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Phase II trial of APR-246 in combination with azacitidine as maintenance therapy for TP53 mutated AML or MDS following allogeneic stem cell transplant
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.
Primary: 1. To assess relapse-free survival (RFS) in patients with TP53 mutated AML or MDS who receive combination maintenance treatment with APR-246 with azacitidine after undergoing allogeneic hematopoietic stem cell transplant (HSCT). 2. To evaluate the safety and tolerability of APR-246 in combination with azacitidine as maintenance treatment post-HSCT. Secondary: 1. To assess the overall survival (OS). 2.To asses non-relapse mortality (NRM). 3.To assess time to progression (TTP). 4.To evaluate cumulative incidence of Grades II-IV and III-IV acute graft versus host disease (GVHD). 5.To evaluate 12-month cumulative incidence of mild, moderate, and severe GVHD. 6.To evaluate post-transplant engraftment via chimerism studies in blood.
APR-246 (); azacitidine (5-azacitidine)