Vidaza and Valproic Acid Post Allogeneic Transplant for High Risk AML and MDS | Aplastic Anemia and MDS International Foundation

Clinical Trial: NCT02124174

Vidaza and Valproic Acid Post Allogeneic Transplant for High Risk AML and MDS
For more details on this clinical trial, including contact information, please see this trial’s listing on clinicaltrials.gov:
Purpose: 

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.

Status: 
Recruiting
Study Date: 
Sun, 01/01/2012 to Sun, 01/01/2017
Bone Marrow Disease(s): 
myelodysplastic syndromes (MDS)
Associated Drug(s): 
Intervention: 
Drug: Vidaza and Valproic Acid Days 1-5: 5-Azacytidine 40 mg/m^2 daily Days 1-5: +Valproic acid 15 mg/kg daily Days 6-28: Valproic acid 15 mg/kg daily *treatments will be repeated on the same days of each cycle for up to 4 total cycles. Each cycle will consist of 28 days. Other Names: Vidaza Valproic Acid Azacitadine