{"preliminary_commentary":{"by_channel":{"x_thread":3},"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":"NCT01865617","nct_id":"NCT01865617","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct01865617. 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 anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.\n\nDisease subgroup: ALL Tumor Burden: high Dose level: 1 up to 2x105 EGFR+ cells/kg","label":"ALL (high tumor burden) dose level 1","type":"EXPERIMENTAL"},{"description":"Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.\n\nDisease subgroup: ALL Tumor Burden: high Dose level: 2 up to 2x106 EGFR+ cells/kg","label":"ALL (high tumor burden) dose level 2","type":"EXPERIMENTAL"},{"description":"Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.\n\nDisease subgroup: ALL Tumor Burden: high Dose level: 3 up to 2x107 EGFR+ cells/kg","label":"ALL (high tumor burden) dose level 3","type":"EXPERIMENTAL"},{"description":"Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.\n\nDisease subgroup: ALL Tumor Burden: low Dose level: 1 up to 2x105 EGFR+ cells/kg","label":"ALL (low tumor burden) dose level 1","type":"EXPERIMENTAL"},{"description":"Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.\n\nDisease subgroup: ALL Tumor Burden: high Dose level: 2 up to 2x106 EGFR+ cells/kg","label":"ALL (low tumor burden) dose level 2","type":"EXPERIMENTAL"},{"description":"Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.\n\nDisease subgroup: CLL Dose level: 1 up to 2x105 EGFR+ cells/kg","label":"CLL dose level 1","type":"EXPERIMENTAL"},{"description":"Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.\n\nDisease subgroup: CLL Dose level: 2 up to 2x106 EGFR+ cells/kg","label":"CLL dose level 2","type":"EXPERIMENTAL"},{"description":"Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.\n\nDisease subgroup: CLL Dose level: 3 up to 2x107 EGFR+ cells/kg","label":"CLL dose level 3","type":"EXPERIMENTAL"},{"description":"Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.\n\nDisease subgroup: CLL (ibrutinib) Dose level: 2 up to 2x106 EGFR+ cells/kg","label":"CLL (ibrutinib) dose level 2","type":"EXPERIMENTAL"},{"description":"Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.\n\nDisease subgroup: NHL Dose level: 1 up to 2x105 EGFR+ cells/kg","label":"NHL dose level 1","type":"EXPERIMENTAL"},{"description":"Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.\n\nDisease subgroup: NHL Dose level: 2 up to 2x106 EGFR+ cells/kg","label":"NHL dose level 2","type":"EXPERIMENTAL"},{"description":"Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.\n\nDisease subgroup: NHL Dose level: 3 up to 2x107 EGFR+ cells/kg","label":"NHL dose level 3","type":"EXPERIMENTAL"},{"description":"Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells IV over 20-30 minutes on day 0. Treatment may be repeated in no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity.\n\nDisease subgroup: NHL Dose level: 2 up to 2x106 EGFR+ cells/kg","label":"NHL (dose dense) dose level 2","type":"EXPERIMENTAL"}],"collaborators":["National Cancer Institute (NCI)"],"completion_date":{"date":"2021-03-26","type":"ACTUAL"},"conditions":["CD19-Positive Neoplastic Cells Present","Recurrent Adult Acute Lymphoblastic Leukemia","Recurrent Chronic Lymphocytic Leukemia","Recurrent Diffuse Large B-Cell Lymphoma","Recurrent Mantle Cell Lymphoma","Recurrent Non-Hodgkin Lymphoma","Recurrent Small Lymphocytic Lymphoma","Refractory Acute Lymphoblastic Leukemia","Refractory Chronic Lymphocytic Leukemia","Refractory Diffuse Large B-Cell Lymphoma","Refractory Mantle Cell Lymphoma","Refractory Non-Hodgkin Lymphoma","Refractory Small Lymphocytic Lymphoma"],"enrollment":{"count":204,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes","otherNames":[],"type":"BIOLOGICAL"}],"last_update":"2022-05-25","lead_sponsor":"Fred Hutchinson Cancer Center","official_title":"Phase I/II Study of Immunotherapy for Advanced CD19+ Chronic Lymphocytic Leukemia, Acute Lymphoblastic Leukemia/Lymphoma and Non-Hodgkin Lymphoma With Defined Subsets of Autologous T Cells Engineered to Express a CD19-Specific Chimeric Antigen Receptor","overall_status":"COMPLETED","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2021-03-26","type":"ACTUAL"},"primary_outcomes":[{"measure":"Death Within 8 Weeks of the Study Cell Infusion Thought to be Definitely or Probably Related to Chimeric Antigen Receptor (CAR) T Cell Therapy","timeFrame":"Within 8 weeks of the study cell infusion"},{"measure":"Dose Limiting Toxicities","timeFrame":"30 days"},{"measure":"Objective Response Rate of Complete Response and Partial Response","timeFrame":"Up to 1 year"},{"measure":"Overall Survival","timeFrame":"Up to 1 year"},{"measure":"Progression Free Survival","timeFrame":"Up to 1 year"}],"references":[{"citation":"Ortiz-Maldonado V, Liang EC, Huang JJ, Jeon Y, Hirayama AV, Kimble EL, Portuguese AJ, Khouderchah C, Braathen K, Torkelson A, Kirchmeier D, Shadman M, Maloney DG, Riddell SR, Turtle CJ, Gauthier J. A novel dose-dense strategy for CD19-directed CAR T-cell therapy is associated with durable responses without increased toxicity in patients with B-cell non-Hodgkin lymphoma. Haematologica. 2026 Jul 2. doi: 10.3324/haematol.2025.300321. Online ahead of print.","pmid":"42389828","type":"DERIVED"},{"citation":"Fiorenza S, Zheng Y, Purushe J, Bock TJ, Sarthy J, Janssens DH, Sheih AS, Kimble EL, Kirchmeier D, Phi TD, Gauthier J, Hirayama AV, Riddell SR, Wu Q, Gottardo R, Maloney DG, Yang JYH, Henikoff S, Turtle CJ. Histone marks identify novel transcription factors that parse CAR-T subset-of-origin, clinical potential and expansion. Nat Commun. 2024 Sep 27;15(1):8309. doi: 10.1038/s41467-024-52503-2.","pmid":"39333103","type":"DERIVED"},{"citation":"Liang EC, Albittar A, Huang JJ, Hirayama AV, Kimble EL, Portuguese AJ, Chapuis A, Shadman M, Till BG, Cassaday RD, Milano F, Kiem HP, Riddell SR, Turtle CJ, Maloney DG, Gauthier J. Factors associated with long-term outcomes of CD19 CAR T-cell therapy for relapsed/refractory CLL. Blood Adv. 2023 Nov 28;7(22):6990-7005. doi: 10.1182/bloodadvances.2023011399.","pmid":"37774014","type":"DERIVED"},{"citation":"Juluri KR, Wu QV, Voutsinas J, Hou J, Hirayama AV, Mullane E, Miles N, Maloney DG, Turtle CJ, Bar M, Gauthier J. Severe cytokine release syndrome is associated with hematologic toxicity following CD19 CAR T-cell therapy. Blood Adv. 2022 Apr 12;6(7):2055-2068. doi: 10.1182/bloodadvances.2020004142.","pmid":"34666344","type":"DERIVED"},{"citation":"Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2.","pmid":"34515338","type":"DERIVED"},{"citation":"Gauthier J, Bezerra ED, Hirayama AV, Fiorenza S, Sheih A, Chou CK, Kimble EL, Pender BS, Hawkins RM, Vakil A, Phi TD, Steinmetz RN, Jamieson AW, Bar M, Cassaday RD, Chapuis AG, Cowan AJ, Green DJ, Kiem HP, Milano F, Shadman M, Till BG, Riddell SR, Maloney DG, Turtle CJ. Factors associated with outcomes after a second CD19-targeted CAR T-cell infusion for refractory B-cell malignancies. Blood. 2021 Jan 21;137(3):323-335. doi: 10.1182/blood.2020006770.","pmid":"32967009","type":"DERIVED"},{"citation":"Hirayama AV, Gauthier J, Hay KA, Voutsinas JM, Wu Q, Pender BS, Hawkins RM, Vakil A, Steinmetz RN, Riddell SR, Maloney DG, Turtle CJ. High rate of durable complete remission in follicular lymphoma after CD19 CAR-T cell immunotherapy. Blood. 2019 Aug 15;134(7):636-640. doi: 10.1182/blood.2019000905.","pmid":"31648294","type":"DERIVED"},{"citation":"Hirayama AV, Gauthier J, Hay KA, Voutsinas JM, Wu Q, Gooley T, Li D, Cherian S, Chen X, Pender BS, Hawkins RM, Vakil A, Steinmetz RN, Acharya UH, Cassaday RD, Chapuis AG, Dhawale TM, Hendrie PC, Kiem HP, Lynch RC, Ramos J, Shadman M, Till BG, Riddell SR, Maloney DG, Turtle CJ. The response to lymphodepletion impacts PFS in patients with aggressive non-Hodgkin lymphoma treated with CD19 CAR T cells. Blood. 2019 Apr 25;133(17):1876-1887. doi: 10.1182/blood-2018-11-887067. Epub 2019 Feb 19.","pmid":"30782611","type":"DERIVED"},{"citation":"Tuazon SA, Li A, Gooley T, Eunson TW, Maloney DG, Turtle CJ, Linenberger ML, Connelly-Smith LS. Factors affecting lymphocyte collection efficiency for the manufacture of chimeric antigen receptor T cells in adults with B-cell malignancies. Transfusion. 2019 May;59(5):1773-1780. doi: 10.1111/trf.15178. Epub 2019 Feb 6.","pmid":"30729531","type":"DERIVED"},{"citation":"Hay KA, Gauthier J, Hirayama AV, Voutsinas JM, Wu Q, Li D, Gooley TA, Cherian S, Chen X, Pender BS, Hawkins RM, Vakil A, Steinmetz RN, Schoch G, Chapuis AG, Till BG, Kiem HP, Ramos JD, Shadman M, Cassaday RD, Acharya UH, Riddell SR, Maloney DG, Turtle CJ. Factors associated with durable EFS in adult B-cell ALL patients achieving MRD-negative CR after CD19 CAR T-cell therapy. Blood. 2019 Apr 11;133(15):1652-1663. doi: 10.1182/blood-2018-11-883710. Epub 2019 Feb 6.","pmid":"30728140","type":"DERIVED"},{"citation":"Hill JA, Li D, Hay KA, Green ML, Cherian S, Chen X, Riddell SR, Maloney DG, Boeckh M, Turtle CJ. Infectious complications of CD19-targeted chimeric antigen receptor-modified T-cell immunotherapy. Blood. 2018 Jan 4;131(1):121-130. doi: 10.1182/blood-2017-07-793760. Epub 2017 Oct 16.","pmid":"29038338","type":"DERIVED"},{"citation":"Turtle CJ, Hanafi LA, Berger C, Gooley TA, Cherian S, Hudecek M, Sommermeyer D, Melville K, Pender B, Budiarto TM, Robinson E, Steevens NN, Chaney C, Soma L, Chen X, Yeung C, Wood B, Li D, Cao J, Heimfeld S, Jensen MC, Riddell SR, Maloney DG. CD19 CAR-T cells of defined CD4+:CD8+ composition in adult B cell ALL patients. J Clin Invest. 2016 Jun 1;126(6):2123-38. doi: 10.1172/JCI85309. Epub 2016 Apr 25.","pmid":"27111235","type":"DERIVED"}],"start_date":{"date":"2013-05-22","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Laboratory Treated T Cells in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia, Non-Hodgkin Lymphoma, or Acute Lymphoblastic Leukemia","url":"https://clinicaltrials.gov/study/NCT01865617"},"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/nct01865617"}