NCT07504458RecruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 30 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 16 Mar 2026
- Start date
- 8 Jun 2026
- Primary completion date
- Mar 2027
- Lead sponsor
- Quetzal Therapeutics
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT07504458
- EU CT number
- 2025-524810-28-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 150
- From 8 Jun 2026 to the primary completion date, Mar 2027
- 36 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Lab values
- Participants who have significant heart rhythm problems including long QT syndrome, serious arrhythmias, very slow heart rate, or prolonged QTc on ECG
Other
- Participants who have central nervous system leukemia
- Participants who are pregnant, breastfeeding, or unwilling to use contraception
Who the study is looking for
- 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
Age in the registry: 18 years to 71 years · Sex: All · Does not accept healthy volunteers
Sites (36)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institut Catala d'Oncologia (ICO) Badalona - Hospital Universitari Germans Trias i Pujol Coordinator of this site? Confirm its status | Badalona | Spain | Recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario San Pedro de Alcántara Coordinator of this site? Confirm its status | Cáceres | Spain | Recruiting |
| Hospital Regional Universitario de Malaga Coordinator of this site? Confirm its status | Málaga | Spain | Recruiting |
| Hospital Universitario Central De Asturias Coordinator of this site? Confirm its status | Oviedo | Spain | Recruiting |
| Hospital Universitari Son Espases Coordinator of this site? Confirm its status | Palma de Mallorca | Spain | Recruiting |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Centre Hospitalier Universitaire (CHU) de Bordeaux - Groupe Hospitalier Sud, Centre François Magendie Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| CHU Grenoble Alpes - Hôpital Michallon Coordinator of this site? Confirm its status | La Tronche | France | Recruiting |
| Centre Hospitalier Régional Universitaire (CHRU) de Nancy - Hôpitaux de Brabois Coordinator of this site? Confirm its status | Nancy | France | Recruiting |
| Centre Hospitalier Universitaire (CHU) de Nice - Hôpital de l'Archet 1 Coordinator of this site? Confirm its status | Nice | France | Recruiting |
| Assistance Publique - Hôpitaux de Paris (AP-HP), Hôpital Saint-Louis Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Centre Hospitalier Universitaire (CHU) de Saint-Étienne - Hôpital Nord Coordinator of this site? Confirm its status | Saint-Priest-en-Jarez | France | Recruiting |
| Hopitaux Universitaires de Strasbourg Coordinator of this site? Confirm its status | Strasbourg | France | Recruiting |
| Hospital Tor Vergata Roma Coordinator of this site? Confirm its status | Roma | Italy | Recruiting |
| Azienda ULSS 8 "Berica" - Ospedale San Bortolo Coordinator of this site? Confirm its status | Vicenza | Italy | Recruiting |
| Institutul Oncologic Prof. Dr. Ion Chiricuta Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Recruiting |
| University of Michigan Coordinator of this site? Confirm its status | Ann Arbor | United States | Recruiting |
| Augusta University Medical Center Coordinator of this site? Confirm its status | Augusta | United States | Recruiting |
| Johns Hopkins Kimmel Cancer Center Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| University of Maryland Medical Center Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| University of Alabama at Birmingham (UAB) Coordinator of this site? Confirm its status | Birmingham | United States | Recruiting |
| Roswell Park Comprehensive Cancer Center Coordinator of this site? Confirm its status | Buffalo | United States | Recruiting |
| University of North Carolina at Chapel Hill Coordinator of this site? Confirm its status | Chapel Hill | United States | Recruiting |
| University of Virginia Health Coordinator of this site? Confirm its status | Charlottesville | United States | Recruiting |
| The Ohio State University -Wexner Medical Center Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| City of Hope Comprehensive Cancer Center Coordinator of this site? Confirm its status | Duarte | United States | Recruiting |
| The University of Texas MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| University of California, Irvine Coordinator of this site? Confirm its status | Irvine | United States | Recruiting |
| University of Kentucky/Markey Cancer Center Coordinator of this site? Confirm its status | Lexington | United States | Recruiting |
| USC / Norris Comprehensive Cancer Center Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Sarah Cannon Research Institute at TriStar Centennial Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| UCI Health - UCI Medical Center Coordinator of this site? Confirm its status | Orange | United States | Recruiting |
| Stanford University School of Medicine Coordinator of this site? Confirm its status | Stanford | United States | Recruiting |
| Montefiore Medical Center Coordinator of this site? Confirm its status | The Bronx | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.