Testing QTX-2101 with ATRA in adults newly diagnosed with acute promyelocytic leukemia
Tests QTX-2101 with ATRA in adults newly diagnosed with low-risk acute promyelocytic leukemia.
Plain-language title generated from the registry record
Registry title: Pivotal Open-label Phase 3 Clinical Study of QTX-2101 in Adult Patients With Acute Promyelocytic Leukemia
Key facts
- Where
- Cluj-Napoca, RomaniaSee the site
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 71 years old?
Source: NCT07504458, who can take part
Where in Romania
- Institutul Oncologic Prof. Dr. Ion ChiricutaCluj-Napoca, RomaniaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Quetzal Therapeutics
- Trial code
- NCT07504458EU 2025-524810-28-00
- Record updated
- 30 October 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: Participants having serious ongoing medical conditions or infections including uncontrolled infections, severe organ disease, or conditions that make study participation unsafe; 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; 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 who are pregnant, breastfeeding, or unwilling to use contraception.