A Phase 1b Study Evaluating the Safety and Tolerability of ABT-199 in Combination With Rituximab in Subjects With Relapsed Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

Study Identifier
M13-365
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
Not available
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Study Complete

Results Available

Scientific Result Summary
Available Language(s): English

Study Details

Medical Condition
  • Blood Cancer - Small Lymphocytic Lymphoma (SLL)
  • Blood Cancer - Chronic Lymphocytic Leukemia (CLL)
  • Study Drug
  • ABT-199
  • Rituximab
  • Phase
    Phase 1
    Sex
    Female & Male
    Age
    18 - 99 Years

    Protocol Summary

    This is a Phase 1b, open-label, multicenter study evaluating the safety and tolerability of ABT-199 in combination with rituximab in up to 50 subjects with Relapsed Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma. The primary objectives of this study are to assess the safety profile, to determine the maximum tolerated dose and establish the Recommended Phase Two Dose of ABT-199 when administered in combination with rituximab. The dose escalation portion of the study will include approximately 30 subjects. Once the recommended phase two dose and schedule have been determined, up to 20 additional subjects will be enrolled in an expanded safety portion of the study. Subjects who meet criteria for CR, CRi, or MRD-negative PR during the study may discontinue ABT 199. If disease progression occurs, as defined by iwCLL NCI/WG criteria for tumor response, or MRD progression, subjects may re-initiate ABT-199.

    Study Locations

    Location
    Status
    Location
    Moores Cancer Center at UC San Diego /ID# 70398
    La Jolla, California, United States, 92093
    Status
    Not applicable
    Location
    Northwestern University Feinberg School of Medicine /ID# 71593
    Chicago, Illinois, United States, 60611-2927
    Status
    Not applicable
    Location
    North Shore University Hospital /ID# 71813
    New Hyde Park, New York, United States, 11040
    Status
    Not applicable
    Location
    Duke Cancer Center /ID# 71393
    Durham, North Carolina, United States, 27710-3000
    Status
    Not applicable
    Location
    Peter MacCallum Cancer Ctr /ID# 70394
    Melbourne, Victoria, Australia, 3000
    Status
    Not applicable
    Location
    The Royal Melbourne Hospital /ID# 70393
    Parkville, Victoria, Australia, 3050
    Status
    Not applicable