{"preliminary_commentary":{"by_channel":{"x_thread":3,"youtube":1},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build."},"free_build":{"available":false},"name":"NCT01886872","nct_id":"NCT01886872","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct01886872. The price is quoted from the commentary indexed so far and fixed at order. Final coverage is set when the report is built. 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":750,"size":"focused","size_rule":"Focused: 1–150 verified HCP statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Patients receive rituximab IV on day 1 (day 0 course 1) and bendamustine hydrochloride IV over 30 minutes on days 1-2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression may crossover to Arm II. Additionally, patients undergo bone marrow aspiration and biopsy, blood sample collection, and CT throughout the study.","label":"Arm I (rituximab, bendamustine hydrochloride)","type":"ACTIVE_COMPARATOR"},{"description":"Patients receive ibrutinib PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo bone marrow aspiration and biopsy, blood sample collection, and CT throughout the study.","label":"Arm II (ibrutinib)","type":"EXPERIMENTAL"},{"description":"Patients receive ibrutinib as in Arm II. Patients receive rituximab IV on days 1, 8, 15, and 22 of course 2 and on day 1 of courses 3-6. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo bone marrow aspiration and biopsy, blood sample collection, and CT throughout the study.","label":"Arm III (ibrutinib, rituximab)","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2027-06-24","type":"ESTIMATED"},"conditions":["Stage I Chronic Lymphocytic Leukemia","Stage II Chronic Lymphocytic Leukemia","Stage III Chronic Lymphocytic Leukemia","Stage IV Chronic Lymphocytic Leukemia"],"enrollment":{"count":547,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Bendamustine Hydrochloride","type":"DRUG"},{"name":"Biospecimen Collection","type":"PROCEDURE"},{"name":"Bone Marrow Aspiration","type":"PROCEDURE"},{"name":"Bone Marrow Biopsy","type":"PROCEDURE"},{"name":"Computed Tomography","type":"PROCEDURE"},{"name":"Ibrutinib","type":"DRUG"},{"name":"Laboratory Biomarker Analysis","type":"OTHER"},{"name":"Quality-of-Life Assessment","type":"OTHER"},{"name":"Rituximab","type":"BIOLOGICAL"}],"last_update":"2026-10-01","lead_sponsor":"National Cancer Institute (NCI)","official_title":"A Randomized Phase III Study of Bendamustine Plus Rituximab Versus Ibrutinib Plus Rituximab Versus Ibrutinib Alone in Untreated Older Patients (≥ 65 Years of Age) With Chronic Lymphocytic Leukemia (CLL)","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2018-08-07","type":"ACTUAL"},"primary_outcomes":[{"measure":"Progression Free Survival (PFS)","timeFrame":"Time from study entry to the time of documented disease progression or death. The analysis was event driven, performed at 2.5 years after the last patient enrolled;up to 4 years."}],"references":[{"citation":"Woyach JA, Perez Burbano G, Ruppert AS, Miller C, Heerema NA, Zhao W, Wall A, Ding W, Bartlett NL, Brander DM, Barr PM, Rogers KA, Parikh SA, Stephens DM, Brown JR, Lozanski G, Blachly J, Nattam S, Larson RA, Erba H, Litzow M, Luger S, Owen C, Kuzma C, Abramson JS, Little RF, Dinner S, Stone RM, Uy G, Stock W, Mandrekar SJ, Byrd JC. Follow-up from the A041202 study shows continued efficacy of ibrutinib regimens for older adults with CLL. Blood. 2024 Apr 18;143(16):1616-1627. doi: 10.1182/blood.2023021959.","pmid":"38215395","type":"DERIVED"},{"citation":"Ruppert AS, Booth AM, Ding W, Bartlett NL, Brander DM, Coutre S, Brown JR, Nattam S, Larson RA, Erba H, Litzow M, Owen C, Kuzma CS, Abramson JS, Little RF, Smith SE, Stone RM, Byrd JC, Mandrekar SJ, Woyach JA. Adverse event burden in older patients with CLL receiving bendamustine plus rituximab or ibrutinib regimens: Alliance A041202. Leukemia. 2021 Oct;35(10):2854-2861. doi: 10.1038/s41375-021-01342-x. Epub 2021 Jul 17.","pmid":"34274940","type":"DERIVED"},{"citation":"Woyach JA, Ruppert AS, Heerema NA, Zhao W, Booth AM, Ding W, Bartlett NL, Brander DM, Barr PM, Rogers KA, Parikh SA, Coutre S, Hurria A, Brown JR, Lozanski G, Blachly JS, Ozer HG, Major-Elechi B, Fruth B, Nattam S, Larson RA, Erba H, Litzow M, Owen C, Kuzma C, Abramson JS, Little RF, Smith SE, Stone RM, Mandrekar SJ, Byrd JC. Ibrutinib Regimens versus Chemoimmunotherapy in Older Patients with Untreated CLL. N Engl J Med. 2018 Dec 27;379(26):2517-2528. doi: 10.1056/NEJMoa1812836. Epub 2018 Dec 1.","pmid":"30501481","type":"DERIVED"}],"start_date":{"date":"2014-01-15","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Rituximab and Bendamustine Hydrochloride, Rituximab and Ibrutinib, or Ibrutinib Alone in Treating Older Patients With Previously Untreated Chronic Lymphocytic Leukemia","url":"https://clinicaltrials.gov/study/NCT01886872"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/nct01886872"}