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- Title
Phase II trial of denileukin diftitox for relapsed/refractory T-cell non-Hodgkin lymphoma.
- Authors
Dang, Nam H.; Pro, Barbara; Hagemeister, Fredrick B.; Samaniego, Felipe; Jones, Dan; Samuels, Barry I.; Rodriguez, Maria A.; Goy, Andre; Romaguera, Jorge E.; McLaughlin, Peter; Tong, Ann T.; Turturro, Francesco; Walker, Pamela L.; Fayad, Luis
- Abstract
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.
- Subjects
CLINICAL drug trials; CLINICAL pharmacology; T cells; LYMPHOMAS; CANCER; HODGKIN'S disease; RETICULOENDOTHELIAL granulomas
- Publication
British Journal of Haematology, 2007, Vol 136, Issue 3, p439
- ISSN
0007-1048
- Publication type
Article
- DOI
10.1111/j.1365-2141.2006.06457.x