protocolSection identificationModule nctId: NCT06377566, orgStudyIdInfo id: 24-039, briefTitle: A Study of BV-AVD in People With Bulky Hodgkin Lymphoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-17, primaryCompletionDateStruct date: 2027-04, completionDateStruct date: 2027-04, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Memorial Sloan Kettering Cancer Center, class: OTHER, collaborators name: Seagen Inc., descriptionModule briefSummary: 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., conditionsModule conditions: Hodgkin Lymphoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This is a multicenter, investigator-initiated, single-arm phase II trial., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 71, type: ESTIMATED, armsInterventionsModule interventions name: Brentuximab vedotin, interventions name: Doxorubicin, interventions name: Vinblastine, interventions name: Dacarbazine, interventions name: Pembrolizumab, interventions name: Gemcitabine, interventions name: Vinorelbine, interventions name: FDG-PET/CT scan, outcomesModule primaryOutcomes measure: progression-free survival, secondaryOutcomes measure: overall survival, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Miami, status: NOT_YET_RECRUITING, city: Miami, state: Florida, zip: 33136, country: United States, contacts name: Craig Moskowitz, MD, role: CONTACT, phone: 305-243-5302, geoPoint lat: 25.77427, lon: -80.19366, locations facility: Memorial Sloan Kettering Basking Ridge (All Protocol Activities), status: RECRUITING, city: Basking Ridge, state: New Jersey, zip: 07920, country: United States, contacts name: Robert Stuver, MD, role: CONTACT, phone: 646-608-4308, geoPoint lat: 40.70621, lon: -74.54932, locations facility: Memorial Sloan Kettering Monmouth (All Protocol Activities), status: RECRUITING, city: Middletown, state: New Jersey, zip: 07748, country: United States, contacts name: Robert Stuver, MD, role: CONTACT, phone: 646-608-4308, geoPoint lat: 40.39652, lon: -74.09211, locations facility: Memorial Sloan Kettering Bergen (All Protocol Activities), status: RECRUITING, city: Montvale, state: New Jersey, zip: 07645, country: United States, contacts name: Robert Stuver, MD, role: CONTACT, phone: 646-608-4308, geoPoint lat: 41.04676, lon: -74.02292, locations facility: Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities), status: RECRUITING, city: Commack, state: New York, zip: 11725, country: United States, contacts name: Robert Stuver, MD, role: CONTACT, phone: 646-608-4308, geoPoint lat: 40.84288, lon: -73.29289, locations facility: Memorial Sloan Kettering Westchester (All Protocol Activities), status: RECRUITING, city: Harrison, state: New York, zip: 10604, country: United States, contacts name: Robert Stuver, MD, role: CONTACT, phone: 646-608-4308, geoPoint lat: 40.96899, lon: -73.71263, locations facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities), status: RECRUITING, city: New York, state: New York, zip: 10065, country: United States, contacts name: Robert Stuver, MD, role: CONTACT, phone: 646-608-4308, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Memorial Sloan Kettering Nassau (All Protocol Activities), status: RECRUITING, city: Uniondale, state: New York, zip: 11553, country: United States, contacts name: Robert Stuver, MD, role: CONTACT, phone: 646-608-4308, geoPoint lat: 40.70038, lon: -73.59291, hasResults: False