Back to Trials
NCT07504458PHASE3Recruiting

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

Quetzal Therapeutics

Start Date

6/8/2026

Completion Date

12/1/2030

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.

Eligibility Criteria

Age Range: 18 years to 71 years

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

Interventions

DRUG

QTX-2101 + ATRA

DRUG

IV arsenic trioxide (ATO) + ATRA

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Acute Promyelocytic Leukemia (APL)Acute Promyelocytic LeukaemiaAcute Promyelocytic Leukemia With PML-RARAAcute Promyelocytic Leukemia With t(15;17)(q24.1;q21.2); PML-RARAAcute Promyelocytic Leukemia

Locations

Quetzal Site 1

Duarte, California 91010

United States

Quetzal Site 7

Los Angeles, California 90033

United States

Quetzal Site 5

Stanford, California 94305

United States

Quetzal Site 13

Augusta, Georgia 30912

United States

Quetzal Site 4

Buffalo, New York 14203

United States

Quetzal Site 2

The Bronx, New York 10467

United States

Quetzal Site 8

Columbus, Ohio 43210

United States

Quetzal Site 12

Nashville, Tennessee 37203

United States

Quetzal Site 6

Houston, Texas 77030

United States

Quetzal Site 3

Charlottesville, Virginia 22908

United States

Quetzal Site 14

Paris, 75010

France

Quetzal Site 11

Palma de Mallorca, Balearic Islands 07120

Spain

Quetzal Site 10

Cáceres, 10003

Spain

Quetzal Site 9

Valencia, 46026

Spain