{"preliminary_commentary":{"by_channel":{"x_thread":15,"youtube":8,"podcast":5},"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":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT01010061\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's free public preview; the full report is still bought."},"commentary_summary":null,"drugs_tested":[["obinutuzumab"]],"indication":"previously untreated chronic lymphocytic leukemia with comorbidities","name":"CLL11","nct_id":"NCT01010061","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=cll11-nct01010061. 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":1950,"size":"deep","size_rule":"Deep: 301+ verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \\[first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).","label":"obinutuzumab + chlorambucil (GClb)","type":"EXPERIMENTAL"},{"description":"Participants received 375 mg/m\\^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m\\^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).","label":"rituximab + chlorambucil (RClb)","type":"ACTIVE_COMPARATOR"},{"description":"Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.","label":"Chlorambucil (Clb)","type":"ACTIVE_COMPARATOR"}],"collaborators":["German CLL Study Group","Genentech, Inc."],"completion_date":{"date":"2017-08-23","type":"ACTUAL"},"conditions":["Lymphocytic Leukemia, Chronic"],"enrollment":{"count":787,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"obinutuzumab","otherNames":["RO5072759","GA101","GAZYVA®"],"type":"DRUG"},{"name":"rituximab","otherNames":["Rituxan®","MabThera®"],"type":"DRUG"},{"name":"chlorambucil","otherNames":[],"type":"DRUG"}],"last_update":"2018-09-14","lead_sponsor":"Hoffmann-La Roche","official_title":"An Open-label, Multi-center, Three Arm Randomized Study to Investigate the Safety and Efficacy on Progression-free Survival of RO5072759 + Chlorambucil (GClb) Compared to Rituximab + Chlorambucil (RClb) or Chlorambucil (Clb) Alone in Previously Untreated CLL Patients With Comorbidities.","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2012-07-01","type":"ACTUAL"},"primary_outcomes":[{"measure":"Progression-free Survival (PFS)","timeFrame":"Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization)"},{"measure":"Percentage of Participants With Progression Free Survival Events","timeFrame":"Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization)"}],"references":[{"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":"Jaramillo S, Agathangelidis A, Schneider C, Bahlo J, Robrecht S, Tausch E, Bloehdorn J, Hoechstetter M, Fischer K, Eichhorst B, Goede V, Hallek M, Dohner H, Rosenquist R, Ghia P, Stamatopoulos K, Stilgenbauer S. Prognostic impact of prevalent chronic lymphocytic leukemia stereotyped subsets: analysis within prospective clinical trials of the German CLL Study Group (GCLLSG). Haematologica. 2020 Nov 1;105(11):2598-2607. doi: 10.3324/haematol.2019.231027.","pmid":"33131249","type":"DERIVED"},{"citation":"Gibiansky E, Gibiansky L, Buchheit V, Frey N, Brewster M, Fingerle-Rowson G, Jamois C. Pharmacokinetics, exposure, efficacy and safety of obinutuzumab in rituximab-refractory follicular lymphoma patients in the GADOLIN phase III study. Br J Clin Pharmacol. 2019 Sep;85(9):1935-1945. doi: 10.1111/bcp.13974. Epub 2019 Jul 12.","pmid":"31050355","type":"DERIVED"},{"citation":"Goede V, Fischer K, Busch R, Engelke A, Eichhorst B, Wendtner CM, Chagorova T, de la Serna J, Dilhuydy MS, Illmer T, Opat S, Owen CJ, Samoylova O, Kreuzer KA, Stilgenbauer S, Dohner H, Langerak AW, Ritgen M, Kneba M, Asikanius E, Humphrey K, Wenger M, Hallek M. Obinutuzumab plus chlorambucil in patients with CLL and coexisting conditions. N Engl J Med. 2014 Mar 20;370(12):1101-10. doi: 10.1056/NEJMoa1313984. Epub 2014 Jan 8.","pmid":"24401022","type":"DERIVED"}],"start_date":{"date":"2009-12-21","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"CLL11: A Study of Obinutuzumab (RO5072759 [GA101]) With Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 1a)","url":"https://clinicaltrials.gov/study/NCT01010061"},"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/cll11-nct01010061"}