{"commentary":{"count":24,"free_build_floor":8,"listing_floor":3,"by_channel":{"youtube":10,"podcast":7,"x_thread":7},"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\": \"NCT02048813\", \"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":"NCT02048813","nct_id":"NCT02048813","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct02048813. 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":1250,"size":"standard","size_rule":"Standard: 13–40 commentary sources"},"registry":{"acronym":null,"arms":[{"description":"Patients receive ibrutinib PO QD on days 1-28. Beginning cycle 2, patients also receive rituximab IV over 4 hours on days 1 and 2 of cycle 2, and day 1 of cycles 3-7. Treatment repeats every 28 days for 7 cycles in the absence of unacceptable toxicity. In the absence of disease progression, patients may continue ibrutinib PO QD for a maximum of 10 years.","label":"Arm A (ibrutinib, rituximab)","type":"EXPERIMENTAL"},{"description":"Patients receive rituximab IV over 4 hours on days 1 and 2 of cycle 1, and day 1 of cycles 2-6. Patients also receive fludarabine phosphate IV over 30 minutes and cyclophosphamide IV over 30 minutes on days 1-3. Treatment repeats every 28 days for 6 cycles in the absence of unacceptable toxicity.","label":"Arm B (rituximab, fludarabine phosphate, cyclophosphamide)","type":"ACTIVE_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2026-10-09","type":"ESTIMATED"},"conditions":["Anemia","Chronic Lymphocytic Leukemia","Small Lymphocytic Lymphoma"],"enrollment":{"count":529,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Cyclophosphamide","type":"DRUG"},{"name":"Fludarabine Phosphate","type":"DRUG"},{"name":"Ibrutinib","type":"DRUG"},{"name":"Laboratory Biomarker Analysis","type":"OTHER"},{"name":"Pharmacogenomic Study","type":"OTHER"},{"name":"Quality-of-Life Assessment","type":"OTHER"},{"name":"Rituximab","type":"BIOLOGICAL"}],"last_update":"2026-08-28","lead_sponsor":"National Cancer Institute (NCI)","official_title":"A Randomized Phase III Study of Ibrutinib (PCI-32765)-Based Therapy vs Standard Fludarabine, Cyclophosphamide, and Rituximab (FCR) Chemoimmunotherapy in Untreated Younger Patients With Chronic Lymphocytic Leukemia (CLL)","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2018-10-24","type":"ACTUAL"},"primary_outcomes":[{"measure":"Progression-free Survival (PFS) Rate at 3 Years","timeFrame":"Assessed every 3 months until progression up to 4 years and 8 months"}],"references":[{"citation":"O'Connell NS, Zhao F, Lee JW, Ip EH, Peipert JD, Graham N, Smith ML, Gareen IF, Carlos RC, Obeng-Gyasi S, Sparano JA, Shanafelt TD, Thomas ML, Cella D, Wagner LI, Gray R. Importance of Low- and Moderate-Grade Adverse Events in Patients' Treatment Experience and Treatment Discontinuation: An Analysis of the E1912 Trial. J Clin Oncol. 2024 Jan 20;42(3):266-272. doi: 10.1200/JCO.23.00377. Epub 2023 Oct 6.","pmid":"37801678","type":"DERIVED"},{"citation":"Shanafelt TD, Wang XV, Hanson CA, Paietta EM, O'Brien S, Barrientos J, Jelinek DF, Braggio E, Leis JF, Zhang CC, Coutre SE, Barr PM, Cashen AF, Mato AR, Singh AK, Mullane MP, Little RF, Erba H, Stone RM, Litzow M, Tallman M, Kay NE. Long-term outcomes for ibrutinib-rituximab and chemoimmunotherapy in CLL: updated results of the E1912 trial. Blood. 2022 Jul 14;140(2):112-120. doi: 10.1182/blood.2021014960.","pmid":"35427411","type":"DERIVED"},{"citation":"Allan JN, Shanafelt T, Wiestner A, Moreno C, O'Brien SM, Li J, Krigsfeld G, Dean JP, Ahn IE. Long-term efficacy of first-line ibrutinib treatment for chronic lymphocytic leukaemia in patients with TP53 aberrations: a pooled analysis from four clinical trials. Br J Haematol. 2022 Feb;196(4):947-953. doi: 10.1111/bjh.17984. Epub 2021 Dec 5.","pmid":"34865212","type":"DERIVED"},{"citation":"List AF, Sun Z, Verma A, Bennett JM, Komrokji RS, McGraw K, Maciejewski J, Altman JK, Cheema PS, Claxton DF, Luger SM, Mattison RJ, Wassenaar TR, Artz AS, Schiffer CA, Litzow MR, Tallman MS. Lenalidomide-Epoetin Alfa Versus Lenalidomide Monotherapy in Myelodysplastic Syndromes Refractory to Recombinant Erythropoietin. J Clin Oncol. 2021 Mar 20;39(9):1001-1009. doi: 10.1200/JCO.20.01691. Epub 2021 Jan 13.","pmid":"33439748","type":"DERIVED"},{"citation":"Shanafelt TD, Wang XV, Kay NE, Hanson CA, O'Brien S, Barrientos J, Jelinek DF, Braggio E, Leis JF, Zhang CC, Coutre SE, Barr PM, Cashen AF, Mato AR, Singh AK, Mullane MP, Little RF, Erba H, Stone RM, Litzow M, Tallman M. Ibrutinib-Rituximab or Chemoimmunotherapy for Chronic Lymphocytic Leukemia. N Engl J Med. 2019 Aug 1;381(5):432-443. doi: 10.1056/NEJMoa1817073.","pmid":"31365801","type":"DERIVED"}],"start_date":{"date":"2014-03-10","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Ibrutinib and Rituximab Compared With Fludarabine Phosphate, Cyclophosphamide, and Rituximab in Treating Patients With Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma","url":"https://clinicaltrials.gov/study/NCT02048813"},"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/nct02048813"}