NCT07504458PHASE3Recruiting
Pivotal Open-label Phase 3 Clinical Study of QTX-2101 in Adult Patients With Acute Promyelocytic Leukemia
Quetzal Therapeutics
Start Date
6/8/2026
Completion Date
12/1/2030
Summary
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
Age Range: 18 years to 71 years
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
Interventions
DRUG
QTX-2101 + ATRA
DRUG
IV arsenic trioxide (ATO) + ATRA
Conditions
Acute Promyelocytic Leukemia (APL)Acute Promyelocytic LeukaemiaAcute Promyelocytic Leukemia With PML-RARAAcute Promyelocytic Leukemia With t(15;17)(q24.1;q21.2); PML-RARAAcute Promyelocytic Leukemia
Locations
Quetzal Site 1
Duarte, California 91010
United States
Quetzal Site 7
Los Angeles, California 90033
United States
Quetzal Site 5
Stanford, California 94305
United States
Quetzal Site 13
Augusta, Georgia 30912
United States
Quetzal Site 4
Buffalo, New York 14203
United States
Quetzal Site 2
The Bronx, New York 10467
United States
Quetzal Site 8
Columbus, Ohio 43210
United States
Quetzal Site 12
Nashville, Tennessee 37203
United States
Quetzal Site 6
Houston, Texas 77030
United States
Quetzal Site 3
Charlottesville, Virginia 22908
United States
Quetzal Site 14
Paris, 75010
France
Quetzal Site 11
Palma de Mallorca, Balearic Islands 07120
Spain
Quetzal Site 10
Cáceres, 10003
Spain
Quetzal Site 9
Valencia, 46026
Spain