Rituximab plus Fludarabine for patients with WM

Status: COMPLETED
Date: 3/31/2003
Sponsor: Berlex Oncology Inc., Genentech Inc., and the Research Fund for WM at the Dana Farber Cancer Institute
Institution: Dana Farber Cancer Institute and affiliated WMCTG sites in the USA, Canada, UK, Sweden, France and Australia
Physician: Dr. Steven P. Treon

DFCI Protocol 00-257, a multicenter Phase II clinical trial chaired by Dr. Treon was initated in March 2000. In this study, WM patients are receiving combination therapy with fludarabine and rituximab. The intended enrollment for this study is 40 patients, and to date 35 patients have been enrolled. Of the first 21 evaluable patients in this study, 19 patients (90%) patients have demonstrated a response, whilst 3/21 (15%) patients attained a complete remission. The endpoints of this study include assessment of overall and complete response rates, durations of response and assessment of toxicity. Corollary studies examining mechanisms of synergy for fludarabine and rituximab are also being conducted as part of this study. The interim results of this study were presented at the 2nd International Workshop on WM (Athens, 2002) and at the 2002 American Society of Hematology meeting.