Acute Myeloid Leukemia Clinical Trial
Official title:
Randomized Phase II Study of Epigenetic Priming Using Decitabine With Induction Chemotherapy in Patients With Acute Myelogenous Leukemia (AML)
This randomized phase II trial studies how well decitabine works when given together with daunorubicin hydrochloride and cytarabine in treating patients with acute myeloid leukemia. Drugs used in chemotherapy, such as decitabine, daunorubicin hydrochloride, and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Decitabine may help daunorubicin hydrochloride and cytarabine kill more cancer cells by making them more sensitive to the drugs. It is not yet known whether low-dose decitabine is more effective than high-dose decitabine when giving together with daunorubicin hydrochloride and cytarabine in treating acute myeloid leukemia.
OBJECTIVES: Primary I. To "Pick a Winner" by deciding whether further development of epigenetic priming with decitabine prior to standard "7+3" induction chemotherapy should be pursued. Secondary I. To determine whether epigenetic priming with decitabine prior to standard cytarabine and daunorubicin hydrochloride "7+3" induction chemotherapy has sufficient efficacy to warrant further development as assessed by an overall CR1 rate ≥ 50%. II. To establish the safety and expected toxicities of decitabine when used as priming for cytarabine and daunorubicin hydrochloride "7+3" induction chemotherapy in acute myeloid leukemia (AML). III. To assess the pharmacodynamics of deoxyribonucleic acid (DNA) hypomethylation when decitabine is administered as a short infusion. IV. To investigate, in selected cases, the molecular and cellular consequences of decitabine-induced hypomethylation by assessing the effects of decitabine-mediated hypomethylation on transcriptional patterns in AML cells, and by determining the effect of hypomethylation on the differentiation and/or apoptosis of leukemic blasts. (exploratory) V. To identify biomolecular correlates of treatment response (biomarkers) to induction chemotherapy in AML based upon the epigenetic pattern of DNA methylation in AML specimens obtained prior to treatment. (exploratory) OUTLINE: This is a multicenter study. Patients are stratified according to age (less than 50 years vs 50-65 years), white blood cell count (≤ 30 K/mL vs greater than 30 K/mL), cytogenetic risk group (intermediate vs adverse risk), and antecedent hematological condition preceding the diagnosis of acute myeloid leukemia (yes vs no). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive induction chemotherapy comprising daunorubicin hydrochloride intravenously (IV) daily on days 1-3 and cytarabine IV continuously on days 1-7 in the absence of disease progression or unacceptable toxicity. Patients who do not achieve a complete remission (CR) after the first induction-chemotherapy course receive a second identical induction course. Arm II: Patients receive decitabine IV over 1 hour on days -5 to -1. Patients then receive induction chemotherapy as in arm I in the absence of disease progression or unacceptable toxicity. Patients who do not achieve a CR after the first induction-chemotherapy course receive a second identical induction course. Patients undergo blood, bone marrow, and oral mucosa cells sample collection at baseline, prior to induction therapy, and after treatment for DNA methylation studies and pharmacodynamic studies. After completion of study treatment, patients are followed up for up to 10 years. ;
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