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

Study Overview
=================
Brief Summary
-----------------
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.

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

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

Conditions
-----------------
Chronic Lymphocytic Leukemia (CLL)

Intervention / Treatment
-----------------
* Drug: Dinaciclib
* Drug: Ofatumumab


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dinaciclib<br> | Drug: Dinaciclib<br>* 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.<br>* Other names: MK-7965;|
| Active Comparator: Ofatumumab<br> | Drug: Ofatumumab<br>* 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.<br>* Other names: Arzerra;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant Progression Free Survival |  | From date of randomization up to approximately 38 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant Overall Response Rate |  | From date of randomization up to approximately 38 months | 
| Participant Overall Survival Rate |  | From date of randomization until up to approximately 50 months |