{"preliminary_commentary":{"by_channel":{"x_thread":43,"youtube":11,"podcast":11},"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\": \"NCT01332968\", \"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":"2026-10-30T23:36:41.791Z","note":"Automated from the 40 newest of 65 indexed sources (Jan 2021 – Sep 2026). Each question is raised in at least two. Not an Erudio report: no source links. Not medical advice.","passages_read":40,"text":"- Whether obinutuzumab should be preferred over rituximab\n- Whether maintenance is needed after induction, and for whom\n- How to weigh obinutuzumab's potential benefit against toxicity\n- Whether reducing POD24 leads to better long-term outcomes\n\nAlso discussed: bone health."},"drugs_tested":[["obinutuzumab"]],"indication":"previously untreated advanced indolent non-Hodgkin lymphoma","name":"GALLIUM","nct_id":"NCT01332968","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=gallium-nct01332968. 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":null,"arms":[{"description":"Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.","label":"Rituximab+Chemotherapy","type":"ACTIVE_COMPARATOR"},{"description":"Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.","label":"Obinutuzumab+Chemotherapy","type":"EXPERIMENTAL"}],"collaborators":["German Low Grade Lymphoma Study Group","Institute of Cancer Research, United Kingdom"],"completion_date":{"date":"2021-07-30","type":"ACTUAL"},"conditions":["Non-Hodgkin's Lymphoma"],"enrollment":{"count":1401,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Obinutuzumab","otherNames":["GA101; RO5072759"],"type":"DRUG"},{"name":"Cyclophosphamide","otherNames":[],"type":"DRUG"},{"name":"Doxorubicin","otherNames":[],"type":"DRUG"},{"name":"Vincristine","otherNames":[],"type":"DRUG"},{"name":"Prednisone","otherNames":[],"type":"DRUG"},{"name":"Bendamustine","otherNames":[],"type":"DRUG"},{"name":"Rituximab","otherNames":["MabThera/Rituxan"],"type":"DRUG"}],"last_update":"2022-08-11","lead_sponsor":"Hoffmann-La Roche","official_title":"A Multicenter, Phase III, Open-Label, Randomized Study in Previously Untreated Patients With Advanced Indolent Non-Hodgkin's Lymphoma Evaluating the Benefit of GA101 (RO5072759) Plus Chemotherapy Compared With Rituximab Plus Chemotherapy Followed by GA101 or Rituximab Maintenance Therapy in Responders","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2016-02-01","type":"ACTUAL"},"primary_outcomes":[{"measure":"Progression-Free Survival in the Follicular Lymphoma Population, Investigator-Assessed","timeFrame":"Baseline up to data cut-off (up to approximately 4 years and 7 months)"}],"references":[{"citation":"Jorgensen JB, Hansen KV, Nielsen LK, Gade IL, Pedersen MA, Jensen P, Simonsen MR, Knapp A, Gormsen LC, El-Galaly TC. First-line immunochemotherapy for indolent lymphoma does not affect muscle volume: a post hoc analysis of 472 patients in long-term remissions from the GALLIUM study. Leuk Lymphoma. 2026 May;67(6):1352-1361. doi: 10.1080/10428194.2026.2642931. Epub 2026 Mar 25.","pmid":"41879719","type":"DERIVED"},{"citation":"Pott C, Jurinovic V, Trotman J, Kehden B, Unterhalt M, Herold M, Jagt RV, Janssens A, Kneba M, Mayer J, Young M, Schmidt C, Knapp A, Nielsen T, Brown H, Spielewoy N, Harbron C, Bottos A, Mundt K, Marcus R, Hiddemann W, Hoster E. Minimal Residual Disease Status Predicts Outcome in Patients With Previously Untreated Follicular Lymphoma: A Prospective Analysis of the Phase III GALLIUM Study. J Clin Oncol. 2024 Feb 10;42(5):550-561. doi: 10.1200/JCO.23.00838. Epub 2023 Dec 14.","pmid":"38096461","type":"DERIVED"},{"citation":"Pedersen MA, Gormsen LC, Jakobsen LH, Eyre TA, Severinsen MT, Baech J, Dann EJ, Knapp A, Sahin D, Vestergaard P, El-Galaly TC, Jensen P. The impact of CHOP versus bendamustine on bone mineral density in patients with indolent lymphoma enrolled in the GALLIUM study. Br J Haematol. 2024 Apr;204(4):1271-1278. doi: 10.1111/bjh.19194. Epub 2023 Nov 13.","pmid":"37957542","type":"DERIVED"},{"citation":"Casulo C, Herold M, Hiddemann W, Iyengar S, Marcus RE, Seymour JF, Launonen A, Knapp A, Nielsen TG, Mir F. Risk Factors for and Outcomes of Follicular Lymphoma Histological Transformation at First Progression in the GALLIUM Study. Clin Lymphoma Myeloma Leuk. 2023 Jan;23(1):40-48. doi: 10.1016/j.clml.2022.09.003. Epub 2022 Oct 4.","pmid":"36379880","type":"DERIVED"},{"citation":"Hong X, Song Y, Shi Y, Zhang Q, Guo W, Wu G, Li J, Feng J, Kinkolykh A, Knapp A, Lin T. Efficacy and safety of obinutuzumab for the first-line treatment of follicular lymphoma: a subgroup analysis of Chinese patients enrolled in the phase III GALLIUM study. Chin Med J (Engl). 2021 Sep 16;135(4):433-440. doi: 10.1097/CM9.0000000000001737.","pmid":"35194005","type":"DERIVED"},{"citation":"Strefford JC, Nowicka M, Hargreaves CE, Burton C, Davies A, Ganderton R, Hiddemann W, Iriyama C, Klapper W, Latham KV, Martelli M, Mir F, Parker H, Potter KN, Rose-Zerilli MJJ, Sehn LH, Trneny M, Vitolo U, Bolen CR, Klein C, Knapp A, Oestergaard MZ, Cragg MS. Single-nucleotide Fcgamma receptor polymorphisms do not impact obinutuzumab/rituximab outcome in patients with lymphoma. Blood Adv. 2021 Aug 10;5(15):2935-2944. doi: 10.1182/bloodadvances.2020003985.","pmid":"34323957","type":"DERIVED"},{"citation":"Davies A, Trask P, Demeter J, Florschutz A, Hanel M, Kinoshita T, Pettengell R, Quach H, Robinson S, Sadullah S, Sancho JM, Udvardy M, Witzens-Harig M, Knapp A, Liu W. Health-related quality of life in the phase III GALLIUM study of obinutuzumab- or rituximab-based chemotherapy in patients with previously untreated advanced follicular lymphoma. Ann Hematol. 2020 Dec;99(12):2837-2846. doi: 10.1007/s00277-020-04021-6. Epub 2020 Apr 20.","pmid":"32314038","type":"DERIVED"},{"citation":"Klanova M, Oestergaard MZ, Trneny M, Hiddemann W, Marcus R, Sehn LH, Vitolo U, Bazeos A, Goede V, Zeuner H, Knapp A, Sahin D, Spielewoy N, Bolen CR, Cardona A, Klein C, Venstrom JM, Nielsen T, Fingerle-Rowson G. Prognostic Impact of Natural Killer Cell Count in Follicular Lymphoma and Diffuse Large B-cell Lymphoma Patients Treated with Immunochemotherapy. Clin Cancer Res. 2019 Aug 1;25(15):4634-4643. doi: 10.1158/1078-0432.CCR-18-3270. Epub 2019 May 3.","pmid":"31053601","type":"DERIVED"},{"citation":"Kusumoto S, Arcaini L, Hong X, Jin J, Kim WS, Kwong YL, Peters MG, Tanaka Y, Zelenetz AD, Kuriki H, Fingerle-Rowson G, Nielsen T, Ueda E, Piper-Lepoutre H, Sellam G, Tobinai K. Risk of HBV reactivation in patients with B-cell lymphomas receiving obinutuzumab or rituximab immunochemotherapy. Blood. 2019 Jan 10;133(2):137-146. doi: 10.1182/blood-2018-04-848044. Epub 2018 Oct 19.","pmid":"30341058","type":"DERIVED"},{"citation":"Trotman J, Barrington SF, Belada D, Meignan M, MacEwan R, Owen C, Ptacnik V, Rosta A, Fingerle-Rowson GR, Zhu J, Nielsen T, Sahin D, Hiddemann W, Marcus RE, Davies A; PET investigators from the GALLIUM study. Prognostic value of end-of-induction PET response after first-line immunochemotherapy for follicular lymphoma (GALLIUM): secondary analysis of a randomised, phase 3 trial. Lancet Oncol. 2018 Nov;19(11):1530-1542. doi: 10.1016/S1470-2045(18)30618-1. Epub 2018 Oct 8.","pmid":"30309758","type":"DERIVED"},{"citation":"Hiddemann W, Barbui AM, Canales MA, Cannell PK, Collins GP, Durig J, Forstpointner R, Herold M, Hertzberg M, Klanova M, Radford J, Seymour JF, Tobinai K, Trotman J, Burciu A, Fingerle-Rowson G, Wolbers M, Nielsen T, Marcus RE. Immunochemotherapy With Obinutuzumab or Rituximab for Previously Untreated Follicular Lymphoma in the GALLIUM Study: Influence of Chemotherapy on Efficacy and Safety. J Clin Oncol. 2018 Aug 10;36(23):2395-2404. doi: 10.1200/JCO.2017.76.8960. Epub 2018 Jun 1.","pmid":"29856692","type":"DERIVED"},{"citation":"Marcus R, Davies A, Ando K, Klapper W, Opat S, Owen C, Phillips E, Sangha R, Schlag R, Seymour JF, Townsend W, Trneny M, Wenger M, Fingerle-Rowson G, Rufibach K, Moore T, Herold M, Hiddemann W. Obinutuzumab for the First-Line Treatment of Follicular Lymphoma. N Engl J Med. 2017 Oct 5;377(14):1331-1344. doi: 10.1056/NEJMoa1614598.","pmid":"28976863","type":"DERIVED"}],"start_date":{"date":"2011-07-06","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of Obinutuzumab (RO5072759) Plus Chemotherapy in Comparison With Rituximab Plus Chemotherapy Followed by Obinutuzumab or Rituximab Maintenance in Patients With Untreated Advanced Indolent Non-Hodgkin's Lymphoma (GALLIUM)","url":"https://clinicaltrials.gov/study/NCT01332968"},"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/gallium-nct01332968"}