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Pivotal Open-label Phase 3 Clinical Study of QTX-2101 in Adult Patients With Acute Promyelocytic Leukemia
NCT07504458 · Quetzal Therapeutics
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Official title
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
About this 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.
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
Study design
Enrollment target: 150 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-06-08
Estimated completion: 2030-12
Last updated: 2026-09-10
Interventions
Drug: QTX-2101 + ATRADrug: IV arsenic trioxide (ATO) + ATRA
Primary outcomes
- • Maximum observed plasma (concentration (Cmax) of QTX-2101 for ASIII (Up to 1 cycle of consolidation therapy (each cycle is 8 weeks))
- • Molecular complete remission (molecular CR) rate (Up to 60 days of induction and 3 8-week cycles of consolidation treatment)
Sponsor
Quetzal Therapeutics · industry
All locations (24)
Quetzal Site 16Recruiting
Birmingham, Alabama, United States
Quetzal Site 1Recruiting
Duarte, California, United States
Quetzal Site 7Recruiting
Los Angeles, California, United States
Quetzal Site 5Recruiting
Stanford, California, United States
Quetzal Site 13Recruiting
Augusta, Georgia, United States
Quetzal Site 18Recruiting
Lexington, Kentucky, United States
Quetzal Site 23Recruiting
Baltimore, Maryland, United States
Quetzal Site 22Recruiting
Ann Arbor, Michigan, United States
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Buffalo, New York, United States
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The Bronx, New York, United States
Quetzal Site 8Recruiting
Columbus, Ohio, United States
Quetzal Site 12Recruiting
Nashville, Tennessee, United States
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Houston, Texas, United States
Quetzal Site 3Recruiting
Charlottesville, Virginia, United States
Quetzal Site 17Recruiting
Bordeaux, France
Quetzal Site 14Recruiting
Paris, France
Quetzal Site 24Recruiting
Strasbourg, France
Quetzal Site 19Recruiting
Cluj-Napoca, Romania
Quetzal Site 11Recruiting
Palma de Mallorca, Balearic Islands, Spain
Quetzal Site 21Recruiting
Badalona, Spain
Quetzal Site 15Recruiting
Barcelona, Spain
Quetzal Site 10Recruiting
Cáceres, Spain
Quetzal Site 20Recruiting
Oviedo, Spain
Quetzal Site 9Recruiting
Valencia, Spain