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NCT01476410 (CLINICAL TRIAL / BRENTUXIMAB VEDOTIN / SGN-035 / ADCETRIS®)

Study Title
Brentuximab Vedotin and Combination Chemotherapy in Treating Older Patients With Previously Untreated Stage II-IV Hodgkin Lymphoma (NCT01476410)

Trial Description
This phase II trial studies how well giving brentuximab vedotin (Adcetris®; Seattle Genetics, Inc.  Also known as SGN35) together with combination chemotherapy works in treating older patients with previously untreated stage II-IV Hodgkin lymphoma (HL). Monoclonal antibody-drug conjugates, such as brentuximab vedotin, can block cancer growth in different ways by targeting certain cells.

Drugs used in chemotherapy, such as doxorubicin hydrochloride, vinblastine, and dacarbazine (AVD), work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving brentuximab vedotin, doxorubicin hydrochloride, vinblastine, and dacarbazine together may kill more cancer cells.

This trial is sponsored by Northwestern University. [1]

Study Data

  • Conditions:
    • Adult Lymphocyte Depletion Hodgkin Lymphoma
    • Adult Lymphocyte Predominant Hodgkin Lymphoma
    • Adult Mixed Cellularity Hodgkin Lymphoma
    • Adult Nodular Sclerosis Hodgkin Lymphoma
    • Stage II, III, and IV Adult Hodgkin Lymphoma
  • Interventions:
    • Drugs used in this trial
      • Brentuximab Vedotin(Adcetris®; Seattle Genetics, Inc.)
      • Doxorubicin (Doxil®; TTY Bio pharmacy Company Limited)
      • Vinblastine (Velban®; Eli Lilly and Company)
      • Dacarbazine (DTIC-Dome®; Bayer Pharmaceuticals Corporation)
      • Procedure: quality-of-life assessment
      • Procedure: positron emission tomography
      • Genetic: DNA analysis
      • Genetic: RNA analysis
      • Genetic: polymorphism analysis
      • Radiation: fludeoxyglucose F 18
      • Other: laboratory biomarker analysis
      • Other: immunohistochemistry staining method
  • Phase: II
  • Estimated Enrollment: 48
  • Start: November 2011
  • Estimated Completion: May 2018
  • Last verified: March 2015

Study Schematic

NCT01476410 (CLINICAL TRIAL / BRENTUXIMAB VEDOTIN / SGN-035 / ADCETRIS®)

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Last Editorial review: July 16, 2016
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.

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