Ignite Creation Date:
2024-05-06 @ 7:10 AM
Last Modification Date:
2024-10-26 @ 11:46 AM
Study NCT ID:
NCT02489929
Status:
UNKNOWN
Last Update Posted:
2015-07-03
First Post:
2015-05-28
Brief Title:
Evaluation of Cytidine Deaminase for Patient Suffering of a Myelodysplastic Syndrom or an AML Treated by Azacytidine
Sponsor:
Assistance Publique Hopitaux De Marseille
Organization:
Assistance Publique Hopitaux De Marseille
Study Overview
Official Title:
Evaluation of Cytidine Deaminase for Patient Suffering of a Myelodysplasic Syndrom or an Acute Myeloid Leukemia and Treated by Azacytidine
Status:
UNKNOWN
Status Verified Date:
2015-07
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Myelodysplastic syndrome MDS is a group of medical conditions derived from progressive bone marrow failure that result in ineffective production of blood cells Depending on the severity MDS reduces the quality of life to the point of being life-threatening There is a probability of death at all stages of the disease due to complications and co-morbidities with progression to acute myeloid leukemia AML being the worst evolution Azacytidine is a nucleosidic analog with original epigenetic mechanism of action that is widely used for treating a variety of myelodysplasic syndromes Although generally well tolerated severe and sometimes life-threatening toxicities were unexpectedly observed in some patients Genetic polymorphism affecting cytidine deaminase CDA the liver enzyme responsible for azacytidine detoxification step could be responsible for poor clinical outcome due to on the one hand to severe toxicities in deficient patients and on the other hand on treatment failure in ultrametabolizer patientsThis clinical study aims at correlating the values in CDA levels with the risk of drug-related toxicities and to the clinical response to azacytidine treatment
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None