Open-label Extension Study in Patients 65 Years or Older With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Study Identifier
PCYC-1116-CA
CT.gov Identifier
NCT01724346
EudraCT Identifier
2012-003968-44
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
Available Language(s): English
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Plain Language Summary
Available Language(s): Ukrainian, Turkish, English, Hebrew, Italian, Polish
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Study Details

Medical Condition
  • Blood Cancer - Chronic Lymphocytic Leukemia (CLL)
  • Blood Cancer - Small Lymphocytic Lymphoma (SLL)
    • Study Drug
  • Ibrutinib
  • Next-line ibrutinib
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    65+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    1. Randomized in the parent study, PCYC-1115-CA 2. Informed consent for Study PCYC-1116-CA 3. Independent review committee (IRC)-confirmed disease progression (PD) in the parent study PCYC-1115-CA or closure of the parent study
    Exclusion Criteria:
    1. Disease progression involving the central nervous system (CNS) or transformation to another histology 2. Intervening chemotherapy, immunotherapy, or investigational agent specifically to treat CLL if administered before date of IRC confirmed progressive disease 3. In the 4 weeks before dosing: radiation therapy, major surgery, or receipt of an investigational drug 4. Requirement for treatment with a strong CYP3A inhibitor 5. Uncontrolled systemic infection or requirement for IV antibiotics 6. Noncompliance on the parent study(PCYC-1115-CA)

    Protocol Summary

    An Open-label Extension Study in Patients 65 Years or Older with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) Who Participated in Study PCYC-1115-CA (Ibrutinib versus Chlorambucil)

    Study Locations

    Location
    Status
    Location
    City of Hope /ID# 1116-0047
    Duarte, California, United States, 91010
    Status
    Not applicable
    Location
    Moores Cancer Center at UC San Diego /ID# 1116-0408
    La Jolla, California, United States, 92093
    Status
    Not applicable
    Location
    Stanford University/Stanford Cancer Center, Campus Drive /ID# 1116-0038
    Stanford, California, United States, 94305
    Status
    Not applicable
    Location
    University of Chicago /ID# 1116-0126
    Chicago, Illinois, United States, 60637
    Status
    Not applicable
    Location
    Norton Cancer Institute - St Matthews /ID# 1116-0071
    Louisville, Kentucky, United States, 40207
    Status
    Not applicable
    Location
    Comprehensive Cancer Centers of Nevada /ID# 1116-0712
    Henderson, Louisiana, United States, 89052
    Status
    Not applicable
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