{"preliminary_commentary":{"by_channel":{"x_thread":3},"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":false},"commentary_summary":null,"drugs_tested":null,"indication":null,"name":"A041702","nct_id":"NCT03737981","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=a041702-nct03737981. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. 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_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Patients receive ibrutinib PO QD on days 1-28. Patients also receive obinutuzumab IV on days 1, 2, 8, and 15 of cycle 1, and on day 1 of cycles 2-6. Treatment repeats every 28 days for up to 14 cycles in the absence of disease progression or unacceptable toxicity. Beginning cycle 15, patients receive ibrutinib PO QD every 28 days in the absence of disease progression or unacceptable toxicity.","label":"Arm I (ibrutinib, obinutuzumab)","type":"ACTIVE_COMPARATOR"},{"description":"Patients receive ibrutinib PO QD on days 1-28. Patients also receive obinutuzumab IV on days 1, 2, 8, and 15 of cycle 1, and on day 1 of cycles 2-6. Beginning cycle 3, patients also receive venetoclax PO QD on days 1-28. Treatment repeats every 28 days for 14 cycles in the absence of disease progression or unacceptable toxicity. All patients will then receive a 15th cycle of ibrutinib. Beginning cycle 16, patients who do not achieve a BM MRD negative CR, receive ibrutinib PO QD every 28 days in the absence of disease progression or unacceptable toxicity. Patients who achieve a BM MRD negative CR undergo observation every 3 cycles for 6 years, then every 6 cycles thereafter.","label":"Arm II (ibrutinib, obinutuzumab, venetoclax)","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2026-12-29","type":"ESTIMATED"},"conditions":["Chronic Lymphocytic Leukemia","Small Lymphocytic Lymphoma"],"enrollment":{"count":465,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Ibrutinib","otherNames":["BTK Inhibitor PCI-32765","CRA 032765","CRA-032765","CRA032765","Imbruvica","PCI 32765","PCI-32765","PCI32765"],"type":"DRUG"},{"name":"Obinutuzumab","otherNames":["Anti-CD20 Monoclonal Antibody R7159","GA 101","GA-101","GA101","Gazyva","huMAB(CD20)","R 7159","R-7159","R7159","RO 5072759","RO-5072759","RO5072759"],"type":"BIOLOGICAL"},{"name":"Observation Activity","otherNames":["Observation"],"type":"OTHER"},{"name":"Venetoclax","otherNames":["ABT 199","ABT-0199","ABT-199","ABT199","GDC 0199","GDC-0199","GDC0199","RG7601","Venclexta","Venclyxto"],"type":"DRUG"}],"last_update":"2026-10-26","lead_sponsor":"National Cancer Institute (NCI)","official_title":"A Randomized Phase III Study of Ibrutinib Plus Obinutuzumab Versus Ibrutinib Plus Venetoclax and Obinutuzumab in Untreated Older Patients (>/= 65 Years of Age) With Chronic Lymphocytic Leukemia (CLL)","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2025-01-17","type":"ACTUAL"},"primary_outcomes":[{"measure":"Progression-free Survival (PFS)","timeFrame":"5 years"}],"references":[],"start_date":{"date":"2019-01-31","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Testing the Addition of a New Anti-cancer Drug, Venetoclax, to the Usual Treatment (Ibrutinib and Obinutuzumab) in Untreated, Older Patients With Chronic Lymphocytic Leukemia","url":"https://clinicaltrials.gov/study/NCT03737981"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.1","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/a041702-nct03737981"}