p53/p16-Independent Epigenetic Therapy With Oral Decitabine/Tetrahydrouridine for Refractory/Relapsed Lymphoid Malignancies

Inclusion Criteria

• •Histologically or cytologically-proven T- or B-cell lymphoma
• •Subjects must have received 1 or more prior therapies for this disease and have had stable disease or progressive disease based upon the criteria from the Revised Response Criteria for Malignant Lymphoma78, or intolerable toxicities precluding further therapy with a prior regimen
• •Subjects must have measurable disease per Revised Response Criteria for Malignant Lymphoma78
• •ECOG performance status 0 - 2
• •Adequate organ function as defined by the following criteria:
• •* Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase \[SGOT\]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase \[SGPT\]) ≤ 2.5 x laboratory upper limit of normal (ULN)
• •* Total serum bilirubin ≤ 2.0 x ULN (except if Gilbert's disease)
• •* Absolute neutrophil count (ANC) ≥ 1500/uL
• •* Platelets ≥ 50,000/uL
• •* Hemoglobin ≥ 8.0 g/dL (transfusion permitted)
• •* Serum calcium ≤ 12.0 mg/dL
• •* Serum Creatinine ≤ 3.0 mg/dL
• •Patients with history of CNS lymphoma can be enrolled if the CNS disease has been controlled with therapy for a minimum of 4 weeks. Brain MRI is not required for eligibility.
• •Subjects must have the ability to understand and the willingness to sign a written informed consent document.