A Multi-Center Study of Ibrutinib in Combination With MEDI4736 in Subjects With Relapsed or Refractory Lymphomas

Study Identifier
PCYC-1136-CA
CT.gov Identifier
NCT02401048
EudraCT Identifier
Not available
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
Available Language(s): English
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Study Details

Medical Condition
  • Blood Cancer - Diffuse Large B-Cell Lymphoma (DLBCL)
  • Blood Cancer - Follicular Lymphoma (FL)
    • Study Drug
  • Ibrutinib
  • MEDI4736
    • Phase
    Phase 1/Phase 2
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Pathologically documented relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL) * Measurable disease sites on CT scan (\>1.5 cm in longest dimension) * Adequate hematologic function: 1. Absolute Neutrophil Count \>1500 cells/mm3 2. Platelets \>50000 cells/mm3 3. Hemoglobin \>8.0 g/dL * Adequate hepatic and renal function: 1. AST or ALT ≤2.5 x ULN 2. Bilirubin ≤1.5 x ULN 3. Estimated creatinine clearance (Cockcroft-Gault) \>40 mL/min * ECOG 0 or 1
    Exclusion Criteria:
    * Received prior therapies: ibrutinib, or other BTK inhibitor and/or anti-PD1, anti-PD-L1, anti-PD-L2, anti-CD137, or CTLA-4 antibody * Requires treatment or prophylaxis with a strong cytochrome P450 (CYP) 3A inhibitor * Primary CNS lymphoma or evidence of CNS involvement by lymphoma

    Protocol Summary

    The purpose of this study is to evaluate the efficacy, safety and tolerability of the combination treatment of ibrutinib and MEDI4736 in subjects with relapsed or refractory lymphomas.

    Study Locations

    Location
    Status
    Location
    Site-0397
    Birmingham, Alabama, United States, 35294
    Status
    Not applicable
    Location
    Site-0047
    Duarte, California, United States, 91010
    Status
    Not applicable
    Location
    Site-0038
    Stanford, California, United States, 94305
    Status
    Not applicable
    Location
    Site-0388
    Miami, Florida, United States, 33136
    Status
    Not applicable
    Location
    Site-0126
    Chicago, Illinois, United States, 60637
    Status
    Not applicable
    Location
    Site-0020/0173
    Boston, Massachusetts, United States, 02114
    Status
    Not applicable
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