CC-486, Lenalidomide, and Obinutuzumab for the Treatment of Recurrent or Refractory CD20 Positive B-cell Lymphoma

Exclusion Criteria

• •* At time of study entry CD4+ T-cells must have recovered from prior lymphoma therapy to \>= 250/mm\^3
• •* At the time of study entry the HIV viral load must be undetectable by standard laboratory assay
• •* During prior lymphoma therapy, patients must not have experienced documented infections attributed to the HIV+ status
• •* No history of non-adherence to cART and willing to adhere to cART while on study
• •* Antiretroviral drugs with overlapping or similar toxicity profiles as study agents not allowed:
• •* Efavirenz not allowed due to potential central nervous system (CNS) toxicity
• •* Stavudine not allowed due to potential neuropathic effects
• •* Zidovudine not allowed due to myelosuppressive effects
• •* Patients must be willing to be followed at a minimum of approximately every 3 months by physician expert in HIV disease management
• •Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
• •Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
• •Use of any other experimental drug or therapy within 28 days of baseline
• •Known hypersensitivity to lenalidomide, thalidomide, obinutuzumab, or mannitol
• •A history of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs
• •Any prior use of obinutuzumab or CC-486
• •Concurrent use of other anti-cancer agents or treatments
• •Known active hepatitis B or C. Patients on suppressive therapy with a negative viral load and no evidence of hepatic damage are eligible
• •Uncontrolled systemic fungal, bacterial or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy and/or other treatment)
• •Active central nervous system (CNS) involvement by lymphoma, including leptomeningeal involvement
• •Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. A history of hemolytic anemia associated with the lymphoma does not exclude a patient from the study
• •Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking azacitidine)
• •For CC-486: History of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis), celiac disease (i.e., sprue), prior gastrectomy or upper bowel removal, or any other gastrointestinal disorder or defect that would interfere with the absorption, distribution, metabolism or excretion of the study drug (CC-486) and/or predispose the subject to an increased risk of gastrointestinal toxicity
• •Abnormal coagulation parameters (prothrombin time \[PT\] \> 15 seconds, partial thromboplastin time \[PTT\] \> 40 seconds, and/or international normalized ratio \[INR\] \> 1.5)
• •Significant active cardiac disease within the previous 6 months including:
• •* New York Heart Association (NYHA) class 4 congestive heart failure (CHF)
• •* Unstable angina
• •* Myocardial infarction