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RATIONALE: Drugs used in chemotherapy, such as bendamustine hydrochloride, 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 bendamustine hydrochloride together with gemtuzumab ozogamicin may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of bendamustine hydrochloride when given together with gemtuzumab ozogamicin in treating older patients with previously untreated acute myeloid leukemia or myelodysplastic syndrome.
I.To determine the maximum tolerated dose (MTD) that is associated with a CR rate of at least 40%, and a rate of grade 3-4 extramedullary toxicity < 30% in patients aged 60 or older with previously untreated AML or high-risk MDS.
I. To determine the disease-free survival (DFS), and overall survival (OS) after therapy at each level of the dosing strategy.
OUTLINE: This is a phase I, dose-escalation study of bendamustine hydrochloride followed by a phase II study.
Patients receive bendamustine IV on days 1-5 and gemtuzumab ozogamicin IV over 2 hours on days 1 and 14. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years then annually thereafter for 3 years.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
bendamustine hydrochloride, gemtuzumab ozogamicin
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Not yet recruiting
Fred Hutchinson Cancer Research Center
Published on BioPortfolio: 2014-08-27T03:13:01-0400
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