Vidaza and Valproic Acid Post Allogeneic Transplant for High Risk AML and MDS
Status:
Recruiting
Trial end date:
2022-01-01
Target enrollment:
Participant gender:
Summary
Phase II trial combining azacitidine with valproic acid as maintenance therapy post
allogeneic stem cell transplantation in patients with high-risk MDS/AML. We hypothesize that
adding valproic acid to azacitidine will improve outcomes via both direct anti-tumor and
immunologically mediated antitumor response with alloreactive donor lymphocytes, having an
additive effect and extending 1 year survival in patient with high-risk AML/MDS after
hematopoietic stem cell transplant. Based on aforementioned data from the US Department of
Health and Human Services, standard 1 year survival for AML after stem cell transplant is
near 40%. We hypothesize that valproic acid and azacitidine will prolong survival, with a 1
year survival goal of 60%. In addition to assessing for 1 year survival, we will have
secondary objectives of assessing progression-free survival, relapse, and toxicity. The
primary toxicity endpoint from this will be cytopenias and infections.