A Study Evaluating the Safety and Pharmacokinetics of ABT-199 in Combination With Bendamustine/Rituximab (BR) in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma
A Study Evaluating the Safety and Pharmacokinetics of ABT-199 in Combination With Bendamustine/Rituximab (BR) in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma
This is a Phase 1, open-label, multicenter study evaluating the safety, pharmacokinetic
 profile, and preliminary efficacy of ABT-199 in combination with Bendamustine/Rituximab in
 approximately 60 subjects with relapsed or refractory non-Hodgkin's lymphoma. This study will
 evaluate the safety and pharmacokinetic profile of ABT-199 in approximately 60 subjects when
 administered in combination with Bendamustine/Rituximab following a dose escalation scheme,
 with the objective of defining the dose limiting toxicity and the maximum tolerated dose.
Inclusion Criteria:

 -  Subject must have histologically documented diagnosis of non-Hodgkin's lymphoma as
 defined by a B-cell neoplasm in the World Health Organization classification scheme
 except as noted in exclusion criteria.

 -  Subject (non-diffuse large B-cell lymphoma) must have relapsed or refractory
 non-Hodgkin's lymphoma, and require treatment in the opinion of the investigator.

 -  Subject with diffuse large B-cell lymphoma must have relapsed diffuse large B-cell
 lymphoma or must have progressed after salvage therapy (with or without standard
 chemotherapy) for diffuse large B-cell lymphoma. The subject must have received first
 line therapy with Rituximab-Cyclophosphamide, Hydroxydaunomycin, Vincristine
 (Oncovin), Prednisone (R-CHOP) [or a similar standard rituximab-containing front-line
 chemoimmunotherapy regimen including, but not limited to Etoposide, Prednisone,
 Vincristine (Oncovin), Cyclophosphamide, Doxorubicin (Hydrochloride) + Rituximab
 (EPOCH + R); Rituximab, Cyclophosphamide, Etoposide, Procarbazine, Prednisone (RCEPP);
 Rituximab, Cyclophosphamide, Mitoxantrone (Novantrone), Vincristine (Oncovin),
 Prednisone (RCNOP); Dose-adjusted-Etoposide, Prednisone, Vincristine(Oncovin),
 Cyclophosphamide, Doxorubicin (Hydrocloride) (DA-EPOCH); and Rituximab,
 Cyclophosphamide, Etoposide, Vincristine (Oncovin), Prednisone (RCEOP)].

 -  Subject must have adequate coagulation, renal, and hepatic function, per laboratory
 reference range at Screening.

 Exclusion Criteria:

 -  Subject has been diagnosed with Post-Transplant Lymphoproliferative Disease, Burkitt's
 lymphoma, Burkitt-like lymphoma, lymphoblastic lymphoma/leukemia, chronic lymphocytic
 leukemia, small lymphocytic lymphoma or mantle cell lymphoma (MCL).

 -  Subject has refractory diffuse large B-cell lymphoma, defined as meeting any of the
 following criteria:

 -  Subject progressed during or within 3 months of completion of a planned course of
 first-line therapy with Rituximab-Cyclophosphamide, Hydroxydaunomycin,
 Vincristine (Oncovin), Prednisone (R-CHOP) or an equivalent regimen;

 -  Subject had no response (i.e., stable disease only) to first-line therapy with
 R-Cyclophosphamide, Hydroxydaunomycin, Vincristine (Oncovin), Prednisone (R-CHOP)
 or an equivalent regimen;

 -  Subject progressed during or within 2 months of completion of their last planned
 course of salvage therapy with chemotherapy (with or without rituximab, may
 include autologous stem cell transplant).

 -  Subject has tested positive for human immunodeficiency virus (HIV).

 -  Subject has a cardiovascular disability status of New York Heart Association Class
 greater or equal to 2. Class 2 is defined as cardiac disease in which patients are
 comfortable at rest but ordinary physical activity, results in fatigue, palpitations,
 dyspnea or anginal pain.

 -  Subject has a significant history of renal, neurologic, psychiatric, endocrinologic,
 metabolic, immunologic, or hepatic disease that in the opinion of the Investigator
 would adversely affect his/her participating in this study.