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

Clinical Trial: NCT02124174

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