A Study of the Efficacy of ABT-199 in Subjects With Relapsed/Refractory or Previously Untreated Chronic Lymphocytic Leukemia With the 17p Deletion

Inclusion Criteria:

- Subject must be greater than or equal to 18 years of age.

- Subject must have diagnosis of CLL that meets published 2008 Modified IWCLL NCI-WG
(International Workshop for Chronic Lymphocytic Leukemia National Cancer
Institute-Working Group) Guidelines.

- Subject has an indication for treatment according to the 2008 Modified IWCLL NCI
WG Guidelines;

- Subject has clinically measurable disease (lymphocytosis > 5 × 10^9/L and/or
palpable and measurable nodes by physical exam and/or organomegaly assessed by
physical exam);

- Subject must be refractory or have relapsed after receiving at least one prior
line of therapy (subjects that have progressed after 1 cycle of treatment or have
completed at least 2 cycles of treatment for a given line of therapy) or
previously untreated CLL (previously untreated CLL subjects must have received no
prior chemotherapy or immunotherapy. Subjects with a history of emergency,
loco-regional radiotherapy (e.g., for relief of compressive signs or symptoms)
are eligible. In addition, subjects must meet the CLL diagnostic criteria above
and must have > 5 × 109/L B Lymphocytes in the peripheral blood.);

- Subjects must have 17p deletion, assessed by local laboratory (in bone marrow or
peripheral blood) or assessed by central laboratory (peripheral blood).

- Subject has an Eastern Cooperative Oncology Group (ECOG) performance score of less
than or equal to 2.

- Subject must have adequate bone marrow function at Screening as follows:

- Absolute Neutrophil Count (ANC) greater than or equal to 1000/µL, or

- For subjects with an ANC less than 1000/µL at Screening and bone marrow heavily
infiltrated with underlying disease (unless cytopenia is clearly due to marrow
involvement of CLL), growth factor support may be administered after Screening
and prior to the first dose of ABT-199 to achieve the ANC eligibility criteria
(greater than or equal to 1000/µL);

- Platelets greater than 30,000/mm3 (without transfusion support within 14 days of
Screening, without evidence of mucosal bleeding, without known history of
bleeding episode within 3 months of Screening, and without history of bleeding
disorder);

- Hemoglobin greater than or equal to 8.0 g/dL.

- Subject must have adequate coagulation, renal, and hepatic function, per laboratory
reference range at Screening as follows:

- Activated partial thromboplastin time (aPTT) and prothrombin time (PT) not to
exceed 1.5 × the upper limit of normal;

- Calculated creatinine clearance greater than 50 mL/min using 24-hour Creatinine
Clearance or modified Cockcroft-Gault equation (using Ideal Body Mass [IBM]
instead of Mass). For subjects that have BMI of > 30 kg/m2 or < 19 kg/m2, 24-hour
measured urine creatinine clearance is required;

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or
equal to 3.0 × the upper normal limit of institution's normal range; Bilirubin
less than or equal to 1.5 × upper limit of normal. Subjects with Gilbert's
Syndrome may have a bilirubin greater 1.5 × upper limit of normal, per
correspondence between the investigator and AbbVie medical monitor.

- For subjects at high risk of tumor lysis syndrome a pre-approval by the AbbVie medical
monitor is required prior to enrollment.

Exclusion Criteria:

- Subject has undergone an allogeneic stem cell transplant.

- Subject has developed Richter's transformation confirmed by biopsy.

- Subject has prolymphocytic leukemia.

- Subject has active and uncontrolled autoimmune cytopenias (for 2 weeks prior to
Screening), including autoimmune hemolytic anemia and idiopathic thrombocytopenic
purpura despite low dose corticosteroids.

- Subject has previously received ABT-199.

- 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 within 14 days or 5 half-lives as applicable
prior to the first dose of study drug, or has not recovered to less than Common
Toxicity Criteria (CTC) grade 2 clinically significant adverse effect(s)/toxicity(s)
of the previous therapy:

- Any anti-cancer therapy including chemotherapy, or radiotherapy;

- Investigational therapy, including targeted small molecule agents.

- Subject has known allergy to both xanthine oxidase inhibitors and rasburicase.