{"preliminary_commentary":{"by_channel":{"youtube":117,"podcast":72,"x_thread":43,"x_video":1},"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\": \"NCT02910583\", \"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":{"generated_at":"2026-10-30T23:11:40.830Z","note":"Automated from the 40 newest of 233 indexed sources (Oct 2025 – Oct 2026). Each question is raised in at least two. Not an Erudio report: no source links. Not medical advice.","passages_read":40,"text":"- Whether the original regimen can be reused after relapse following fixed-duration therapy\n- Whether treatment duration should differ for high-risk disease\n- How MRD should guide treatment duration, including whether to stop at undetectable MRD\n\nAlso discussed: resistance mutations, IGHV status."},"drugs_tested":[["ibrutinib","venetoclax"]],"indication":"treatment-naïve chronic lymphocytic leukemia/small lymphocytic lymphoma","name":"CAPTIVATE","nct_id":"NCT02910583","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=captivate-nct02910583. 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":1950,"size":"deep","size_rule":"Deep: 301+ verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"Captivate","arms":[{"description":"Participants receive 420 mg of single-agent ibrutinib for first 3 cycles followed by ibrutinib plus venetoclax combination treatment (ibrutinib 420 mg and venetoclax 400 mg orally once daily on a continuous schedule) for 12 cycles (a cycle is defined by 28 days) or until disease progression or unacceptable toxicity.","label":"Fixed Duration (FD) Cohort: Open Label Ibrutinib + Venetoclax","type":"EXPERIMENTAL"},{"description":"Participants receive 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase).\n\nParticipants with confirmed uMRD are randomized to receive ibrutinib 420 mg orally once daily on a continuous schedule until MRD-positive relapse, disease progression (PD), or unacceptable toxicity.\n\nAfter MRD-positive relapse or disease progression (PD) by iwCLL criteria, participants can reintroduce 400 mg venetoclax with a 5-week ramp up. If venetoclax is to be reintroduced, venetoclax treatment is to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative) until PD or unacceptable toxicity.","label":"MRD Cohort/Confirmed Undetectable MRD (uMRD): Randomized to Ibrutinib (Blinded)","type":"EXPERIMENTAL"},{"description":"Participants receive 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase).\n\nParticipants with confirmed uMRD are randomized to receive placebo orally once daily on a continuous schedule until MRD-positive relapse, PD or unacceptable toxicity.\n\nIf MRD-positive relapse or PD is confirmed after restaging per iwCLL criteria, participants can first reintroduce oral daily ibrutinib with the option of subsequently reintroducing 400 mg venetoclax with a 5-week ramp up, if subsequent disease relapse per iwCLL criteria occurs after ibrutinib reintroduction. If venetoclax is to be reintroduced, venetoclax treatment is to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative) until PD or unacceptable toxicity.","label":"MRD Cohort/Confirmed uMRD: Randomized Placebo (Blinded)","type":"PLACEBO_COMPARATOR"},{"description":"Participants receive 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre randomization phase).\n\nParticipants with uMRD not confirmed are randomized to receive open-label ibrutinib 420 mg orally once daily on a continuous schedule until PD or unacceptable toxicity.\n\nIn case of confirmed PD after restaging per iwCLL criteria, participants can continue ibrutinib and reintroduce venetoclax treatment. If venetoclax is to be reintroduced, venetoclax treatment is to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative) until PD or unacceptable toxicity.","label":"MRD Cohort/uMRD Not Confirmed: Randomized to Ibrutinib (Open-Label)","type":"EXPERIMENTAL"},{"description":"Participants receive 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre randomization phase).\n\nParticipants with uMRD not confirmed are randomized to receive open-label ibrutinib 420 mg and venetoclax 400 mg orally once daily on a continuous schedule until PD or unacceptable toxicity. Venetoclax was allowed for administration up to 2 years cumulatively from first dose started in the pre-randomization phase to last dose in the randomization phase.","label":"MRD Cohort/uMRD Not Confirmed: Randomized Ibrutinib + Venetoclax (Open-Label)","type":"EXPERIMENTAL"}],"collaborators":["Janssen Research & Development, LLC"],"completion_date":{"date":"2024-03-27","type":"ACTUAL"},"conditions":["Leukemia","Chronic Lymphocytic Leukemia","Small Lymphocytic Lymphoma"],"enrollment":{"count":323,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"ibrutinib","otherNames":[],"type":"DRUG"},{"name":"venetoclax","otherNames":[],"type":"DRUG"},{"name":"Placebo","otherNames":[],"type":"DRUG"}],"last_update":"2026-09-10","lead_sponsor":"Pharmacyclics LLC.","official_title":"Phase 2 Study of the Combination of Ibrutinib Plus Venetoclax in Subjects With Treatment-naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma","overall_status":"COMPLETED","phases":["PHASE2"],"primary_completion_date":{"date":"2020-11-12","type":"ACTUAL"},"primary_outcomes":[{"measure":"MRD Cohort: 1-Year Disease-Free Survival (DFS) Rate in Confirmed uMRD Randomized Participants","timeFrame":"1 year after randomization"},{"measure":"FD Cohort: Complete Response Rate (CRR; Complete Response/Complete Response With Incomplete Blood Count Recovery [CR/CRi]) Rate","timeFrame":"From the first dose of ibrutinib to the first confirmed PD, for a median follow-up of 69.0 months."}],"references":[{"citation":"Castonguay M, Anderson MA, Thompson P, Seymour JF. Venetoclax retreatment in chronic lymphocytic leukemia is biologically rational and clinically effective. Blood Adv. 2026 May 26;10(10):3357-3366. doi: 10.1182/bloodadvances.2026019871.","pmid":"41843779","type":"DERIVED"},{"citation":"Moreno C, Solman IG, Tam CS, Grigg A, Scarfo L, Kipps TJ, Srinivasan S, Mali RS, Zhou C, Dean JP, Szafer-Glusman E, Choi M. Immune restoration with ibrutinib plus venetoclax in first-line chronic lymphocytic leukemia: the phase 2 CAPTIVATE study. Blood Adv. 2023 Sep 26;7(18):5294-5303. doi: 10.1182/bloodadvances.2023010236.","pmid":"37315225","type":"DERIVED"},{"citation":"Wierda WG, Allan JN, Siddiqi T, Kipps TJ, Opat S, Tedeschi A, Badoux XC, Kuss BJ, Jackson S, Moreno C, Jacobs R, Pagel JM, Flinn I, Pak Y, Zhou C, Szafer-Glusman E, Ninomoto J, Dean JP, James DF, Ghia P, Tam CS. Ibrutinib Plus Venetoclax for First-Line Treatment of Chronic Lymphocytic Leukemia: Primary Analysis Results From the Minimal Residual Disease Cohort of the Randomized Phase II CAPTIVATE Study. J Clin Oncol. 2021 Dec 1;39(34):3853-3865. doi: 10.1200/JCO.21.00807. Epub 2021 Oct 7.","pmid":"34618601","type":"DERIVED"}],"start_date":{"date":"2016-09-28","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Ibrutinib Plus Venetoclax in Subjects With Treatment-naive Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma (CLL/SLL)","url":"https://clinicaltrials.gov/study/NCT02910583"},"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/captivate-nct02910583"}