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

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