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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

Sponsor: Quetzal Therapeutics · Participants: 150 · Started: Jun 8, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07504458

Locations in the U.S.

AlabamaQuetzal Site 16, Birmingham
CaliforniaQuetzal Site 1, Duarte
Quetzal Site 7, Los Angeles
Quetzal Site 5, Stanford
GeorgiaQuetzal Site 13, Augusta
KentuckyQuetzal Site 18, Lexington
MarylandQuetzal Site 23, Baltimore
MichiganQuetzal Site 22, Ann Arbor
New YorkQuetzal Site 4, Buffalo
Quetzal Site 2, The Bronx
North CarolinaQuetzal Site 27, Chapel Hill
OhioQuetzal Site 8, Columbus
TennesseeQuetzal Site 12, Nashville
TexasQuetzal Site 6, Houston
VirginiaQuetzal 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.