Trial · NCT07504458
Pivotal Open-label Phase 3 Clinical Study of QTX-2101 in Adult Patients With Acute Promyelocytic Leukemia
NCT07504458, Phase 3, Recruiting, Quetzal Therapeutics
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pivotal Open-label Phase 3 Clinical Study of QTX-2101 in Adult Patients With Acute Promyelocytic Leukemia. Trials, record NCT07504458. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07504458
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pivotal Open-label Phase 3 Clinical Study of QTX-2101 in Adult Patients With Acute Promyelocytic Leukemia
- NCT number
- NCT07504458
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 150 participants, estimated
- Lead sponsor
- Quetzal Therapeutics
- 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, Acute Promyelocytic Leukemia
- Interventions
- QTX-2101 + ATRA, IV arsenic trioxide (ATO) + ATRA
- First posted
- 2026-03-31
- Last updated
- 2026-10-30
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum observed plasma (concentration (Cmax) of QTX-2101 for ASIII | Up to 1 cycle of consolidation therapy (each cycle is 8 weeks) | Cmax is defined as the maximum observed plasma concentration following administration of \[investigational product\], determined from plasma concentration-time data. |
| Primary | Molecular complete remission (molecular CR) rate | Up to 60 days of induction and 3 8-week cycles of consolidation treatment | mCR is defined as the absence of detectable PML-RARA fusion transcript in bone marrow assessed by a validated quantitative reverse transcription polymerase chain reaction (RT-qPCR) assay .The mCR rate is defined as the proportion of participants achieving molecular remission at the specified assessment time point following induction and consolidation therapy. |
| Secondary | To characterize the safety and tolerability of QTX-2101/ATRA and IV ATO/ATRA | Throughout approximately 10 months of study treatment | Treatment emergent adverse events |
| Secondary | To characterize the event-free survival (EFS) of QTX-2101/ATRA | 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 | |
| Secondary | Area under the plasma concentration-time curve (AUC) of QTX-2101 for ASIII | Up to 10 months | AUC is defined as the area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC₀-t) and/or extrapolated to infinity (AUC₀-∞), calculated using noncompartmental methods. |
| Secondary | To complete a model-based concentration QT relationship evaluation | Up to 10 months | Time-matched difference in change from baseline in QTcF interval between active treatment and placebo, derived from triplicate 12-lead ECGs at each post-dose time point |
| Secondary | EORTC QLQ-C30 domain unit of measure and measurement tool | Up to 10 months | Change from baseline in EORTC QLQ-C30 global health status (0-100 scale) |
| Secondary | EQ-5D-5L domain unit of measure and measurement tool | Up to 10 months | Change from baseline in EQ-5D-5L index score (0-100) |
| Secondary | Overall Survival | 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 | OS is defined as the time from randomization to death from any cause. Participants who are alive at the time of analysis will be censored at the date last known to be alive. |
| Secondary | Event Free Survival (EFS) | 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 | EFS is defined as the time from randomization to the first occurrence of any of the following events: failure to achieve hematologic or molecular remission, relapse (hematologic or molecular), or death from any cause. Participants without an event at the time of analysis will be censored at the date of last adequate disease assessment. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07504458
GET https://conductscience.org/api/trials/v1/NCT07504458/registered