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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01580228
Recruitment Status : Completed
First Posted : April 18, 2012
Last Update Posted : February 23, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia (CLL) Drug: Dinaciclib Drug: Ofatumumab Phase 3

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : August 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Arm Intervention/treatment
Experimental: Dinaciclib Drug: Dinaciclib
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.
Other Names:
  • SCH-727965
  • MK-7965

Active Comparator: Ofatumumab Drug: 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

Primary Outcome Measures :
  1. Participant Progression Free Survival [ Time Frame: From date of randomization up to approximately 38 months ]

Secondary Outcome Measures :
  1. Participant Overall Response Rate [ Time Frame: From date of randomization up to approximately 38 months ]
  2. Participant Overall Survival Rate [ Time Frame: From date of randomization until up to approximately 50 months ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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


  • 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

Publications of Results:
Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT01580228     History of Changes
Other Study ID Numbers: P07714
2011-005186-20 ( EudraCT Number )
First Posted: April 18, 2012    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs