Abstract
Alemtuzumab has shown considerable activity in untreated and relapsed chronic lymphocytic leukaemia. We report our long-term experience in 21 patients within a randomized phase III trial investigating the role of alemtuzumab for consolidation therapy after first-line fludarabine +/- cyclophosphamide, which was stopped prematurely due to severe infections. However, after a median follow-up of 48 months, progression-free survival was significantly prolonged for patients receiving alemtuzumab consolidation compared to those with no further treatment (P = 0.004). Minimal residual disease (MRD) levels were persistently reduced after consolidation. Therefore, despite toxicity, MRD reduction by alemtuzumab consolidation translates into a significantly improved long-term clinical outcome.
Publication types
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Clinical Trial, Phase III
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Randomized Controlled Trial
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Research Support, Non-U.S. Gov't
MeSH terms
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Adolescent
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Adult
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Aged
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Alemtuzumab
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Antibodies, Monoclonal / therapeutic use*
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Antibodies, Monoclonal, Humanized
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Antibodies, Neoplasm / therapeutic use*
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Antineoplastic Agents / therapeutic use*
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Cyclophosphamide / therapeutic use
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Disease-Free Survival
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Female
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Follow-Up Studies
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Humans
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Kaplan-Meier Estimate
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Leukemia, Lymphocytic, Chronic, B-Cell / drug therapy
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Leukemia, Lymphocytic, Chronic, B-Cell / mortality
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Male
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Middle Aged
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Neoplasm, Residual / drug therapy
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Remission Induction
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Treatment Outcome
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Vidarabine / analogs & derivatives
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Vidarabine / therapeutic use
Substances
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Antibodies, Monoclonal
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Antibodies, Monoclonal, Humanized
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Antibodies, Neoplasm
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Antineoplastic Agents
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Alemtuzumab
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Cyclophosphamide
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Vidarabine
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fludarabine