A Randomized Phase 3 Study of Fludarabine and Rituximab With or Without Genasense® (Oblimersen Sodium) in Previously Untreated Subjects With Chronic Lymphocytic Leukemia
Inclusion Criteria:
- Previously untreated subjects with intermediate-or high-risk CLL(modified Rai Stages
I-IV)
- Measurable disease as primarily established by the National Cancer
Institute-sponsored Working Group(NCI-WG) Guidelines for the diagnosis of CLL
- Requiring therapy for active disease, as primarily defined by the NCI-WG Guidelines
- Eastern Cooperative Oncology Group Performance Status < 2
- Adequate organ function determined , 14 days prior to the first dose of study
medication
Exclusion Criteria:
- Absolute Lymphocyte count > 100,000/uL
- Prior chemotherapy or other therapy for CLL, including allogeneic transplant
- Less than 3 weeks from any prior major surgery at the time of informed consent
- Failure to recover from any serious adverse effect of surgery
- History of autoimmune hemolytic anemia or autoimmune thrombocytopenia
- Active serious infection requiring systemic anti-infective therapy