A Study of BV-AVD in People With Bulky Hodgkin Lymphoma
Trial Parameters
Brief Summary
The purpose of this study is to test whether BV-AVD is an effective treatment in people with early stage, bulky Hodgkin lymphoma that was recently diagnosed and who have not yet received any treatments for their disease. BV is a type of drug called an antibody-drug conjugate (ADC). ADCs are a substance made up of a monoclonal antibody chemically linked to a drug. Antibodies are proteins made by the immune system to fight infections and other possible harms to the body. The monoclonal antibody binds to specific proteins or receptors found on certain types of cells, including cancer cells. The linked drug enters these cells and kills them without harming other cells. Researchers think BV may be an effective treatment for this type of cancer because the drug targets cells that have CD30, which play a role in cancer cell growth. By destroying these cells, BV may help slow or stop the growth of the cancer. AVD (doxorubicin, vinblastine, and dacarbazine) is a treatment regimen that works by stopping the growth of cancer cells, either by killing the cells or by stopping them from dividing. The researchers think that BV in combination with AVD may work better than AVD alone to slow or stop the growth of the cancer.
Eligibility Criteria
Inclusion Criteria: * Histological diagnosis of classical, CD30-positive Hodgkin lymphoma confirmed at enrolling institution. * Ann Arbor stage I or II FDG-avid disease by FDG-PET/CT. * Disease bulk defined as any lymph node mass with transverse maximal diameter ≥ 7.0 cm or coronal maximal diameter ≥ 7.0 cm on CT imaging. * Age 18 and over. * ECOG Performance Status ≤ 2 * Females of childbearing age must be on an acceptable form of birth control per institutional standards during the treatment period. * Males must consistently use an acceptable form of contraception per institutional standards during the treatment period. Exclusion Criteria: * Prior systemic therapy or radiation therapy for Hodgkin lymphoma (excluding corticosteroids) * Cardiac ejection fraction \< 50% as measured by echocardiogram. * Platelet count ≤ 75,000/µL. * Hemoglobin level ≤ 7.0 mg/dL. * Absolute neutrophil count ≤ 1.0 K/µL. * Serum creatinine clearance \< 30 mL/minute as estimated by the Cockcroft-Gault Method