NCT07504458From ClinicalTrials.govRecruiting

Pivotal Open-label Phase 3 Clinical Study of QTX-2101 in Adult Patients With Acute Promyelocytic Leukemia

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

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

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: Quetzal Therapeutics
Enrolment target: 150
Started: 8 June 2026
Main results due: March 2027
Study sites: 28
Registry updated: 23 September 2026

Can you take part?

Ages 18 years to 71 years.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the 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

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(28)

Quetzal Site 16
Birmingham, Alabama, United States
Recruiting
Quetzal Site 1
Duarte, California, United States
Recruiting
Quetzal Site 7
Los Angeles, California, United States
Recruiting
Quetzal Site 5
Stanford, California, United States
Recruiting
Quetzal Site 13
Augusta, Georgia, United States
Recruiting
Quetzal Site 18
Lexington, Kentucky, United States
Recruiting
Quetzal Site 23
Baltimore, Maryland, United States
Recruiting
Quetzal Site 22
Ann Arbor, Michigan, United States
Recruiting
Quetzal Site 4
Buffalo, New York, United States
Recruiting
Quetzal Site 2
The Bronx, New York, United States
Recruiting
Quetzal Site 27
Chapel Hill, North Carolina, United States
Recruiting
Quetzal Site 8
Columbus, Ohio, United States
Recruiting
Quetzal Site 12
Nashville, Tennessee, United States
Recruiting
Quetzal Site 6
Houston, Texas, United States
Recruiting
Quetzal Site 3
Charlottesville, Virginia, United States
Recruiting
Quetzal Site 17
Bordeaux, France
Recruiting
Quetzal Site 25
La Tronche, France
Recruiting
Quetzal Site 14
Paris, France
Recruiting
Quetzal Site 24
Strasbourg, France
Recruiting
Quetzal Site 26
Vicenza, Italy
Recruiting
Quetzal Site 19
Cluj-Napoca, Romania
Recruiting
Quetzal Site 11
Palma de Mallorca, Balearic Islands, Spain
Recruiting
Quetzal Site 21
Badalona, Spain
Recruiting
Quetzal Site 28
Barcelona, Spain
Recruiting
Quetzal Site 15
Barcelona, Spain
Recruiting
Quetzal Site 10
Cáceres, Spain
Recruiting
Quetzal Site 20
Oviedo, Spain
Recruiting
Quetzal Site 9
Valencia, Spain
Recruiting

Showing 28 of 28 sites. 28 of the 28 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07504458. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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