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| Title | Efficacy of bendamustine in patients with relapsed or refractory chronic lymphocytic leukemia: a phase I/II study of the German CLL Study Group |
|---|---|
| Protocol IDs | --- |
| Participating Countries | Germany |
| Status | completed |
| Design | Prospective, open-label, oligocentric phase I/II trial |
| Primary Endpoint(s) | DLT, MTD |
| Secondary Endpoint(s) | Response rate (PR +CR) |
| Study Population | B-CLL, Binet-Stage C or B, refractory or relapsed at least one prior therapy (CLB or F) Age ≥ 18 years |
| Treatment | Bendamustin (100/90/80/70 mg/m2/d; d1-2)/dose escalation q21d; min. 3, max. 6 cycles |
| Patients recruited | 16 patients, 10 patients evaluable |
| Time schedule | Recruitment period: 30.10.2000 - 15.11.2001 End of study: Mar 2002 Clinical Study Report / Publication: Oct 2005 End of archiving period: Mar 2012 |
| Sponsor | Ribosepharm GmbH |
| Principal investigator(s) | Prof. M. Hallek, University of Cologne Prof. B. Emmerich, University of Munich (LMU) |
| Publication(s) | Bergmann MA, Goebeler ME, Herold M, Emmerich B, Wilhelm M, Ruelfs C,
Boening L, Hallek MJ; German CLL Study Group Efficacy of bendamustine in patients with relapsed or refractory chronic lymphocytic leukemia: results of a phase I/II study of the German CLL Study Group Haematologica. 2005 Oct;90(10):1357-64 |