Oral Azacitidine Plus Salvage Chemotherapy in Relapsed/Refractory Diffuse Large B Cell Lymphoma

Inclusion Criteria:

- Histologic confirmation of relapsed/refractory disease of one of the following: DLBCL,
transformed DLBCL, grade 3B follicular lypmphoma, B-Cell lymphoma unclassifiable with
features intermediate between diffuse large B-cell lypmphoma and Burkitt lymphoma,
primary mediastinal B cell lymphoma.

- Patients are encouraged to have a biopsy at screening but this may be waived with
permission from the primary investigator.

- eligible for high dose chemotherapy and autologous stem cell transplant (ASCT)

- measurable disease on cross section imaging by PET and/or CT that is at least 1.5 cm
in the longest diameter and measurable in two perpendicular dimensions as defined by
IWG criteria.

- at least 18 years ole

- Able to understand and voluntarily sign consent prior to any study related assessments
or procedures

- Performance status of 0-2 on the ECOG scale

- Adequate organ function as specified in the protocol.

- must have received at least one prior CD20 containing multi-agent chemotherapy regimen
(R-CHOP, R-EPOCH). Bendamustine and rituximab can be the prior regimen if used for
follicular lymphoma or marginal zone lymphoma and susequently transformed to DLBCL.

- A pre-phase treatment with prednisoe at 1mg/kg/day or equivalent, for a maximum of 10
days leading up to the first dose of CC-486 is allowed. No washout period is
necessitated for steroids.

- Women of child-bearing potential (WOCBP) should be advised to avoid becoming pregnanct
and men should be advised not to father a child while receiving treatment with
azacitidine. All men and women of child-bearing potential must use acceptable methods
of birth control throughout the study.

Exclusion Criteria:

- Women who are pregnant or breast-feeding.

- more than three prior treatments for the large cell component of lymphoma. Radiation
therapy does not count as a line of therapy

- patients with history or active CNS lymphoma

- Previous history of autologous or allogeneic stem cell transplantation

- uncontroled systemic fungal, bacterial or viral infection

- history of stroke or intracranial hemorrhage within 6 months prior to registration

- prior history of malignancy other than DLBCL unless subjet is free of disease for more
than 2 years from signing consent. Exceptions include basal cell carcinoma of the
skin; squamous cell carcinoma of the skin; carcinoma in situ of the cervix or breast;
previously treated localized prostate cancer with normal PSA levels.

- significant active cardiac disease

- active viral infection of hepatitis type B or C.

- seropositive for HIV

- known or suspected hypersensitivity to azacitidine or mannitol

- patients with advanced malignant hepatic tumors

- any condition causing an inability to swallow pills

- receipt of live vaccine within 28 days prior to registration

- anti-cancer therapy within 21 days prior to registration. Prior radiation within 14
days prior to registration

- any other illness that in the opinion of the investigator, would exclude the patient
from participating