Status(es): Active, not recruiting
Study Date(s): Friday, January 11, 2019 to Sunday, November 1, 2020
Disease(s): myelodysplastic syndromes (MDS)
Age Group: 18 years and older
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.
The p53, or P53, protein is coded by the TP53 gene which is mutated in a portion of patients with MDS. The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for APR-246 in combination with azacitidine for the treatment of myelodysplastic syndromes (MDS) with a susceptible TP53 mutation. For more information, please see: