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

Sponsor
Merck Sharp & Dohme LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT01580228
Collaborator
(none)
44
Enrollment
2
Arms
28
Duration (Months)

Study Details

Study Description

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
Phase 3

Detailed Description

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

Study Design

Study Type:
Interventional
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 :
Aug 1, 2012
Actual Primary Completion Date :
Dec 1, 2014
Actual Study Completion Date :
Dec 1, 2014

Arms and Interventions

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 Names:
  • Arzerra

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Participant Progression Free Survival [From date of randomization up to approximately 38 months]

    Secondary Outcome Measures

    1. Participant Overall Response Rate [From date of randomization up to approximately 38 months]

    2. Participant Overall Survival Rate [From date of randomization until up to approximately 50 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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

    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

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Merck Sharp & Dohme LLC

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Merck Sharp & Dohme LLC
    ClinicalTrials.gov Identifier:
    NCT01580228
    Other Study ID Numbers:
    • P07714
    • 2011-005186-20
    First Posted:
    Apr 18, 2012
    Last Update Posted:
    Feb 23, 2017
    Last Verified:
    Feb 1, 2017
    Additional relevant MeSH terms:
    Leukemia
    Leukemia, Lymphoid
    Leukemia, Lymphocytic, Chronic, B-Cell
    Ofatumumab

    Study Results

    No Results Posted as of Feb 23, 2017