Rituximab, bendamustine, and lenalidomide in patients with aggressive B cell lymphoma not eligible for high-dose chemotherapy or anthracycline-based therapy: phase I results of the SAKK 38/08 trial.

Details

Serval ID
serval:BIB_9EE26C5FC900
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Rituximab, bendamustine, and lenalidomide in patients with aggressive B cell lymphoma not eligible for high-dose chemotherapy or anthracycline-based therapy: phase I results of the SAKK 38/08 trial.
Journal
Annals of Hematology
Author(s)
Hitz F., Fischer N., Pabst T., Caspar C., Berthod G., Eckhardt K., Berardi Vilei S., Zucca E., Mey U.
Working group(s)
Swiss Group for Clinical Cancer Research (SAKK) Bern Switzerland
ISSN
1432-0584 (Electronic)
ISSN-L
0939-5555
Publication state
Published
Issued date
2013
Volume
92
Number
8
Pages
1033-1040
Language
english
Notes
Publication types: Journal ArticlePublication Status: ppublish. pdf type: ORIGINAL ARTICLE
Abstract
This phase I trial was designed to develop a new effective and well-tolerated regimen for patients with aggressive B cell lymphoma not eligible for front-line anthracycline-based chemotherapy or aggressive second-line treatment strategies. The combination of rituximab (375 mg/m(2) on day 1), bendamustine (70 mg/m(2) on days 1 and 2), and lenalidomide was tested with a dose escalation of lenalidomide at three dose levels (10, 15, or 20 mg/day) using a 3 + 3 design. Courses were repeated every 4 weeks. The recommended dose was defined as one level below the dose level identifying ≥2/6 patients with a dose-limiting toxicity (DLT) during the first cycle. Thirteen patients were eligible for analysis. Median age was 77 years. WHO performance status was 0 or 1 in 12 patients. The Charlson Comorbidity Index showed relevant comorbidities in all patients. Two DLTs occurred at the second dose level (15 mg/day) within the first cycle: one patient had prolonged grade 3 neutropenia, and one patient experienced grade 4 cardiac adverse event (myocardial infarction). Additional grade 3 and 4 toxicities were as follows: neutropenia (31 %), thrombocytopenia (23 %), cardiac toxicity (31 %), fatigue (15 %), and rash (15 %). The dose of lenalidomide of 10 mg/day was recommended for a subsequent phase II in combination with rituximab 375 mg/m(2) on day 1 and bendamustine 70 mg/m(2) on days 1 and 2.
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Web of science
Create date
11/08/2013 8:20
Last modification date
20/08/2019 15:05
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