{"commentary":{"count":142,"free_build_floor":8,"listing_floor":3,"by_channel":{"youtube":69,"podcast":48,"x_thread":25},"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":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT02950051\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's public preview; the full report is still bought."},"name":"GAIA","nct_id":"NCT02950051","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=gaia-nct02950051. 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":1950,"size":"deep","size_rule":"Deep: 41+ commentary sources"},"registry":{"acronym":"GAIA","arms":[{"description":"Patients up to age 65: 6 cycles (q28d) of Fludarabine + Cyclophosphamide + Rituximab (FCR)\n\nPatients older than 65 years: 6 cycles (q28d) of Bendamustine + Rituximab (BR)","label":"Standard chemoimmunotherapy (SCIT)","type":"ACTIVE_COMPARATOR"},{"description":"6 cycles (q28d) of RVe + 6 cycles (q28d) of Venetoclax (alone)","label":"Rituximab + Venetoclax (RVe)","type":"EXPERIMENTAL"},{"description":"6 cycles (q28d) of GVe + 6 cycles (q28d) of Venetoclax (alone)","label":"Obinutuzumab + Venetoclax (GVe)","type":"EXPERIMENTAL"},{"description":"6 cycles (q28d) of GIVe + 6 cycles (q28d) of Ibrutinib plus Venetoclax.\n\nAdministration of ibrutinib will be continued for a maximum of 36 months or until MRD negativity, start of new anti-CLL therapy or inacceptable toxicity, whatever occurs first.","label":"Obinutuzumab + Ibrutinib + Venetoclax (GIVe)","type":"EXPERIMENTAL"}],"collaborators":["Janssen-Cilag Ltd.","Hoffmann-La Roche","AbbVie","Stichting Hemato-Oncologie voor Volwassenen Nederland","Nordic CLL Study Group (NCLLSG)","Swiss Cancer Institute","Cancer Trials Ireland","Israeli CLL Study Group"],"completion_date":{"date":"2024-02-29","type":"ACTUAL"},"conditions":["Chronic Lymphocytic Leukemia"],"enrollment":{"count":926,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Fludarabine","type":"DRUG"},{"name":"Cyclophosphamide","type":"DRUG"},{"name":"Rituximab","type":"BIOLOGICAL"},{"name":"Bendamustine","type":"DRUG"},{"name":"Venetoclax","type":"DRUG"},{"name":"Obinutuzumab","type":"BIOLOGICAL"},{"name":"Ibrutinib","type":"DRUG"}],"last_update":"2024-12-30","lead_sponsor":"German CLL Study Group","official_title":"A Phase 3 Multicenter, Randomized, Prospective, Open-label Trial of Standard Chemoimmunotherapy (FCR/BR) Versus Rituximab Plus Venetoclax (RVe) Versus Obinutuzumab (GA101) Plus Venetoclax (GVe) Versus Obinutuzumab Plus Ibrutinib Plus Venetoclax (GIVe) in Fit Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL) Without Del(17p) or TP53 Mutation","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2024-02-29","type":"ACTUAL"},"primary_outcomes":[{"measure":"Miminimal residual disease (MRD) negativity rate in peripheral blood (PB)","timeFrame":"Month 15"},{"measure":"Progression free survival (PFS)","timeFrame":"anticipated for January 2023 (after 213 events occured and 73 months after the first patient has been randomized"}],"references":[{"citation":"Furstenau M, Kater AP, Robrecht S, von Tresckow J, Zhang C, Gregor M, Thornton P, Staber PB, Tadmor T, Lindstrom V, Juliusson G, Janssens A, Levin MD, da Cunha-Bang C, Schneider C, Goldschmidt N, Vandenberghe E, Rossi D, Benz R, Nosslinger T, Heintel D, Poulsen CB, Christiansen I, Frederiksen H, Enggaard L, Posthuma EFM, Issa DE, Visser HPJ, Bellido M, Kutsch N, Durig J, Stehle A, Vohringer M, Bottcher S, Schulte C, Simon F, Fink AM, Fischer K, Holmes EE, Kreuzer KA, Ritgen M, Bruggemann M, Tausch E, Stilgenbauer S, Hallek M, Niemann CU, Eichhorst B. First-line venetoclax combinations versus chemoimmunotherapy in fit patients with chronic lymphocytic leukaemia (GAIA/CLL13): 4-year follow-up from a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2024 Jun;25(6):744-759. doi: 10.1016/S1470-2045(24)00196-7.","pmid":"38821083","type":"RESULT"},{"citation":"Eichhorst B, Niemann CU, Kater AP, Furstenau M, von Tresckow J, Zhang C, Robrecht S, Gregor M, Juliusson G, Thornton P, Staber PB, Tadmor T, Lindstrom V, da Cunha-Bang C, Schneider C, Poulsen CB, Illmer T, Schottker B, Nosslinger T, Janssens A, Christiansen I, Baumann M, Frederiksen H, van der Klift M, Jager U, Leys MBL, Hoogendoorn M, Lotfi K, Hebart H, Gaska T, Koene H, Enggaard L, Goede J, Regelink JC, Widmer A, Simon F, De Silva N, Fink AM, Bahlo J, Fischer K, Wendtner CM, Kreuzer KA, Ritgen M, Bruggemann M, Tausch E, Levin MD, van Oers M, Geisler C, Stilgenbauer S, Hallek M; GCLLSG, the HOVON and Nordic CLL Study Groups, the SAKK, the Israeli CLL Association, and Cancer Trials Ireland. First-Line Venetoclax Combinations in Chronic Lymphocytic Leukemia. N Engl J Med. 2023 May 11;388(19):1739-1754. doi: 10.1056/NEJMoa2213093.","pmid":"37163621","type":"RESULT"},{"citation":"Jebaraj BMC, Tausch E, Yosifov DY, Schneider C, Furstenau M, Zhang C, Robrecht S, da Cunha-Bang C, Levin MD, Staber PB, Huber H, Tadmor T, Thornton P, Gregor M, Fink AM, Fischer K, Kreuzer KA, Ritgen M, Hallek MJ, Kater AP, Niemann CU, Eichhorst BF, Stilgenbauer S. Telomere length in chronic lymphocytic leukemia treated with venetoclax-based regimen in GAIA/CLL13 and CLL2-GIVe trials. Blood. 2026 Oct 6:blood.2025032302. doi: 10.1182/blood.2025032302. Online ahead of print.","pmid":"42837320","type":"DERIVED"},{"citation":"Furstenau M, Niemann CU, Robrecht S, Rotbain EC, Eurelings L, Giza A, von Tresckow J, Zhang C, Gregor M, Thornton P, Staber PB, Tadmor T, Lindstrom V, Juliusson G, Janssens A, da Cunha-Bang C, Schneider C, Herishanu Y, O'Shea D, Baumann M, Widmer A, Nosslinger T, Poulsen CB, Frederiksen H, Lotfi K, Ranti J, Enggaard L, Velders G, Vekemans MC, de Heer K, Snijders TF, Siemes C, Wendtner CM, Knauf W, Kroeber A, Zahn MO, Illmer T, Schottker B, Simon F, Fink A, Fischer K, D'Brot R, Holmes E, Kreuzer KA, Ritgen M, Bruggemann M, Tausch E, Stilgenbauer S, Levin MD, Hallek M, Kater AP, Eichhorst B. Venetoclax combinations in untreated CLL: 5-year results and patient-reported outcomes analysis of the CLL13/GAIA trial. Blood. 2026 Jun 18;147(25):3025-3038. doi: 10.1182/blood.2025032160.","pmid":"41911073","type":"DERIVED"},{"citation":"Langerbeins P, Giza A, Robrecht S, Cramer P, von Tresckow J, Al-Sawaf O, Fink AM, Furstenau M, Kutsch N, Simon F, Goede V, Hoechstetter M, Niemann CU, da Cunha-Bang C, Kater A, Dubois J, Gregor M, Staber PB, Tausch E, Schneider C, Stilgenbauer S, Eichhorst B, Fischer K, Hallek M. Reassessing the chronic lymphocytic leukemia International Prognostic Index in the era of targeted therapies. Blood. 2024 Jun 20;143(25):2588-2598. doi: 10.1182/blood.2023022564.","pmid":"38620092","type":"DERIVED"},{"citation":"Furstenau M, Thus YJ, Robrecht S, Mellink CHM, van der Kevie-Kersemaekers AM, Dubois J, von Tresckow J, Patz M, Gregor M, Thornton P, Staber PB, Tadmor T, Levin MD, da Cunha-Bang C, Schneider C, Poulsen CB, Illmer T, Schottker B, Janssens A, Christiansen I, Nosslinger T, Baumann M, Hebart H, Gaska T, Regelink JC, Dompeling EC, Lindstrom V, Juliusson G, Widmer A, Goede J, Goldschmidt N, Simon F, De Silva N, Fink AM, Fischer K, Wendtner CM, Ritgen M, Bruggemann M, Tausch E, Spaargaren M, Eldering E, Stilgenbauer S, Niemann CU, Hallek M, Eichhorst B, Kreuzer KA, Kater AP. High karyotypic complexity is an independent prognostic factor in patients with CLL treated with venetoclax combinations. Blood. 2023 Aug 3;142(5):446-459. doi: 10.1182/blood.2023019634.","pmid":"37172204","type":"DERIVED"},{"citation":"Furstenau M, Langerbeins P, De Silva N, Fink AM, Robrecht S, von Tresckow J, Simon F, Hohloch K, Droogendijk J, van der Klift M, van der Spek E, Illmer T, Schottker B, Fischer K, Wendtner CM, Tausch E, Stilgenbauer S, Niemann CU, Gregor M, Kater AP, Hallek M, Eichhorst B. COVID-19 among fit patients with CLL treated with venetoclax-based combinations. Leukemia. 2020 Aug;34(8):2225-2229. doi: 10.1038/s41375-020-0941-7. Epub 2020 Jun 29. No abstract available.","pmid":"32601378","type":"DERIVED"}],"start_date":{"date":"2016-12-13","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Standard Chemoimmunotherapy (FCR/BR) Versus Rituximab + Venetoclax (RVe) Versus Obinutuzumab (GA101) + Venetoclax (GVe) Versus Obinutuzumab + Ibrutinib + Venetoclax (GIVe) in Fit Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL) Without Del(17p) or TP53 Mutation","url":"https://clinicaltrials.gov/study/NCT02950051"},"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/gaia-nct02950051"}