Clinical trial · Interventional
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
NCT07504458CI-TRIAL-00125155QUATRO-APLrecruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Promyelocytic Leukaemia | Acute Promyelocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Acute Promyelocytic Leukemia (APL) | Acute Promyelocytic Leukemia | ONTOLOGY_EXACT | 0.85 |
| Acute Promyelocytic Leukemia With PML-RARA | Acute Promyelocytic Leukemia with t(15;17)(q24.1;q21.2); PML-RARA | CURATED_BROADER | 0.80 |
| Acute Promyelocytic Leukemia With t(15;17)(q24.1;q21.2); PML-RARA | Acute Promyelocytic Leukemia with t(15;17)(q24.1;q21.2); PML-RARA | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IV arsenic trioxide (ATO) + ATRA | Drug | — | UNRESOLVED |
| QTX-2101 + ATRA | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- QTX-2101
- description
- QTX-2101 (oral arsenic trioxide; ATO) All-trans-retinoic-acid (ATRA; oral)
- interventionNames
- Drug: QTX-2101 + ATRA
- type
- ACTIVE_COMPARATOR
- label
- IV ATO
- description
- IV Arsenic Trioxide (ATO) All-trans-retinoic-acid (ATRA; oral)
- interventionNames
- Drug: IV arsenic trioxide (ATO) + ATRA
Primary outcomes (2)
- measure
- Maximum observed plasma (concentration (Cmax) of QTX-2101 for ASIII
- timeFrame
- Up to 1 cycle of consolidation therapy (each cycle is 8 weeks)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 71 Years
Show eligibility criteria text
Inclusion Criteria: 1. Informed Consent 2. Participants must be between 18 and under 71 years of age 3. Participants must have a confirmed diagnosis of APL proven by standard genetic testing (t(15;17) or PML-RARA) 4. Participants must be classified as low- or intermediate-risk APL 5. Participants must be willing and able to comply with the scheduled study visits, treatment plans, laboratory tests, contraception guidance, and other procedures Exclusion Criteria 1. Participants who have significant heart rhythm problems including long QT syndrome, serious arrhythmias, very slow heart rate, or prolonged QTc on ECG 2. Participants who have central nervous system leukemia 3. Participants having serious ongoing medical conditions or infections including uncontrolled infections, severe organ disease, or conditions that make study participation unsafe 4. Participants who are pregnant, breastfeeding, or unwilling to use contraception 5. Participants who are unable to safely take study medication, including severe neuropathy, inability to swallow oral medication, malabsorption issues, or known allergy to ATO or ATRA
References
Publications (0)
Data not yet available
No reference posted for this study.