{"commentary":{"count":136,"free_build_floor":8,"listing_floor":3,"by_channel":{"youtube":70,"podcast":51,"x_thread":13,"x_video":2},"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\": \"NCT02005471\", \"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":"MURANO","nct_id":"NCT02005471","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=murano-nct02005471. 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":"MURANO","arms":[{"description":"Participants will receive bendamustine 70 milligrams per meter square (mg/m\\^2) via intravenous (IV) infusion on Days 1 and 2 of each 28-day cycle for 6 cycles, in combination with rituximab 375 mg/m\\^2 via IV infusion on Day 1 of Cycle 1 followed by 500 mg/m\\^2 on Day 1 of Cycles 2-6.","label":"Bendamustine + Rituximab","type":"ACTIVE_COMPARATOR"},{"description":"Participants will be initially placed on a venetoclax 5 weeks ramp-up period, and will receive an initial dose of 20 milligrams (mg) via tablet orally once daily (QD). Then the dose will be incremented weekly up to a maximum dose of 400 mg. Participants will then continue receiving venetoclax 400 mg QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards, as directed by the investigator, in combination with rituximab 375 mg/m\\^2 via IV infusion on Day 1 of Cycle 1 followed by 500 mg/m\\^2 on Day 1 of Cycles 2-6.","label":"Venetoclax + Rituximab","type":"EXPERIMENTAL"},{"description":"Participants entering the Crossover Substudy will have a 5-week venetoclax dose ramp-up period to reach the target dose of 400 mg QD. Following the venetoclax ramp-up period, Participants will receive 6 cycles of rituximab consisting of a single infusion on the first day of each 28-day cycle. Participants will continue to take their daily dose of venetoclax during the rituximab cycles. Participants who have not progressed following the completion of the 6 cycles will continue to receive venetoclax monotherapy until disease progression or for a maximum of 2 years from Cycle 1 Crossover Day 1 of the Substudy.","label":"Bendamustine + Rituximab Crossover Substudy","type":"EXPERIMENTAL"},{"description":"Participants entering the Re-Treatment Substudy will have a 5-week venetoclax dose ramp-up period to reach the target dose of 400 mg QD. Following the venetoclax ramp-up period, Participants will receive 6 cycles of rituximab consisting of a single infusion on the first day of each 28-day cycle. Participants will continue to take their daily dose of venetoclax during the rituximab cycles. Participants who have not progressed following the completion of the 6 cycles will continue to receive venetoclax monotherapy until disease progression or for a maximum of 2 years from Cycle 1 Re-Treatment Day 1 of the Substudy.","label":"Venetoclax + Rituximab Re-Treatment","type":"EXPERIMENTAL"}],"collaborators":["AbbVie"],"completion_date":{"date":"2022-08-03","type":"ACTUAL"},"conditions":["Chronic Lymphocytic Leukemia"],"enrollment":{"count":389,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Bendamustine","type":"DRUG"},{"name":"Venetoclax","type":"DRUG"},{"name":"Rituximab","type":"DRUG"}],"last_update":"2023-10-17","lead_sponsor":"Hoffmann-La Roche","official_title":"A Multicenter, Phase III, Open-Label, Randomized Study in Relapsed/Refractory Patients With Chronic Lymphocytic Leukemia to Evaluate the Benefit of Venetoclax (GDC-0199/ABT-199) Plus Rituximab Compared With Bendamustine Plus Rituximab","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2017-05-08","type":"ACTUAL"},"primary_outcomes":[{"measure":"Percentage of Participants With PD as Assessed by the Investigator Using Standard International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines or Death","timeFrame":"Baseline up to PD or death from any cause, whichever occurred first (up to approximately 8 years 5 months)"},{"measure":"Progression-Free Survival (PFS) as Assessed by the Investigator Using Standard iwCLL Guidelines","timeFrame":"Baseline up to PD or death, whichever occurred first (up to approximately 8 years 5 months)"}],"references":[{"citation":"Kater AP, Harrup R, Kipps TJ, Eichhorst B, Owen CJ, Assouline S, Lamanna N, Robak T, de la Serna J, Jaeger U, Cartron G, Montillo M, Mellink C, Langerak AW, Chyla B, Popovic R, Jiang Y, Millen R, Lefebure M, Thadani-Mulero M, Boyer M, Seymour JF. The MURANO study: final analysis and retreatment/crossover substudy results of VenR for patients with relapsed/refractory CLL. Blood. 2025 Jun 5;145(23):2733-2745. doi: 10.1182/blood.2024025525.","pmid":"40009494","type":"DERIVED"},{"citation":"Badawi M, Chen X, Marroum P, Suleiman AA, Mensing S, Koenigsdorfer A, Schiele JT, Palenski T, Samineni D, Hoffman D, Menon R, Salem AH. Bioavailability Evaluation of Venetoclax Lower-Strength Tablets and Oral Powder Formulations to Establish Interchangeability with the 100 mg Tablet. Clin Drug Investig. 2022 Aug;42(8):657-668. doi: 10.1007/s40261-022-01172-4. Epub 2022 Jul 13.","pmid":"35829925","type":"DERIVED"},{"citation":"Seymour JF, Kipps TJ, Eichhorst BF, D'Rozario J, Owen CJ, Assouline S, Lamanna N, Robak T, de la Serna J, Jaeger U, Cartron G, Montillo M, Mellink C, Chyla B, Panchal A, Lu T, Wu JQ, Jiang Y, Lefebure M, Boyer M, Kater AP. Enduring undetectable MRD and updated outcomes in relapsed/refractory CLL after fixed-duration venetoclax-rituximab. Blood. 2022 Aug 25;140(8):839-850. doi: 10.1182/blood.2021015014.","pmid":"35605176","type":"DERIVED"},{"citation":"Kater AP, Wu JQ, Kipps T, Eichhorst B, Hillmen P, D'Rozario J, Assouline S, Owen C, Robak T, de la Serna J, Jaeger U, Cartron G, Montillo M, Dubois J, Eldering E, Mellink C, Van Der Kevie-Kersemaekers AM, Kim SY, Chyla B, Punnoose E, Bolen CR, Assaf ZJ, Jiang Y, Wang J, Lefebure M, Boyer M, Humphrey K, Seymour JF. Venetoclax Plus Rituximab in Relapsed Chronic Lymphocytic Leukemia: 4-Year Results and Evaluation of Impact of Genomic Complexity and Gene Mutations From the MURANO Phase III Study. J Clin Oncol. 2020 Dec 1;38(34):4042-4054. doi: 10.1200/JCO.20.00948. Epub 2020 Sep 28.","pmid":"32986498","type":"DERIVED"},{"citation":"Kater AP, Seymour JF, Hillmen P, Eichhorst B, Langerak AW, Owen C, Verdugo M, Wu J, Punnoose EA, Jiang Y, Wang J, Boyer M, Humphrey K, Mobasher M, Kipps TJ. Fixed Duration of Venetoclax-Rituximab in Relapsed/Refractory Chronic Lymphocytic Leukemia Eradicates Minimal Residual Disease and Prolongs Survival: Post-Treatment Follow-Up of the MURANO Phase III Study. J Clin Oncol. 2019 Feb 1;37(4):269-277. doi: 10.1200/JCO.18.01580. Epub 2018 Dec 3.","pmid":"30523712","type":"DERIVED"},{"citation":"Seymour JF, Kipps TJ, Eichhorst B, Hillmen P, D'Rozario J, Assouline S, Owen C, Gerecitano J, Robak T, De la Serna J, Jaeger U, Cartron G, Montillo M, Humerickhouse R, Punnoose EA, Li Y, Boyer M, Humphrey K, Mobasher M, Kater AP. Venetoclax-Rituximab in Relapsed or Refractory Chronic Lymphocytic Leukemia. N Engl J Med. 2018 Mar 22;378(12):1107-1120. doi: 10.1056/NEJMoa1713976.","pmid":"29562156","type":"DERIVED"},{"citation":"Jones AK, Freise KJ, Agarwal SK, Humerickhouse RA, Wong SL, Salem AH. Clinical Predictors of Venetoclax Pharmacokinetics in Chronic Lymphocytic Leukemia and Non-Hodgkin's Lymphoma Patients: a Pooled Population Pharmacokinetic Analysis. AAPS J. 2016 Sep;18(5):1192-1202. doi: 10.1208/s12248-016-9927-9. Epub 2016 May 27.","pmid":"27233802","type":"DERIVED"}],"start_date":{"date":"2014-03-17","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study to Evaluate the Benefit of Venetoclax Plus Rituximab Compared With Bendamustine Plus Rituximab in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)","url":"https://clinicaltrials.gov/study/NCT02005471"},"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/murano-nct02005471"}