Title | Fludarabine versus chlorambucil in first line therapy of elderly patients (more than 65 years) with advanced chronic lymphocytic leukemia (CLL) |
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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 |
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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 |