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

Quetzal Therapeutics

Status and phase: Enrolling; Phase 3

Conditions: Acute Promyelocytic Leukemia With PML-RARA; Acute Promyelocytic Leukemia; Acute Promyelocytic Leukemia (APL); Acute Promyelocytic Leukemia With t(15;17)(q24.1;q21.2); PML-RARA; Acute Promyelocytic Leukaemia

Treatments: Drug: IV arsenic trioxide (ATO) + ATRA; Drug: QTX-2101 + ATRA

Study type: Interventional

Funder types: Industry

Identifiers

NCT07504458

QTX-2101-301

2025-524810-28-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 71 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. Informed Consent
2. Participants must be between 18 and under 71 years of age
3. Participants must have a confirmed diagnosis of APL proven by standard genetic testing (t(15;17) or PML-RARA)
4. Participants must be classified as low- or intermediate-risk APL
5. Participants must be willing and able to comply with the scheduled study visits, treatment plans, laboratory tests, contraception guidance, and other procedures

Exclusion Criteria

1. Participants who have significant heart rhythm problems including long QT syndrome, serious arrhythmias, very slow heart rate, or prolonged QTc on ECG
2. Participants who have central nervous system leukemia
3. Participants having serious ongoing medical conditions or infections including uncontrolled infections, severe organ disease, or conditions that make study participation unsafe
4. Participants who are pregnant, breastfeeding, or unwilling to use contraception
5. 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

QTX-2101

Experimental group

Description:

QTX-2101 (oral arsenic trioxide; ATO) All-trans-retinoic-acid (ATRA; oral)

Treatment:

Drug: QTX-2101 + ATRA

IV ATO

Active Comparator group

Description:

IV Arsenic Trioxide (ATO) All-trans-retinoic-acid (ATRA; oral)

Treatment:

Drug: IV arsenic trioxide (ATO) + ATRA