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| 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 |
| Recruitment Status | closed |
| 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 | study start: 08/1999 recruitment period: 19.08.1999 - 22.09.2004 |
| Protocol Version | 1999 Protocol 22.09.2000 Amendment 1 |
| Principal investigators | Prof. Dr. M. Hallek, University of Cologne Prof. Dr. B. Emmerich, University of Munich (LMU) |
| Publications | 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 |