Acute Myeloid Leukemia Clinical Trial
Official title:
A Phase II Trial With Azacitidine Single Agent in Newly Diagnosed Acute Myelogenous Leukemia (AML) Veterans Administration (VA) Elderly Patients Who Are Ineligible for Standard Induction Therapy: A Department of Veterans Affairs Multi-Site Study
The drug that will be used in this study is called Azacitidine. Azacitidine belongs to a group of drugs which may restore normal control in cancer cells by affecting the genes and proteins in the body. Azacitidine is approved by the FDA for the treatment of Myelodysplastic Syndrome (MDS), a pre-leukemic bone marrow disease. The purpose of this study is to find out what effect the drug Azacitidine has on Acute Myeloid Leukemia (AML) in elderly patients.
Prior to starting treatment individuals being considered for this study will be evaluated to
determine if they are eligible to participate in the study. There are certain prestudy test
that are required: physical exam, blood tests, ECG, chest x-ray, bone marrow aspirate and
biopsy to confirm the diagnosis of AML.
Treatment regimen consists of Azacitidine IV/SQ on days 1-5 every 28 days. If the
Azacitidine is given IV it will be given over 15-40 minutes. The treatment will be given for
a minimum of 4 treatment cycles. Blood samples will be taken every week to monitor for side
effects of the Azacitidine. A bone marrow aspirate will be done every 3-4 months to
determine the response to the study drug or until the disease progresses. There is also a
quality of life questionnaire that will be completed at the beginning of the study and every
4 weeks while on the study.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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