A Phase 3 Study Comparing Dinaciclib Versus Ofatumumab in Patients With Refractory Chronic Lymphocytic Leukemia (P07714 AM2)

Dinaciclib is a cyclin-dependent kinase (CDK) inhibitor, specific for CDK 1, 2, 5 and 9.

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