This trial is active, not recruiting.

Condition chronic lymphocytic leukemia (cll)
Treatments dinaciclib, ofatumumab
Phase phase 3
Target CDK4
Sponsor Merck Sharp & Dohme Corp.
Start date August 2012
End date December 2014
Trial size 466 participants
Trial identifier NCT01580228, 2011-005186-20, P07714


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
dinaciclib SCH-727965
Dinaciclib administered intravenously over 2 hours at a dose of 7 mg/m^2 on Day 1, 10 mg/m^2 on Day 8, and 14 mg/m^2 on Day 15 in Cycle 1. Starting in Cycle 2 and thereafter, dinaciclib will be dosed at 14 mg/m^2 on Days 1, 8, and 15 of each 28-day cycle for a total of 12 cycles.
(Active Comparator)
ofatumumab Arzerra
Ofatumumab administered intravenously at a dose of 300 mg on Cycle 1 Day 1, followed by 2000 mg on Cycle 1 Days 8, 15, and 22; Cycle 2 Days 1, 8, 15, and 22; followed 5 weeks later on Day 1 of Cycles 4-12.

Primary Outcomes

Participant Progression Free Survival
time frame: From date of randomization up to approximately 38 months

Secondary Outcomes

Participant Overall Response Rate
time frame: From date of randomization up to approximately 38 months
Participant Overall Survival Rate
time frame: From date of randomization until up to approximately 50 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Phase 3 Study to Evaluate the Efficacy and Safety of Dinaciclib or Ofatumumab in Subjects With Refractory Chronic Lymphocytic Leukemia
Description Dinaciclib is a cyclin-dependent kinase (CDK) inhibitor, specific for CDK 1, 2, 5 and 9.
Trial information was received from ClinicalTrials.gov and was last updated in September 2014.
Information provided to ClinicalTrials.gov by Merck Sharp & Dohme Corp..