Immunotherapy/Chemotherapy in Classic Hodgkin Lymphoma

A PHASE III, RANDOMIZED STUDY OF NIVOLUMAB (OPDIVO) PLUS AVD OR BRENTUXIMAB VEDOTIN (ADCETRIS) PLUS AVD IN PATIENTS (AGE >/= 12 YEARS) WITH NEWLY DIAGNOSED ADVANCED STAGE CLASSICAL HODGKIN LYMPHOMA

  • Clinical Trial Information

    Trial Contact: Walton, Sherri; Manchola-Orozco, Carolina

    Trial Phone: 321.841.1907 ; 321.841.7293

  • IRB No: S1826

    Protocol Abbrev: S1826

    Principal Investigator: Julio J Hajdenberg, MD

    Phase: Drug: Phase III

    Age Group: Adult

    Secondary Protocol No: S1826 Hodkin Lymphoma

    Treatment: chemotherapy, brentuximab vedotin, radiation

    Therapies Involved: Medication; Radiation

    ClinicalTrials.gov ID: NCT03907488

  • Objective

    This randomized phase III trial compares immunotherapy drugs (nivolumab or brentuximab vedotin) when given with combination chemotherapy in treating patients with newly diagnosed stage III or IV classic Hodgkin lymphoma. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Brentuximab vedotin is a monoclonal antibody, brentuximab, linked to a toxic agent called vedotin. Brentuximab attaches to cancer cells in a targeted way and delivers vedotin to kill them. Drugs used in chemotherapy, such as doxorubicin, vinblastine, and dacarbazine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The addition of nivolumab or brentuximab vedotin to combination chemotherapy may shrink the cancer or extend the time without disease symptoms coming back.

  • Key Eligibility

    All patients must have histologically confirmed newly diagnosed, previously untreated stage III or IV classical Hodgkin lymphoma (nodular sclerosing, mixed cellularity, lymphocyte-rich, or lymphocyte-depleted, or not otherwise specified [NOS]). Nodular lymphocyte predominant Hodgkin lymphoma is not eligible