{"commentary":{"count":253,"free_build_floor":8,"listing_floor":3,"by_channel":{"youtube":108,"podcast":95,"x_thread":48,"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\": \"NCT03740529\", \"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":"NCT03740529","nct_id":"NCT03740529","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct03740529. 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":null,"arms":[{"description":"Dose Escalation and determination of MTD; multiple dose levels of pirtobrutinib to be evaluated","label":"Phase I Dose Escalation (Pirtobrutinib Monotherapy)","type":"EXPERIMENTAL"},{"description":"CLL/SLL patients with no prior therapy.","label":"Phase 2 (Pirtobrutinib Monotherapy) Cohort 3","type":"EXPERIMENTAL"},{"description":"Non-blastoid MCL patients treated with a prior BTK-inhibitor containing regimen.","label":"Phase 2 (Pirtobrutinib Monotherapy) Cohort 1","type":"EXPERIMENTAL"},{"description":"CLL/SLL patients treated with prior therapy, BTK inhibitor naïve.","label":"Phase 2 (Pirtobrutinib Monotherapy) Cohort 4","type":"EXPERIMENTAL"},{"description":"CLL/SLL patients treated with 2 or more prior regimens, including a BTK inhibitor-containing regimen.","label":"Phase 2 (Pirtobrutinib Monotherapy) Cohort 2","type":"EXPERIMENTAL"},{"description":"WM patients treated with a prior BTK inhibitor-containing regimen.","label":"Phase 2 (Pirtobrutinib Monotherapy) Cohort 5","type":"EXPERIMENTAL"},{"description":"MZL patients treated with a prior BTK inhibitor-containing regimen.","label":"Phase 2 (Pirtobrutinib Monotherapy) Cohort 6","type":"EXPERIMENTAL"},{"description":"Defined as CLL/SLL or NHL not otherwise specified in Cohorts 1 through 6, inclusive of CLL/SLL, Richter's transformation, or low grade NHL with transformation, blastoid MCL, and patients with history of CNS involvement or primary CNS lymphoma. In the event the Sponsor electively closes Cohorts 2-4 prior to completion, patients with CLL/SLL who are ineligible to participate in or unable to access late phase studies of pirtobrutinib may be eligible to enroll in this cohort Diffuse large B-cell lymphoma (DLBCL) is excluded. MCL without prior BTK inhibitor treatment is excluded. Patients enrolling to Cohort 7 must have received one or more prior therapies or have no available approved therapy with demonstrated clinical benefit with the exception of untreated Richter's transformation, which is allowed.","label":"Phase 2 (Pirtobrutinib Monotherapy) Cohort 7","type":"EXPERIMENTAL"},{"description":"Relapsed/Refractory CLL will receive the recommended Phase 2 dose of pirtobrutinib in combination with venetoclax","label":"Phase 1b Dose Expansion (Pirtobrutinib Combination Therapy) Arm A","type":"EXPERIMENTAL"},{"description":"Relapsed/Refractory CLL will receive the recommended Phase 2 dose of pirtobrutinib in combination with venetoclax and rituximab","label":"Phase 1b Dose Expansion (Pirtobrutinib Combination Therapy) Arm B","type":"EXPERIMENTAL"},{"description":"Patients to receive the recommended Phase 2 dose of pirtobrutinib","label":"Phase 1 Dose Expansion (Pirtobrutinib Monotherapy)","type":"EXPERIMENTAL"}],"collaborators":["Eli Lilly and Company"],"completion_date":{"date":"2025-12-23","type":"ACTUAL"},"conditions":["Chronic Lymphocytic Leukemia","Waldenstrom Macroglobulinemia","Mantle Cell Lymphoma","Marginal Zone Lymphoma","B-cell Lymphoma","Small Lymphocytic Lymphoma"],"enrollment":{"count":803,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Pirtobrutinib","type":"DRUG"},{"name":"Venetoclax","type":"DRUG"},{"name":"Rituximab","type":"DRUG"}],"last_update":"2026-01-27","lead_sponsor":"Loxo Oncology, Inc.","official_title":"A Phase 1/2 Study of Oral LOXO-305 in Patients With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) or Non-Hodgkin Lymphoma (NHL)","overall_status":"COMPLETED","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2025-01-27","type":"ACTUAL"},"primary_outcomes":[{"measure":"Maximum Tolerated Dose (MTD)","timeFrame":"Up to 24 Months"},{"measure":"Recommended dose for further study","timeFrame":"Up to 24 Months"},{"measure":"To assess the preliminary anti-tumor activity of pirtobrutinib based on ORR as assessed by an Independent Review Committee (IRC).","timeFrame":"Up to 24 months"},{"measure":"To evaluate the safety of pirtobrutinib in combination with venetoclax (Arm A) by assessing incidence and severity of treatment-emergent adverse events as determined by CTCAE v5.0","timeFrame":"Up to 24 Months"},{"measure":"To evaluate the safety of pirtobrutinib in combination with venetoclax and rituximab (Arm B) by assessing incidence and severity of treatment-emergent adverse events as determined by CTCAE v5.0","timeFrame":"Up to 24 Months"}],"references":[{"citation":"Bell R, O'Brien LM, Yuen E, Liu D, Chapman SC. Population pharmacokinetic analysis of pirtobrutinib, a non-covalent BTK inhibitor, in patients with hematological malignancies from the Phase 1/2 BRUIN study. Cancer Chemother Pharmacol. 2026 Sep 24;96(1):111. doi: 10.1007/s00280-026-04951-4.","pmid":"42786239","type":"DERIVED"},{"citation":"Palomba ML, Patel MR, Eyre TA, Jurczak W, Lewis D, Gastinne T, Ma S, Cohen JB, Patel K, Brown JR, Scarfo L, Munir T, Lech-Maranda E, Hoffmann MS, Ujjani CS, Fakhri B, Wang ML, Izutsu K, Nagai H, Tam CS, Rhodes JM, Vose J, McKinney M, Gerson JN, Barve MA, Kuss B, Koh Y, Barrett A, Treon SP, Castillo JJ, Seymour JF, Ruppert AS, McNeely SC, Walgren RA, Tsai DE, Bao K, Nair B, Woyach J, Cheah CY. Safety and activity of pirtobrutinib in patients with relapsed or refractory Waldenstrom macroglobulinaemia: 5-year follow-up of the open-label, multicentre, phase 1/2 BRUIN trial. Lancet Haematol. 2026 May;13(5):e284-e296. doi: 10.1016/S2352-3026(26)00037-2.","pmid":"42069409","type":"DERIVED"},{"citation":"Patel K, Vose JM, Nasta SD, Brown JR, Maddocks KJ, Woyach JA, Shah NN, Fakhri B, Tessoulin B, Ma S, Jagadeesh D, Lech-Maranda E, Coombs CC, Patel MR, Rhodes JM, Ujjani C, Hoffmann MS, Cheah CY, Munir T, Lewis D, Scarfo L, Eyre TA, Alencar A, Cohen JB, Zelenetz AD, Tsai DE, Li M, Bian Y, Abada P, Balbas M, Zinzani PL. Pirtobrutinib, a highly selective, noncovalent (reversible) BTKi in R/R marginal zone lymphoma: phase 1/2 BRUIN study. Blood Adv. 2026 Apr 14;10(7):2441-2451. doi: 10.1182/bloodadvances.2025017489.","pmid":"41544219","type":"DERIVED"},{"citation":"Brown JR, Nguyen B, Desikan SP, Won H, Tantawy SI, McNeely SC, Marella N, Randeria HS, Hanson LM, Parker A, Botelho SC, Woyach JA, Patel K, Tam CS, Eyre TA, Cheah CY, Shah NN, Ghia P, Jurczak W, Balbas M, Nair B, Abada P, Wang C, Wang D, Roeker LE, Gandhi V, Wierda WG. Genomic determinants of response and resistance to pirtobrutinib in relapsed/refractory chronic lymphocytic leukemia. Blood. 2026 Jan 1;147(1):24-34. doi: 10.1182/blood.2024027009.","pmid":"41055698","type":"DERIVED"},{"citation":"Shah NN, Zinzani PL, Wang M, Nasta SD, Lech-Maranda E, Ogawa Y, Fakhri B, Kuss B, Miyashita K, Patel K, Coombs CC, Ma S, Patel MR, Barve MA, Tessoulin B, Stathis A, Ennishi D, Hashimoto D, Kojima K, Zelenetz AD, Cohen JB, Vose JM, Maddocks KJ, Munir T, Sun F, Bian Y, Balbas M, Tsai DE, Abada P, Cheah CY. Pirtobrutinib, a highly selective, noncovalent (reversible) BTKi in R/R follicular lymphoma: phase 1/2 BRUIN study. Blood Adv. 2025 Dec 9;9(23):5954-5964. doi: 10.1182/bloodadvances.2024014975.","pmid":"40845254","type":"DERIVED"},{"citation":"Lamanna N, Tam CS, Woyach JA, Alencar AJ, Palomba ML, Zinzani PL, Flinn IW, Fakhri B, Cohen JB, Kontos A, Konig H, Ruppert AS, Chatterjee A, Sizelove R, Compte L, Tsai DE, Jurczak W. Evaluation of bleeding risk in patients who received pirtobrutinib in the presence or absence of antithrombotic therapy. EJHaem. 2024 Sep 27;5(5):929-939. doi: 10.1002/jha2.1013. eCollection 2024 Oct.","pmid":"39415923","type":"DERIVED"},{"citation":"Wierda WG, Shah NN, Cheah CY, Lewis D, Hoffmann MS, Coombs CC, Lamanna N, Ma S, Jagadeesh D, Munir T, Wang Y, Eyre TA, Rhodes JM, McKinney M, Lech-Maranda E, Tam CS, Jurczak W, Izutsu K, Alencar AJ, Patel MR, Seymour JF, Woyach JA, Thompson PA, Abada PB, Ho C, McNeely SC, Marella N, Nguyen B, Wang C, Ruppert AS, Nair B, Liu H, Tsai DE, Roeker LE, Ghia P. Pirtobrutinib, a highly selective, non-covalent (reversible) BTK inhibitor in patients with B-cell malignancies: analysis of the Richter transformation subgroup from the multicentre, open-label, phase 1/2 BRUIN study. Lancet Haematol. 2024 Sep;11(9):e682-e692. doi: 10.1016/S2352-3026(24)00172-8. Epub 2024 Jul 18.","pmid":"39033770","type":"DERIVED"},{"citation":"Roeker LE, Woyach JA, Cheah CY, Coombs CC, Shah NN, Wierda WG, Patel MR, Lamanna N, Tsai DE, Nair B, Wang C, Zhao X, Liu D, Radtke D, Chapman S, Marella N, McNeely SC, Brown JR. Fixed-duration pirtobrutinib plus venetoclax with or without rituximab in relapsed/refractory CLL: the phase 1b BRUIN trial. Blood. 2024 Sep 26;144(13):1374-1386. doi: 10.1182/blood.2024024510.","pmid":"38861666","type":"DERIVED"},{"citation":"Telaraja D, Kasamon YL, Collazo JS, Leong R, Wang K, Li P, Dahmane E, Yang Y, Earp J, Grimstein M, Rodriguez LR, Theoret MR, Gormley NJ. FDA Approval Summary: Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma. Clin Cancer Res. 2024 Jan 5;30(1):17-22. doi: 10.1158/1078-0432.CCR-23-1272.","pmid":"37624619","type":"DERIVED"},{"citation":"Mato AR, Woyach JA, Brown JR, Ghia P, Patel K, Eyre TA, Munir T, Lech-Maranda E, Lamanna N, Tam CS, Shah NN, Coombs CC, Ujjani CS, Fakhri B, Cheah CY, Patel MR, Alencar AJ, Cohen JB, Gerson JN, Flinn IW, Ma S, Jagadeesh D, Rhodes JM, Hernandez-Ilizaliturri F, Zinzani PL, Seymour JF, Balbas M, Nair B, Abada P, Wang C, Ruppert AS, Wang D, Tsai DE, Wierda WG, Jurczak W. Pirtobrutinib after a Covalent BTK Inhibitor in Chronic Lymphocytic Leukemia. N Engl J Med. 2023 Jul 6;389(1):33-44. doi: 10.1056/NEJMoa2300696.","pmid":"37407001","type":"DERIVED"},{"citation":"Wang ML, Jurczak W, Zinzani PL, Eyre TA, Cheah CY, Ujjani CS, Koh Y, Izutsu K, Gerson JN, Flinn I, Tessoulin B, Alencar AJ, Ma S, Lewis D, Lech-Maranda E, Rhodes J, Patel K, Maddocks K, Lamanna N, Wang Y, Tam CS, Munir T, Nagai H, Hernandez-Ilizaliturri F, Kumar A, Fenske TS, Seymour JF, Zelenetz AD, Nair B, Tsai DE, Balbas M, Walgren RA, Abada P, Wang C, Zhao J, Mato AR, Shah NN. Pirtobrutinib in Covalent Bruton Tyrosine Kinase Inhibitor Pretreated Mantle-Cell Lymphoma. J Clin Oncol. 2023 Aug 20;41(24):3988-3997. doi: 10.1200/JCO.23.00562. Epub 2023 May 16.","pmid":"37192437","type":"DERIVED"},{"citation":"Aslan B, Kismali G, Iles LR, Manyam GC, Ayres ML, Chen LS, Gagea M, Bertilaccio MTS, Wierda WG, Gandhi V. Pirtobrutinib inhibits wild-type and mutant Bruton's tyrosine kinase-mediated signaling in chronic lymphocytic leukemia. Blood Cancer J. 2022 May 20;12(5):80. doi: 10.1038/s41408-022-00675-9.","pmid":"35595730","type":"DERIVED"},{"citation":"Kipps TJ. Mining the Microenvironment for Therapeutic Targets in Chronic Lymphocytic Leukemia. Cancer J. 2021 Jul-Aug 01;27(4):306-313. doi: 10.1097/PPO.0000000000000536.","pmid":"34398557","type":"DERIVED"},{"citation":"Mato AR, Shah NN, Jurczak W, Cheah CY, Pagel JM, Woyach JA, Fakhri B, Eyre TA, Lamanna N, Patel MR, Alencar A, Lech-Maranda E, Wierda WG, Coombs CC, Gerson JN, Ghia P, Le Gouill S, Lewis DJ, Sundaram S, Cohen JB, Flinn IW, Tam CS, Barve MA, Kuss B, Taylor J, Abdel-Wahab O, Schuster SJ, Palomba ML, Lewis KL, Roeker LE, Davids MS, Tan XN, Fenske TS, Wallin J, Tsai DE, Ku NC, Zhu E, Chen J, Yin M, Nair B, Ebata K, Marella N, Brown JR, Wang M. Pirtobrutinib in relapsed or refractory B-cell malignancies (BRUIN): a phase 1/2 study. Lancet. 2021 Mar 6;397(10277):892-901. doi: 10.1016/S0140-6736(21)00224-5.","pmid":"33676628","type":"DERIVED"}],"start_date":{"date":"2019-03-15","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of Oral LOXO-305 in Patients With Previously Treated CLL/SLL or NHL","url":"https://clinicaltrials.gov/study/NCT03740529"},"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/nct03740529"}