A Phase 1b Study Evaluating the Safety and Tolerability of ABT-199 in Combination With Rituximab in Subjects With Relapsed Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

Exclusion Criteria

• •Chronic lymphocytic leukemia or Small Lymphocytic Lymphoma subject has undergone an allogeneic or autologous stem cell transplant.
• •Subject has uncontrolled autoimmune hemolytic anemia or thrombocytopenia.
• •Subject has tested positive for human immunodeficiency virus.
• •Seropositivity for hepatitis B surface antigen or hepatitis C virus antibody or ribonucleic acid.
• •History of severe allergic or anaphylactic reactions to rituximab.
• •Subject has received a live viral vaccine within 6 months prior to the first dose of study drug.
• •Subject has received a monoclonal antibody for anti-neoplastic intent within 8 weeks prior to the first dose of study drug.
• •Subject has received any of the following within 14 days prior to the first dose of study drug, or has not recovered to less than grade 2 clinically significant adverse effect(s)/toxicity(s) of the previous therapy:
• •* Any anti-cancer therapy including chemotherapy, immunotherapy, or radiotherapy;
• •* Investigational therapy, including targeted small molecule agents.
• •Subject has a cardiovascular disability status of New York Heart Association Class greater then or equal to 2. Class 2 is defined as cardiac disease in which subjects are comfortable at rest but ordinary physical activity results in fatigue, palpitations, dyspnea or anginal pain.
• •Subject has a significant history of renal, neurologic, psychiatric, pulmonary, endocrinologic, metabolic, immunologic, cardiovascular, or hepatic disease that in the opinion of the investigator would adversely affect his/her participating in this study.
• •Subject has a history of other active malignancies other than CLL/SLL within the past 2 years prior to study entry, with the exception of:
• •* Adequately treated in situ carcinoma of the cervix uteri;
• •* Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin;
• •* Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent.
• •Subject has malabsorption syndrome or other condition that precludes enteral route of administration.
• •Subject exhibits evidence of other clinically significant ongoing or recent condition(s) including, but not limited to:
• •* Ongoing systemic infection (viral, bacterial, or fungal);
• •* Diagnosis of fever and neutropenia within 1 week prior to study drug administration