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 (23) 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
Alabama
Quetzal Site 16
RECRUITING
Birmingham
California
Quetzal Site 1
RECRUITING
Duarte
Quetzal Site 7
RECRUITING
Los Angeles
Quetzal Site 5
RECRUITING
Stanford
Georgia
Quetzal Site 13
RECRUITING
Augusta
Kentucky
Quetzal Site 18
RECRUITING
Lexington
Maryland
Quetzal Site 23
RECRUITING
Baltimore
Michigan
Quetzal Site 22
RECRUITING
Ann Arbor
New York
Quetzal Site 4
RECRUITING
Buffalo
Quetzal Site 2
RECRUITING
The Bronx
Ohio
Quetzal Site 8
RECRUITING
Columbus
Tennessee
Quetzal Site 12
RECRUITING
Nashville
Texas
Quetzal Site 6
RECRUITING
Houston
Virginia
Quetzal Site 3
RECRUITING
Charlottesville
Other Locations
France
Quetzal Site 17
RECRUITING
Bordeaux
Quetzal Site 14
RECRUITING
Paris
Romania
Quetzal Site 19
RECRUITING
Cluj-napoca
Spain
Quetzal Site 21
RECRUITING
Badalona
Quetzal Site 15
RECRUITING
Barcelona
Quetzal Site 10
RECRUITING
Cáceres
Quetzal Site 20
RECRUITING
Oviedo
Quetzal Site 11
RECRUITING
Palma De Mallorca
Quetzal Site 9
RECRUITING
Valencia
Time Frame
Start Date: 2026-06-08
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