2001
DOI: 10.1200/jco.2001.19.2.376
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Pivotal Phase III Trial of Two Dose Levels of Denileukin Diftitox for the Treatment of Cutaneous T-Cell Lymphoma

Abstract: Denileukin diftitox has been shown to be a useful and important agent in the treatment of patients whose CTCL is persistent or recurrent despite other therapeutic interventions.

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Cited by 560 publications
(356 citation statements)
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“…72 Six of the 14 patients treated at the lower dose achieved a response, with 3 CRs (either CR or CCR). However, CRs only occurred in patients with stage I disease.…”
Section: Denileukin Diftitoxmentioning
confidence: 95%
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“…72 Six of the 14 patients treated at the lower dose achieved a response, with 3 CRs (either CR or CCR). However, CRs only occurred in patients with stage I disease.…”
Section: Denileukin Diftitoxmentioning
confidence: 95%
“…The median duration of response for all patients in the study was 6.9 months (range 2.7-46.1). 72 In addition, there was no clear indication of any dose response relationship. Routine premedication with systemic corticosteroids was prohibited in this study.…”
Section: Denileukin Diftitoxmentioning
confidence: 97%
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“…Denileukin diftitox is a fusion protein comprised of human IL-2 fused to a truncated diphtheria toxin which has high affinity for the IL-2 receptor and is internalized upon receptor binding, leading to liberation of the toxin and the induction of apoptosis. Phase I/II studies demonstrated objective responses in approximately one-third of patients [237][238][239], leading to a phase III study which randomized 71 patients with CD25 positive (i.e., 20% T cells positive by immunohistochemistry) CTCL, most with advanced-stage disease, to either 9 or 18 lg/kg/day of Dd given intravenously on five consecutive days every 3 weeks for up to eight cycles [240]. An objective response, 20% partial and 10% complete, was observed in 30% of patients, while an additional 32% of patients had stable disease.…”
Section: Denileukin Diftitoxmentioning
confidence: 99%
“…Of note, Dd should not be administered in a facility ill equipped to provide cardiopulmonary resuscitation. Severe and persistent transaminitis, thyrotoxicosis, loss of visual acuity or color vision, and rhabdomyolysis have been reported but are uncommon [240,[246][247][248]. Investigations combining Dd with conventional chemotherapeutic agents are ongoing.…”
Section: Denileukin Diftitoxmentioning
confidence: 99%