Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma

Study Identifier
PCYC-1141-CA
CT.gov Identifier
NCT02947347
EudraCT Identifier
2016-003202-14
EUCTIS ID
2023-507271-21-00
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Protocol
Available Language(s): English
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Statistical Analysis Plan
Available Language(s): English
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Plain Language Summary
Available Language(s): English, Dutch (Belgium), French (Belgium), German (Belgium), Czech, Dutch, French, Greek, German (Austria), Hungarian, Italian, Polish, Portuguese (Native), Spanish, Turkish
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Study Details

Medical Condition
  • Blood Cancer - Follicular Lymphoma (FL)
    • Study Drug
  • Ibrutinib Oral Capsule
  • Placebo
  • Rituximab
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    60+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Histologically confirmed diagnosis of follicular lymphoma CD20+ (Grade 1, 2 or 3a) Ann Arbor Stage II, III or IV disease. * Measurable disease * Subjects 70 years of age or older; OR subjects 60-69 years of age who have one or more comorbidities. * Meets one or more Groupe d'Etude des Lymphomes Folliculaire (GELF) criteria. * Adequate hematologic function within protocol-defined parameters. * Adequate hepatic and renal function within protocol-defined parameters. * ECOG performance status score of 0-2.
    Exclusion Criteria:
    * Transformed lymphoma * Prior treatment for follicular lymphoma. * Central nervous system lymphoma or leptomeningeal disease. * Currently active, clinically significant cardiovascular disease.

    Protocol Summary

    This is a randomized, double-blind, placebo-controlled, multicenter Phase 3 study to evaluate the efficacy and safety of ibrutinib in combination with rituximab versus placebo in combination with rituximab in treatment naïve participants with follicular lymphoma (FL).

    Study Locations

    Location
    Status
    Location
    Southern Cancer Center
    Mobile, Alabama, United States, 36526
    Status
    Not applicable
    Location
    City of Hope
    Duarte, California, United States, 91010
    Status
    Not applicable
    Location
    Sansum Clinic
    Santa Barbara, California, United States, 93105
    Status
    Not applicable
    Location
    UCLA Hematology/Oncology
    Santa Monica, California, United States, 90095
    Status
    Not applicable
    Location
    Helen F. Graham Cancer Center and Research Institute
    Newark, Delaware, United States, 19713
    Status
    Not applicable
    Location
    SCRI Florida Cancer Specialists South
    Fort Myers, Florida, United States, 33916
    Status
    Not applicable
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