CLL2K Trial

Title Treatment of relapsed / refractory chronic lymphocytic leukemia (CLL) with Bendamustin / Mitoxantrone (BM)
Protocol IDs NCT00274963
Participating Countries Germany
Status completed
Contact DCLLSG Office: Tel. +49 (0) 221-478-88220
Design Prospective, open-label, multicentre, phase II trial
Primary Endpoint(s) Overall remission rate (CR + PR)
Secondary Endpoint(s) Time to progression (TTP), tolerance of treatment, safety and overall survival
Study Population B-CLL with need for treatment,
relapsed or refractory
Age  ≥ 18 years
Treatment Bendamustin 50 mg/m²/d, d1-3
Mitoxantrone 10 mg/m²/d, d1;
q28d, max 4 cycles
Patients recruited 59 patients
Time schedule Recruitment period: 09.07.2004 - 07.11.2007
End of study: Oct 2009
Clinical Study Report / Publication: May 2012
End of archiving period: Oct 2019
Sponsor DCLLSG/Koblenz/Prof. Dr. Hubert Köppler
Principal investigator Prof. Dr. Hubert Köppler, Koblenz
Publications Köppler H, Fuss H, Hurtz HJ, Knigge O, Losem C, Reschke D, Schmitz S, Weide R, Weiß J, Hallek M; for the GCLLSG
Bendamustine plus mitoxantrone for relapsed/refractory chronic lymphocytic leukaemia (CLL): results of a multicentre phase II study of the German CLL Study Group (GCLLSG)
Br J Haematol. 2012 May 10. doi: 10.1111/j.1365-2141.2012.09132.x [Epub ahead of print]