This is a Phase 1b/2 study for men and women with a myeloid neoplasm: myelodysplastic syndrome (MDS), a myeloproliferative neoplasm (MPN), or chronic myelomonocytic leukemia (CMML), who are positive for a TP53 mutation.
This research study is being done because there is a great need for more effective treatments for subjects with myeloid neoplasms. In particular, the mutational status of TP53 is thought to be an important prognostic factor in MDS patients. Therefore, there is a great need to develop new therapies for TP53 mutated patients. It is thought that APR-246 treats myeloid neoplasms facilitating cell death in TP53 mutant cancer cells. Azacitidine is a hypomethylating agent that kills abnormal blood cells.
The study drugs will be administered following the below schedule:
Lead in phase:
Treatment Phase (Each Cycle):
Subjects will continue on treatment as long as they are responding to therapy and not experiencing unacceptable side effects