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NCT01578967 (CLINICAL TRIAL / BRENTUXIMAB VEDOTIN / SGN-035 / ADCETRIS®)

Study Title
Induction Chemo w/ABVD Followed by Brentuximab Vedotin Consolidation in Newly Diagnosed, Non-Bulky Stage I/II Hodgkin Lymphoma (NCT01578967)

Trial Description
The standard chemotherapy for Hodgkin lymphoma is called ABVD which is a combination of 4 chemotherapy drugs (doxorubicin, bleomycin, vinblastine, and dacarbazine).  The ABVD regimen was developed in the early 1970’s as an alternative to MOPP (mechlorethamine, vincristine, procarbazine and  prednisone), the first combination regimen for the treatment of Hodgkin’s disease developed in 1964 by researchers at the National Cancer Institute.

The number of cycles of ABVD chemotherapy Hodgkin lymphoma patients receive is about 4-6 cycles. In addition to the ABVD chemotherapy, patients with Hodgkin lymphoma will routinely receive radiation therapy. The use of chemotherapy and radiation may cause long term treatment related side effects such as heart problems and other cancers. Researchers are trying to find if combining ABVD chemotherapy with new drugs and reducing the number of ABVD chemotherapy cycles given is just as effective as the standard Hodgkin treatment.

Brentuximab vedotin is approved by the United States Food and Drug administration (FDA) for the treatment of Hodgkin lymphoma that has come back (relapsed). For this research study, the use of brentuximab vedotin in newly diagnosed Hodgkin lymphoma is considered investigational.

Brentuximab vedotin is an antibody that also has a chemotherapy drug attached to it. Antibodies are proteins that are part of your immune system. They can stick to and attack specific targets on cells. The antibody part of the brentuximab vedotin sticks to a target called CD30. CD30 is an important molecule on some cancer cells and some normal cells of the immune system.

The purpose of this research study is to see the effects of treatment with fewer cycles of the combination chemotherapy, ABVD, followed by the study drug brentuximab vedotin has on study participants and Hodgkins lymphoma.

This trial is sponsored by UNC Lineberger Comprehensive Cancer CenterMillennium Pharmaceuticals. [1]

Study Data

  • Condition: Adult Hodgkin Lymphoma
  • Interventions:
  • Phase: 48
  • Estimated Enrollment: 15
  • Start: April 2012
  • Estimated Completion: January 2018
  • Last verified: June 2016

Study Schematic

Screen Shot 2016-07-18 at 3.40.29 PM

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Last Editorial review: July 17, 2016
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.

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