{"preliminary_commentary":{"by_channel":{"x_thread":3},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":false},"commentary_summary":null,"drugs_tested":null,"indication":"advanced stage Hodgkin lymphoma","name":"HD0801","nct_id":"NCT00784537","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=hd0801-nct00784537. The price is an estimate of verified statements from the commentary indexed so far. Final coverage is set when the report is built. You never pay more than quoted: if the report is delivered at a smaller size, you pay that size's price, and anything paid above it is refunded. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_rule":"Never more than quoted: the buyer pays the smaller of price_usd and the price the delivered edition is sold at.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"HD0801","arms":[{"description":"Two courses of ABVD. Early restaging with FDG-PET scan (PET-2)\n\nThe subsequent treatment will be as it follows:\n\n* PET-2 positive patients will be high-dose salvage treatment;\n* PET-2 negative patients will be treated with four additional courses of ABVD (for a total of six courses).\n\nThe following restaging procedures are planned as it follows:\n\n* Optional: Whole body CT scan after the fourth course of ABVD; no therapy change will be made according to CT scan.\n* Mandatory: Whole body CT and FDG-PET scans after the sixth course of ABVD (PET-6).\n\nPET-6 negative patients will be randomized to first arm:\n\nNo radiotherapy.","label":"Arm A","type":"OTHER"},{"description":"Two courses of ABVD. Early restaging with FDG-PET scan (PET-2)\n\nThe subsequent treatment will be as it follows:\n\n* PET-2 positive patients will be high-dose salvage treatment;\n* PET-2 negative patients will be treated with four additional courses of ABVD (for a total of six courses).\n\nThe following restaging procedures are planned as it follows:\n\n* Optional: Whole body CT scan after the fourth course of ABVD; no therapy change will be made according to CT scan.\n* Mandatory: Whole body CT and FDG-PET scans after the sixth course of ABVD (PET-6).\n\nPET-6 negative patients will be randomized to second arm:\n\nAdjuvant radiotherapy (30 Gy) on sites of initial bulky disease.","label":"Arm B","type":"OTHER"}],"collaborators":["Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte"],"completion_date":{"date":"2016-01","type":"ACTUAL"},"conditions":["Hodgkin's Lymphoma"],"enrollment":{"count":520,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"ABVD","otherNames":[],"type":"DRUG"},{"name":"ABVD and Radiotherapy","otherNames":[],"type":"DRUG"}],"last_update":"2018-02-08","lead_sponsor":"Fondazione Italiana Linfomi - ETS","official_title":"Early Salvage With High Dose Chemotherapy and Stem Cell Transplantation in Advanced Stage Hodgkin's Lymphoma Patients With Positive PET After Two Courses of ABVD (PET-2 Positive) and Comparison of RT Versus no RT in PET-2 Negative Patients","overall_status":"COMPLETED","phases":["PHASE2","PHASE3"],"primary_completion_date":{"date":"2015-01","type":"ACTUAL"},"primary_outcomes":[{"measure":"To evaluate if patients resistant to the initial treatment for residual PET-positive masses after the first two courses of ABVD (PET-2 positive), can be salvaged by early shift to high-dose chemotherapy supported by stem cell rescue.","timeFrame":"4 years"}],"references":[{"citation":"Kreuzberger N, Goldkuhle M, von Tresckow B, Kobe C, Sickinger MT, Monsef I, Skoetz N. Positron emission tomography-adapted therapy for first-line treatment in adults with Hodgkin lymphoma. Cochrane Database Syst Rev. 2025 Mar 26;3(3):CD010533. doi: 10.1002/14651858.CD010533.pub3.","pmid":"40135712","type":"DERIVED"},{"citation":"Ricardi U, Levis M, Evangelista A, Gioia DM, Sacchetti GM, Gotti M, Re A, Buglione M, Pavone V, Nardella A, Nassi L, Zanni M, Franzone P, Frezza GP, Pulsoni A, Grapulin L, Santoro A, Rigacci L, Simontacchi G, Tani M, Zaja F, Abruzzese E, Botto B, Zilioli VR, Rota-Scalabrini D, Freilone R, Ciccone G, Filippi AR, Zinzani PL. Role of radiotherapy to bulky sites of advanced Hodgkin lymphoma treated with ABVD: final results of FIL HD0801 trial. Blood Adv. 2021 Nov 9;5(21):4504-4514. doi: 10.1182/bloodadvances.2021005150.","pmid":"34597375","type":"DERIVED"},{"citation":"Zinzani PL, Broccoli A, Gioia DM, Castagnoli A, Ciccone G, Evangelista A, Santoro A, Ricardi U, Bonfichi M, Brusamolino E, Rossi G, Anastasia A, Zaja F, Vitolo U, Pavone V, Pulsoni A, Rigacci L, Gaidano G, Stelitano C, Salvi F, Rusconi C, Tani M, Freilone R, Pregno P, Borsatti E, Sacchetti GM, Argnani L, Levis A. Interim Positron Emission Tomography Response-Adapted Therapy in Advanced-Stage Hodgkin Lymphoma: Final Results of the Phase II Part of the HD0801 Study. J Clin Oncol. 2016 Apr 20;34(12):1376-85. doi: 10.1200/JCO.2015.63.0699. Epub 2016 Feb 16.","pmid":"26884559","type":"DERIVED"}],"start_date":{"date":"2008-09"},"study_type":"INTERVENTIONAL","title":"High-dose Chemotherapy and Stem Cell Transplantation, in Patients PET-2 Positive, After 2 Courses of ABVD and Comparison of RT Versus no RT in PET-2 Negative Patients","url":"https://clinicaltrials.gov/study/NCT00784537"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.2","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/hd0801-nct00784537"}