Acute Myelogenous Leukemia Clinical Trial
Official title:
Aezea (Cenersen) in Combination With Chemotherapy for Treatment of Acute Myelogenous Leukemia Subjects ≥55 Years of Age With No Response to Single Frontline Induction Course in a Randomized Double-Blind Placebo-Controlled Multi-Center Study
The purpose of this study is to assess whether treatment with cenersen in combination with 4 cycles of high and low-dose chemotherapy (idarubicin and cytarabine) improves the complete response rate in acute myelogenous leukemia (AML) patients ≥ 55 years of age who did not show a response (CR, CRi, or PR) to a single aggressive frontline induction course.
Cenersen is a phosphorothioate antisense oligonucleotide of sequence
5'-CCCTG5-CTCCC10-CCCTG15-GCTCC20-3'. For AML, cenersen is specific for blocking p53
expression in the stem cells. When AML stem cells are dividing, cenersen sensitizes them to
even low-level DNA damage of the type caused by idarubicin, etoposide and possibly ara-C.
Because AML stem cells are not all dividing at any given time, this protocol is designed to
treat patients with a total of four cycles of cenersen plus chemotherapy within a two to
three month period. For a limited period of time, proliferating non-stem cells can be
expected to maintain or even expand the tumor while the stem cells are being depleted. If
the proliferating non-stem cells are not resupplied by the stem cells, they will all become
end stage blasts after a few divisions and undergo elimination.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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