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APR-246 in Combination With Azacitidine for TP53 Mutated AML (Acute Myeloid Leukemia) or MDS (Myelodysplastic Syndromes) Following Allogeneic Stem Cell Transplant
NCT03931291 · View on ClinicalTrials.gov ↗
Study Summary
A multi-center, open label, Phase II clinical trial to assess the safety and efficacy of APR-246 in combination with azacitidine as maintenance therapy after allogeneic HSCT (hematopoietic stem cell transplant) for patients with TP53 mutant AML or MDS.
Conditions Studied
Interventions
- DRUG APR-246
Study Locations (7)
Massachusetts
- Massachusetts General Hospital — Boston
- Dana Farber Cancer Institute — Boston
Florida
- H. Lee Moffitt Cancer Center & Research Institute — Tampa
Maryland
- Johns Hopkins, Sidney Kimmel Comprehensive Cancer Center — Baltimore
New York
- Memorial Sloan Kettering Cancer Center — New York
Tennessee
- Vanderbilt Ingram Cancer Center — Nashville
Washington
- Fred Hutchinson Cancer Center — Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2019-09-16 |
| Est. Completion | 2022-01-14 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03931291
The ClinicalTrials.gov registry entry for NCT03931291 describes a study currently listed as completed. It is categorized as Phase 2, 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 33 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 Acute Myeloid Leukemia or Myelodysplastic Syndromes appearing as the primary indexed condition, and to 1 intervention — of which APR-246 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: NCT03931291 reports 7 study locations spanning 6 distinct geographic areas — top geographies include Massachusetts, Florida, Maryland. 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 NCT03931291 about?
NCT03931291 is a clinical study titled "APR-246 in Combination With Azacitidine for TP53 Mutated AML (Acute Myeloid Leukemia) or MDS (Myelodysplastic Syndromes) Following Allogeneic Stem Cell Transplant". A multi-center, open label, Phase II clinical trial to assess the safety and efficacy of APR-246 in combination with azacitidine as maintenance therapy after allogeneic HSCT (hematopoietic stem cell transplant) for patients with TP53 mutant AML or MDS.
What is the current status of trial NCT03931291?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 33 participants. The study started on 2019-09-16. Estimated completion is 2022-01-14.
What conditions does trial NCT03931291 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia or Myelodysplastic Syndromes. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03931291?
The interventions under investigation include: APR-246 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03931291?
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 NCT03931291 being conducted?
This trial has 7 study locations across Florida, Maryland, Massachusetts, New York, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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