| A Multicenter Phase II Trial to Determine the Safety and Efficacy of Combination Therapy With Denileukin Diftitox and CHOP in Untreated Peripheral T-Cell Lymphoma: The CONCEPT Study. | |
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MedLine Citation:
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PMID: 23278639 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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ABSTRACT This phase II study to determine the safety and efficacy of denileukin diftitox (DD) and CHOP enrolled patients with newly diagnosed peripheral T-cell lymphoma (PTCL). Forty-nine received DD 18 µg/kg/day (days 1, 2) with CHOP (day 3) every 21 days ≤6-8 cycles. Intent-to-treat (ITT) and safety populations comprised all patients. In the ITT population, overall response rate was 65%, median duration of response was 30 months, and median progression-free survival was 12 months. Median overall survival was not attained at the end of the study, and overall survival rate was 63.3%. The 2 most frequent treatment-related adverse events (AEs) were fatigue and nausea. Most frequent AEs ≥grade 3 within the hematologic system were lymphopenia (24.5%), neutropenia (20.4%), and leukopenia (18.4%). Three treatment-related deaths occurred. DD plus CHOP was well tolerated, and progression-free and overall survival improved versus historical comparison with CHOP alone. Confirmation in larger trials is warranted. ClinicalTrials.gov Identifier: NCT00211185. |
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Authors:
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Francine M Foss; Nelida Sjak-Shie; Andre Goy; Eric Jacobsen; Ranjana Advani; Mitchell R Smith; Rami Komrokji; Kelly Pendergrass; Vanessa Bolejack |
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Publication Detail:
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Type: JOURNAL ARTICLE Date: 2013-1-2 |
Journal Detail:
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Title: Leukemia & lymphoma Volume: - ISSN: 1029-2403 ISO Abbreviation: Leuk. Lymphoma Publication Date: 2013 Jan |
Date Detail:
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Created Date: 2013-1-2 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 9007422 Medline TA: Leuk Lymphoma Country: - |
Other Details:
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Languages: ENG Pagination: - Citation Subset: - |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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