An Extension Study of ABT-199 in Subjects With Advanced Non-Hodgkin's Lymphoma
Status: | Active, not recruiting |
---|---|
Conditions: | Lymphoma, Lymphoma |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - 99 |
Updated: | 10/11/2018 |
Start Date: | December 20, 2013 |
End Date: | June 19, 2019 |
An Extension Study of Venetoclax in Subjects With Advanced Non-Hodgkin's Lymphoma
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.
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.
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disease progression, toxicity, withdrawn consent, other).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).
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