A Study Evaluating the Impact of Venetoclax on the Quality of Life for Subjects With Relapsed (Your Cancer Has Come Back) or Refractory (no Response to Previous Cancer Treatments) Chronic Lymphocytic Leukemia (CLL) While Receiving Venetoclax Monotherapy (a Single Agent).
A Study Evaluating the Impact of Venetoclax on the Quality of Life for Subjects With Relapsed (Your Cancer Has Come Back) or Refractory (no Response to Previous Cancer Treatments) Chronic Lymphocytic Leukemia (CLL) While Receiving Venetoclax Monotherapy (a Single Agent).
The purpose of this open-label, single-arm study is to evaluate the impact of venetoclax on
 the quality of life of participants including those with with relapsed/refractory (R/R)
 chronic lymphocytic leukemia (CLL; a type of cancer affecting the blood and the bone marrow)
 with or without the 17p deletion or TP53 mutation, including subjects with an unknown status,
 as well as R/R CLL subjects who have been previously treated with B-cell receptor inhibitor
 (BCRi) therapy. The starting dose of venetoclax is 20 mg once daily. The dose must be
 gradually increased over a period of 5 weeks up to the daily dose of 400mg. Participants may
 continue receiving venetoclax for up to 2 years. After the treatment period, participants may
 continue on into a 2-year follow-up period.
Inclusion Criteria:

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

 -  Participant has relapsed/refractory disease (received at least one prior therapy).

 -  Diagnosis of CLL that meets published 2008 Modified International Workshop on CLL
 National Cancer Institute - Working Group (IWCLL NCI-WG) Guidelines and:

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

 -  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)

 -  with or without 17p deletion or TP53 mutation

 -  may have been previously treated with a prior B-cell receptor inhibitor therapy

 -  Adequate bone marrow function.

 Exclusion Criteria:

 -  Participant has developed Richter's transformation or Prolymphocytic leukemia (PLL).

 -  Participant has previously received venetoclax.

 -  History of active malignancies other than CLL within the past 2 years prior to first
 dose of venetoclax, with the exception of:

 -  adequately treated in situ carcinoma of the cervix uteri

 -  adequately treated basal cell carcinoma or localized squamous cell carcinoma of
 the skin

 -  previous malignancy confined and surgically resected (or treated with other
 modalities) with curative intent.

 -  Active and uncontrolled autoimmune cytopenias (within 2 weeks prior to screening),
 including autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenic purpura
 (ITP), despite low dose corticosteroids.

 -  Prior allogeneic stem cell transplant.