{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,4]],"date-time":"2026-11-04T02:54:28Z","timestamp":1793760868843,"version":"4.6.1"},"reference-count":48,"publisher":"American Society of Hematology","issue":"11","content-domain":{"domain":["ashpublications.org"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2023,9,14]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>The final analysis of the open-label, multicenter phase 2 CLL2-GIVe trial shows response and tolerability of the triple combination of obinutuzumab, ibrutinib, and venetoclax (GIVe regimen) in 41 previously untreated patients with high-risk chronic lymphocytic leukemia (CLL) with del(17p) and\/or TP53 mutation. Induction consisted of 6 cycles of GIVe; venetoclax and ibrutinib were continued up to cycle 12 as consolidation. Ibrutinib was given until cycle 15 or up to cycle 36 in patients not achieving a complete response and with detectable minimal residual disease. The primary end point was the complete remission rate at cycle 15, which was achieved at 58.5% (95% CI, 42.1-73.7; P\u00a0&amp;lt; .001). The last patient reached the end of the study in January 2022. After a median observation time of 38.4 months (range, 3.7-44.9), the 36-month progression-free survival was 79.9%, and the 36-month overall survival was 92.6%. Only 6 patients continued ibrutinib maintenance. Adverse events of concern were neutropenia (48.8%, grade \u22653) and infections (19.5%, grade \u22653). Cardiovascular toxicity grade 3 occurred as atrial fibrillation at a rate of 2.4% between cycles 1 and 12, as well as hypertension (4.9%) between cycles 1 and 6. The incidence of adverse events of any grade and grade \u22653 was highest during induction and decreased over time. Progressive disease was observed in 7 patients between cycles 27 and 42. In conclusion, the CLL2-GIVe regimen is a promising fixed-duration, first-line treatment for patients with high-risk CLL with a manageable safety profile.<\/jats:p>","DOI":"10.1182\/blood.2023020013","type":"journal-article","created":{"date-parts":[[2023,6,26]],"date-time":"2023-06-26T12:53:46Z","timestamp":1687784026000},"page":"961-972","update-policy":"https:\/\/doi.org\/10.1182\/blood.2019cm0000","source":"Crossref","is-referenced-by-count":52,"title":["Final analysis of the CLL2-GIVe trial: obinutuzumab, ibrutinib, and venetoclax for untreated CLL with del(17p)\/\n                    <i>TP53<\/i>\n                    mut"],"prefix":"10.1182","volume":"142","author":[{"given":"Henriette","family":"Huber","sequence":"first","affiliation":[{"name":"1Sektion CLL, Klinik f\u00fcr Innere Medizin III, Universit\u00e4tsklinikum Ulm, Ulm, Germany"},{"name":"2Medizinische Klinik III, St\u00e4dtisches Klinikum Karlsruhe, Karlsruhe, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eugen","family":"Tausch","sequence":"additional","affiliation":[{"name":"1Sektion CLL, Klinik f\u00fcr Innere Medizin III, Universit\u00e4tsklinikum Ulm, Ulm, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christof","family":"Schneider","sequence":"additional","affiliation":[{"name":"1Sektion CLL, Klinik f\u00fcr Innere Medizin III, Universit\u00e4tsklinikum Ulm, Ulm, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Simone","family":"Edenhofer","sequence":"additional","affiliation":[{"name":"1Sektion CLL, Klinik f\u00fcr Innere Medizin III, Universit\u00e4tsklinikum Ulm, Ulm, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julia","family":"von Tresckow","sequence":"additional","affiliation":[{"name":"3Department I of Internal Medicine and Center of Integrated Oncology Aachen Cologne Bonn Duesseldorf, University Hospital of Cologne, Cologne, 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