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	University of Alabama at Birmingham (UAB), Birmingham
California	City of Hope Comprehensive Cancer Center, Duarte University of California, Irvine, Irvine USC Norris Comprehensive Cancer Center, Los Angeles UCI Health - UCI Medical Center, Orange Stanford University School of Medicine, Stanford
Georgia	Augusta University Medical Center, Augusta
Kentucky	University of Kentucky Markey Cancer Center, Lexington
Maryland	Johns Hopkins Kimmel Cancer Center, Baltimore University of Maryland Medical Center, Baltimore
Michigan	University of Michigan, Ann Arbor
New York	Roswell Park Comprehensive Cancer Center, Buffalo Montefiore Medical Center, The Bronx
North Carolina	University of North Carolina at Chapel Hill, Chapel Hill
Ohio	The Ohio State University Wexner Medical Center, Columbus
Tennessee	Sarah Cannon Research Institute at TriStar Centennial Medical Center, Nashville
Texas	The University of Texas MD Anderson Cancer Center, Houston
Virginia	University of Virginia Health, Charlottesville

Conditions

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.