Sprung-Navigation
| Title | Phase-II-trial of combined immunochemotherapy with Fludarabine, Cyclophosphamide and Rituximab in patients with B-PLL |
|---|---|
| Protocol IDs | NCT00278213 |
| Participating Countries | Germany |
| Status | prematurely terminated due to slow recruitment |
| Contact | DCLLSG Office: Tel. +49 (0) 221-478-88220 |
| Design | Prospektive, open-label, multicentre, non-randomized phase II trial |
| Primary Endpoint(s) | Freedom from treatment failure (FFTF), overall survival, progression-free-survival, remission rates, toxicities |
| Study Population | B-PLL, Binet-stage A, B, C Max 3 prior therapies Age > 18 to < 75 years |
| Treatment | Rituximab (375 mg/m²/d, 1st cycle: d0, from 2nd cycle: d1)+ Fludarabine (25 mg/m²/d, d1-3) + Cyclophosphamide (250 mg/m²/d, d1-3) q28d, max 6 cycles |
| Patients recruited | 21 patients |
| Time schedule | Recruitment period: 01 Sep. 1999 - 27 Nov. 2003 End of study: Apr 2006 End of archiving period: Apr 2016 |
| Sponsor | DCLLSG/Erfurt/Herold |
| Principal investigator | Prof. Dr. M. Herold, HELIOS Klinikum Erfurt GmbH |