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APR-246 & Azacitidine for the Treatment of TP53 Mutant Myelodysplastic Syndromes (MDS)
NCT03745716 · View on ClinicalTrials.gov ↗
Study Summary
A Phase III, multicenter, randomized study to compare the rate of complete response (CR) and duration of CR, in patients with TP53-mutated MDS who will receive APR-246 and azacitidine or azacitidine alone.
Conditions Studied
Interventions
- DRUG Azacitidine
- DRUG APR-246 + azacitidine
Study Locations (20)
Florida
- Memorial Health Care System South Florida — Hollywood
- Mayo Clinic Jacksonville — Jacksonville
- Moffitt Cancer Center — Tampa
California
- City of Hope — Duarte
- Stanford University Cancer Research Center — Palo Alto
Illinois
- Robert H Lurie Comprehensive Cancer Center, Northwestern University — Chicago
- University Of Chicago Medicine — Chicago
Massachusetts
- Massachusetts General Hospital — Boston
- Dana Farber Cancer Institute — Boston
New York
- Cornell Medical Center — New York
- Memorial Sloan Kettering Cancer Center — New York
Pennsylvania
- University of Pennsylvania, Abramson Cancer Center — Philadelphia
- University of Pittsburgh Medical Center, Hillman Cancer Center — Pittsburgh
Connecticut
- Yale Cancer Center — New Haven
Iowa
- University of Iowa Hospitals and Clinics, Holden Cancer Center — Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 154 participants |
| Start Date | 2019-01-11 |
| Est. Completion | 2022-01-14 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03745716
The ClinicalTrials.gov registry entry for NCT03745716 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 154 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Aprea Therapeutics, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with MDS appearing as the primary indexed condition, and to 2 interventions — of which Azacitidine is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03745716 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Florida, California, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03745716 about?
NCT03745716 is a clinical study titled "APR-246 & Azacitidine for the Treatment of TP53 Mutant Myelodysplastic Syndromes (MDS)". A Phase III, multicenter, randomized study to compare the rate of complete response (CR) and duration of CR, in patients with TP53-mutated MDS who will receive APR-246 and azacitidine or azacitidine alone.
What is the current status of trial NCT03745716?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 154 participants. The study started on 2019-01-11. Estimated completion is 2022-01-14.
What conditions does trial NCT03745716 study?
This clinical trial studies the following conditions: MDS. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03745716?
The interventions under investigation include: Azacitidine (DRUG), APR-246 + azacitidine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03745716?
This trial is sponsored by Aprea Therapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03745716 being conducted?
This trial has 20 study locations across California, Connecticut, Florida, Illinois, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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