Actively Recruiting
Pivotal Open-label Phase 3 Clinical Study of QTX-2101 in Adult Patients With Acute Promyelocytic Leukemia
Led by Quetzal Therapeutics · Updated on 2026-04-16
150
Participants Needed
4
Research Sites
243 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pivotal Open-label Phase 3 Clinical Study of QTX-2101 in Adult Patients With Acute Promyelocytic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide informed consent
- Between 18 and under 71 years of age
- Confirmed diagnosis of acute promyelocytic leukemia by standard genetic testing (t(15;17) or PML-RARA)
- Classified as low- or intermediate-risk acute promyelocytic leukemia
- Willing and able to follow study visits, treatment plans, laboratory tests, contraception guidance, and other procedures
You will not qualify if you...
- Significant heart rhythm problems including long QT syndrome, serious arrhythmias, very slow heart rate, or prolonged QTc on ECG
- Central nervous system leukemia
- Serious ongoing medical conditions or infections including uncontrolled infections or severe organ disease
- Pregnant, breastfeeding, or unwilling to use contraception
- Unable to safely take study medication due to severe neuropathy, inability to swallow oral medication, malabsorption, or known allergy to arsenic trioxide or all-trans retinoic acid
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Quetzal Site 1
Duarte, California, United States, 91010
Actively Recruiting
2
Quetzal Site 4
Buffalo, New York, United States, 14203
Actively Recruiting
3
Quetzal Site 2
The Bronx, New York, United States, 10467
Actively Recruiting
4
Quetzal Site 3
Charlottesville, Virginia, United States, 22908
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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