Acute Myeloid Leukemia Clinical Trial
Official title:
A Phase I/II Trial of the Combination 5-azacitidine and Gemtuzumab Ozogamicin Therapy for Treatment of Relapsed AML
This study will test an experimental combination of the drugs Mylotarg and 5-azacitidine in the hopes of finding a treatment that may be effective against Acute Myeloid Leukemia that has come back after treatment.
In the Phase I portion of the study patients with a diagnosis of AML who have relapsed
disease will be treated with an assigned number of doses of 5 azacitidine followed by
Mylotarg administered two times over two weeks
In the Phase II portion of the study patients will be treated with the dose of 5azacitidine
determined to be safe in the Phase I portion of the study followed by Mylotarg.
A sample of blood or bone marrow will be obtained prior to initiation of treatment and
another sample obtained after treatment with 5-azacitidine but before Mylotarg and the
samples will be tested in the laboratory to determine response to treatment.
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