Recruiting NCT07504458
Pivotal Open-label Phase 3 Clinical Study of QTX-2101 in Adult Patients With Acute Promyelocytic Leukemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: QTX-2101 + ATRA, IV arsenic trioxide (ATO) + ATRA.
- Who it may be relevant to
- Registry 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. Basic parameters: 18 years — 71 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, France, Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- 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 - 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-wee
Primary outcome measures
- Maximum observed plasma (concentration (Cmax) of QTX-2101 for ASIII [Time frame: Up to 1 cycle of consolidation therapy (each cycle is 8 weeks)]
- Molecular complete remission (molecular CR) rate [Time frame: Up to 60 days of induction and 3 8-week cycles of consolidation treatment]
Secondary outcome measures (8)
- To characterize the safety and tolerability of QTX-2101/ATRA and IV ATO/ATRA [Time frame: Throughout approximately 10 months of study treatment]
- To characterize the event-free survival (EFS) of QTX-2101/ATRA [Time frame: Assessed for up to 3 years after the first dose of treatment, or until treatment failure (disease progression), death, or study completion, whichever occurs first]
- Area under the plasma concentration-time curve (AUC) of QTX-2101 for ASIII [Time frame: Up to 10 months]
- To complete a model-based concentration QT relationship evaluation [Time frame: Up to 10 months]
- EORTC QLQ-C30 domain unit of measure and measurement tool [Time frame: Up to 10 months]
- EQ-5D-5L domain unit of measure and measurement tool [Time frame: Up to 10 months]
- Overall Survival [Time frame: Assessed for up to 3 years after the first dose of treatment, or until treatment failure (disease progression), death, or study completion, whichever occurs first]
- Event Free Survival (EFS) [Time frame: Assessed for up to 3 years after the first dose of treatment, or until treatment failure (disease progression), death, or study completion, whichever occurs first]
Eligibility criteria
Inclusion criteria
- Informed Consent
- Participants must be between 18 and under 71 years of age
- Participants must have a confirmed diagnosis of APL proven by standard genetic testing (t(15;17) or PML-RARA)
- Participants must be classified as low- or intermediate-risk APL
- Participants must be willing and able to comply with the scheduled study visits, treatment plans, laboratory tests, contraception guidance, and other procedures
Exclusion criteria
- Participants who have significant heart rhythm problems including long QT syndrome, serious arrhythmias, very slow heart rate, or prolonged QTc on ECG
- Participants who have central nervous system leukemia
- Participants having serious ongoing medical conditions or infections including uncontrolled infections, severe organ disease, or conditions that make study participation unsafe
- Participants who are pregnant, breastfeeding, or unwilling to use contraception
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 11 centers
- Quetzal Site 16 — Birmingham
- Quetzal Site 1 — Duarte
- Quetzal Site 7 — Los Angeles
- Quetzal Site 5 — Stanford
- Quetzal Site 13 — Augusta
- Quetzal Site 4 — Buffalo
- Quetzal Site 2 — The Bronx
- Quetzal Site 8 — Columbus
- … and 3 more centers
Spain · 4 centers
- Quetzal Site 11 — Palma de Mallorca
- Quetzal Site 15 — Barcelona
- Quetzal Site 10 — Cáceres
- Quetzal Site 9 — Valencia
France · 1 center
- Quetzal Site 14 — Paris
Identifiers
NCT: NCT07504458 · QTX-2101-301 · 2025-524810-28-00