A Pilot Trial of AVD in addition to Brentuximab Vedotin (SGN-35) in the Treatment of Stage II-IV HIV-Associated Hodgkin Lymphoma
This research is being done to develop better treatments for Hodgkin lymphoma in patients with HIV. This study will test the safety and activity of brentuximab vedotin given with chemotherapy called AVD. AVD is a combination of three chemotherapy drugs (adriamycin, vinblastine, and dacarbazine). AVD is a change from ABVD, the standard therapy for Hodgkin lymphoma. The ï¿½Bï¿½ in ABVD, bleomycin, was removed because it caused lung problems when combined with brentuximab vedotin. Researchers do not know if AVD and brentuximab vedotin is better or worse than FDA-approved treatments for Hodgkinï¿½s lymphoma in people with HIV.
People with advanced HIV and advanced stage Hodgkin Lymphoma who are -over 18years old -read,understand and communicate in English -are not pregnant - have HIV-1 infection, as documented by any federally approved, licensed HIV rapid test performed in conjunction with screening (or ELISA test kit and confirmed by Western blot or other approved test). -have histologic diagnosis of CD30-positive classical Hodgkin Lymphoma (cHL) -have previously untreated HIV-cHL - currently on an antiretroviral regimen -have CD4 count greater than 50 cells/mcg - Hepatitis B or C negative with no signs of cirrhosis, or if infected with Hepatitis B, receiving anti-Hepatitis B therapy.
Hodgkin lymphoma is a cancer of certain immune cells called B cells. B cells play an important role in fighting infection. This clinical trial uses a drug called brentuximab vedotin. The brand name is ADCENTRISTM. The U.S. Food and Drug Administration (FDA) approved brentuximab vedotin to treat certain cancers. It is used for Hodgkin lymphoma that has failed other treatment or simply came back. Over 350 people with cancer have already taken brentuximab vedotin in completed clinical studies. These studies showed that brentuximab vedotin is safe and effective for treating certain cancers, including Hodgkin lymphoma. However, these studies did not include persons with HIV. Researchers are studying brentuximab vedotin in other clinical trials to learn more about its side effects and use for other diseases. This trial will study whether it helps patients who have HIV and advanced Hodgkin lymphoma.
09/16/2014 04:03 AM