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OncoMatch/Clinical Trials/NCT07504458

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

Is NCT07504458 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including QTX-2101 + ATRA and IV arsenic trioxide (ATO) + ATRA for acute promyelocytic leukemia (apl).

Phase 3RecruitingQuetzal TherapeuticsNCT07504458Data as of May 2026

Treatment: QTX-2101 + ATRA · IV arsenic trioxide (ATO) + ATRAThis 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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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Biomarker criteria

Required: RARA PML-RARA fusion

confirmed diagnosis of APL proven by standard genetic testing (t(15;17) or PML-RARA)

Lab requirements

Cardiac function

no significant heart rhythm problems including long qt syndrome, serious arrhythmias, very slow heart rate, or prolonged qtc on ecg

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Quetzal Site 1 · Duarte, California
  • Quetzal Site 2 · The Bronx, New York

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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