Phase II trial of denileukin diftitox for relapsed/refractory T-cell non-Hodgkin lymphoma

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

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

125 Scopus citations


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 μg/kg/d × 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.

Original languageEnglish (US)
Pages (from-to)439-447
Number of pages9
JournalBritish Journal of Haematology
Issue number3
StatePublished - Feb 2007


  • Denileukin diftitox
  • Non-Hodgkin lymphoma
  • Ontak
  • Relapsed/refractory T-cell non-Hodgkin lymphoma
  • T-cell non-Hodgkin lymphoma

ASJC Scopus subject areas

  • Hematology


Dive into the research topics of 'Phase II trial of denileukin diftitox for relapsed/refractory T-cell non-Hodgkin lymphoma'. Together they form a unique fingerprint.

Cite this