Metabolically Optimized, Non-cytotoxic Low Dose Weekly Decitabine/Venetoclax in MDS and AML
Status:
Not yet recruiting
Trial end date:
2024-01-01
Target enrollment:
Participant gender:
Summary
Myeloid malignancies which include AML and MDS are cancers of the bone marrow which lead to
bone marrow failure. The bone marrow is the place or factory in the body where components of
blood such as red cells, platelets and white cells are made. In bone marrow failure, the
ability of the bone marrow to make these cells is decreased. The decreased bone marrow
function is the result from abnormalities that develop in the malignant cells which prevent
the normal maturation process by which bone marrow cells develop into red blood cells, white
blood cells and platelets. The malignant cells in the bone marrow are not good at maturing to
make the components of the blood that you need, they occupy space in the bone marrow and
prevent the function of remaining normal bone marrow cells.
DNA is a chemical substance within cells that stores information needed for cell growth and
cell behavior. One approach to treating the malignant cells is to give chemotherapy which
damages DNA within these cells and causes their death. Unfortunately, such therapy has
side-effects, since even normal cells can be affected by the treatment.
Decitabine is FDA approved for treatment of MDS and AML. Venetoclax is approved for AML in
combination with Azacitidine for patients with AML or are over age 75 or unfit for
chemotherapy. In this study, Decitabine and venetoclax will be administered using a low dose
weekly schedule in an attempt to improve efficacy by decreasing the side effects often seen
when these drugs are given at standard dosing.