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Cited by 873

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Venetoclax and Obinutuzumab in Patients with CLL and Coexisting Conditions

Fischer, Kirsten, Al-Sawaf, Othman, Bahlo, Jasmin, Fink, Anna-Maria, Tandon, Maneesh, Dixon, Mark, Robrecht, Sandra, Warburton, Simon, Humphrey, Kathryn, Samoylova, Olga, Liberati, Anna M., Pinilla-Ibarz, Javier, Opat, Stephen, Sivcheva, Liliya, Le Dû, Katell, Fogliatto, Laura M., Niemann, Carsten U., Weinkove, Robert, Robinson, Sue, Kipps, Thomas J., Boettcher, Sebastian, Tausch, Eugen, Humerickhouse, Rod, Eichhorst, Barbara, Wendtner, Clemens-Martin, Langerak, Anton W., Kreuzer, Karl-Anton, Ritgen, Matthias, Goede, Valentin, Stilgenbauer, Stephan, Mobasher, Mehrdad, Hallek, Michael·2019·New England Journal of Medicine

Abstract

BACKGROUND: The BCL2 inhibitor venetoclax has shown activity in patients with chronic lymphocytic leukemia (CLL), but its efficacy in combination with other agents in patients with CLL and coexisting conditions is not known. METHODS: In this open-label, phase 3 trial, we investigated fixed-duration treatment with venetoclax and obinutuzumab in patients with previously untreated CLL and coexisting conditions. Patients with a score of greater than 6 on the Cumulative Illness Rating Scale (scores range from 0 to 56, with higher scores indicating more impaired function of organ systems) or a calculated creatinine clearance of less than 70 ml per minute were randomly assigned to receive venetoclax-obinutuzumab or chlorambucil-obinutuzumab. The primary end point was investigator-assessed progression-free survival. The safety of each regimen was also evaluated. RESULTS: deletion, mutation, or both and in patients with unmutated immunoglobulin heavy-chain genes. Grade 3 or 4 neutropenia occurred in 52.8% of patients in the venetoclax-obinutuzumab group and in 48.1% of patients in the chlorambucil-obinutuzumab group, and grade 3 or 4 infections occurred in 17.5% and 15.0%, respectively. All-cause mortality was 9.3% in the venetoclax-obinutuzumab group and 7.9% in the chlorambucil-obinutuzumab group. These differences were not significant. CONCLUSIONS: Among patients with untreated CLL and coexisting conditions, venetoclax-obinutuzumab was associated with longer progression-free survival than chlorambucil-obinutuzumab. (Funded by F. Hoffmann-La Roche and AbbVie; ClinicalTrials.gov number, NCT02242942.).

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Metadata

Authors
Fischer, K., Al-Sawaf, O., Bahlo, J., Fink, A.-M., Tandon, M., Dixon, M., Robrecht, S., Warburton, S., Humphrey, K., Samoylova, O., Liberati, A. M., Pinilla-Ibarz, J., Opat, S., Sivcheva, L., Le Dû, K., Fogliatto, L. M., Niemann, C. U., Weinkove, R., Robinson, S., Kipps, T. J., Boettcher, S., Tausch, E., Humerickhouse, R., Eichhorst, B., Wendtner, C.-M., Langerak, A. W., Kreuzer, K.-A., Ritgen, M., Goede, V., Stilgenbauer, S., Mobasher, M., & Hallek, M.
Venue
New England Journal of Medicine
Published
2019-06-06
Volume
380
Issue
23
Pages
2225-2236
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
OpenAlex
W2948436219
Cited by
873
References
29
FWCI
58.23
Type
journal article
Language
en
Open access
closed

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CoChat. (2026). Citation check: Venetoclax and Obinutuzumab in Patients with CLL and Coexisting Conditions. https://app.cochat.ai/papers/10.1056/nejmoa1815281
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Fischer, K., Al-Sawaf, O., Bahlo, J., Fink, A.-M., Tandon, M., Dixon, M., Robrecht, S., Warburton, S., Humphrey, K., Samoylova, O., Liberati, A. M., Pinilla-Ibarz, J., Opat, S., Sivcheva, L., Le Dû, K., Fogliatto, L. M., Niemann, C. U., Weinkove, R., Robinson, S., . . . Hallek, M. (2019). Venetoclax and Obinutuzumab in Patients with CLL and Coexisting Conditions. New England Journal of Medicine. https://doi.org/10.1056/nejmoa1815281

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

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