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

RecruitingPhase 3

Sponsor: Quetzal Therapeutics

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

Interventions: QTX-2101 + ATRA, IV arsenic trioxide (ATO) + ATRA

Countries: United States, France, Spain

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 overview

Sex: ALL

Age: 18 Years to 71 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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

Locations (18)

Birmingham, Alabama, United States
Duarte, California, United States
Los Angeles, California, United States
Stanford, California, United States
Augusta, Georgia, United States
Lexington, Kentucky, United States
Buffalo, New York, United States
The Bronx, New York, United States
Columbus, Ohio, United States
Nashville, Tennessee, United States
Houston, Texas, United States
Charlottesville, Virginia, United States
Bordeaux, France
Paris, France
Palma de Mallorca, Balearic Islands, Spain
Barcelona, Spain
Cáceres, Spain
Valencia, Spain