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NCT Number: NCT07504458

Pivotal Open-label Phase 3 Clinical Study of QTX-2101 in Adult Patients With 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.

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Key information

Conditions

Acute Promyelocytic Leukemia (APL) Acute Promyelocytic Leukaemia Acute Promyelocytic Leukemia Acute Promyelocytic Leukemia With PML-RARA Acute Promyelocytic Leukemia With t(15;17)(q24.1;q21.2); PML-RARA Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Leukemia, Promyelocytic, Acute Neoplasms Neoplasms by Histologic Type Neoplasms by Site

Age range

18 year–71 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Quetzal Site 11, Palma de Mallorca, Balearic Islands, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

QTX-2101 + ATRA

Drug

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

Drug

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.

Primary outcomes

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

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

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

  2. Molecular complete remission (molecular CR) rate

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

    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.

Secondary outcomes

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

    Time frame: Throughout approximately 10 months of study treatment

    Treatment emergent adverse events

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

    Time frame: 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

    Time frame: Up to 10 months

    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.

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

    Time frame: Up to 10 months

    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

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

    Time frame: Up to 10 months

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

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

    Time frame: Up to 10 months

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

  7. Overall Survival

    Time frame: 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

    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.

  8. Event Free Survival (EFS)

    Time frame: 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

    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.

Sponsors and collaborators

Lead sponsor

Quetzal Therapeutics

Industry

Registry information

Official study 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

Acronym: QUATRO-APL

Important dates

Study start
2026
Primary completion
2027
Study completion
2030
First posted
Mar 31, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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