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NCT03745716 · ClinicalTrials.gov registry record · Phase 3
APR-246 & Azacitidine for the Treatment of TP53 Mutant Myelodysplastic Syndromes (MDS)
A Phase 3 study of MDS, sponsored by Aprea Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 154
- Enrollment target
- 20
- Study locations
NCT03745716: Completed Phase 3 study of MDS, sponsored by Aprea Therapeutics.
NCT03745716 is a Phase 3 study of MDS that has completed, run by Aprea Therapeutics. The registered enrollment target is 154 participants, above the 90-participant average among 22 other MDS trials with a reported enrollment target (71% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03745716, a Phase 3 study of MDS, has completed, sponsored by Aprea Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 154 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
To compare the complete response rate, defined as the proportion of patients who achieve complete remission (CR) with APR 246 + azacitidine treatment vs. azacitidine only.
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 |
What the finished NCT03745716 record still lists
NCT03745716 is an interventional study that assigns participants to a tested intervention. The registered 154 participants enrollment target is mid-sized for trials with a published cap, above the 90-participant average among 22 other MDS trials with a reported enrollment target (71% higher).
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.
NCT03745716 names 20 study sites across 13 states, led by Florida, California, Illinois.
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.
What interventions are being tested in trial NCT03745716?
The interventions under investigation include: Azacitidine (DRUG), APR-246 + azacitidine (DRUG).
Who is sponsoring clinical trial NCT03745716?
This trial is sponsored by Aprea Therapeutics, which has 9 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for MDS
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03745716's enrollment target sits among peer trials
154 2nd of 22 the highest of 22 other MDS trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other MDS 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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