NCT07504458
Locations in the U.S.
| Alabama | Quetzal Site 16, Birmingham |
| California | Quetzal Site 1, Duarte Quetzal Site 7, Los Angeles Quetzal Site 5, Stanford |
| Georgia | Quetzal Site 13, Augusta |
| Kentucky | Quetzal Site 18, Lexington |
| Maryland | Quetzal Site 23, Baltimore |
| Michigan | Quetzal Site 22, Ann Arbor |
| New York | Quetzal Site 4, Buffalo Quetzal Site 2, The Bronx |
| North Carolina | Quetzal Site 27, Chapel Hill |
| Ohio | Quetzal Site 8, Columbus |
| Tennessee | Quetzal Site 12, Nashville |
| Texas | Quetzal Site 6, Houston |
| Virginia | Quetzal Site 3, Charlottesville |
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.