Étude multicentrique ouverte, à bras unique de Phase 3b destinée à évaluer l’efficacité de Venetoclax (ABT-199) chez les sujets atteints d’une leucémie lymphoïde chronique (LLC) en récidive/réfractaires, y compris chez ceux présentant la délétion 17p ou la mutation TP53 OU ceux réfractaires ou intolérants aux inhibiteurs des récepteurs des cellules B (BCRi)

Drug: Venetoclax

Inclusion Criteria:

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

- Participant has relapsed/refractory disease (received at least 1 prior therapy)

- Participant has diagnosis of CLL that meets published 2008 Modified International
Workshop for Chronic Lymphocytic Leukemia National Cancer Institute Working Group
(IWCLL NCI-WG) Guidelines and:

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

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

- In addition, participants:

- with or without 17p deletion or TP53 mutation, assessed by a local laboratory in
bone marrow or peripheral blood are eligible

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

- Participant must have adequate bone marrow function, coagulation profile, renal, and
hepatic function, per laboratory at Screening

Exclusion Criteria:

- Participant has developed Richter's transformation or Prolymphocytic leukemia

- 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

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

- Participant has undergone an allogeneic stem cell transplant

- Treatment with any of the following within five half-lives or 14 days (if half-life
unknown) as applicable prior to the first dose of venetoclax, or clinically
significant adverse effect(s)/toxicity(s) of the previous therapy have not resolved to
< National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
v4.03 Grade 2:

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

- Investigational therapy, including targeted small molecule agents

- Participant is human immunodeficiency virus (HIV) positive

- Participant has known allergy to both xanthine oxidase inhibitors and rasburicase