Abstract
There have been concerns about serious infusion-related adverse drug reactions (ADR) with rituximab in chronic lymphocytic leukemia (CLL). We therefore conducted an observational trial in which CLL patients planned for rituximab-containing therapy were eligible. Ninety-six patients from 19 centers were enrolled. The most common regimen was rituximab, fludarabine and cyclophosphamide. Fifty-six patients experienced ADR during rituximab infusion. Reactions ≥ grade 3 occurred in five patients and no cases of tumor lysis syndrome were recorded. Despite a high number of circulating tumor cells few severe ADR were noted. Thus, rituximab-containing regimens can be considered safe for CLL patients in general practice.
Keywords:
Adverse reaction; Chronic lymphocytic leukemia; Rituximab; Therapy.
Copyright © 2014 Elsevier Ltd. All rights reserved.
Publication types
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Clinical Trial
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Multicenter Study
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Observational Study
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Research Support, Non-U.S. Gov't
MeSH terms
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Adult
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Aged
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Aged, 80 and over
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Antibodies, Monoclonal, Murine-Derived / administration & dosage*
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Antibodies, Monoclonal, Murine-Derived / adverse effects*
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Antineoplastic Combined Chemotherapy Protocols / administration & dosage*
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Antineoplastic Combined Chemotherapy Protocols / adverse effects*
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Cyclophosphamide / administration & dosage
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Cyclophosphamide / adverse effects
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Female
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Humans
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Leukemia, Lymphocytic, Chronic, B-Cell / blood
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Leukemia, Lymphocytic, Chronic, B-Cell / drug therapy*
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Leukemia, Lymphocytic, Chronic, B-Cell / epidemiology
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Leukemia, Lymphocytic, Chronic, B-Cell / pathology
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Male
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Middle Aged
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Prospective Studies
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Rituximab
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Sweden / epidemiology
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Vidarabine / administration & dosage
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Vidarabine / adverse effects
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Vidarabine / analogs & derivatives
Substances
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Antibodies, Monoclonal, Murine-Derived
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Rituximab
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Cyclophosphamide
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Vidarabine
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fludarabine