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NCT03931291 · ClinicalTrials.gov registry record · Phase 2
APR-246 in Combination With Azacitidine for TP53 Mutated AML (Acute Myeloid Leukemia) or MDS (Myelodysplastic Syndromes) Following Allogeneic Stem Cell Transplant
A Phase 2 study of Acute Myeloid Leukemia or Myelodysplastic Syndromes, sponsored by Aprea Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 33
- Enrollment target
- 7
- Study locations
NCT03931291: Completed Phase 2 study of Acute Myeloid Leukemia or Myelodysplastic Syndromes, sponsored by Aprea Therapeutics.
NCT03931291 is a Phase 2 study of Acute Myeloid Leukemia or Myelodysplastic Syndromes that has completed, run by Aprea Therapeutics. The registered enrollment target is 33 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (75% lower). The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03931291, a Phase 2 study of Acute Myeloid Leukemia or Myelodysplastic Syndromes, has completed, sponsored by Aprea Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 33 participants
- Enrollment target
- 7
- Study locations
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.
Primary Outcome
Relapse-free survival (RFS) at 12 months or longer if data permits. RFS was defined as the time from HCT to relapse after HCT or death, whichever occurred first.
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 |
What the finished NCT03931291 record still lists
NCT03931291 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (75% lower).
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.
NCT03931291 lists 7 locations in 6 states (Massachusetts, Florida, Maryland).
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.
What interventions are being tested in trial NCT03931291?
The interventions under investigation include: APR-246 (DRUG).
Who is sponsoring clinical trial NCT03931291?
This trial is sponsored by Aprea Therapeutics, which has 9 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03931291's enrollment target sits among peer trials
33 1553rd of 2000 higher than 438 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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