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
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 71
Healthy Volunteers: f
View:
• 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
Locations
United States
California
Quetzal Site 1
RECRUITING
Duarte
New York
Quetzal Site 4
RECRUITING
Buffalo
Quetzal Site 2
RECRUITING
The Bronx
Virginia
Quetzal Site 3
RECRUITING
Charlottesville
Time Frame
Start Date: 2026-04
Estimated Completion Date: 2030-12
Participants
Target number of participants: 150
Treatments
Experimental: QTX-2101
QTX-2101 (oral arsenic trioxide; ATO) All-trans-retinoic-acid (ATRA; oral)
Active_comparator: IV ATO
IV Arsenic Trioxide (ATO) All-trans-retinoic-acid (ATRA; oral)
Related Therapeutic Areas
Sponsors
Leads: Quetzal Therapeutics