A Phase 3 Study Comparing Dinaciclib Versus Ofatumumab in Patients With Refractory Chronic Lymphocytic Leukemia (P07714)

Inclusion Criteria:

* Aged 18 years or older
* Confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL)
* Fludarabine or chemoimmunotherapy refractory disease defined as: failing to respond to or relapsed within 6 months of completing fludarabine or another purine analog alone or in combination regimens, or failing to respond to chemoimmunotherapy or relapsed within 24 months of completing therapy with a combination of chemotherapy plus an anti-CD20 monoclonal antibody
* Eastern Cooperative Oncology Group (ECOG) Performance status 0, 1, or 2
* Adequate organ function and laboratory parameters
* Women of child-bearing potential who are not currently sexually active must

agree to use a medically accepted method of contraception should they become

sexually active while participating in the study

Exclusion Criteria:

* Symptomatic brain metastases or primary central nervous system malignancy
* Treatment with a CYP3A4 inhibitor or inducer within 1 week prior to randomization, or any chemotherapy or biologic therapy within 4 weeks prior to randomization
* Known human immunodeficiency virus (HIV) infection or a known HIV-related

malignancy

* Participants with with clinically active hepatitis B or C defined as disease that requires therapy
* Positive test for glucose-6 phosphate dehydrogenase (G6PD) deficiency
* Prior allogeneic bone marrow transplant
* Presence of Richter's transformation
* Indeterminate deletion 17p status
* Previous treatment with ofatumumab, dinaciclib, or other CDK inhibitors
* Active autoimmune anemia or thrombocytopenia unless stable, which is defined as being responsive to corticosteroids or other standard therapy