Ibrutinib Plus Venetoclax in Subjects With Treatment-naive Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma (CLL/SLL)

Study Identifier
PCYC-1142-CA
CT.gov Identifier
NCT02910583
EudraCT Identifier
2016-002293-12
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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Scientific Result Summary
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Plain Language Summary
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Study Details

Medical Condition
  • Blood Cancer - Leukemia (Other)
  • Blood Cancer - Chronic Lymphocytic Leukemia (CLL)
  • Blood Cancer - Small Lymphocytic Lymphoma (SLL)
    • Study Drug
  • ibrutinib
  • venetoclax
  • Placebo
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    18 - 70 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Diagnosis of CLL/SLL that meets 2008 International Workshop on Chronic Lymphocytic Leukemia (IWCLL) diagnostic criteria (Hallek et al), with active disease meeting at least 1 IWCLL criteria for requiring treatment. * Measurable nodal disease by computed tomography (CT) * Adequate hepatic, and renal function * Adequate hematologic function * absolute neutrophil count \>750/µL * platelet count \>30,000 /μL * hemoglobin \>8.0 g/dL
    Exclusion Criteria:
    * Any prior therapy used for treatment of CLL/SLL * Known allergy to xanthine oxidase inhibitors and/or rasburicase for subjects at risk for tumor lysis syndrome (TLS)

    Protocol Summary

    This is a multicenter, 2-cohort Phase 2 study assessing both minimal residual disease (MRD)-guided discontinuation and fixed duration therapy with the combination of ibrutinib + venetoclax in subjects with treatment-naïve CLL or SLL.

    Study Locations

    Location
    Status
    Location
    City of Hope /ID# 1142-0047
    Duarte, California, United States, 91010
    Status
    Not applicable
    Location
    Moores Cancer Center at UC San Diego /ID# 1142-0241
    La Jolla, California, United States, 92093
    Status
    Not applicable
    Location
    UC Irvine Medical Center - Chao Family Comprehensive Cancer Center /ID# 1142-0008
    Orange, California, United States, 92868-3201
    Status
    Not applicable
    Location
    Norton Cancer Center /ID# 1142-0071
    Louisville, Kentucky, United States, 40202
    Status
    Not applicable
    Location
    Rutgers Cancer Institute of New Jersey /ID# 1142-1193
    New Brunswick, New Jersey, United States, 08901
    Status
    Not applicable
    Location
    Northwell Health/Long Island Jewish Hospital /ID# 1142-0350
    New Hyde Park, New York, United States, 11042
    Status
    Not applicable
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