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, Boettcher, Sebastian, Doehner, Hartmut, Kneba, Michael, Dreyling, Martin, Binder, Mascha ORCID: 0000-0003-0663-3004, Hallek, Michael, Wendtner, Clemens-Martin, Bergmann, Manuela and Fischer, Kirsten (2016). Bendamustine and rituximab in combination with lenalidomide in patients with chronic lymphocytic leukemia. Eur. J. Haematol., 97 (3). S. 253 - 261. HOBOKEN: WILEY. ISSN 1600-0609

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Abstract

PurposeA 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 MethodsSeventeen 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. ResultsThe 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. ConclusionBRL 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.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Maurer, ChristianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Pflug, NataliUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bahlo, JasminUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kluth, SandraUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rhein, ChristinaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Cramer, PaulaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gross-Ophoff, CarolinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Langerbeins, PetraUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fink, Anna-MariaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Eichhorst, BarbaraUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kreuzer, Karl-AntonUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fischer, NorbertUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Tausch, EugenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Stilgenbauer, StephanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Boettcher, SebastianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Doehner, HartmutUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kneba, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Dreyling, MartinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Binder, MaschaUNSPECIFIEDorcid.org/0000-0003-0663-3004UNSPECIFIED
Hallek, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wendtner, Clemens-MartinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bergmann, ManuelaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fischer, KirstenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-264334
DOI: 10.1111/ejh.12714
Journal or Publication Title: Eur. J. Haematol.
Volume: 97
Number: 3
Page Range: S. 253 - 261
Date: 2016
Publisher: WILEY
Place of Publication: HOBOKEN
ISSN: 1600-0609
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
PHASE-II TRIAL; ANTITUMOR-ACTIVITY; FLUDARABINE; CYCLOPHOSPHAMIDE; DIAGNOSIS; CHEMOIMMUNOTHERAPY; GUIDELINES; RESISTANCE; THERAPYMultiple languages
HematologyMultiple languages
Refereed: Yes
URI: http://kups.ub.uni-koeln.de/id/eprint/26433

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