Multi-center Trial of Revlimid® and Rituximab, for First-Line Treatment of Chronic Lymphocytic Leukemia (CLL)
Status:
Unknown status
Trial end date:
2011-07-01
Target enrollment:
Participant gender:
Summary
The study is a two-arm, multi-center trial of Revlimid® and Rituximab, for the frontline
treatment of patients with Chronic Lymphocytic Leukemia (CLL) designed and conducted by the
CLL Research Consortium (CRC). The purpose of this study is to determine the response rate of
the combination of Revlimid® and Rituximab in previously untreated CLL patients in two arms-
those aged 65 years and above and those younger than 65. Secondary objectives will evaluate
the safety of the combination of Revlimid® and Rituximab, response duration, improvement in
hematologic parameters, and the significance of the tumor flare reaction. All patients will
have assessment of known prognostic factors for CLL as well as novel prognostic factors will
be evaluated for predicting response to treatment. Biologic corollary studies are designed to
evaluate the mechanism of Revlimid® in CLL and the combination of Revlimid® and Rituximab.