Document Detail


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.
MedLine Citation:
PMID:  23278639     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
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.
Authors:
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:
Type:  JOURNAL ARTICLE     Date:  2013-1-2
Journal Detail:
Title:  Leukemia & lymphoma     Volume:  -     ISSN:  1029-2403     ISO Abbreviation:  Leuk. Lymphoma     Publication Date:  2013 Jan 
Date Detail:
Created Date:  2013-1-2     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9007422     Medline TA:  Leuk Lymphoma     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
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