Acute Myeloid Leukemia Clinical Trial
Official title:
Study of Dendrogenin A / Oxysterols Balance Between Healthy Volunteers and Acute Myeloid Leukemia Patients. Modulations of the Balance During Cytarabine/Anthracycline Treatment - OxyLAM
Dendrogenin A is present in mammals normal tissues and fluids, notably blood. It is down-represented or absent in cancer cell lines and tumors. In the opposite, OCDO is accumulated in cancerous conditions and virtually absent of normal tissues. This study will try to determine modulations of these oxysterols and protein involved in their metabolism between Acute myeloid leukemia (AML) patient samples and normal blood or marrow, for evaluation of these markers as companion biomarkers for Dendrogenin A treatment.
Background : Acute myeloid leukemia is an unmet medical need since 5-year overall survival is
40-50% in younger adults and 10-15% in elderly. Dendrogenin A is a natural novel anticancer
agent showing potent antileukemic activity which is under-represented in tumors. Dendrogenin
A inhibits Cholesterol epoxide hydrolase and so modulates levels of substrates and products
of this enzymatic complex.
Purpose : This is a biomedical study of interventional type which includes 30 patients and 30
blood samples as well as 5 marrow samples from healthy donors. It will last 24 month, 8
months recruiting and 16 months follow-up. Patients with acute myeloid leukemia for which an
indication of chemotherapy treatment is retained will be enrolled in this study. This study
will compare oxysterols (Dendrogenin A, 6-oxo-cholestane-3beta,5alpha-diol - OCDO) and
related proteins as biomarkers of the disease between the two populations.
Interventions : The patients included in this study will be processed according to the
standard treatment in force for their disease. This study does not in any way interfere with
this treatment regimen, and is only based on additional samples of blood and bone marrow in
acts planned in the prognostic or follow-up protocols. Treatment shall start within the 15
days following inclusion and first sampling.
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