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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 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.
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.
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 154 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 90-participant average among 22 other MDS trials with a reported enrollment target (71% higher). The listed sponsor is Aprea Therapeutics, which has 9 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 13 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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