RecruitingPhase 3NCT07504458

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

Sponsor

Quetzal Therapeutics

Enrollment

150 participants

Start Date

Jun 8, 2026

Study Type

INTERVENTIONAL

Conditions

Acute promyelocytic leukaemia Acute Promyelocytic Leukemia Acute Promyelocytic Leukemia With PML-RARA Acute Promyelocytic Leukemia (APL)Acute Promyelocytic Leukemia With t(15;17)(q24.1;q21.2); PML-RARA

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.

Eligibility

Min Age: 18 YearsMax Age: 71 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called IV arsenic trioxide (ATO) + ATRA and a drug called QTX-2101 + ATRA for people with acute promyelocytic leukemia, acute promyelocytic leukemia (apl), and other related conditions. The study is currently recruiting participants at 12 locations. People eligible for this study include aged 18 Years to 71 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGQTX-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.

DRUGIV 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.

Locations(14)

Quetzal Site 1

Duarte, California, United States

Quetzal Site 7

Los Angeles, California, United States

Quetzal Site 5

Stanford, California, United States

Quetzal Site 13

Augusta, Georgia, United States

Quetzal Site 4

Buffalo, New York, United States

Quetzal Site 2

The Bronx, New York, United States

Quetzal Site 8

Columbus, Ohio, United States

Quetzal Site 12

Nashville, Tennessee, United States

Quetzal Site 6

Houston, Texas, United States

Quetzal Site 3

Charlottesville, Virginia, United States

Quetzal Site 14

Paris, France

Quetzal Site 11

Palma de Mallorca, Balearic Islands, Spain

Quetzal Site 10

Cáceres, Spain

Quetzal Site 9

Valencia, Spain

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NCT07504458

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