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- Titel:
Final analysis of the CLL2-GIVe trial: obinutuzumab, ibrutinib, and venetoclax for untreated CLL with del(17p)/TP53mut.
- Dokumenttyp:
- Article; Multicenter Study; Journal Article; Research Support, Non-U.S. Gov't
- Autor(en):
- Huber, Henriette; Tausch, Eugen; Schneider, Christof; Edenhofer, Simone; von Tresckow, Julia; Robrecht, Sandra; Giza, Adam; Zhang, Can; Fürstenau, Moritz; Dreger, Peter; Ritgen, Matthias; Illmer, Thomas; Illert, Anna Lena; Dürig, Jan; Böttcher, Sebastian; Niemann, Carsten U; Kneba, Michael; Al-Sawaf, Othman; Kreuzer, Karl-Anton; Fink, Anna-Maria; Fischer, Kirsten; Döhner, Hartmut; Hallek, Michael; Eichhorst, Barbara; Stilgenbauer, Stephan
- Abstract:
- 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 < .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 ≥3) and infections (19.5%, grade ≥3). 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 ≥3 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.
- Zeitschriftentitel:
- Blood
- Jahr:
- 2023
- Band / Volume:
- 142
- Heft / Issue:
- 11
- Seitenangaben Beitrag:
- 961-972
- Volltext / DOI:
- doi:10.1182/blood.2023020013
- PubMed:
- http://view.ncbi.nlm.nih.gov/pubmed/37363867
- Print-ISSN:
- 0006-4971
- TUM Einrichtung:
- 1036; 290; Professur für Personalisierte Onkologie (Prof. Illert)
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