Abstract
Gemtuzumab ozogamicin (GO), an anti-CD33 immunoconjugate, was combined with high dose cytarabine (HiDAC; cytarabine 3g/m(2) over 3h daily for 5 days) for adults with relapsed or refractory AML. HiDAC plus GO 9mg/m(2) on day 7 and 4.5mg/m(2) on day 14 was not tolerated, but HiDAC followed by GO 9mg/m(2) on day 7 was safe: 12/37 (32%) patients with relapsed AML achieved complete remission. Median overall survival was 8.9 months. No grade 4 hepatic veno-occlusive disease was observed. This regimen merits further study, both in this setting and as a remission consolidation therapy.
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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Comparative Study
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Research Support, N.I.H., Extramural
MeSH terms
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Aged
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Aminoglycosides / administration & dosage
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Antibodies, Monoclonal / administration & dosage
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Antibodies, Monoclonal, Humanized
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Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
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Case-Control Studies
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Cohort Studies
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Cytarabine / administration & dosage
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Dose-Response Relationship, Drug
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Drug Resistance, Neoplasm / drug effects*
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Female
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Gemtuzumab
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Humans
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Idarubicin / administration & dosage
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Leukemia, Myeloid, Acute / drug therapy*
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Leukemia, Myeloid, Acute / pathology
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Male
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Middle Aged
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Neoplasm Recurrence, Local / drug therapy*
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Neoplasm Recurrence, Local / pathology
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Remission Induction
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Survival Rate
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Treatment Outcome
Substances
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Aminoglycosides
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Antibodies, Monoclonal
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Antibodies, Monoclonal, Humanized
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Cytarabine
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Gemtuzumab
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Idarubicin