{"preliminary_commentary":{"by_channel":{"x_thread":2,"youtube":1},"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":[["rituximab"],["R-FC"]],"indication":"mantle cell lymphoma in elderly patients","name":"European MCL Elderly","nct_id":"NCT00209209","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=european-mcl-elderly-nct00209209. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. 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_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"MCLelderly","arms":[{"description":"1. randomisation: R-CHOP\n2. randomisation: IFN maintenance","label":"1","type":"ACTIVE_COMPARATOR"},{"description":"1. randomisation: R-FC\n2. randomisation: Rituximab maintnenance","label":"2","type":"EXPERIMENTAL"}],"collaborators":["German Low Grade Lymphoma Study Group","Lymphoma Study Association","HOVON - Dutch Haemato-Oncology Association","Nordic Lymphoma Group"],"completion_date":{"date":"2018-12","type":"ESTIMATED"},"conditions":["Lymphoma, Mantle-Cell"],"enrollment":{"count":570,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Rituximab","otherNames":[],"type":"DRUG"},{"name":"Cyclophosphamide","otherNames":[],"type":"DRUG"},{"name":"Doxorubicin","otherNames":[],"type":"DRUG"},{"name":"Vincristine","otherNames":[],"type":"DRUG"},{"name":"Prednisone","otherNames":[],"type":"DRUG"},{"name":"Fludarabine","otherNames":[],"type":"DRUG"},{"name":"Interferon-alpha","otherNames":[],"type":"DRUG"},{"name":"pegylated formula Interferon-alpha 2b","otherNames":[],"type":"DRUG"},{"name":"chemotherapy: R-CHOP","otherNames":[],"type":"PROCEDURE"},{"name":"chemotherapy: R-FC","otherNames":[],"type":"PROCEDURE"},{"name":"Interferon maintenance","otherNames":[],"type":"PROCEDURE"},{"name":"Rituximab maintenance","otherNames":[],"type":"PROCEDURE"}],"last_update":"2017-03-07","lead_sponsor":"European Mantle Cell Lymphoma Network","official_title":"Efficacy of Maintenance Therapy With Rituximab After Induction Chemotherapy (R-CHOP vs. R-FC) for Elderly Patients With Mantle Cell Lymphoma Not Suitable for Autologous Stem Cell Transplantation","overall_status":"UNKNOWN","phases":["PHASE3"],"primary_completion_date":{"date":"2018-12","type":"ESTIMATED"},"primary_outcomes":[{"measure":"First randomisation: Reduction of lymphoma mass measured by the complete remission (CR) rate","timeFrame":null},{"measure":"Second randomisation: progression-free survival after end of initial chemotherapy","timeFrame":null}],"references":[{"citation":"Kluin-Nelemans HC, Hoster E, Hermine O, Walewski J, Trneny M, Geisler CH, Stilgenbauer S, Thieblemont C, Vehling-Kaiser U, Doorduijn JK, Coiffier B, Forstpointner R, Tilly H, Kanz L, Feugier P, Szymczyk M, Hallek M, Kremers S, Lepeu G, Sanhes L, Zijlstra JM, Bouabdallah R, Lugtenburg PJ, Macro M, Pfreundschuh M, Prochazka V, Di Raimondo F, Ribrag V, Uppenkamp M, Andre M, Klapper W, Hiddemann W, Unterhalt M, Dreyling MH. Treatment of older patients with mantle-cell lymphoma. N Engl J Med. 2012 Aug 9;367(6):520-31. doi: 10.1056/NEJMoa1200920.","pmid":"22873532","type":"RESULT"},{"citation":"Hoster E, Delfau-Larue MH, Macintyre E, Jiang L, Stilgenbauer S, Vehling-Kaiser U, Salles G, Thieblemont C, Tilly H, Wirths S, Feugier P, Hubel K, Schmidt C, Ribrag V, Kluin-Nelemans JC, Dreyling M, Pott C; European MCL MRD Working Group and the European MCL Network. Predictive Value of Minimal Residual Disease for Efficacy of Rituximab Maintenance in Mantle Cell Lymphoma: Results From the European Mantle Cell Lymphoma Elderly Trial. J Clin Oncol. 2024 Feb 10;42(5):538-549. doi: 10.1200/JCO.23.00899. Epub 2023 Nov 22.","pmid":"37992261","type":"DERIVED"},{"citation":"Kluin-Nelemans HC, Hoster E, Hermine O, Walewski J, Geisler CH, Trneny M, Stilgenbauer S, Kaiser F, Doorduijn JK, Salles G, Szymczyk M, Tilly H, Kanz L, Schmidt C, Feugier P, Thieblemont C, Zijlstra JM, Ribrag V, Klapper W, Pott C, Unterhalt M, Dreyling MH. Treatment of Older Patients With Mantle Cell Lymphoma (MCL): Long-Term Follow-Up of the Randomized European MCL Elderly Trial. J Clin Oncol. 2020 Jan 20;38(3):248-256. doi: 10.1200/JCO.19.01294. Epub 2019 Dec 5.","pmid":"31804876","type":"DERIVED"},{"citation":"Hoster E, Klapper W, Hermine O, Kluin-Nelemans HC, Walewski J, van Hoof A, Trneny M, Geisler CH, Di Raimondo F, Szymczyk M, Stilgenbauer S, Thieblemont C, Hallek M, Forstpointner R, Pott C, Ribrag V, Doorduijn J, Hiddemann W, Dreyling MH, Unterhalt M. Confirmation of the mantle-cell lymphoma International Prognostic Index in randomized trials of the European Mantle-Cell Lymphoma Network. J Clin Oncol. 2014 May 1;32(13):1338-46. doi: 10.1200/JCO.2013.52.2466. Epub 2014 Mar 31.","pmid":"24687837","type":"DERIVED"},{"citation":"Pott C, Hoster E, Delfau-Larue MH, Beldjord K, Bottcher S, Asnafi V, Plonquet A, Siebert R, Callet-Bauchu E, Andersen N, van Dongen JJ, Klapper W, Berger F, Ribrag V, van Hoof AL, Trneny M, Walewski J, Dreger P, Unterhalt M, Hiddemann W, Kneba M, Kluin-Nelemans HC, Hermine O, Macintyre E, Dreyling M. Molecular remission is an independent predictor of clinical outcome in patients with mantle cell lymphoma after combined immunochemotherapy: a European MCL intergroup study. Blood. 2010 Apr 22;115(16):3215-23. doi: 10.1182/blood-2009-06-230250. Epub 2009 Dec 23.","pmid":"20032498","type":"DERIVED"}],"start_date":{"date":"2004-01-14","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Induction Chemotherapy (R-CHOP Vs. R-FC) Followed by Interferon Maintenance Versus Rituximab Maintenance in MCL","url":"https://clinicaltrials.gov/study/NCT00209209"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.1","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/european-mcl-elderly-nct00209209"}