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

Inclusion Criteria:

• Subject must be greater then or equal to 18 years of age.
• Subject must have newly diagnosed or relapsed Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma.
• Subject has an Eastern Cooperative Oncology Group performance score of less then or equal to 1.
• Subject must have adequate bone marrow independent of growth factor support per local laboratory reference range at Screening.
• Subject must have adequate coagulation, renal, and hepatic function, per laboratory reference range at Screening.

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 biologic agent for anti-neoplastic intent within 30 days prior to the first dose of study drug.

• Subject has received any of the following agents 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 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.