DCLLSG

CLL5 Trial

Title Fludarabine versus chlorambucil in first line therapy of elderly patients (more than 65 years) with advanced chronic lymphocytic leukemia (CLL)
Protocol IDs ISRCTN36294212
NCT00262795
Participating Countries Germany
Status completed
Contact DCLLSG Office: Tel. +49 (0) 221-478-88220
Design Prospektive, open-label, multicentre, randomized phase III trial
Primary Endpoint(s) Overall survival, progression-free survival (PFS), duration of remission
Secondary Endpoint(s) Incidence of side effects, quality of life
Study Population B-CLL, Binet-Stage C or B/A with need for treatment
No pretreatment
Age  > 65 to < 80 years
Treatment Arm F:
Fludarabine (25 mg/m2/d, d1-5)
q28d; max 6 cycles
Arm CLB:
Chlorambucil (0,4 mg - max. 0,8 mg/kg/d, d1)
q15d, max. 12 month
Patients recruited 206 patients ( F-Arm: 101, CLB-Arm: 105)
Time schedule Recruitment period: 19.08.1999 - 22.09.2004
End of study: Jan 2005
Clinical Study Report / Publication: Oct 2009
End of archiving period: Jan. 2015
Sponsor University of Cologne
Principal investigators Prof. Dr. M. Hallek, University of Cologne
Prof. Dr. B. Emmerich, University of Munich (LMU)
Publications Goede V, Cramer P, Busch R, Bergmann M, Stauch M, Hopfinger G, Stilgenbauer S, Doehner H, Westermann A, Wendtner CM, Eichhorst B, Hallek M
Interactions between comorbidity and treatment of chronic lymphocytic leukemia: results of German Chronic Lymphocytic Leukemia Study Group trials
Haematologica. 2014 Jun;99(6):1095-100


Cramer P, Bahlo J, Eichhorst B, Fischer K, Hallek M
Extramedullary manifestations of chronic lymphocytic leukaemia are not unusual
Leuk Res. 2013 Dec 1. pii: S0145-2126(13)00416-5

Eichhorst BF, Fischer K, Fink AM, Elter T, Wendtner CM, Goede V, Bergmann M, Stilgenbauer S, Hopfinger G, Ritgen M, Bahlo J, Busch R, Hallek M
Limited clinical relevance of imaging techniques in the follow-up of patients with advanced chronic lymphocytic leukemia: results of a meta-analysis
Blood. 2011 Feb 10;117(6):1817-21

Eichhorst BF, Busch R, Stilgenbauer S, Stauch M, Bergmann MA, Ritgen M, Kranzhofer N, Rohrberg R, Soling U, Burkhard O, Westermann A, Goede V, Schweighofer CD, Fischer K, Fink AM, Wendtner CM, Brittinger G, Dohner H, Emmerich B, Hallek M
First line therapy with fludarabine compared to chlorambucil does not result in a major benefit for elderly patients with advanced chronic lymphocytic leukemia
Blood. 2009 Oct 15;114(16):3382-91