Spots Global Cancer Trial Database for Phase II Trial of Alisertib With Induction Chemotherapy in High-risk AML

Study Description

Brief Summary: This research study is studying a targeted therapy (a form of treatment that uses drugs or other substances to identify and attack specific types of cancer cells with less harm to normal cells) as a possible treatment for high-risk acute myeloid leukemia. The names of the study interventions involved in this study are: * Alisertib / MLN8237 * Cytarabine / Cytosine Arabinoside * Idarubicin / Idarubicin hydrochloride * Daunorubicin (Can be used in place of idarubicin)

Detailed Description: This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied. As part of this research study, the participant will take alisertib in combination with conventional chemotherapies, idarubicin and cytarabine. Alisertib has not been approved by the FDA (U.S. Food and Drug Administration) for acute myeloid leukemia (AML). However, cytarabine and idarubicin have both been approved by the FDA for treatment of AML. It also means that the FDA (U.S. Food and Drug Administration) has not approved giving alisertib with idarubicin and cytarabine for use in participants, including participants with this type of cancer. Earlier pre-clinical studies and clinical trials have suggested the alisertib may have clinical promise as a single agent in acute myeloid leukemia. Alisertib is a selective small molecule inhibitor of Aurora A kinase, an enzyme which may play a role in the survival of leukemia cells. Alisertib is being studied for the treatment of advanced malignancies, including AML. Essentially, this means that alisertib may work to halt the growth of malignancy (abnormal cells dividing without control and invading nearby tissues) through a targeted mechanism. By combining alisertib with standard chemotherapy, the hope is to enhance the efficacy of current treatment used for acute myeloid leukemia. An earlier study of this combination has completed accrual, and demonstrated that the regimen is well tolerated. Through this study, the investigators would like to determine if the addition of alisertib to standard 7+3 chemotherapy improves efficacy as measured by the rate of complete remission (a decreased or disappearance of signs and symptoms of cancer).

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Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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