Phase 2 Safety and Efficacy Study of AT-101 in Combination With Rituximab in Patients With Chronic Lymphocytic Leukemia

Inclusion Criteria: Diagnosis of CLL as defined by the NCI-working group Previous treatment with standard systemic chemotherapy or immunotherapy. Disease progression or relapse after treatment. Indication for treatment as defined by the NCI Working Group Guidelines (Cheson, 1996) ECOG performance status ≤ 2 Adequate liver and renal and bone marrow function Exclusion Criteria: Treatment of CLL with chemotherapy, monoclonal antibody or radiotherapy within 60 days prior to entering the study. Acute toxicities from prior therapy must have resolved to Grade ≤ 1. Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification Severe or debilitating pulmonary disease (dyspnea at rest, significant shortness of breath, COPD) Active secondary malignancy or history of other malignancy within the last five years Active symptomatic fungal, bacterial and/or viral infection including active HIV or viral hepatitis (A, B or C). Patients who are contraindicated for treatment with rituximab Diagnosis of prolymphocytic leukemia, hairy cell leukemia, leukemic phase of non-Hodgkin's lymphoma, or other non-B-CLL B-cell malignancy; T-CLL or other T-cell malignancy