{"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":[["venetoclax","R-CHOP"],["venetoclax","G-CHOP"]],"indication":"B-cell non-Hodgkin lymphoma","name":"CAVALLI","nct_id":"NCT02055820","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=cavalli-nct02055820. 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":"Phase I: Participants will receive 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle will consist of 21 days. Phase II: Participants will receive 6 cycles of CHOP and 8 cycles of venetoclax (at dose determined in Phase I) + obinutuzumab. Each cycle will consist of 21 days. For both phase I and II, participants with ongoing response without excessive toxicity may receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.","label":"Venetoclax + G-CHOP Arm","type":"EXPERIMENTAL"},{"description":"Phase I: Participants will receive 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle will consist of 21 days. Phase II: Participants will receive 6 cycles of CHOP and 8 cycles of venetoclax (at dose determined in Phase I) + rituximab. Each cycle will consist of 21 days. For both phase I and II, participants with ongoing response without excessive toxicity may receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.","label":"Venetoclax + R-CHOP Arm","type":"EXPERIMENTAL"}],"collaborators":["AbbVie"],"completion_date":{"date":"2019-06-28","type":"ACTUAL"},"conditions":["Lymphoma, Non-Hodgkin"],"enrollment":{"count":267,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Venetoclax","otherNames":["GDC-0199, ABT-199"],"type":"DRUG"},{"name":"Cyclophosphamide","otherNames":[],"type":"DRUG"},{"name":"Obinutuzumab","otherNames":[],"type":"DRUG"},{"name":"Rituximab","otherNames":["MabThera/Rituxan"],"type":"DRUG"},{"name":"Doxorubicin","otherNames":[],"type":"DRUG"},{"name":"Vincristine","otherNames":[],"type":"DRUG"},{"name":"Prednisone","otherNames":[],"type":"DRUG"}],"last_update":"2020-06-11","lead_sponsor":"Hoffmann-La Roche","official_title":"A Phase Ib/II, Open-Label Study Evaluating the Safety, Efficacy and Pharmacokinetics of GDC-0199 (ABT-199) in Combination With Rituximab (R) or Obinutuzumab (G) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Patients With B-Cell Non-Hodgkin's Lymphoma (NHL) and DLBCL","overall_status":"COMPLETED","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2017-06-28","type":"ACTUAL"},"primary_outcomes":[{"measure":"Safety: Number of Participants With Dose-Limiting Toxicities (DLTs)","timeFrame":"Start of venetoclax administration (Cycle 1 Day 4 or 3 days after first CHOP dose) up to end of Cycle 2 (cycle length = 21 days)"},{"measure":"Percentage of Previously Untreated DLBCL Participants With Complete Response (CR) Defined by Positron Emission Tomography-Computed Tomography (PET/CT) Scan Using the Modified Lugano Classification Assessed by Independent Review Committee (IRC)","timeFrame":"Baseline up to end of treatment (up to approximately 6 months)"},{"measure":"Percentage of Participants With CR Defined by PET/CT Scan in Previously Untreated DLBCL Co-Expressing Both Bcl-2 and c-Myc Proteins (DE-DLBCL) Participants Assessed by IRC","timeFrame":"Baseline up to end of treatment (up to approximately 6 months)"}],"references":[{"citation":"Zelenetz AD, Salles G, Mason KD, Casulo C, Le Gouill S, Sehn LH, Tilly H, Cartron G, Chamuleau MED, Goy A, Tam CS, Lugtenburg PJ, Petrich AM, Sinha A, Samineni D, Herter S, Ingalla E, Szafer-Glusman E, Klein C, Sampath D, Kornacker M, Mobasher M, Morschhauser F. Venetoclax plus R- or G-CHOP in non-Hodgkin lymphoma: results from the CAVALLI phase 1b trial. Blood. 2019 May 2;133(18):1964-1976. doi: 10.1182/blood-2018-11-880526. Epub 2019 Mar 8.","pmid":"30850381","type":"RESULT"},{"citation":"Samineni D, Huang W, Gibiansky L, Ding H, Zhang R, Li C, Sinha A, Rajwanshi R, Humphrey K, Bazeos A, Salem AH, Miles D. Population Pharmacokinetics and Exposure-Response Analyses for Venetoclax in Combination with R-CHOP in Relapsed/Refractory and Previously Untreated Patients with Diffuse Large B Cell Lymphoma. Adv Ther. 2022 Jan;39(1):598-618. doi: 10.1007/s12325-021-01919-z. Epub 2021 Nov 25.","pmid":"34822104","type":"DERIVED"},{"citation":"Morschhauser F, Feugier P, Flinn IW, Gasiorowski R, Greil R, Illes A, Johnson NA, Larouche JF, Lugtenburg PJ, Patti C, Salles GA, Trneny M, de Vos S, Mir F, Samineni D, Kim SY, Jiang Y, Punnoose E, Sinha A, Clark E, Spielewoy N, Humphrey K, Bazeos A, Zelenetz AD. A phase 2 study of venetoclax plus R-CHOP as first-line treatment for patients with diffuse large B-cell lymphoma. Blood. 2021 Feb 4;137(5):600-609. doi: 10.1182/blood.2020006578.","pmid":"33538797","type":"DERIVED"}],"start_date":{"date":"2013-11-17","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study Evaluating the Safety, Efficacy and Pharmacokinetics of Venetoclax Combined With Chemotherapy in Participants With B-Cell Non-Hodgkin's Lymphoma (NHL) and DLBCL","url":"https://clinicaltrials.gov/study/NCT02055820"},"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/cavalli-nct02055820"}