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Pivotal Open-label Phase 3 Clinical Study of QTX-2101 in Adult Patients With Acute Promyelocytic Leukemia
Sponsor: Quetzal Therapeutics
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.
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
Key Details
Gender
All
Age Range
18 Years - 71 Years
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2026-06-08
Completion Date
2030-12
Last Updated
2026-10-30
Healthy Volunteers
No
Conditions
Interventions
QTX-2101 + ATRA
The experimental regimen consists of IV ATO administered once daily during induction, given continuously, for up to a maximum of 60 days. During consolidation, QTX-2101 is administered once daily, per investigator's protocol. ATRA is administered orally in two divided daily doses during induction, given continuously until bone marrow remission (not exceeding 60 days). During consolidation, ATRA is taken orally in two divided daily doses following a 2-weeks-on / 2-weeks-off schedule within each 8-week cycle.
IV arsenic trioxide (ATO) + ATRA
The comparator regimen consists of IV ATO administered once daily during induction, given continuously, for up to a maximum of 60 days. During consolidation, IV ATO is administered once daily, per investigator's protocol. ATRA is administered orally in two divided daily doses during induction, given continuously until bone marrow remission (not exceeding 60 days). During consolidation, ATRA is taken orally in two divided daily doses following a 2-weeks-on / 2-weeks-off schedule within each 8-week cycle.
Locations (36)
University of Alabama at Birmingham (UAB)
Birmingham, Alabama, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
University of California, Irvine
Irvine, California, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
UCI Health - UCI Medical Center
Orange, California, United States
Stanford University School of Medicine
Stanford, California, United States
Augusta University Medical Center
Augusta, Georgia, United States
University of Kentucky Markey Cancer Center
Lexington, Kentucky, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Johns Hopkins Kimmel Cancer Center
Baltimore, Maryland, United States
University of Michigan
Ann Arbor, Michigan, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Sarah Cannon Research Institute at TriStar Centennial Medical Center
Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
University of Virginia Health
Charlottesville, Virginia, United States
Centre Hospitalier Universitaire (CHU) de Bordeaux - Groupe Hospitalier Sud, Centre François Magendie
Bordeaux, France
CHU Grenoble Alpes - Hôpital Michallon
La Tronche, France
Centre Hospitalier Régional Universitaire (CHRU) de Nancy - Hôpitaux de Brabois
Nancy, France
Centre Hospitalier Universitaire (CHU) de Nice - Hôpital de l'Archet 1
Nice, France
Assistance Publique - Hôpitaux de Paris (AP-HP), Hôpital Saint-Louis
Paris, France
Centre Hospitalier Universitaire (CHU) de Saint-Étienne - Hôpital Nord
Saint-Priest-en-Jarez, France
Hôpitaux Universitaires de Strasbourg
Strasbourg, France
Hospital Tor Vergata Roma
Roma, Italy
Azienda ULSS 8 Berica - Ospedale San Bortolo
Vicenza, Italy
Institutul Oncologic "Prof. Dr. Ion Chiricuță"
Cluj-Napoca, Romania
Hospital Universitari Son Espases
Palma de Mallorca, Balearic Islands, Spain
Institut Català d'Oncologia (ICO) Badalona - Hospital Universitari Germans Trias i Pujol
Badalona, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital Universitario San Pedro de Alcántara
Cáceres, Spain
Hospital Regional Universitario de Málaga
Málaga, Spain
Hospital Universitario Central de Asturias
Oviedo, Spain
Hospital Universitario y Politécnico La Fe
Valencia, Spain