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| Title | Fludarabine versus fludarabine plus cyclophosphamide in first line therapy of younger patients (up to 65 years) with advanced chronic lymphocytic leukemia (CLL) |
|---|---|
| Protocol IDs | ISRCTN75653261 NCT00276848 German study register number(Krebsgesellschaft): 153 |
| Participating Countries | Germany, Austria |
| Status | completed |
| Contact | DCLLSG Office: Tel. +49 (0) 221-478-88220 |
| Design | Prospektive, open-label, multicentre, randomized phase III trial |
| Primary Endpoint(s) | Rate of remission, duaration of remission, progression-free survival (PFS), overall survival |
| 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 ≥ 18 to ≤ 65 years |
| Treatment | Arm F: Fludarabine (25 mg/m2/d, d1-5) q28d; max 6 cycles Arm FC: Fludarabine (25 mg/m2/d, d1-3) + Cyclophosphamide (250 mg/m2/d, d1-3) q28d; max 6 cycles |
| Patients recruited | 375 patients (F-Arm: 189, FC-Arm: 186) |
| Time schedule | Recruitment period: 24 June 1999 - 15 July 2003 End of study: July 2008 Clinical Study Report / Publication: May 2007 End of archiving period: July 2018 |
| Sponsor | University of Cologne (GCLLSG/Cologne) |
| Principal investigators | Prof. Dr. M. Hallek, University of Cologne Prof. Dr. B. Emmerich, University of Munich (LMU) |
| Publications | Jebaraj BMC, Tausch E, Landau DA, Bahlo J, Robrecht S, Taylor-Weiner AN, Bloehdorn J, Scheffold A, Mertens D, Böttcher S, Kneba M, Jäger U, Zenz T, Wenger MK, Fingerle-Rowson G, Wendtner C, Fink AM, Wu CJ, Eichhorst B, Fischer K, Hallek M, Döhner H, Stilgenbauer S Short telomeres are associated with inferior outcome, genomic complexity, and clonal evolution in chronic lymphocytic leukemia Leukemia. 2019 Mar 25. doi: 10.1038/s41375-019-0446-4. [Epub ahead of print] 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, Hopfinger G, Pasold R, Hensel M, Steinbrecher C, Siehl S, Jager U, Bergmann M, Stilgenbauer S, Schweighofer C, Wendtner CM, Dohner H, Brittinger G, Emmerich B, Hallek M; German CLL Study Group. Fludarabine plus cyclophosphamide versus fludarabine alone in first-line therapy of younger patients with chronic lymphocytic leukemia. Blood. 2006; 107(3): 885 - 891 Eichhorst BF, Busch R, Obwandner T, Kuhn-Hallek I, Herschbach P, Hallek M; German CLL Study Group. Health-related quality of life in younger patients with chronic lymphocytic leukemia treated with fludarabine plus cyclophosphamide or fludarabine alone for first-line therapy: a study by the German CLL Study Group J Clin Oncol. 2007 May 1;25(13):1722-31 |