Title | Prognostic factors and risk-adapted therapy in patients with early stage chronic lymphocytic leukemia |
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Protocol IDs | NCT00262782 ISRCTN31378214 German study register number (Krebsgesellschaft): 138 |
Participating Countries | Germany |
Status | completed |
Contact | DCLLSG Office: Tel. +49 (0) 221-478-88220 |
Design | Prospektive, open-label, multicentre, risk stratified phase III trial |
Primary Endpoint(s) | Progression-free survival |
Secondary Endpoint(s) | Overall survival, quality of life, incidence of infections |
Study Population | B-CLL, Binet-Stage A No pretreatment Age ≥ 18 to ≤ 75 years |
Treatment | F Arm: Fludarabine (25 mg/m2/d, d1-5) q28d; max 6 cycles |
Watch & Wait Arm: watch & wait |
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Patients recruited | 877 patients |
Time schedule | Recruitment period: 12 Sept. 1997 - 07 Dec. 2004 End of study: June 2010 Clinical Study Report / Publication: Aug. 2013 End of archiving period: June 2020 |
Sponsor | University of Cologne |
Principal investigators | Prof. Dr. M. Hallek, University of Cologne Prof. Dr. B. Emmerich, University of Munich (LMU) |
Publications | Hoechstetter MA, Busch R, Eichhorst B, Bühler A, Winkler D, Bahlo J, Robrecht S, Eckart MJ, Vehling-Kaiser U, Jacobs G, Jäger U, Hurtz HJ, Hopfinger G, Hartmann F, Fuss H, Abenhardt W, Blau I, Freier W, Müller L, Goebeler M, Wendtner C, Fischer K, Herling CD, Starck M, Bentz M, Emmerich B, Döhner H, Stilgenbauer S, Hallek M Prognostic model for newly diagnosed CLL patients in Binet stage A: results of the multicenter, prospective CLL1 trial of the German CLL study group Leukemia. 2020 Feb 10 doi: 10.1038/s41375-020-0727-y. [Epub ahead of print] Hoechstetter MA, Busch R, Eichhorst B, Bühler A, Winkler D, Eckart MJ, Vehling-Kaiser U, Schimke H, Jäger U, Hurtz HJ, Hopfinger G, Hartmann F, Fuss H, Abenhardt W, Blau I, Freier W, Müller L, Goebeler M, Wendtner C, Bahlo J, Fischer K, Bentz M, Emmerich B, Döhner H, Hallek M, Stilgenbauer S Early, risk-adapted treatment with fludarabine in binet stage a chronic lymphocytic leukemia patients: Results of the CLL1 trial of the German CLL study group Leukemia. 2017 Aug 14 [Epub ahead of print] Göbel M, Eisele L, Möllmann M, Hüttmann A, Johansson P, Scholtysik R, Bergmann M, Busch R, Döhner H, Hallek M, Seiler T, Stilgenbauer S, Klein-Hitpass L, Dührsen U, Dürig J Progranulin is a novel independent predictor of disease progression and overall survival in chronic lymphocytic leukemia PLoS One. 2013 Aug 23;8(8):e72107 Manuela A. Bergmann, Barbara F. Eichhorst, Raymonde Busch, Hartmut Doehner, Ursula Vehling-Kaiser, Wolfgang Abenhardt, Michael Hallek Early and Risk-Adapted Therapy with Fludarabine in High-Risk Binet Stage A CLL Patients Prolongs Progression Free Survival but Not Overall Survival: Results of the CLL1 Protocol of the German CLL Study Group (GCLLSG) Blood 2007 110(11):2038 [Abstract] Manuela A. Bergmann, Barbara F. Eichhorst, Raymonde Busch, Dagmar Adorf, Stephan Stilgenbauer, Michael J. Eckart, Clemens-Martin Wendtner, Michael Hallek Prospective Evaluation of Prognostic Parameters in Early Stage Chronic Lymphocytic Leukemia (CLL): Results of the CLL1-Protocol of the German CLL Study Group (GCLLSG) Blood 2007 110(11):625 [Abstract] |