Ibrutinib in Combination With Lenalidomide and Rituximab in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Study Identifier
PCYC-1123-CA
CT.gov Identifier
NCT02077166
EudraCT Identifier
2013-004341-17
EUCTIS ID
Not available
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
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Plain Language Summary
Available Language(s): English, Dutch, German
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Study Details

Medical Condition
  • Blood Cancer - Diffuse Large B-Cell Lymphoma (DLBCL)
    • Study Drug
  • Ibrutinib
  • Lenalidomide
  • Rituximab
    • Phase
    Phase 1/Phase 2
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Pathologically confirmed relapsed/ refractory DLBCL * Must have previously received first line treatment regimen * Must be ineligible for high dose therapy/ stem cell transplantation * Measurable disease sites on computed tomography (CT) scan (\>1.5 cm in longest dimension) * prothrombin time/international normalized ratio (PT/INR) \< 1.5 x upper limit of normal (ULN) and partial thromboplastin time (PTT; activated partial thromboplastin time \[aPTT\]) \<1.5 x ULN * Men and women ≥18 years of age * Eastern Cooperative Oncology Group (ECOG) \< 2 * Adequate hepatic and renal function * Adequate hematologic function
    Exclusion Criteria:
    * Medically apparent central nervous system lymphoma or leptomeningeal disease * History of allogeneic stem-cell (or other organ) transplantation * Any chemotherapy, external beam radiation therapy, or anticancer antibodies within 2 weeks * Radio- or toxin-immunoconjugates within 10 weeks * Concurrent enrollment in another therapeutic investigational study or have previously taken ibrutinib and/or lenalidomide.

    Protocol Summary

    This Phase 1b/2 study is designed to assess the safety and efficacy of ibrutinib in combination with lenalidomide and rituximab in subjects with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) not eligible for transplant.

    Study Locations

    Location
    Status
    Location
    University of Alabama
    Birmingham, Alabama, United States, 35294
    Status
    Not applicable
    Location
    Banner MD Anderson Cancer Center
    Gilbert, Arizona, United States, 85234
    Status
    Not applicable
    Location
    Cedar Sinai Medical Center
    Los Angeles, California, United States, 90048
    Status
    Not applicable
    Location
    UCLA Medical Center
    Los Angeles, California, United States, 90095
    Status
    Not applicable
    Location
    University of Florida
    Gainesville, Florida, United States, 32610
    Status
    Not applicable
    Location
    Rush University Medical Center
    Chicago, Illinois, United States, 60612
    Status
    Not applicable
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