Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2025-12-25 @ 3:08 AM
NCT ID:
NCT01520805
Brief Summary:
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 \[AZA\]).
Detailed Description:
A new therapy for AML is necessary because, although there are several treatment options for patients with AML, these treatments are very toxic and not available to all AML patients or only useful for acute promyelocytic leukemia (APL). Also, there is essentially no treatment for patients with refractory or relapsed AML outside of bone marrow transplant. Accordingly, there is a great medical need for a safe and effective therapy for AML, especially refractory and relapsed AML. Also, although hypomethylating agents have been found to be effective against MDS, these agents are toxic. Furthermore, after relapsing from a hypomethylating agent, there is no treatment for this disease.
A nearly completed clinical trial of CPI-613 (Cornerstone Study# CL-CPI-613-009 or Wake Forest Study# CCCWFU 29109, under IND# 107,800) shows that CPI-613 is well tolerated at doses as high as 3,000 mg/m2. Results from this nearly completed trial also suggest that CPI- 613 may be effective against refractory and relapsed AML, as well as against MDS that is relapsed from a hypomethylating agent. Therefore, CPI-613 may be a suitable treatment option for refractory/relapsed AML and MDS relapsed from a hypomethylating agent. The promising preliminary efficacy data from Study# CL-CPI-613-009 (Wake Forest Study# CCCWFU 29109, under IND# 107,800) is the basis on which Cornerstone is conducting the current Phase 2a trial to further assess the efficacy of CPI-613 against these diseases.
Study:
NCT01520805
Study Brief:
Protocol Section:
NCT01520805