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

> **NCT07504458** · PHASE3 · RECRUITING · sponsor: **Quetzal Therapeutics** · enrollment: 150 (estimated)

## Conditions studied

- 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

- **DRUG:** QTX-2101 + ATRA
- **DRUG:** IV arsenic trioxide (ATO) + ATRA

## Key facts

- **NCT ID:** NCT07504458
- **Lead sponsor:** Quetzal Therapeutics
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2026-04
- **Primary completion:** 2027-03
- **Final completion:** 2030-12
- **Target enrollment:** 150 (ESTIMATED)
- **Last updated:** 2026-04-16


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT07504458

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT07504458, "Pivotal Open-label Phase 3 Clinical Study of QTX-2101 in Adult Patients With Acute Promyelocytic Leukemia". Retrieved via AI Analytics 2026-06-24 from https://api.ai-analytics.org/clinical/NCT07504458. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*