This research study is evaluating drugs called Millennium 9708 (referred to as MLN9708) in
combination with standard therapy for acute myeloid leukemia (AML) consisting of daunorubicin
and cytarabine as a possible treatment for the patient AML.
This research study is a clinical trial comprised of two Phase I portions an induction
treatment (initial treatment), and a consolidation treatment (which is given later). The
patient is being asked to participate in one or both phase I portions of this study.
A phase I study tests the safety of an investigational drug or combination of drugs. Phase I
studies also try to define the appropriate dose of the investigational drugs to use for
further studies. "Investigational" means that the drug combination is being studied. It also
means that the FDA (U.S. Food and Drug Administration) has not approved the drug combination
for the participant's type of cancer.
In this research study, the investigators are studying the safety and tolerability of MLN9708
in combination with standard treatment for adults 60 years of age or older with AML.
In the first phase I portion of treatment ("induction") participants will receive MLN9708 in
combination with daunorubicin and cytarabine. Once the maximally tolerated dose (MTD) of
MLN9708 is established in this induction portion, up to 36 additional participants will be
enrolled in the portion focusing on consolidation.
The drugs daunorubicin and cytarabine have been approved by the FDA (U.S. Food and Drug
Administration). MLN9708 is not approved by the FDA.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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