A Phase 3 Study of Ibrutinib (PCI-32765) Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

Study Identifier
PCYC-1112-CA
CT.gov Identifier
EudraCT Identifier
EUCTIS ID
Not available
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Study Complete

Results Available

Protocol
Available Language(s): English
Statistical Analysis Plan
Available Language(s): English

Study Details

Medical Condition
  • Blood Cancer - Chronic Lymphocytic Leukemia (CLL)
  • Blood Cancer - Small Lymphocytic Lymphoma (SLL)
  • Study Drug
  • ofatumumab
  • ibrutinib
  • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18+ years

    Protocol Summary

    The purpose of the study is to evaluate whether treatment with ibrutinib as a monotherapy results in a clinically significant improvement in progression free survival (PFS) as compared to treatment with ofatumumab in patients with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

    Study Locations

    Location
    Status
    Location
    Site #408
    La Jolla, California, United States, 92093-0698
    Status
    Not applicable
    Location
    Site #377
    Los Angeles, California, United States, 90095
    Status
    Not applicable
    Location
    Site #403
    Santa Maria, California, United States, 93454
    Status
    Not applicable
    Location
    Site #038
    Stanford, California, United States, 94035
    Status
    Not applicable
    Location
    Site #411
    Norwalk, Connecticut, United States, 06856
    Status
    Not applicable
    Location
    Site #107
    Marietta, Georgia, United States, 30060
    Status
    Not applicable
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