A Study of Venetoclax in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
A Study of Venetoclax in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
This is a Phase 2, open-label, multicenter study, evaluating the efficacy of venetoclax in
 participants with relapsed or refractory Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic
 Lymphoma (SLL) either in presence of 17p deletion (Cohort 1) or those who have failed a
 B-receptor signaling pathway inhibitor (BCRI) therapy and who have also failed were
 intolerant to or were unable to receive chemoimmunotherapy (CIT) irrespective of 17p status
 (Cohort 2).
Inclusion Criteria:

 -  Participant must have a diagnosis of relapsed or refractory chronic lymphocytic
 leukemia (CLL)/SLL that meets 2008 Modified International Workshop for Chronic
 Lymphocytic Leukemia (iwCLL) NCI-WG Guidelines and the following:

 -  Participant must have an indication for treatment according to the 2008 Modified
 iwCLL National Cancer Institute-Working Group (NCI-WG) Guidelines.

 -  CLL participant must have measurable disease (B-lymphocytosis greater than 5 ×
 10^9/L or an enlarged lymph node(s) (LDi > 1.5 cm at baseline) or hepatomegaly or
 splenomegaly due to CLL).

 -  SLL participant must have presence of lymphadenopathy and absence of cytopenias
 caused by a clonal marrow infiltrate.

 -  Participant must have relapsed or refractory CLL/SLL after receiving at least one
 prior line of therapy.

 -  Participant must have 17p deletion, assessed by a central laboratory.

 -  Participants (in Cohort 1) must have 17p deletion, assessed by a central laboratory.

 -  Participants (in Cohort 2) must meet both of the following:

 -  Relapsed/refractory disease to B-Cell Receptor Signaling Pathway Inhibitor (BCRI)
 treatment;

 -  And either of the following: (a) relapsed/refractory disease to
 chemoimmunotherapy (CIT), or (b) ineligible to receive CIT, defined as having 17p
 deletion, or Cumulative Illness Rating Scale (CIRS) >6 or calculated creatinine
 clearance <70 mL/min.

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

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

 -  No known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
 infection.

 Exclusion Criteria:

 -  Participant has undergone an allogeneic stem cell transplant.

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

 -  Participant has prolymphocytic leukemia.

 -  Participant has active and uncontrolled autoimmune cytopenias (for 2 weeks prior to
 screening), including autoimmune hemolytic anemia (AIHA) and idiopathic
 thrombocytopenic purpura (ITP).

 -  Participant has previously received venetoclax.

 -  Participant is known to be positive for Human Immunodeficiency Virus (HIV).

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

 -  Participant has received any of the following within 14 days or 5 half-lives
 (whichever is shorter) prior to the first dose of study drug, or has not recovered to
 less than Common Toxicity Criteria for Adverse Events (CTCAE) grade 2 clinically
 significant adverse effect(s)/toxicity(s) of the previous therapy:

 -  Any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy or
 targeted small molecule agents.

 -  Investigational therapy, including targeted small molecule agents.

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