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

ClinicalTrials.gov ID: NCT07504458

Public ClinicalTrials.gov record NCT07504458. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Oct 28, 2026, 9:26 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT07504458
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: Quetzal Therapeutics; Industry
Enrollment: 150 participants

Conditions and interventions

Conditions

Interventions

QTX-2101 + ATRA Drug
IV arsenic trioxide (ATO) + ATRA Drug

Drug

Eligibility (public fields only)

Age range: 18 Years to 71 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jun 8, 2026 (Actual)
Primary completion: Mar 2027 (Estimated)
Completion: Dec 2030 (Estimated)
Last update posted: Oct 20, 2026

2026 – 2030

United States locations

U.S. sites: 18
U.S. states: 12
U.S. cities: 17

Facility	City	State	ZIP	Site status
Quetzal Site 16	Birmingham	Alabama	35233	Recruiting
Quetzal Site 1	Duarte	California	91010	Recruiting
Quetzal Site 31	Irvine	California	92612	Recruiting
Quetzal Site 7	Los Angeles	California	90033	Recruiting
Quetzal Site 32	Orange	California	92868	Recruiting
Quetzal Site 5	Stanford	California	94305	Recruiting
Quetzal Site 13	Augusta	Georgia	30912	Recruiting
Quetzal Site 18	Lexington	Kentucky	40536	Recruiting
Quetzal Site 23	Baltimore	Maryland	21201	Recruiting
Quetzal Site 34	Baltimore	Maryland	21231	Recruiting
Quetzal Site 22	Ann Arbor	Michigan	48109	Recruiting
Quetzal Site 4	Buffalo	New York	14203	Recruiting
Quetzal Site 2	The Bronx	New York	10467	Recruiting
Quetzal Site 27	Chapel Hill	North Carolina	27514	Recruiting
Quetzal Site 8	Columbus	Ohio	43210	Recruiting
Quetzal Site 12	Nashville	Tennessee	37203	Recruiting
Quetzal Site 6	Houston	Texas	77030	Recruiting
Quetzal Site 3	Charlottesville	Virginia	22908	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 17 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07504458, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Oct 20, 2026 · Synced Oct 28, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT07504458 live on ClinicalTrials.gov.

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