Phase I Epigenetic Priming Using Decitabine With Induction Chemotherapy in AML
Status:
Completed
Trial end date:
2009-12-01
Target enrollment:
Participant gender:
Summary
This is an open label phase I study designed to explore the feasibility, safety and biologic
activity of epigenetic priming with decitabine prior to standard cytarabine, daunorubicin
induction chemotherapy in younger patients with less-than-favorable risk AML.
Primary Objective: To find an appropriate dose level for decitabine when used as priming for
cytarabine and daunorubicin "7+3" induction chemotherapy in AML.
Secondary Objectives:
1. To establish the safety and expected toxicities of decitabine when used as priming for
cytarabine and daunorubicin "7+3" induction chemotherapy in AML.
2. To establish the optimal dose schedule of decitabine required to broadly demethylate
cytosine residues in genomic regulatory regions.
3. To investigate, in selected cases, the molecular and cellular consequences of
decitabine-induced hypomethylation by a) establishing the extent and degree of
hypomethylation at specific genomic loci required to reactivate the expression of
repressed genes and by b) determining the effect of hypomethylation on the
differentiation and/or apoptosis of leukemic blasts.