Pivotal Open-label Phase 3 Clinical Study of QTX-2101 in Adult Patients With Acute Promyelocytic Leukemia
Sponsor: Quetzal Therapeutics
Sponsor score: 0
ClinicalTrials ID:NCT07504458
This Phase 3 study assesses the efficacy and safety of QTX-2101 with ATRA in adults with low-risk APL. Eligible participants are 18-70 years old with confirmed APL and no significant heart issues or CNS leukemia. The trial compares oral QTX-2101 with IV ATO, both combined with ATRA, following specific dosing schedules during induction and consolidation phases.
Patient Parameters
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Program Overview
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
- Informed Consent
- Participants must be between 18 and under 71 years of age
- Participants must have a confirmed diagnosis of APL proven by standard genetic testing (t(15;17) or PML-RARA)
- Participants must be classified as low- or intermediate-risk APL
- Participants must be willing and able to comply with the scheduled study visits, treatment plans, laboratory tests, contraception guidance, and other procedures
Exclusion Criteria
- Participants who have significant heart rhythm problems including long QT syndrome, serious arrhythmias, very slow heart rate, or prolonged QTc on ECG
- Participants who have central nervous system leukemia
- Participants having serious ongoing medical conditions or infections including uncontrolled infections, severe organ disease, or conditions that make study participation unsafe
- Participants who are pregnant, breastfeeding, or unwilling to use contraception
- 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
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Quetzal Site 1 | 91010 | Duarte | California |
| Quetzal Site 4 | 14203 | Buffalo | New York |
| Quetzal Site 2 | 10467 | The Bronx | New York |
| Quetzal Site 3 | 22908 | Charlottesville | Virginia |
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