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A Phase 3 Study to Evaluate the Efficacy and Safety of Dinaciclib or Ofatumumab in Subjects With Refractory Chronic Lymphocytic Leukemia

Phase 3
18 Years
Open (Enrolling)
Chronic Lymphocytic Leukemia (CLL)

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Trial Information

A Phase 3 Study to Evaluate the Efficacy and Safety of Dinaciclib or Ofatumumab in Subjects With Refractory Chronic Lymphocytic Leukemia

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Participant Progression Free Survival

Outcome Time Frame:

From date of randomization up to approximately 38 months

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

August 2012

Completion Date:

April 2016

Related Keywords:

  • Chronic Lymphocytic Leukemia (CLL)
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid



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