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| 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: |
| FCR-arm 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 |
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| BR-arm 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 |
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| 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 |