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Phase II trial of denileukin diftitox for relapsed/refractory T‐cell non‐Hodgkin lymphoma
Author(s) -
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
Publication year - 2007
Publication title -
british journal of haematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.907
H-Index - 186
eISSN - 1365-2141
pISSN - 0007-1048
DOI - 10.1111/j.1365-2141.2006.06457.x
Subject(s) - diphtheria toxin , refractory (planetary science) , medicine , lymphoma , gastroenterology , t cell lymphoma , progressive disease , phases of clinical research , clinical endpoint , oncology , surgery , clinical trial , chemotherapy , biology , biochemistry , astrobiology , toxin
Summary 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 μ g/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.