Journal article
Ibrutinib as initial therapy for patients with chronic lymphocytic leukemia
JA Burger, A Tedeschi, PM Barr, T Robak, C Owen, P Ghia, O Bairey, P Hillmen, NL Bartlett, J Li, D Simpson, S Grosicki, S Devereux, H McCarthy, S Coutre, H Quach, G Gaidano, Z Maslyak, DA Stevens, A Janssens Show all
New England Journal of Medicine | MASSACHUSETTS MEDICAL SOC | Published : 2015
Abstract
Background Chronic lymphocytic leukemia (CLL) primarily affects older persons who often have coexisting conditions in addition to disease-related immunosuppression and myelosuppression. We conducted an international, open-label, randomized phase 3 trial to compare two oral agents, ibrutinib and chlorambucil, in previously untreated older patients with CLL or small lymphocytic lymphoma. METHODS We randomly assigned 269 previously untreated patients who were 65 years of age or older and had CLL or small lymphocytic lymphoma to receive ibrutinib or chlorambucil. The primary end point was progression-free survival as assessed by an independent review committee. RESULTS The median age of the pati..
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Awarded by National Cancer Institute
Funding Acknowledgements
Funded by Pharmacyclics and others; RESONATE-2 ClinicalTrials.gov number, NCT01722487.