| Exclusion Criteria: | 1) The subject has a history of or is clinically suspicious for cancer-related Central Nervous System (CNS) disease.
2) Subject has a history of severe allergic or anaphylactic reactions to human, humanized, chimeric or murine monoclonal antibodies.
3) The subject has undergone an allogeneic stem cell transplant.
4) The subject exhibits evidence of other clinically significant uncontrolled condition(s) including, but not limited to: uncontrolled systemic infection (viral, bacterial, or fungal); diagnosis of fever and neutropenia within 1 week prior to study drug administration.
5) The subject had an underlying, predisposing condition of bleeding or currently exhibits signs of bleeding.
6) The subject has a recent history of non-chemotherapy induced thrombocytopenic associated bleeding (within 6 months prior to the first dose of study drug).
7) The subject is currently receiving or requires anticoagulation therapy or any drugs or herbal supplements that effect platelet function, with the exception of low-dose anticoagulation medications that are used to maintain the patency of a central intravenous catheter.
8) The subject has active immune thrombocytopenic purpura or a history of being refractory to platelet transfusions (within 1 year prior to the first dose of study drug).
9) Subject has active peptic ulcer disease or other hemorrhagic esophagitis/gastritis.
10) The subject has a significant history of cardiovascular disease (e.g., myocardial infarction [MI], thrombotic, or thromboembolic event in the last 6 months), renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, or hepatic disease that in the opinion of the investigator would adversely affect his/her participating in this study.
11) Female subject is pregnant or breast-feeding.
12) Subject has tested positive for Hepatitis B or Hepatitis C.
13) The subject has tested positive for HIV (due to potential drug-drug interactions between anti-retroviral medications and ABT-263, as well as anticipated ABT-263 mechanism based lymphopenia that may potentially increase the risk of opportunistic infections and potential drug-drug interactions with certain anti-infective agents).
14) Subject has a history of other active malignancies within three years prior to study entry, with the exception of: adequately treated in situ carcinoma of the cervix uteri; basal or squamous cell carcinoma of the skin; in situ carcinoma of the bladder; previous malignancy confined and surgically resected with curative intent.
15) The subject has a history of prior toxicity from fludarabine, cyclophophamide, or rituximab if enrolling on Arm A or bendamustine or rituximab if enrolling on Arm B that resulted in permanent discontinuation of treatments.
16) Subject has prior significant toxicity from ABT-263.
17) Subject has received immunization with live vaccine within 6 months prior to first dose of study drug.
18) The subject has received antibody therapy (except rituximab) within 30 days prior to the first dose of study drug.
19) The subject has received any anti-cancer therapy, including chemotherapy, immunotherapy, radiotherapy, hormonal (with the exception of hormones for thyroid conditions or estrogen replacement [ERT]), or any investigational therapy 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.
20) The subject has received steroid therapy for anti-neoplastic intent within 7 days prior to the first dose of study drug. Exception of steroid use includes inhaled steroids for asthma, topical steroids, or replacement/stress corticosteroids.
21) Subject has received aspirin within 7 days prior to the first dose of study drug.
22) The subject has consumed grapefruit or grapefruit products within 3 days prior to the first dose of study drug.
23) Any subdural hematoma.
24) The subject has received known CYP3A inhibitors (e.g., ketoconazole, clarithromycin) within 7 days prior to first dose of study drug. |