Abstract
This phase I/II study was designed to demonstrate the tolerance and the efficacy of a combination of pegylated interferon-α 2a to Imatinib mesylate (IM) 600mg daily in cytogenetically IM-resistant but in CHR chronic phase CML patients. The combination was generally well tolerated in the 15 evaluable patients. A significant reduction of the Ph1(+) BM metaphases was observed in these poor prognosis patients, with 2 long-term CCyR including 2 MMR. After a median follow-up of 43 months, 93% of patients are alive. The addition of PegIFNα2a to IM600 is feasible, and able to overcome resistance within this context.
Copyright © 2010 Elsevier Ltd. All rights reserved.
Publication types
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Clinical Trial, Phase I
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Clinical Trial, Phase II
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Multicenter Study
MeSH terms
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Adult
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Antineoplastic Agents / administration & dosage*
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Antineoplastic Agents / adverse effects
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Antineoplastic Agents / therapeutic use
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Benzamides
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Humans
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Imatinib Mesylate
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Interferon alpha-2
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Interferon-alpha / administration & dosage*
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Interferon-alpha / adverse effects
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Interferon-alpha / therapeutic use
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Leukemia, Myelogenous, Chronic, BCR-ABL Positive / drug therapy*
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Leukemia, Myelogenous, Chronic, BCR-ABL Positive / genetics
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Leukemia, Myelogenous, Chronic, BCR-ABL Positive / pathology
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Middle Aged
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Piperazines / administration & dosage*
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Piperazines / adverse effects
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Piperazines / therapeutic use
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Polyethylene Glycols / administration & dosage*
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Polyethylene Glycols / adverse effects
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Polyethylene Glycols / therapeutic use
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Pyrimidines / administration & dosage*
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Pyrimidines / adverse effects
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Pyrimidines / therapeutic use
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Recombinant Proteins
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Remission Induction*
Substances
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Antineoplastic Agents
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Benzamides
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Interferon alpha-2
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Interferon-alpha
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Piperazines
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Pyrimidines
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Recombinant Proteins
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Polyethylene Glycols
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Imatinib Mesylate
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peginterferon alfa-2a