An Extension Study of ABT-199 in Subjects With Advanced Non-Hodgkin's Lymphoma

Study Identifier
M13-835
CT.gov Identifier
NCT01969695
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Scientific Result Summary
Available Language(s): English
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Study Details

Medical Condition
  • Blood Cancer - Non-Hodgkin's Lymphoma (General)
    • Study Drug
  • ABT-199
    • Phase
    Phase 1
    Sex
    Female & Male
    Age
    18 - 99 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Subject has completed a prior ABT-199 study (and had met the criteria for a diagnosis of NHL and all other eligibility criteria for the previous study) and the investigator believes that treatment with ABT-199 is in the best interest of the subject.
    Exclusion Criteria:
    * Subject discontinued ABT-199 administration before completing the prior study (due to disease progression, toxicity, withdrawn consent, other). * Subject has any medical condition that in the opinion of the investigator places the subject at an unacceptably high risk for toxicities. * Subject has not recovered to ≤ Grade 2 clinically significant adverse effect(s)/toxicity(ies) of previous therapy. * Subject has been diagnosed with Post-Transplant Lymphoproliferative Disease (PTLD), Burkitt's lymphoma, Burkitt-like lymphoma, lymphoblastic lymphoma/leukemia, chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or mantle cell lymphoma (MCL).

    Protocol Summary

    This is a Phase 1, open-label, multicenter, extension study. Subjects with non-Hodgkin's lymphoma (NHL) (excluding chronic lymphocytic lymphoma \[CLL\], small lymphocytic lymphoma \[SLL\], and mantle cell lymphoma \[MCL\]) who completed a prior ABT-199 study, or were active and assigned to ABT-199 when the study was completed, may roll over into this extension study. Subjects will receive ABT-199 during this study.

    Study Locations

    Location
    Status
    Location
    University of Arizona Arthritis Center /ID# 101359
    Tucson, Arizona, United States, 85719-1478
    Status
    Not applicable
    Location
    Dartmouth-Hitchcock Med Ctr /ID# 92596
    Lebanon, New Hampshire, United States, 03756
    Status
    Not applicable
    Location
    Hackensack Univ Med Ctr /ID# 101417
    Hackensack, New Jersey, United States, 07601
    Status
    Not applicable