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A Randomized, Double-Blind, Placebo-Controlled, Phase III Study of Brentuximab Vedotin and CHP (A+CHP) versus CHOP in the Frontline Treatment of Patients with CD30- Positive Mature T-cell Lymphomas

Conditions

Non-Hodgkin's Lymphoma

Trial Phase

Phase III

Trial Purpose and Description

Trial Purpose

This is a double-blind, randomized, multicenter, phase 3 clinical trial to compare the efficacy and safety of brentuximab vedotin in combination with CHP with the standard-of-care CHOP in patients with CD30-positive mature T-cell lymphomas.


Participation Guidelines

Age:
Gender:

Eligibility Criteria

Inclusion Criteria:

  • Patients with newly diagnosed, CD30-positive mature T-cell lymphomas
  • Fluorodeoxyglucose (FDG)-avid disease by PET and measurable disease of at least 1.5 cm by CT
  • Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2

Exclusion Criteria:

  • History of another primary invasive malignancy that has not been in remission for at least 3 years
  • Current diagnosis of primary cutaneous CD30-positive T-cell lymphoproliferative disorders and lymphomas or mycosis fungoides
  • History of progressive multifocal leukoencephalopathy (PML)
  • Cerebral/meningeal disease related to the underlying malignancy

Sponsor:
Seattle Genetics, Inc.
Dates:
05/20/2014
Last Updated:
Study HIC#:
1303011743