drugset / Trial / NCT03745716

APR-246 & Azacitidine for the Treatment of TP53 Mutant Myelodysplastic Syndromes (MDS)

NCT03745716

Phase 3 Completed 154 enrolled Aprea Therapeutics
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2019-01-11
Primary completion
2020-11-27
Completion
2022-01-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Azacitidine Other / unclassified
Subject eprenetapopt Small molecule