Abstract
MABLE investigated the efficacy and safety of rituximab plus bendamustine or rituximab plus chlorambucil in fludarabine-ineligible patients with chronic lymphocytic leukemia. Patients received rituximab plus bendamustine or rituximab plus chlorambucil every four weeks for six cycles. Rituximab plus chlorambucil-treated patients without a complete response after Cycle 6 received chlorambucil monotherapy for at least six additional cycles or until complete response. The primary endpoint was complete response rate (confirmed by bone marrow biopsy) after Cycle 6 in first-line patients. Secondary endpoints included progression-free survival, overall survival, minimal residual disease, and safety. Overall, 357 patients were randomized (rituximab plus bendamustine, n=178;rituximab plus chlorambucil, n=179;intent-to-treat population), including 241 first-line patients (n=121 and n=120, respectively);355 patients received treatment (n=177 and n=178, respectively;safety population). In first-line patients, complete response rate after Cycle 6 (rituximab plus bendamustine, 24%;rituximab plus chlorambucil, 9%;P=0.002) and median progression-free survival (rituximab plus bendamustine, 40 months;rituximab plus chlorambucil, 30 months;P=0.003) were higher with rituximab plus bendamustine than rituximab plus chlorambucil. Overall response rate and overall survival were not different. In first-line patients with a complete response, minimal residual disease-negativity was higher with rituximab plus bendamustine than rituximab plus chlorambucil (66% vs. 36%). Overall adverse event incidence was similar (rituximab plus bendamustine, 98%;rituximab plus chlorambucil, 97%). Rituximab plus bendamustine may be a valuable first-line option for fludarabine-ineligible patients with chronic lymphocytic leukemia. clinicaltrials.gov identifier: 01056510
Item Type: | Journal article |
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Faculties: | Medicine |
Subjects: | 600 Technology > 610 Medicine and health |
URN: | urn:nbn:de:bvb:19-epub-63522-4 |
ISSN: | 0390-6078 |
Language: | English |
Item ID: | 63522 |
Date Deposited: | 19. Jul 2019, 12:13 |
Last Modified: | 04. Nov 2020, 13:42 |