MGCD0103 Administered in Combination With Azacitidine (Vidaza®) to Subjects With Relapsed or Refractory Hodgkin or Non-Hodgkin Lymphoma

Inclusion Criteria

• •Age ≥ 18 years.
• •Histologically confirmed diagnosis of classical Hodgkin's lymphoma or NHL (follicular, DLBCL, or mantle cell) and confirmed relapsed or refractory disease. 1)Subjects with a diagnosis of classical Hodgkin's lymphoma MUST have relapsed following a prior autologous, allogeneic or reduced intensity allogeneic stem cell transplant. Subjects who received an allogeneic transplant must have no evidence of graft versus host disease (GVHD), and have discontinued treatment with immunosuppressive agents ≥ 3 months prior to enrollment in this study. 2)Subjects with DLBCL must be ineligible for, or have refused, autologous stem cell transplant, or have relapsed following transplant. 3)Subjects with MCL must have relapsed after prior treatment and not be eligible for autologous stem cell transplant (ASCT) or have relapsed following ASCT. 4)Subjects with NHL who may have received a prior allogeneic stem cell transplant must have no evidence of GVHD, and have discontinued treatment with immunosuppressive agents ≥ 3 months prior to enrollment in this study.
• •Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 Evidence of measurable disease (ie, at least one lesion that can accurately be measured in at least two dimensions as ≥15 mm with spiral CT scan). 1)If only single target lesion must be PET positive, and measure ≥20mm in two dimensions (required only for subjects with Hodgkin's lymphoma and DLBCL).
• •Adequate organ function including: 1)Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L (≥1500/mm\^3); and 2)Platelets ≥ 50 x 10\^9/L (≥50,000/mm\^3); and 3)Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (unless increased due to Gilbert's Syndrome or hemolysis); and 4)AST (SGOT) and ALT (SGPT) ≤ 2.5 x ULN; and 5)Serum creatinine ≤ 1.5 x ULN.
• •At least 3 weeks elapsed since any prior anticancer therapy (standard or investigational) and full recovery (NCI CTCAE grade 1) from the toxic effects of that treatment.
• •For women of childbearing potential, a negative serum pregnancy test within 7 days of treatment, a negative urine pregnancy test immediately prior to the first treatment with study drugs, and use of 2 physician-approved methods of birth control throughout the study and for a period of 3 months following the study.
• •Written informed consent, willingness, and ability to comply with all study procedures.