| Phase II trial of denileukin diftitox for relapsed/refractory T-cell non-Hodgkin lymphoma. | |
MedLine Citation:
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PMID: 17233846 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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This phase II study evaluated the safety and efficacy of denileukin diftitox, an interleukin-2-diphtheria toxin fusion protein, in relapsed/refractory T-cell non-Hodgkin lymphoma (T-NHL), excluding cutaneous T-cell lymphoma. Eligible patients received denileukin diftitox 18 microg/kg/d x 5 d every 3 weeks for up to eight cycles. Tumour staging was performed every two cycles and the primary endpoint was the objective response rate [complete response (CR) + partial response (PR)]. For 27 patients enrolled, median age: 55 years (range 26-80 years), 70.4% male, and mean prior therapies: 2.5 (range 1-6). Objective responses (six CRs, seven PRs) were achieved in 13 patients (48.1%), stable disease in eight (29.6%) and six (22.2%) had progressive disease. An objective response was achieved in eight of 13 patients (61.5%) with CD25(+) tumours (four CR/four PR) and five of 11 patients (45.5%) with CD25(-) tumours (two CR/three PR). Median progression-free survival was 6 months (range, 1-38+ months). Most adverse reactions were grade 1/2 and transient. No grade 4-5 toxicities were reported. Denileukin diftitox had significant activity and was well tolerated in relapsed/refractory T-NHL, with responses observed in both CD25(+) and CD25(-) tumours. Further studies of denileukin diftitox in combination with other agents are warranted in previously untreated and relapsed/refractory T-NHL. |
Authors:
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Nam H Dang; Barbara Pro; Fredrick B Hagemeister; Felipe Samaniego; Dan Jones; Barry I Samuels; Maria A Rodriguez; Andre Goy; Jorge E Romaguera; Peter McLaughlin; Ann T Tong; Francesco Turturro; Pamela L Walker; Luis Fayad |
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Publication Detail:
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Type: Clinical Trial, Phase II; Journal Article; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: British journal of haematology Volume: 136 ISSN: 0007-1048 ISO Abbreviation: Br. J. Haematol. Publication Date: 2007 Feb |
Date Detail:
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Created Date: 2007-01-19 Completed Date: 2007-03-29 Revised Date: 2013-06-03 |
Medline Journal Info:
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Nlm Unique ID: 0372544 Medline TA: Br J Haematol Country: England |
Other Details:
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Languages: eng Pagination: 439-47 Citation Subset: IM |
Affiliation:
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Department of Hematologic Malignancies, Nevada Cancer Institute, Las Vegas, NV 89135, USA. ndang@nvcancer.org |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adult Aged Aged, 80 and over Antineoplastic Agents / adverse effects, therapeutic use* Diphtheria Toxin / adverse effects, therapeutic use* Disease-Free Survival Drug Administration Schedule Drug Resistance, Neoplasm Fatigue Female Humans Interleukin-2 / adverse effects, therapeutic use* Interleukin-2 Receptor alpha Subunit / analysis Lymphoma, T-Cell / drug therapy*, immunology, metabolism Male Middle Aged Neoplasm Recurrence, Local / drug therapy* Neoplasm Staging Recombinant Fusion Proteins / adverse effects, therapeutic use Transaminases / metabolism Treatment Outcome |
| Chemical | |
Reg. No./Substance:
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0/Antineoplastic Agents; 0/Diphtheria Toxin; 0/Interleukin-2; 0/Interleukin-2 Receptor alpha Subunit; 0/Recombinant Fusion Proteins; 25E79B5CTM/denileukin diftitox; EC 2.6.1.-/Transaminases |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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