Safety and Effectiveness Study of CPI-613 to Treat Refractory or Relapsed Leukemia and Myelodysplastic Syndrome | Aplastic Anemia and MDS International Foundation

Clinical Trial: NCT01520805

Safety and Effectiveness Study of CPI-613 to Treat Refractory or Relapsed Leukemia and Myelodysplastic Syndrome
For more details on this clinical trial, including contact information, please see this trial’s listing on clinicaltrials.gov:
Purpose: 

The purpose of this study is to determine whether CPI-613 is effective and safe in either patients with refractory or relapsed acute myeloid leukemia (AML) or patients with myelodysplastic syndrome (MDS) who have failed therapy with a hypomethylating agent (such as decitabine [Vidaza] and azacitidine [AZA]).

Status: 
Recruiting
Study Date: 
Fri, 01/01/2016 to Sat, 12/01/2018
Bone Marrow Disease(s): 
myelodysplastic syndromes (MDS)
Intervention: 
Drug: CPI-613 CPI-613 drug product, provided in concentrated form at 50 mg/mL, must be diluted with D5W prior to administration. CPI-613 is to be infused intravenously (IV) via a central venous catheter. The dose of CPI-613 will be either the Maximum Tolerated Dose (MTD) or the highest No-Significant- Adverse-Effects-Dose-Level (NOAEL), as determined from the nearly completed Phase 1 dose-escalation clinical trial in patients with hematologic malignancies (i.e., Cornerstone Study# CL-CPI-613-009 or Wake Forest Study# CCCWFU 29109, under IND 107,800). Other Names: 6,8-bis-benzylsulfanyloctanoic acid 6,8-bis(benzylthio)octanoic acid 6,8-bis-benzylsulfonyloctanoic acid Bylantra