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

Authors

  • Nam H. Dang,

    1. Department of Hematologic Malignancies, Nevada Cancer Institute, Las Vegas, NV
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  • Barbara Pro,

    1. Departments of Lymphoma/Myeloma, Hematopathology, Diagnostic Radiology, and Cardiology, University of Texas M.D. Anderson Cancer Center, Houston, TX
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  • Fredrick B. Hagemeister,

    1. Departments of Lymphoma/Myeloma, Hematopathology, Diagnostic Radiology, and Cardiology, University of Texas M.D. Anderson Cancer Center, Houston, TX
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  • Felipe Samaniego,

    1. Departments of Lymphoma/Myeloma, Hematopathology, Diagnostic Radiology, and Cardiology, University of Texas M.D. Anderson Cancer Center, Houston, TX
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  • Dan Jones,

    1. Departments of Lymphoma/Myeloma, Hematopathology, Diagnostic Radiology, and Cardiology, University of Texas M.D. Anderson Cancer Center, Houston, TX
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  • Barry I. Samuels,

    1. Departments of Lymphoma/Myeloma, Hematopathology, Diagnostic Radiology, and Cardiology, University of Texas M.D. Anderson Cancer Center, Houston, TX
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  • Maria A. Rodriguez,

    1. Departments of Lymphoma/Myeloma, Hematopathology, Diagnostic Radiology, and Cardiology, University of Texas M.D. Anderson Cancer Center, Houston, TX
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  • Andre Goy,

    1. Departments of Lymphoma/Myeloma, Hematopathology, Diagnostic Radiology, and Cardiology, University of Texas M.D. Anderson Cancer Center, Houston, TX
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  • Jorge E. Romaguera,

    1. Departments of Lymphoma/Myeloma, Hematopathology, Diagnostic Radiology, and Cardiology, University of Texas M.D. Anderson Cancer Center, Houston, TX
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  • Peter McLaughlin,

    1. Departments of Lymphoma/Myeloma, Hematopathology, Diagnostic Radiology, and Cardiology, University of Texas M.D. Anderson Cancer Center, Houston, TX
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  • Ann T. Tong,

    1. Departments of Lymphoma/Myeloma, Hematopathology, Diagnostic Radiology, and Cardiology, University of Texas M.D. Anderson Cancer Center, Houston, TX
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  • Francesco Turturro,

    1. Louisiana State University Health Sciences Center, Feist-Weiller Cancer Center, Shreveport, LA, USA
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  • Pamela L. Walker,

    1. Departments of Lymphoma/Myeloma, Hematopathology, Diagnostic Radiology, and Cardiology, University of Texas M.D. Anderson Cancer Center, Houston, TX
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  • Luis Fayad

    1. Departments of Lymphoma/Myeloma, Hematopathology, Diagnostic Radiology, and Cardiology, University of Texas M.D. Anderson Cancer Center, Houston, TX
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Dr Nam H. Dang, Department of Hematologic Malignancies, Nevada Cancer Institute, 10441 W. Twain Ave., Las Vegas, NV 89135, USA. E-mail: ndang@nvcancer.org

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 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.

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