Pivotal Open-label Phase 3 Clinical Study of QTX-2101 in Adult Patients With Acute Promyelocytic Leukemia
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
ClinicalTrials.gov ID
NCT07504458
Lead Sponsor
Quetzal TherapeuticsINDUSTRY
Overall Status
Recruiting
Study Type
Interventional
Phase
Phase 3
Enrollment
150Estimated
Last Update Posted
Sep 10, 2026Actual
Start Date
Jun 8, 2026Actual
Primary Completion Date
Mar 2027Estimated
Completion Date
Dec 2030Estimated
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
Brief 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.
Acute Promyelocytic Leukemia (APL)
Acute Promyelocytic Leukaemia
Acute Promyelocytic Leukemia With PML-RARA
Acute Promyelocytic Leukemia With t(15;17)(q24.1;q21.2); PML-RARA
Acute Promyelocytic Leukemia
QTX-2101 + ATRA
IV arsenic trioxide (ATO) + ATRA
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
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