Clinical Trial

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

Name: Pivotal Open-label Phase 3 Clinical Study of QTX-2101 in Adult Patients With Acute Promyelocytic Leukemia — clinical trial record (NCT07504458)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Study acronym: QUATRO-APL

Recruiting Phase 3

View on ClinicalTrials.gov →

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.

Protocol Amendment History 1 change

notable Trial sites expanded: 7 -> 11 locations 2026-07-11

Trial Details

NCT Number	NCT07504458
Lead 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
Enrollment	150 participants
Start Date	2026-06-08
Primary Completion	2027-03 (estimated)
Study Completion	2030-12 (estimated)
Updated on ClinicalTrials.gov	2026-08-13