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A Phase 3 Study Comparing Dinaciclib Versus Ofatumumab in Patients With Refractory Chronic Lymphocytic Leukemia (P07714 AM2)

This study is currently recruiting participants.
Verified May 2013 by Merck
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01580228
First received: April 3, 2012
Last updated: May 16, 2013
Last verified: May 2013
History of Changes
  Purpose

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 Intervention Phase
Chronic Lymphocytic Leukemia (CLL)
 Drug: Dinaciclib
Drug: Ofatumumab
 Phase 3

Study Type: Interventional
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

Resource links provided by NLM:

Drug Information available for: Ofatumumab
U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Participant Progression Free Survival [ Time Frame: From date of randomization up to approximately 38 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 466
Study Start Date: August 2012
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01580228

Contacts
Contact: Toll Free Number 1-888-577-8839

  Show 19 Study Locations
Sponsors and Collaborators
Merck
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT01580228     History of Changes
Other Study ID Numbers: P07714, 2011-005186-20
Study First Received: April 3, 2012
Last Updated: May 16, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
 Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013