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Bendamustine and rituximab in combination with lenalidomide in patients with chronic lymphocytic leukemia
Author(s) -
Maurer Christian,
Pflug Natali,
Bahlo Jasmin,
Kluth Sandra,
Rhein Christina,
Cramer Paula,
GrossOphoff Carolin,
Langerbeins Petra,
Fink AnnaMaria,
Eichhorst Barbara,
Kreuzer KarlAnton,
Fischer Norbert,
Tausch Eugen,
Stilgenbauer Stephan,
Böttcher Sebastian,
Döhner Hartmut,
Kneba Michael,
Dreyling Martin,
Binder Mascha,
Hallek Michael,
Wendtner ClemensMartin,
Bergmann Manuela,
Fischer Kirsten
Publication year - 2016
Publication title -
european journal of haematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.904
H-Index - 84
eISSN - 1600-0609
pISSN - 0902-4441
DOI - 10.1111/ejh.12714
Subject(s) - bendamustine , lenalidomide , medicine , rituximab , chronic lymphocytic leukemia , gastroenterology , refractory (planetary science) , toxicity , neutropenia , surgery , leukemia , multiple myeloma , lymphoma , physics , astrobiology
Purpose A phase I/ II trial to assess safety and efficacy of the combination bendamustine, rituximab, and lenalidomide ( BRL ) in patients with chronic lymphocytic leukemia ( CLL ). Patients and Methods Seventeen relapsed or refractory (R/R) and five previously untreated ( FL ) CLL patients were enrolled in the trial. In the R/R cohort, four different dose levels of lenalidomide (maximum 15 mg/d) were used. In the FL cohort, lenalidomide was dose escalated from 5 mg/d to 15 mg/d. Bendamustine was used at doses of 50 or 90 mg/m 2 for R/R or FL treatment, respectively. 375 mg/m 2 Rituximab were used for the first and 500 mg/m 2 for subsequent treatment courses. Treatment consisted of up to six courses of 28 d. Results The maximal tolerable dose of lenalidomide was 5 mg/d. The response rate was 47.1% in R/R and 60% in FL patients. Median progression‐free survival was 8.0 months. Median overall survival was 22.9 and 12.3 months, respectively, in R/R and FL patients. Grade 3/4 hematological toxicity was observed in 71.4%, and severe infections in 47.6% of patients. Due to high toxicity and low response rate of BRL , the trial was closed prematurely. Conclusion BRL was associated with a high toxicity rate, a high number of treatment interruptions, and a low remission rate. Therefore, BRL cannot be considered an appropriate treatment option for patients with CLL .