CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 154 enrolled
Drug / intervention
APR-246 + azacitidine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03745716
NCT03745716Phase 3Completed
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A Phase III Multicenter, Randomized, Open Label Study of APR-246 in Combination With Azacitidine Versus Azacitidine Alone for the Treatment of (Tumor Protein) TP53 Mutant Myelodysplastic Syndromes

Aprea Therapeutics·interventional·Posted Nov 19, 2018·Updated Mar 18, 2025

In Brief

A Phase 3 clinical trial evaluating APR-246 + azacitidine and Azacitidine for MDS. Completed, enrolled 154 participants across 27 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMDS
CountriesFrance, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedNov 19, 2018
Enrollment StartJan 11, 2019
Primary CompletionNov 27, 2020
Study CompletionJan 14, 2022
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 7.6 years ago

Interventions

APR-246 + azacitidinedrug

Patients will be randomized (1:1) to one of two arms: stratified by age (\< 65 years versus ≥ 65): Experimental arm: APR-246 + azacitidine; or Control arm: Azacitidine

Azacitidinedrug

Patients will be randomized (1:1) to one of two arms: stratified by age (\< 65 years versus ≥ 65): Experimental arm: APR-246 + azacitidine; or Control arm: Azacitidine