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Bendamustine Hydrochloride and Gemtuzumab Ozogamicin in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia or Myelodysplastic Syndrome

2014-08-27 03:13:01 | BioPortfolio

Summary

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.

Description

PRIMARY OBJECTIVES:

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.

SECONDARY OBJECTIVES:

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.

Study Design

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

Conditions

Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities

Intervention

bendamustine hydrochloride, gemtuzumab ozogamicin

Location

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle
Washington
United States
98109

Status

Not yet recruiting

Source

Fred Hutchinson Cancer Research Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:01-0400

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Medical and Biotech [MESH] Definitions

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