A Phase 3 Study Comparing Dinaciclib Versus Ofatumumab in Patients With Refractory Chronic Lymphocytic Leukemia (P07714 AM2)
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.
Chronic Lymphocytic Leukemia (CLL)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 3 Study to Evaluate the Efficacy and Safety of Dinaciclib or Ofatumumab in Subjects With Refractory Chronic Lymphocytic Leukemia|
- Participant Progression Free Survival [ Time Frame: From date of randomization up to approximately 38 months ] [ Designated as safety issue: No ]
- Participant Overall Response Rate [ Time Frame: From date of randomization up to approximately 38 months ] [ Designated as safety issue: No ]
- Participant Overall Survival Rate [ Time Frame: From date of randomization until up to approximately 50 months ] [ Designated as safety issue: No ]
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
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||
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.
Other Name: Arzerra
Dinaciclib is a cyclin-dependent kinase (CDK) inhibitor, specific for CDK 1, 2, 5 and 9.