{"commentary":{"count":3,"free_build_floor":8,"listing_floor":3,"by_channel":{"x_thread":3},"note":"Indexed podcasts, YouTube videos and X posts that name this trial. A report screens them, searches for more and cites what clinicians said when it is built."},"free_build":{"available":false},"name":"NCT05675410","nct_id":"NCT05675410","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct05675410. The price is fixed at order. We build the report after the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":750,"size":"focused","size_rule":"Focused: 1–12 commentary sources"},"registry":{"acronym":null,"arms":[{"description":"Patients are stratified by risk status (favorable versus unfavorable) and then all patients receive the ABVD regimen (doxorubicin hydrochloride IV over 3-15 minutes, bleomycin sulfate IV over at least 10 minutes, vinblastine sulfate IV, and dacarbazine IV over 15-60 minutes) on days 1 and 15 of each treatment cycle. Cycles repeat every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo FDG-PET/CT or MRI and are identified as RER or SER. Patients then receive ABVD IV for an additional 2 cycles on study. Each cycle lasts 28 days and ABVD is administered on days 1 and 15 of each cycle in the absence of disease progression or unacceptable toxicity. Patients also undergo FDG-PET, PET, PET-CT, PET-MRI, CT, and/or MRI throughout the trial. Patients may also undergo blood sample collection on trial.","label":"Arm A (ABVD)","type":"ACTIVE_COMPARATOR"},{"description":"Patients are stratified by risk status (favorable versus unfavorable) and then all patients receive the ABVD regimen (doxorubicin hydrochloride IV over 3-15 minutes, bleomycin sulfate IV over at least 10 minutes, vinblastine sulfate IV, and dacarbazine IV over 15-60 minutes) on days 1 and 15 of each treatment cycle. Cycles repeat every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo FDG-PET/CT or MRI and are identified as RER or SER. Patients then receive brentuximab vedotin IV over 30 minutes and nivolumab IV over 30 minutes once during each treatment cycle. Cycles repeat every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo FDG-PET, PET, PET-CT, PET-MRI, CT, and/or MRI throughout the trial. Patients may also undergo blood sample collection on trial.","label":"Arm B (ABVD, brentuximab vedotin, nivolumab)","type":"EXPERIMENTAL"},{"description":"See Detailed Description.","label":"Arm C (ABVD, eBEACOPP or eBPDac, ISRT)","type":"EXPERIMENTAL"},{"description":"Patients are stratified by risk status (favorable versus unfavorable) and then all patients receive the ABVD regimen (doxorubicin hydrochloride IV over 3-15 minutes, bleomycin sulfate IV over at least 10 minutes, vinblastine sulfate IV, and dacarbazine IV over 15-60 minutes) on days 1 and 15 of each treatment cycle. Cycles repeat every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo FDG-PET/CT or MRI and are identified as RER or SER. Patients then receive brentuximab vedotin IV and nivolumab IV as in arm B followed by ISRT. Patients also undergo FDG-PET, PET, PET-CT, PET-MRI, CT, and/or MRI throughout the trial. Patients may also undergo blood sample collection on trial.","label":"Arm D (ABVD, brentuximab vedotin, nivolumab, ISRT)","type":"EXPERIMENTAL"},{"description":"Patients are stratified by risk status (favorable versus unfavorable) and then all patients receive the ABVD regimen (doxorubicin hydrochloride IV over 3-15 minutes, bleomycin sulfate IV over at least 10 minutes, vinblastine sulfate IV, and dacarbazine IV over 15-60 minutes) on days 1 and 15 of each treatment cycle. Cycles repeat every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo FDG-PET/CT or MRI and are identified as RER or SER. Patients then receive AVD regimen (doxorubicin hydrochloride IV over 3-15 minutes, vinblastine IV, and dacarbazine IV over 15-60 minutes) on days 1 and 15 of each treatment cycle. Cycles repeat every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo FDG-PET, PET, PET-CT, PET-MRI, CT, and/or MRI throughout the trial. Patients may also undergo blood sample collection on trial.","label":"Arm E (ABVD, AVD)","type":"EXPERIMENTAL"},{"description":"Patients are stratified by risk status (favorable versus unfavorable) and then all patients receive the ABVD regimen (doxorubicin hydrochloride IV over 3-15 minutes, bleomycin sulfate IV over at least 10 minutes, vinblastine sulfate IV, and dacarbazine IV over 15-60 minutes) on days 1 and 15 of each treatment cycle. Cycles repeat every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo FDG-PET/CT or MRI and are identified as RER or SER. Patients then receive treatment as in arm B. Patients also undergo FDG-PET, PET, PET-CT, PET-MRI, CT, and/or MRI throughout the trial. Patients may also undergo blood sample collection on trial.","label":"Arm F (ABVD, brentuximab vedotin, nivolumab)","type":"EXPERIMENTAL"},{"description":"Patients are stratified by risk status (favorable versus unfavorable) and then all patients receive the ABVD regimen (doxorubicin hydrochloride IV over 3-15 minutes, bleomycin sulfate IV over at least 10 minutes, vinblastine sulfate IV, and dacarbazine IV over 15-60 minutes) on days 1 and 15 of each treatment cycle. Cycles repeat every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo FDG-PET/CT or MRI and are identified as RER or SER. Patients then receive treatment and imaging, and may undergo blood sample collection as in arm C.","label":"Arm G (ABVD, eBEACOPP or eBPDac, ISRT)","type":"EXPERIMENTAL"},{"description":"Patients are stratified by risk status (favorable versus unfavorable) and then all patients receive the ABVD regimen (doxorubicin hydrochloride IV over 3-15 minutes, bleomycin sulfate IV over at least 10 minutes, vinblastine sulfate IV, and dacarbazine IV over 15-60 minutes) on days 1 and 15 of each treatment cycle. Cycles repeat every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo FDG-PET/CT or MRI and are identified as RER or SER. Patients then receive treatment and imaging, and may undergo blood sample collection as in arm D.","label":"Arm H (ABVD, brentuximab vedotin, nivolumab, ISRT)","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2031-04-28","type":"ESTIMATED"},"conditions":["Lugano Classification Limited Stage Hodgkin Lymphoma AJCC v8"],"enrollment":{"count":1875,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Biospecimen Collection","type":"PROCEDURE"},{"name":"Bleomycin Sulfate","type":"BIOLOGICAL"},{"name":"Brentuximab Vedotin","type":"DRUG"},{"name":"Computed Tomography","type":"PROCEDURE"},{"name":"Cyclophosphamide","type":"DRUG"},{"name":"Dacarbazine","type":"DRUG"},{"name":"Doxorubicin Hydrochloride","type":"DRUG"},{"name":"Etoposide","type":"DRUG"},{"name":"Etoposide Phosphate","type":"DRUG"},{"name":"Fludeoxyglucose F-18","type":"OTHER"},{"name":"Involved-site Radiation Therapy","type":"RADIATION"},{"name":"Magnetic Resonance Imaging","type":"PROCEDURE"},{"name":"Nivolumab","type":"BIOLOGICAL"},{"name":"Positron Emission Tomography","type":"PROCEDURE"},{"name":"Prednisolone","type":"DRUG"},{"name":"Prednisone","type":"DRUG"},{"name":"Procarbazine Hydrochloride","type":"DRUG"},{"name":"Questionnaire Administration","type":"OTHER"},{"name":"Vinblastine Sulfate","type":"DRUG"},{"name":"Vincristine Sulfate","type":"DRUG"}],"last_update":"2026-10-09","lead_sponsor":"National Cancer Institute (NCI)","official_title":"A Randomized Phase 3 Interim Response Adapted Trial Comparing Standard Therapy With Immuno-oncology Therapy for Children and Adults With Newly Diagnosed Stage I and II Classic Hodgkin Lymphoma","overall_status":"RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2031-04-28","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Progression-free survival (PFS) in rapid early responder (RER) patients","timeFrame":"From the time of randomization to the earliest time of disease relapse, progression, or death due to any cause, assessed up to 3 years after the randomization of the last patient or when reaching 124 events, whichever comes first"},{"measure":"PFS in slow-early responder (SER) patients","timeFrame":"From the time of randomization to the earliest time of disease relapse, progression, or death due to any cause, assessed up to 3 years after the randomization of the last patient or when reaching 71 events, whichever comes first"}],"references":[{"citation":"Castellino SM, Giulino-Roth L, Harker-Murray P, Kahn JM, Forlenza C, Cho S, Hoppe B, Parsons SK, Kelly KM; COG Hodgkin Lymphoma Committee. Children's Oncology Group's 2023 blueprint for research: Hodgkin lymphoma. Pediatr Blood Cancer. 2023 Sep;70 Suppl 6(Suppl 6):e30580. doi: 10.1002/pbc.30580. Epub 2023 Jul 28.","pmid":"37505794","type":"DERIVED"}],"start_date":{"date":"2023-05-11","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study to Compare Standard Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab Vedotin and Nivolumab","url":"https://clinicaltrials.gov/study/NCT05675410"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"2.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/nct05675410"}