drugset / Trial / NCT07504458

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

NCT07504458

Phase 3 Recruiting 150 enrolled Quetzal Therapeutics
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2026-06-08
Primary completion
2027-03
Completion
2030-12

Drugs

EvaluationDrugModalityDoseRoute
Subject arsenic trioxide Small molecule Oral
Background Tretinoin Small molecule Oral