CLL10 Trial

Title Phase III trial of combined immunochemotherapy with Fludarabine, Cyclophosphamide and Rituximab (FCR) versus Bendamustine and Rituximab (BR) in patients with previously untreated chronic lymphocytic leukaemia
Protocol IDs EUDRACT-2007-007587-21
NCT00769522 (08.10.2008)
Participating Countries Austria, Czech Republic, Denmark, Germany, Switzerland
Status completed
Contact DCLLSG Office: Tel. +49 (0) 221-478-88220
Design Prospective, international, multicentre, open label, 2-arm randomized (1:1) phase III study
Primary Endpoint(s) progression free survival (PFS)
Secondary Endpoints - the duration of remission
- event free survival (EFS)
- overall survival  (OS)
- MRD, complete response rates and partial remission rates
- response rates and survival times in biological subgroups
- rates of toxicities
- quality of life
Study Population B-CLL:
Stage Binet C or stage Binet B and A requiring treatment
No 17p deletion detected by FISH
No pretreatment
Age  ≥ 18 years
Treatment Total of 6 cycles, each with a duration of 28 days:
Fludarabine: 25 mg/m² i.v., days 1-3
Cyclophosphamide: 250 mg/m² i.v., days 1-3
Rituximab: 375 mg/m² i.v., day 0, cycle 1
Rituximab: 500 mg/m² i.v., day 1, cycle 2-6
Bendamustine: 90mg/m² i.v., day 1-2
Rituximab: 375 mg/m² i.v., day 0, cycle 1
Rituximab: 500 mg/m² i.v., day 1, cycle 2-6
Patients recruited 564 patients
Time schedule Recruitment period: 02 Oct. 2008 - 11 Jul. 2011
End of study: Jan. 2018
Clinical Study Report / Publication: scheduled for Jan. 2019
End of archiving period: Jan. 2028
Sponsor University of Cologne
Coordinating Investigator Prof. Dr. Barbara Eichhorst, Internal Medicine I, University Hospital of Cologne
Publications Kurtz DM, Esfahani MS, Scherer F, Soo J, Jin MC, Liu CL, Newman AM, Dührsen U, Hüttmann A, Casasnovas O, Westin JR, Ritgen M, Böttcher S, Langerak AW, Roschewski M, Wilson WH, Gaidano G, Rossi D, Bahlo J, Hallek M, Tibshirani R, Diehn M, Alizadeh AA
Dynamic Risk Profiling Using Serial Tumor Biomarkers for Personalized Outcome Prediction
Cell. 2019 Jul 1. pii: S0092-8674(19)30639-7. doi: 10.1016/j.cell.2019.06.011. [Epub ahead of print]

Al-Sawaf O, Robrecht S, Bahlo J, Fink AM, Cramer P, von Tresckow J, Maurer C, Bergmann M, Seiler T, Lange E, Kneba M, Stilgenbauer S, Döhner H, Kiehl MG, Jäger U, Wendtner CM, Fischer K, Goede V, Hallek M, Eichhorst B, Hopfinger G
Impact of gender on outcome after chemoimmunotherapy in patients with chronic lymphocytic leukaemia: A meta-analysis by the german CLL study group (GCLLSG)
Leukemia. 2017 Jul 12 [Epub ahead of print]

Kovacs G, Robrecht S, Fink AM, Bahlo J, Cramer P, von Tresckow J, Maurer C, Langerbeins P, Fingerle-Rowson G, Ritgen M, Kneba M, Döhner H, Stilgenbauer S, Klapper W, Wendtner CM, Fischer K, Hallek M, Eichhorst B, Böttcher S
Minimal Residual Disease Assessment Improves Prediction of Outcome in Patients With Chronic Lymphocytic Leukemia (CLL) Who Achieve Partial Response: Comprehensive Analysis of Two Phase III Studies of the German CLL Study Group
J Clin Oncol. 2016 Aug 29. pii: JCO671305. [Epub ahead of print]

Eichhorst B, Fink AM, Bahlo J, Busch R, Kovacs G, Maurer C, Lange E, Köppler H, Kiehl M, Sökler M, Schlag R, Vehling-Kaiser U, Köchling G, Plöger C, Gregor M, Plesner T, Trneny M, Fischer K, Döhner H, Kneba M, Wendtner CM, Klapper W, Kreuzer KA, Stilgenbauer S, Böttcher S, Hallek M; international group of investigators; German CLL Study Group (GCLLSG)
First-line chemoimmunotherapy with bendamustine and rituximab versus fludarabine, cyclophosphamide, and rituximab in patients with advanced chronic lymphocytic leukaemia (CLL10): an international, open-label, randomised, phase 3, non-inferiority trial
Lancet Oncol. 2016 Jul;17(7):928-42