A Randomized Phase III Study of Standard Chemotherapy with and without Brentuximab in Patients Newly Diagnosed with Advanced Hodgkin Lymphoma

Protocol
13-056
Full Title
A Randomized, Open-label, Phase 3 Trial of A+AVD Versus ABVD as Frontline Therapy in Patients With Advanced Classical Hodgkin Lymphoma
Phase
III
Purpose

The standard treatment for newly diagnosed Hodgkin lymphoma is a combination of four chemotherapy drugs: doxorubicin, bleomycin, vinblastine, and dacarbazine (abbreviated ABVD). However, despite this treatment, the cancer returns in some patients. This occurs more often in those with advanced stage disease (stage III or IV).

In this study, researchers are comparing the standard treatment of ABVD with a different treatment: the drugs doxorubicin, vinblastine, and dacarbazine (abbreviated AVD) plus another drug called brentuximab vedotin. Brentuximab vedotin is already approved by the U.S. Food and Drug Administration for treating Hodgkin lymphoma which persists despite other treatments. The hope is that this new regimen will be more effective than the standard treatment for reducing the risk of cancer recurrence in patients with advanced untreated Hodgkin lymphoma.

Brentuximab has two parts: one (an antibody) that attaches to a protein on the surface of cancer cells called CD30, and another (an anticancer drug called monomethyl auristatin E) that kills the cancer. Patients will be randomly assigned to receive either ABVD or brentuximab/AVD.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have stage III or IV Hodgkin lymphoma that has not yet been treated.
  • Patients’ cancers must be positive for the CD30 protein (the target of brentuximab).
  • Patients must be able to be ambulatory for more than half of their normal waking hours.
  • This study is open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. David J. Straus at 212-639-8365.

Disease(s)
Lymphoma: Hodgkin's Disease
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