Total bilirubin must be < 1.5 x the upper limit of normal, unless the elevation of bilirubin is thought to be secondary to Gilbert’s syndrome or combined antiretroviral therapy (cART); if, however, the elevated bilirubin is felt to be secondary to antiretroviral therapy, the total bilirubin must be =< 3.5 mg/dL, provided that the direct bilirubin is normal and the aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x the upper limit of normal; also, if the elevated bilirubin is thought to be secondary to cHL the same criteria for hyperbilirubinemia should be applied; however 1 prior cycle of cyclophosphamide is permitted in attempt to make the participant eligible; patients should not be excluded from study participation unless dosing cannot be safely established
Direct bilirubin =< 3 x upper limit of normal (ULN), unless suspected leukemic involvement of the liver
Total bilirubin =< 1.5 times the institutional upper limit of normal (ULN), unless elevated secondary to lymphomatous involvement of liver or biliary system, or due to other HIV medications (e.g., indinavir, tenofovir, or atazanavir); if secondary to lymphomatous involvement, an initial upper limit of total bilirubin 5 mg/dL (85.5 uM/L) should be utilized - for direct bilirubin > 1.2 mg/dL (20.5 uM/L)
Total bilirubin =< 1.5 x upper limit of normal (ULN) (unless hepatic dysfunction is caused by cGVHD)
Evidence of significant renal, hepatic, hematologic, or immunologic disease determined by any one of the following: Estimated creatinine clearance <30 mL/min; ALT or AST level greater than 10-fold the upper limit of normal or total bilirubin greater than 3-fold the upper limit of normal; Manifestations of end-stage liver disease, such as ascites or hepatic encephalopathy; Thrombocytopenia; or CD4+ T cell count below 200 cells per ?L
Total bilirubin =< 2 x institutional upper limit of normal (IULN) except for Gilbert’s disease or when in the opinion of treating physician elevated levels are due to direct involvement of leukemia (e.g., hepatic infiltration or biliary obstruction due to leukemia)
Total bilirubin =< 1.5 x institutional upper limit of normal, unless related to leukemic infiltration or hemolysis
Impaired liver function defined as a total bilirubin > 1.5 x normal range and AST or ALT > 2.5 x normal range unless secondary to Gilbert’s disease, hemolysis or leukemic involvement of the liver
Bilirubin =< 2 unless consistent with Gilbert’s (total/direct > 5)
Direct bilirubin =< 2 x upper limit of normal (ULN) unless deemed to be related to underlying leukemia.
Bilirubin ? 3.0 x ULN, unless due to Gilbert’s syndrome (unless considered due to leukemic organ involvement)
Adequate hepatic function including total bilirubin < 2 x upper limit of normal (ULN) unless increase is due to Gilbert’s disease or leukemic involvement
Total bilirubin < 1.5x upper limit of normal (ULN) unless increase is due to Gilbert’s disease or leukemic involvement
Bilirubin < 1.5 x upper limit of normal (ULN) unless believed due to leukemic infiltration
Unless considered to be due to leukemic organ involvement.
Have AST, ALT, GGT, and AP that are ?2.5*upper limit of normal (ULN) and normal bilirubin (total and direct) regardless of liver involvement.
Low likelihood of being eligible for reduced intensity conditioning HCT based on known information\r\n* Cardiac ejection fraction < 40% or symptomatic coronary artery disease or uncontrolled arrhythmia\r\n* Diffusing capacity of the lungs for carbon monoxide (DLCOc) < 40% or forced expiratory volume in 1 second (FEV1) < 50%\r\n* Estimated glomerular filtration rate (GFR) < 40 ml/min\r\n* Need for supplemental oxygen\r\n* Direct bilirubin or alanine aminotransferase (ALT) > 2 x upper limit of normal, unless these abnormalities are thought to be related to Gilbert’s disease or leukemic infiltration of hepatic parenchyma
Direct bilirubin or ALT > 2 x upper limit of normal, unless these abnormalities are thought to be related to Gilbert’s disease or leukemic infiltration of hepatic parenchyma
Serum bilirubin =< 2 x upper limit of normal, unless proven to be due to disease involvement
The patient has a history of liver disease (excluding Gilbert’s disease and non-active hepatitis C) and/or elevation of transaminases or bilirubin above the normal limit
Direct bilirubin < 1.6 (unless related to Gilbert’s disease or medications)
Patients with creatinine > 2.5 times upper limit of normal unless felt to be related the underlying leukemia by the treating physician or hemolysis or Gilbert's disease
Patients with total bilirubin >= 2.0 times upper limit of normal unless felt to be related the underlying leukemia by the treating physician or hemolysis or Gilbert's disease
Bilirubin =< 2 unless consistent with Gilbert’s (total/direct > 5)
Transaminases less than or equal 3 x upper limit of normal unless related to the disease
Total bilirubin > 3 x ULN unless isolated hyperbilirubinemia is directly related to the acute infection or due to known Gilbert disease; manifestations of end-stage liver disease, such as ascites or hepatic encephalopathy
Total bilirubin =< 1.5 x upper limit of normal unless clearly related to Gilbert’s disease, hemolysis or leukemic infiltrate
Total bilirubin within normal institutional limits (unless isolated indirect hyperbilirubinemia due to Gilbert’s disease)
Total bilirubin =< 1.5 institutional upper limit of normal (ULN), unless elevated secondary to lymphomatous involvement of liver or biliary system, or due to other HIV medications (e.g., indinavir, tenofovir, or atazanavir); for direct bilirubin > 1.2 due to hepatic involvement by tumor for the initial dose of EPOCH drug adjustment
Bilirubin =< 2.0 x the institutional normal upper limit unless secondary to bile duct obstruction by tumor
Total bilirubin =< 2 x institutional upper limit of normal (IULN) except when, in the opinion of the treating physician, is due to direct involvement of lymphoma (e.g., hepatic infiltration or biliary obstruction due to lymphoma) or Gilbert’s disease
Total bilirubin =< 2 x IULN except when in the opinion of treating physician is due to direct involvement of leukemia (e.g. hepatic infiltration or biliary obstruction due to leukemia) or Gilbert’s disease
Total bilirubin < 1.5 times institutional upper normal limit (unless due to disease involvement of liver, hemolysis or a known history of Gilbert’s disease)
Serum total bilirubin ?1.5 × upper limit of normal (ULN), unless considered due to Gilbert's disease, a gene mutation in UGT1A1, or leukemic organ involvement, following approval by the Medical Monitor;
Direct bilirubin =< 1.5 upper limit of normal (ULN) age unless elevation thought to be due or hepatic infiltration by the hematologic malignancy
Adequate liver function, as evidenced by total serum bilirubin =< 1.5 times the upper limit of normal (patients with Gilbert’s disease are eligible, provided intermittent indirect hyperbilirubinemia)
LVEF by ECHO or MUGA within institutional normal limits unless thought to be disease related; DLCO >= 60% with no symptomatic pulmonary disease unless thought to be disease related
Patients must have a direct bilirubin < 1.5 x upper limit of normal (ULN) for age or normal; these criteria may be waived for patients with known or suspected liver involvement by leukemia following review and approval by the study chair or vice chair
If organ function abnormalities are considered due to leukemic infiltration, total bilirubin must be =< 2 x ULN
Total bilirubin =< 1.5 x upper limit of normal (ULN) unless elevation is deemed due to leukemia infiltration; in these patients, dose modification may be required based on standard guidelines
Total bilirubin =< 1.5 x ULN unless bilirubin rise is considered to be the result of leukemic involvement by the PI
Total bilirubin =< 3 times the upper limit of normal unless hepatic dysfunction is related to liver involvement with disease
Direct bilirubin =< 2.0 x upper limit of normal (ULN) (unless considered due to leukemia involvement)
POST-TRANSPLANT ELIGIBILITY CRITERIA:\r\n* In complete remission (CR) (including incomplete blood count recovery [CRi] and marrow CR) on bone marrow biopsy for response assessment after HCT (typically day +30)\r\n* Patient is within 30-100 days after HCT\r\n* Absolute neutrophil count (ANC) >= 1000/uL, platelet count >= 20,000/uL\r\n* ECOG performance status 0-2\r\n* Adequate major organ function, as defined by AST and ALT =< 2 x upper limit of normal\r\n* Total serum bilirubin < 2 x upper limit of normal (unless due to hemolysis or Gilbert’s syndrome, then no upper limit)\r\n* Creatinine =< 2 x upper limit of normal unless there is known chronic kidney disease (CKD) (creatinine must be at baseline for subjects with CKD)\r\n* In agreement to use an effective barrier method of birth control to avoid pregnancy during the study and for a minimum of 30 days after study treatment, for all male and female patients who are fertile
POST-TRANSPLANT EXCLUSION CRITERIA:\r\n* Active grade II-IV acute graft versus host disease (GVHD)\r\n* Uncontrolled, life-threatening infection that is not responding to antimicrobial therapy\r\n* Serum creatinine > 2 x upper limit of normal unless there is known CKD (creatinine must be at baseline for subjects with CKD)\r\n* AST or ALT > 2 x upper limit of normal\r\n* Total bilirubin > 2 x upper limit of normal\r\n* History of psychiatric disorder which may compromise compliance with the protocol or which does not allow for appropriate informed consent\r\n* Pregnancy\r\n* Concurrent use of any other investigational agents on a clinical trial\r\n* Known hypersensitivity to 5-azacytidine\r\n** Prior treatment with 5-azacytidine is allowed
Total bilirubin > 2 times upper normal limit (unless due to tumor involvement of liver or a known history of Gilbert’s disease)
Total bilirubin < 1.5 x within normal institutional limits (unless due to lymphoma involvement of liver or a known history of Gilbert’s disease)
Liver function tests less than 2 x upper limit of normal range (unless related to medications or Gilbert’s disease)
ALT or AST ? twice the upper limit of normal (ULN), unless considered due to organ leukemic involvement;
Total bilirubin < 1.5 x upper limit of reference range (ULRR), unless the patient meets the criteria for Gilbert’s syndrome
Total bilirubin within normal institutional limits; higher values (=< 3 x institutional upper limit of normal [ULN]) are acceptable in participants with: 1. known or suspected cholangitis associated with Crohn’s disease, or 2, known or suspected inborn errors of metabolism that lead to increased bilirubin
Total or conjugated (direct) bilirubin =< 2.5 X ULN within 45 days prior to entry, with the exception of isolated hyperbilirubinemia that is considered due to atazanavir