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RATIONALE: Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as gemtuzumab ozogamicin, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving azacitidine together with gemtuzumab ozogamicin may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving azacitidine together with gemtuzumab ozogamicin works in treating patients relapsed myelodysplastic syndrome, chronic myelomonocytic leukemia, or acute myeloid leukemia who have undergone stem cell transplant.
I. To improve overall survival in patients with post-transplant relapse of myeloid malignancies.
OUTLINE : Patients are assigned to 1 of 2 treatment groups.
GROUP I: Patients with myeloblasts > 5% OR 5-10% receive azacitidine subcutaneously on days 1-7. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity.
GROUP II: Patients with myeloblasts 5-10% OR >= 10% receive azacitidine subcutaneously on days 1-7 and gemtuzumab ozogamicin IV on day 8. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
azacitidine, gemtuzumab ozogamicin
Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center
Published on BioPortfolio: 2014-08-27T03:15:22-0400
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A pediatric acute myeloid leukemia involving both myeloid and monocytoid precursors. At least 20% of non-erythroid cells are of monocytic origin.
A rare acute myeloid leukemia characterized by abnormal EOSINOPHILS in the bone marrow.
An acute myeloid leukemia in which abnormal PROMYELOCYTES predominate. It is frequently associated with DISSEMINATED INTRAVASCULAR COAGULATION.
An acute leukemia exhibiting cell features characteristic of both the myeloid and lymphoid lineages and probably arising from MULTIPOTENT STEM CELLS.
Clonal expansion of myeloid blasts in bone marrow, blood, and other tissue. Myeloid leukemias develop from changes in cells that normally produce NEUTROPHILS; BASOPHILS; EOSINOPHILS; and MONOCYTES.
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Bladder Cancer Brain Cancer Breast Cancer Cancer Cervical Cancer Colorectal Head & Neck Cancers Hodgkin Lymphoma Leukemia Lung Cancer Melanoma Myeloma Ovarian Cancer Pancreatic Cancer ...
Head and neck cancers
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