NCT07504458

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

A Pivotal Open-label Phase 3 Clinical Study Evaluating the Efficacy and Safety of QTX-2101 in Combination With All-trans Retinoic Acid in Newly Diagnosed, Low-risk Acute Promyelocytic Leukemia

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Quetzal Therapeutics · Industry
• Sex: All
• Age: 18 Years – 71 Years
• Healthy volunteers: Not accepted

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.

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

Type	Name	Description
DRUG	QTX-2101 + ATRA	The experimental regimen consists of IV ATO administered once daily during induction, given continuously, for up to a maximum of 60 days. During consolidation, QTX-2101 is administered once daily, per investigator's protocol. ATRA is administered orally in two divided daily doses during induction, given continuously until bone marrow remission (not exceeding 60 days). During consolidation, ATRA is taken orally in two divided daily doses following a 2-weeks-on / 2-weeks-off schedule within each 8-week cycle.
DRUG	IV arsenic trioxide (ATO) + ATRA	The comparator regimen consists of IV ATO administered once daily during induction, given continuously, for up to a maximum of 60 days. During consolidation, IV ATO is administered once daily, per investigator's protocol. ATRA is administered orally in two divided daily doses during induction, given continuously until bone marrow remission (not exceeding 60 days). During consolidation, ATRA is taken orally in two divided daily doses following a 2-weeks-on / 2-weeks-off schedule within each 8-week cycle.

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-03-01
• Completion: 2030-12-01
• First posted: 2026-03-31
• Last updated: 2026-04-16

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study