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