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Azacitidine and Gemtuzumab Ozogamicin in Treating Patients With Relapsed Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia, or Acute Myeloid Leukemia Who Have Undergone Stem Cell Transplant

2014-08-27 03:15:22 | BioPortfolio

Summary

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.

Description

PRIMARY OBJECTIVES:

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities

Intervention

azacitidine, gemtuzumab ozogamicin

Location

Fred Hutchinson Cancer Research Center
Seattle
Washington
United States
98109

Status

Recruiting

Source

Fred Hutchinson Cancer Research Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:22-0400

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Medical and Biotech [MESH] Definitions

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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