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| Title | Treatment of relapsed / refractory chronic lymphocytic leukemia (CLL) with Bendamustin / Mitoxantrone (BM) |
|---|---|
| Protocol IDs | NCT00274963 |
| Participating Countries | Germany |
| Status | completed |
| Contact | DCLLSG Office: Tel. +49 (0) 221-478-88220 |
| Design | Prospective, open-label, multicentre, phase II trial |
| Primary Endpoint(s) | Overall remission rate (CR + PR) |
| Secondary Endpoint(s) | Time to progression (TTP), tolerance of treatment, safety and overall survival |
| Study Population | B-CLL with need for treatment, relapsed or refractory Age ≥ 18 years |
| Treatment | Bendamustin 50 mg/m²/d, d1-3 Mitoxantrone 10 mg/m²/d, d1; q28d, max 4 cycles |
| Patients recruited | 59 patients |
| Time schedule | Recruitment period: 09.07.2004 - 07.11.2007 End of study: Oct 2009 Clinical Study Report / Publication: May 2012 End of archiving period: Oct 2019 |
| Sponsor | DCLLSG/Koblenz/Prof. Dr. Hubert Köppler |
| Principal investigator | Prof. Dr. Hubert Köppler, Koblenz |
| Publications | Köppler H, Fuss H, Hurtz HJ, Knigge O, Losem C, Reschke D, Schmitz S, Weide R, Weiß J, Hallek M; for the GCLLSG Bendamustine plus mitoxantrone for relapsed/refractory chronic lymphocytic leukaemia (CLL): results of a multicentre phase II study of the German CLL Study Group (GCLLSG) Br J Haematol. 2012 May 10. doi: 10.1111/j.1365-2141.2012.09132.x [Epub ahead of print] |