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

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 3

Conditions

Chronic Lymphocytic Leukemia (CLL)

Treatments

Drug: Dinaciclib

Drug: Ofatumumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT01580228

2011-005186-20 (EudraCT Number)

P07714

Details and patient eligibility

About

This study is being conducted to demonstrate the superiority in progression-free survival (PFS) of dinaciclib compared to ofatumumab in chronic lymphocytic leukemia (CLL) participants with del 17p or in the overall population who are refractory to either fludarabine treatment or chemoimmunotherapy.

Full description

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

Enrollment

44 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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