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news.Millennium and Seattle Genetics have begun a randomized open-label Phase III trial, evaluating Adcetris (brentuximab vedotin) in patients with CD30-expressing cutaneous T-cell lymphoma (CTCL).
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The study will be conducted in 124 patients with CTCL, including those with primary cutaneous anaplastic large cell lymphoma (pcALCL) or mycosis fungoides (MF).
The overall response rate, lasting at least four months, with Adcetris in patients with CD30-positive MF or pcALCL, compared to that achieved with therapy in the control arm, is the primary endpoint of the study.
The secondary endpoints include complete response, progression-free survival and burden of symptoms.
Seattle Genetics chief medical officer Thomas Reynolds said data from patients with cutaneous lesions observed in the pivotal trial in systemic anaplastic large cell lymphoma (sALCL) and interim data from investigator-sponsored trials in CTCL with Adcetris, provide a strong rationale for initiating the Phase 3 trial.
"This trial complements many other ongoing and planned trials for patients in need, including two additional Phase 3 trials for front-line Hodgkin lymphoma (HL) and front-line mature T-cell lymphomas, expected to start by late 2012 or early 2013," Reynolds added.