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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) |
| Recruitment Status | closed |
| Design | Prospective, international, multicentre, open label, 2-arm randomized (1:1) phase III study |
| Participating Countries | Austria, Czech Republic, Denmark, Germany, Switzerland |
| 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 - 15 Jul. 2011
End of study: scheduled 01/2018 |
| Protocol Version | 22.09.2008 Protocol (v. 2.3) 25.06.2010 Protocol incl. Amendment1 (v. 3.0 ) 08.03.2011 Amendment2 (Patient Information D, v. 4.2) |
| Sponsor | University of Cologne |
| Coordinating Investigator | Dr. Barbara Eichhorst, Internal Medicine I, University Hospital of Cologne |
| Contact for public queries | German CLL Study Group (GCLLSG) |
| Contact for scientific queries | Dr. Barbara Eichhorst, Internal Medicine I, University Hospital of Cologne Dr. Kirsten Fischer,GCLLSG |
| Documents (publicly available) |
Synopsis Flowchart |
| Documents (password protected) |
Protocol, Registration Forms, Diagnostic Forms, see Download Center |