drugset / Trial / NCT03931291

APR-246 in Combination With Azacitidine for TP53 Mutated AML (Acute Myeloid Leukemia) or MDS (Myelodysplastic Syndromes) Following Allogeneic Stem Cell Transplant

NCT03931291

Phase 2 Completed 33 enrolled Aprea Therapeutics
NaSingle-groupOpen-labelTreatment

Summary

A multi-center, open label, Phase II clinical trial to assess the safety and efficacy of APR-246 in combination with azacitidine as maintenance therapy after allogeneic HSCT (hematopoietic stem cell transplant) for patients with TP53 mutant AML or MDS.

Timeline

Start
2019-09-16
Primary completion
2021-08-27
Completion
2022-01-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Azacitidine Other / unclassified 36 mg/m2 Intravenous
Subject eprenetapopt Small molecule 3.7 g Intravenous