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| Title | Phase 2 study of a combined immunochemotherapy using rituximab and fludarabine in patients with chronic lymphocytic leukemia |
|---|---|
| Protocol IDs | --- |
| Participating Countries | Germany |
| Status | completed |
| Contact | DCLLSG Office: Tel. +49 (0) 221-478-88220 |
| Design | Prospective, open-label, multicentre, non-randomized phase II trial |
| Primary Endpoint(s) | Response rate (CR + PR) |
| Study Population | B-CLL, Binet-Stage C or B +/- pretreatment (not containing fludarabine or anthracyclines, no murine antibodies) Age ≥ 18 years and ≤ 75 Jahre |
| Treatment | Zyklus 1 - 4: Fludarabin (25 mg/m2/d, d1-5) Zyklus 2 - 6: Rituximab (50-375mg/m2, d1(-3)) q28d; |
| Patients recruited | 34 patients 31 patients evaluable (20 pt. without, 11 pt. with prior treatment) |
| Time schedule | Recruitment period: Aug 1999 - Feb 2001 End of study: Nov 2001 Clinical Study Report / Publication: Nov 2002 End of archiving period: Nov 2011 |
| Principal investigator | Prof. Dr. A. Engert, University of Cologne |
| Publication(s) | Schulz H, Klein SK, Rehwald U, Reiser M, Hinke A, Knauf WU, Aulitzky WE, Hensel M,
Herold M, Huhn D, Hallek M, Diehl V, Engert A; German CLL Study Group Phase 2 study of a combined immunochemotherapy using rituximab and fludarabine in patients with chronic lymphocytic leukemia Blood. 2002 Nov 1;100(9):3115-20 |