PLL1 Trial

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