A Phase 2 Open-Label Study of the Efficacy and Safety of ABT-199 (GDC-0199) in Chronic Lymphocytic Leukemia (CLL) Subjects With Relapse or Refractory to B-Cell Receptor Signaling Pathway Inhibitor Therapy

Study Identifier
M14-032
CT.gov Identifier
NCT02141282
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
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Scientific Result Summary
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Plain Language Summary
Available Language(s): English, English
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Study Details

Medical Condition
  • Blood Cancer - Chronic Lymphocytic Leukemia (CLL)
    • Study Drug
  • Venetoclax
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    18 - 99 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Participant must have a diagnosis of chronic lymphocytic leukemia (CLL) that meets 2008 Modified International Workshop on Chronic Lymphocytic Leukemia National Cancer Institute-Working Group (IWCLL NCI-WG) criteria * Participant has relapsed/refractory disease with an indication for treatment * Participant has refractory disease or developed recurrence after therapy with a B-cell receptor pathway inhibitor (BCR PI) * Participant must have an Eastern Cooperative Oncology Group performance score of ≤ 2 * Participant must have adequate bone marrow function at Screening * Participant must have adequate coagulation profile, renal, and hepatic function, per laboratory reference range at Screening
    Exclusion Criteria:
    * Participant has undergone an allogeneic stem cell transplant within the past year * Participant has developed Richter's transformation confirmed by biopsy * Participant has active and uncontrolled autoimmune cytopenia * Participant has malabsorption syndrome or other condition that precludes enteral route of administration * Participant is human immunodeficiency virus (HIV) positive or has chronic hepatitis B or hepatitis C virus requiring treatment * Participant has known contraindication or allergy to both xanthine oxidase inhibitors and rasburicase

    Protocol Summary

    This was an open-label, non-randomized, multicenter, Phase 2 study evaluating the efficacy and safety of ABT-199 in 127 participants with relapsed or refractory chronic lymphocytic leukemia (CLL) after B-cell receptor signaling pathway inhibitors (BCR PI) treatment.

    Study Locations

    Location
    Status
    Location
    Moores Cancer Center at UC San Diego /ID# 128535
    La Jolla, California, United States, 92093
    Status
    Not applicable
    Location
    University of California, Los Angeles /ID# 127262
    Los Angeles, California, United States, 90095
    Status
    Not applicable
    Location
    Stanford University School of Med /ID# 126495
    Stanford, California, United States, 94305-2200
    Status
    Not applicable
    Location
    Georgetown University Hospital /ID# 127261
    Washington D.C., District of Columbia, United States, 20007
    Status
    Not applicable
    Location
    Emory Midtown Infectious Disease Clinic /ID# 131249
    Atlanta, Georgia, United States, 30322
    Status
    Not applicable
    Location
    Northwestern University Feinberg School of Medicine /ID# 126497
    Chicago, Illinois, United States, 60611-2927
    Status
    Not applicable
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