Document Detail

Phase II trial of denileukin diftitox for relapsed/refractory T-cell non-Hodgkin lymphoma.
MedLine Citation:
PMID:  17233846     Owner:  NLM     Status:  MEDLINE    
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.
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:
Type:  Clinical Trial, Phase II; Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  British journal of haematology     Volume:  136     ISSN:  0007-1048     ISO Abbreviation:  Br. J. Haematol.     Publication Date:  2007 Feb 
Date Detail:
Created Date:  2007-01-19     Completed Date:  2007-03-29     Revised Date:  2013-06-03    
Medline Journal Info:
Nlm Unique ID:  0372544     Medline TA:  Br J Haematol     Country:  England    
Other Details:
Languages:  eng     Pagination:  439-47     Citation Subset:  IM    
Department of Hematologic Malignancies, Nevada Cancer Institute, Las Vegas, NV 89135, USA.
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MeSH Terms
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
Interleukin-2 / adverse effects,  therapeutic use*
Interleukin-2 Receptor alpha Subunit / analysis
Lymphoma, T-Cell / drug therapy*,  immunology,  metabolism
Middle Aged
Neoplasm Recurrence, Local / drug therapy*
Neoplasm Staging
Recombinant Fusion Proteins / adverse effects,  therapeutic use
Transaminases / metabolism
Treatment Outcome
Reg. No./Substance:
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

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