Trial Watch: Pivotal Open-label Phase 3 Clinical Study of QTX-2101 in Adult Patients With Acute Promyelocytic Leukemia
Important context
- Trial eligibility (participation has strict criteria): Clinical-trial participation has study-specific eligibility criteria; registry listing does not mean a person qualifies or should enroll.
In plain English
The 30-second version
What happened?
ClinicalTrials.gov confirms that this Phase 3 study is registered and currently listed as Recruiting. This establishes the study's existence and registry-reported design/status, not a treatment benefit.
Why does it matter?
Phase 3 trials can contribute later-stage human evidence. CancerDiscoveries can track this record as results and regulatory information emerge.
What does this not prove?
A registered trial is not proof that the intervention works, is not FDA approval for this cancer or use, and is not a clinical-guideline recommendation.
Keep reading for evidence stage, limitations, study details, and sources.
What changed: ClinicalTrials.gov lists Pivotal Open-label Phase 3 Clinical Study of QTX-2101 in Adult Patients With Acute Promyelocytic Leukemia (NCT07504458) as a Phase 3 interventional cancer study. The registry status is Recruiting, with the record last updated 2026-08-19.
Study snapshot: Phase 3; Recruiting; planned enrollment 150. Conditions listed: 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. A primary outcome listed by the registry is: Maximum observed plasma (concentration (Cmax) of QTX-2101 for ASIII.
This entry tracks verified trial-registry facts. Trial registration by itself does not show that an intervention is effective, safe for a particular person, FDA-approved for this use, or recommended by clinical guidelines.
Population / Applicability
Studied in: Participants ages 18 Years to 71 Years with 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 who meet the study-specific registry eligibility criteria. (Adults)
Eligibility is study-specific. Registry information does not determine whether any individual should enroll in or receive the intervention.
Full evidence details
- Study design
- Not specified in this summary
- Sample size
- 150
- Primary outcome
- Maximum observed plasma (concentration (Cmax) of QTX-2101 for ASIII
- Replication
- Unknown
Funding & Conflicts
ClinicalTrials.gov lists the lead sponsor as Quetzal Therapeutics. Sponsorship is reported for transparency and does not establish efficacy.
Regulatory status by jurisdiction
Country or region not specified
- Status
- Investigational
- Last verified
- 2026-08-19
Cancer-type scope for this record is not yet recorded.
Guideline positions
Guideline
- Position
- Not addressed
- Last verified
- 2026-08-19
Primary evidence supporting this story
- ClinicalTrials.gov — NCT07504458 (opens in a new tab) (Clinical-trial registry) NCT07504458 Primary source NCT07504458
ClinicalTrials.gov — NCT07504458. NCT07504458.
Last reviewed
Trial Watch: Pivotal Open-label Phase 3 Clinical Study of QTX-2101 in Adult Patients With Acute Promyelocytic Leukemia
https://cancerdiscoveries.com/discoveries/trial-watch-pivotal-open-label-phase-3-clinical-study-of-qtx-2101-in-adult-patients-with-acute-promyelocytic-leukemia/
Research type: Registered later-phase trial
What This Means
ClinicalTrials.gov confirms that this Phase 3 study is registered and currently listed as Recruiting. This establishes the study's existence and registry-reported design/status, not a treatment benefit.
What This Doesn't Mean
A registered trial is not proof that the intervention works, is not FDA approval for this cancer or use, and is not a clinical-guideline recommendation.
Why It Matters
Phase 3 trials can contribute later-stage human evidence. CancerDiscoveries can track this record as results and regulatory information emerge.
Important Limitations
- Clinical-trial participation has study-specific eligibility criteria; registry listing does not mean a person qualifies or should enroll.
Primary sources
- ClinicalTrials.gov — NCT07504458 — https://clinicaltrials.gov/study/NCT07504458 (NCT07504458)
Date verified: 2026-08-19
Correction status: No correction or retraction