Bendamustine and rituximab in combination with lenalidomide in patients with chronic lymphocytic leukemia
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Bendamustine and rituximab in combination with lenalidomide in patients with chronic lymphocytic leukemia. / Maurer, Christian; Pflug, Natali; Bahlo, Jasmin; Kluth, Sandra; Rhein, Christina; Cramer, Paula; Gross-Ophoff, Carolin; Langerbeins, Petra; Fink, Anna-Maria; Eichhorst, Barbara; Kreuzer, Karl-Anton; Fischer, Norbert; Tausch, Eugen; Stilgenbauer, Stephan; Böttcher, Sebastian; Döhner, Hartmut; Kneba, Michael; Dreyling, Martin; Binder, Mascha; Hallek, Michael; Wendtner, Clemens-Martin; Bergmann, Manuela; Fischer, Kirsten; German CLL Study Group (GCLLSG).
in: EUR J HAEMATOL, 08.12.2015.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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T1 - Bendamustine and rituximab in combination with lenalidomide in patients with chronic lymphocytic leukemia
AU - Maurer, Christian
AU - Pflug, Natali
AU - Bahlo, Jasmin
AU - Kluth, Sandra
AU - Rhein, Christina
AU - Cramer, Paula
AU - Gross-Ophoff, Carolin
AU - Langerbeins, Petra
AU - Fink, Anna-Maria
AU - Eichhorst, Barbara
AU - Kreuzer, Karl-Anton
AU - Fischer, Norbert
AU - Tausch, Eugen
AU - Stilgenbauer, Stephan
AU - Böttcher, Sebastian
AU - Döhner, Hartmut
AU - Kneba, Michael
AU - Dreyling, Martin
AU - Binder, Mascha
AU - Hallek, Michael
AU - Wendtner, Clemens-Martin
AU - Bergmann, Manuela
AU - Fischer, Kirsten
AU - German CLL Study Group (GCLLSG)
N1 - © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
PY - 2015/12/8
Y1 - 2015/12/8
N2 - 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.
AB - 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.
U2 - 10.1111/ejh.12714
DO - 10.1111/ejh.12714
M3 - SCORING: Journal article
C2 - 26643449
JO - EUR J HAEMATOL
JF - EUR J HAEMATOL
SN - 0902-4441
ER -