DCLLSG

CLL1 Trial

Title Prognostic factors and risk-adapted therapy in patients with early stage chronic lymphocytic leukemia
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
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]