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Acute Promyelocytic Leukemia (APL)Phase 3QUATRO-APLNCT07504458

Pivotal Open-label Phase 3 Clinical Study of QTX-2101 in Adult Patients With Acute Promyelocytic Leukemia

A Phase 3 study testing QTX-2101 + ATRA and IV arsenic trioxide (ATO) + ATRA in people with Acute Promyelocytic Leukemia (APL) and Acute Promyelocytic Leukaemia, run by Quetzal Therapeutics at 36 sites in 5 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 71 years
What is being tested?
QTX-2101 + ATRA and IV arsenic trioxide (ATO) + ATRA
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
36 sitesin 5 countries
Study dates
8 Jun 2026to Dec 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 71 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

36 sites in 5 countries. Contact the study team or a site near you to ask about taking part.

36 sites in 5 countries

United States18 sites, 18 recruiting

  • University of Michigan

    Ann Arbor, Michigan, 48109

    Quetzal Therapeutics Investigator, +13126800501, ClinicalTrials@QuetzalTx.com

    Quetzal Therapeutics Investigator, ClinicalTrials@QuetzalTx.com

    Recruiting

  • Augusta University Medical Center

    Augusta, Georgia, 30912

    Quetzal Therapeutics Investigator, +13126800501, ClinicalTrials@QuetzalTx.com

    Anand Jillella, MD

    Recruiting

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

    Quetzal Therapeutics Investigator, +13126800501, ClinicalTrials@QuetzalTx.com

    Quetzal Therapeutics Investigator, ClinicalTrials@QuetzalTx.com

    Recruiting

  • Johns Hopkins Kimmel Cancer Center

    Baltimore, Maryland, 21231

    Quetzal Therapeutics Investigator, +13126800501, ClinicalTrials@QuetzalTx.com

    Gabriel Ghiaur, MD

    Recruiting

  • University of Alabama at Birmingham (UAB)

    Birmingham, Alabama, 35233

    Quetzal Therapeutics Investigator, +13126800501, ClinicalTrials@QuetzalTx.com

    Quetzal Therapeutics Investigator, ClinicalTrials@QuetzalTx.com

    Recruiting

  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York, 14203

    Quetzal Therapeutics Investigator, +13126800501, ClinicalTrials@QuetzalTx.com

    Eunice Wang, MD

    Recruiting

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27514

    Quetzal Therapeutics Investigator, +13126800501, ClinicalTrials@QuetzalTx.com

    Joshua Zeidner, MD

    Recruiting

  • University of Virginia Health

    Charlottesville, Virginia, 22908

    Quetzal Therapeutics Investigator, +13126800501, ClinicalTrials@QuetzalTx.com

    Daniel Reed, MD

    Recruiting

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210

    Quetzal Therapeutics Investigator, +13126800501, ClinicalTrials@QuetzalTx.com

    Uma Borate, MD

    Recruiting

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

    Quetzal Therapeutics Investigator, +13126800501, ClinicalTrials@QuetzalTx.com

    Vinod Pullarkat, MD

    Recruiting

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

    Quetzal Therapeutics Investigator, +13126800501, ClinicalTrials@QuetzalTx.com

    Farhad Ravandi, MD

    Recruiting

  • University of California, Irvine

    Irvine, California, 92612

    Quetzal Therapeutics Investigator, +13126800501, ClinicalTrials@QuetzalTx.com

    Kiran Naqvi, MD

    Recruiting

  • University of Kentucky Markey Cancer Center

    Lexington, Kentucky, 40536

    Quetzal Therapeutics Investigator, +13126800501, ClinicalTrials@QuetzalTx.com

    Quetzal Therapeutics Investigator, ClinicalTrials@QuetzalTx.com

    Recruiting

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

    Quetzal Therapeutics Investigator, +13126800501, ClinicalTrials@QuetzalTx.com

    Eric Tam, MD

    Recruiting

  • Sarah Cannon Research Institute at TriStar Centennial Medical Center

    Nashville, Tennessee, 37203

    Quetzal Therapeutics Investigator, +13126800501, ClinicalTrials@QuetzalTx.com

    Steven Strickland, MD

    Recruiting

  • UCI Health - UCI Medical Center

    Orange, California, 92868

    Quetzal Therapeutics Investigator, +13126800501, ClinicalTrials@QuetzalTx.com

    Kiran Naqvi, MD

    Recruiting

  • Stanford University School of Medicine

    Stanford, California, 94305

    Quetzal Therapeutics Investigator, +13126800501, ClinicalTrials@QuetzalTx.com

    Tian Yi Zhang, MD

    Recruiting

  • Montefiore Medical Center

    The Bronx, New York, 10467

    Quetzal Therapeutics Investigator, +13126800501, ClinicalTrials@QuetzalTx.com

    Aditi Shastri, MD

    Recruiting

Other trials in United States

Spain8 sites, 8 recruiting

  • Institut Català d'Oncologia (ICO) Badalona - Hospital Universitari Germans Trias i Pujol

    Badalona, 08916

    Quetzal Therapeutics Investigator, +13126800501, ClinicalTrials@QuetzalTx.com

    Susana Vives Polo, MD

    Recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

    Quetzal Therapeutics Investigator, +13126800501, ClinicalTrials@QuetzalTx.com

    Olga Salamero Garcia, MD

    Recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041

    Quetzal Therapeutics Investigator, +13126800501, ClinicalTrials@QuetzalTx.com

    Ana Garrido Diaz, MD

    Recruiting

  • Hospital Universitario San Pedro de Alcántara

    Cáceres, 10003

    Quetzal Therapeutics Investigator, +13126800501, ClinicalTrials@QuetzalTx.com

    Juan Miguel Bergua Burgúes, MD

    Recruiting

  • Hospital Regional Universitario de Málaga

    Málaga, 29010

    Quetzal Therapeutics Investigator, +13126800501, ClinicalTrials@QuetzalTx.com

    Alejandro Contento Gonzalo, MD

    Recruiting

  • Hospital Universitario Central de Asturias

    Oviedo, 33011

    Quetzal Therapeutics Investigator, +13126800501, ClinicalTrials@QuetzalTx.com

    Maria Teresa Bernal Castillo, MD

    Recruiting

  • Hospital Universitari Son Espases

    Palma de Mallorca, Balearic Islands, 07120

    Quetzal Therapeutics Investigator, +13126800501, ClinicalTrials@QuetzalTx.com

    Andres Novo Garcia, MD

    Recruiting

  • Hospital Universitario y Politécnico La Fe

    Valencia, 46026

    Quetzal Therapeutics Investigator, +13126800501, ClinicalTrials@QuetzalTx.com

    Pau Montesinos Fernández, MD

    Recruiting

Other trials in Spain

France7 sites, 7 recruiting

  • Centre Hospitalier Universitaire (CHU) de Bordeaux - Groupe Hospitalier Sud, Centre François Magendie

    Bordeaux, 33000

    Quetzal Therapeutics Investigator, +13126800501, ClinicalTrials@QuetzalTx.com

    Pierre-Yves Dumas, MD

    Recruiting

  • CHU Grenoble Alpes - Hôpital Michallon

    La Tronche, 38700

    Quetzal Therapeutics Investigator, +13126800501, ClinicalTrials@QuetzalTx.com

    Martin Carre, MD

    Recruiting

  • Centre Hospitalier Régional Universitaire (CHRU) de Nancy - Hôpitaux de Brabois

    Nancy, 54500

    Quetzal Therapeutics Investigator, +13126800501, ClinicalTrials@QuetzalTx.com

    Caroline Bonmati, MD

    Recruiting

  • Centre Hospitalier Universitaire (CHU) de Nice - Hôpital de l'Archet 1

    Nice, 06202

    Quetzal Therapeutics Investigator, +13126800501, ClinicalTrials@QuetzalTx.com

    Thomas Cluzeau, MD

    Recruiting

  • Assistance Publique - Hôpitaux de Paris (AP-HP), Hôpital Saint-Louis

    Paris, 75010

    Quetzal Therapeutics Investigator, +13126800501, ClinicalTrials@QuetzalTx.com

    Pierre Fenaux, MD

    Recruiting

  • Centre Hospitalier Universitaire (CHU) de Saint-Étienne - Hôpital Nord

    Saint-Priest-en-Jarez, 42270

    Quetzal Therapeutics Investigator, +13126800501, ClinicalTrials@QuetzalTx.com

    Emmanuelle Tavernier-Tardy, MD

    Recruiting

  • Hôpitaux Universitaires de Strasbourg

    Strasbourg, 67000

    Quetzal Therapeutics Investigator, +13126800501, ClinicalTrials@QuetzalTx.com

    Marie-Pierre Ledoux, MD

    Recruiting

Other trials in France

Italy2 sites, 2 recruiting

  • Hospital Tor Vergata Roma

    Roma, 00133

    Quetzal Therapeutics Investigator, +13126800501, ClinicalTrials@QuetzalTx.com

    Maria Teresa Voso, MD

    Recruiting

  • Azienda ULSS 8 Berica - Ospedale San Bortolo

    Vicenza, 36100

    Quetzal Therapeutics Investigator, +13126800501, ClinicalTrials@QuetzalTx.com

    Maria Cristina Miggiano, MD

    Recruiting

Other trials in Italy

Romania1 site, 1 recruiting

  • Institutul Oncologic "Prof. Dr. Ion Chiricuță"

    Cluj-Napoca, 400015

    Quetzal Therapeutics Investigator, +13126800501, ClinicalTrials@QuetzalTx.com

    Minhea Zdrenghea, MD

    Recruiting

Other trials in Romania

About this study

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

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.

Being tested
QTX-2101 + ATRA, IV arsenic trioxide (ATO) + ATRA
Keywords
APL, Acute Promyelocytic Leukemia, Hematology, Oncology, Leukemia, Hematologic Disease, Drug Therapy, Therapeutics, Blood Cancer, Heme Malignancy, Arsenic, low-risk APL, standard-risk APL
Medical subject headings
Leukemia, Promyelocytic, Acute, Neoplasms, Leukemia, Hematologic Diseases, Hematologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QTX-2101 + ATRADrug

    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) + ATRADrug

    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.

Study groups in NCT07504458
Study groupRoleWhat they receive
QTX-2101ExperimentalQTX-2101 (oral arsenic trioxide; ATO) All-trans-retinoic-acid (ATRA; oral)
Receives: Drug: QTX-2101 + ATRA
IV ATOActive comparatorIV Arsenic Trioxide (ATO) All-trans-retinoic-acid (ATRA; oral)
Receives: Drug: IV arsenic trioxide (ATO) + ATRA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum observed plasma (concentration (Cmax) of QTX-2101 for ASIII

    Cmax is defined as the maximum observed plasma concentration following administration of [investigational product], determined from plasma concentration-time data.

    Measured: Up to 1 cycle of consolidation therapy (each cycle is 8 weeks)

  2. Molecular complete remission (molecular CR) rate

    mCR is defined as the absence of detectable PML-RARA fusion transcript in bone marrow assessed by a validated quantitative reverse transcription polymerase chain reaction (RT-qPCR) assay .The mCR rate is defined as the proportion of participants achieving molecular remission at the specified assessment time point following induction and consolidation therapy.

    Measured: Up to 60 days of induction and 3 8-week cycles of consolidation treatment

Secondary outcomes (8)

  1. To characterize the safety and tolerability of QTX-2101/ATRA and IV ATO/ATRA

    Treatment emergent adverse events

    Measured: Throughout approximately 10 months of study treatment

  2. To characterize the event-free survival (EFS) of QTX-2101/ATRA

    Measured: Assessed for up to 3 years after the first dose of treatment, or until treatment failure (disease progression), death, or study completion, whichever occurs first

  3. Area under the plasma concentration-time curve (AUC) of QTX-2101 for ASIII

    AUC is defined as the area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC₀-t) and/or extrapolated to infinity (AUC₀-∞), calculated using noncompartmental methods.

    Measured: Up to 10 months

  4. To complete a model-based concentration QT relationship evaluation

    Time-matched difference in change from baseline in QTcF interval between active treatment and placebo, derived from triplicate 12-lead ECGs at each post-dose time point

    Measured: Up to 10 months

  5. EORTC QLQ-C30 domain unit of measure and measurement tool

    Change from baseline in EORTC QLQ-C30 global health status (0-100 scale)

    Measured: Up to 10 months

  6. EQ-5D-5L domain unit of measure and measurement tool

    Change from baseline in EQ-5D-5L index score (0-100)

    Measured: Up to 10 months

  7. Overall Survival

    OS is defined as the time from randomization to death from any cause. Participants who are alive at the time of analysis will be censored at the date last known to be alive.

    Measured: Assessed for up to 3 years after the first dose of treatment, or until treatment failure (disease progression), death, or study completion, whichever occurs first

  8. Event Free Survival (EFS)

    EFS is defined as the time from randomization to the first occurrence of any of the following events: failure to achieve hematologic or molecular remission, relapse (hematologic or molecular), or death from any cause. Participants without an event at the time of analysis will be censored at the date of last adequate disease assessment.

    Measured: Assessed for up to 3 years after the first dose of treatment, or until treatment failure (disease progression), death, or study completion, whichever occurs first

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2026
  2. Study start8 Jun 2026
  3. Primary completionMar 2027 (estimated)
  4. Study completionDec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07504458
Sponsor's protocol ID
QTX-2101-301
Other IDs
2025-524810-28-00, 2025
Acronym
QUATRO-APL
Status last verified
Jun 2026
First submitted
16 Mar 2026
Last updated
30 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing QTX-2101 + ATRA and IV arsenic trioxide (ATO) + ATRA in people with Acute Promyelocytic Leukemia (APL) and Acute Promyelocytic Leukaemia, run by Quetzal Therapeutics at 36 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in United States, Spain, France, Italy, Romania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum observed plasma (concentration (Cmax) of QTX-2101 for ASIII (time frame: Up to 1 cycle of consolidation therapy (each cycle is 8 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07504458.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.

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