Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (except patients with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)Xx_NEWLINE_xXPARTICIPANTS NOT ON THE HODGKIN LYMPHOMA EXPANSION COHORT: Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) =< 3 x ULN for subjects with Gilbert’s disease or with atazanavir- or indinavir-induced unconjugated hyperbilirubinemia without aspartate aminotransferase (AST) or alanine aminotransferase (ALT) elevation and must have a total bilirubin less than 3.0 mg/dL, within 2 weeks prior to enrollmentXx_NEWLINE_xXPARTICIPANTS ON THE HODGKIN LYMPHOMA EXPANSION COHORT: Total bilirubin: =<1.5 × institutional upper limit of normal (ULN), or =< 3 x ULN for participants with Gilbert’s disease or with atazanavir- or indinavir-induced unconjugated hyperbilirubinemia without AST or ALT elevation, and must have a total bilirubin less than 3.0 mg/dL), within 2 weeks prior to enrollmentXx_NEWLINE_xXBilirubin less than 1.5 mg/dL (except for patients with Gilbert’s Syndrome of indirect hyperbilirubinemia)Xx_NEWLINE_xXTotal 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 establishedXx_NEWLINE_xXMust be obtained within 14 days prior to registration for protocol therapy: Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXMust have total bilirubin ? 1.5 × institutional ULN [? 2.0 x ULN in presence of liver metastases] within 14 days prior to randomization.Xx_NEWLINE_xXDirect bilirubin ? 1.5 × ULN (may be assumed if total bilirubin is below ULN)Xx_NEWLINE_xXTotal bilirubin ? 1.5 x ULN (unless has Gilbert's syndrome)Xx_NEWLINE_xXWithin 14 days of treatment initiation: Serum total bilirubin =< upper limit of normal (ULN) OR direct bilirubin =< ULN for patients with total bilirubin levels > ULN; (except patients with Gilbert’s syndrome, who must have a total bilirubin less than 3.0 mg/dL)Xx_NEWLINE_xXTotal serum bilirubin =< 1.5 x ULNXx_NEWLINE_xXWithin 6 weeks prior to randomization: Total bilirubin must be =< upper limit of normal (ULN) for the laboratory (lab) unless the patient has a bilirubin elevation > ULN to 1.5 x ULN due to Gilbert’s disease or similar syndrome involving slow conjugation of bilirubinXx_NEWLINE_xXBilirubin =< 1.5 x ULN upper limit of normal (except in patients with documented Gilbert’s disease, who must have a total bilirubin =< 3.0 mg/dL), must be obtained within 8 weeks prior to screening for protocol therapyXx_NEWLINE_xXELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Bilirubin =< 1.5 x ULN (except in patients with documented Gilbert’s disease, who must have a total bilirubin =< 3.0 mg/dL)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) in absence of Gilbert disease (total bilirubin =< 3 x ULN with Gilbert); also, if hyperbilirubinemia is clearly attributed to liver metastases total bilirubin =< 3 x ULN is permittedXx_NEWLINE_xXRe-registration: total bilirubin =< 1.5 x ULN in absence of Gilbert disease (total bilirubin =< 3 x ULN with Gilbert); if hyperbilirubinemia is clearly attributed to liver metastases, total bilirubin =< 3 x ULN is permittedXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN except subjects with normal direct bilirubin or those with known Gilbert’s syndrome, obtained within 4 weeks prior to randomizationXx_NEWLINE_xXTotal bilirubin =< 1.5 X institutional upper limit of normal (ULN) (except subjects with Gilbert syndrome, who can have total bilirubin < 3 mg/dL) must be obtained =< 7 days prior to protocol registrationXx_NEWLINE_xXWithin 2 weeks prior to registration: Total bilirubin =< 1.5 x ULNXx_NEWLINE_xXPatients must have total bilirubin =< 1.5 x IULNXx_NEWLINE_xXPatients must have total bilirubin =< 2.5 x IULNXx_NEWLINE_xXTotal bilirubin =< ULN (institutional upper limit of normal) except elevated total bilirubin < 1.5 x ULN due to Gilbert’s disease or similar syndrome involving slow conjugation of bilirubin, measured within 28 days prior to randomizationXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (IULN) (except Gilbert’s syndrome, who must have a total bilirubin < 3.0 mg/dL), obtained within 28 days prior to step 2 registrationXx_NEWLINE_xXIf total bilirubin is > upper limit of normal (ULN) (NOTE: in subjects with Gilbert’s syndrome, if total bilirubin is \r\n> ULN, measure direct and indirect bilirubin and if direct bilirubin is within normal range, subject may be eligible) orXx_NEWLINE_xXWithin 14 days prior to registration: Total Bilirubin =< 1.5 x ULN (patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled)Xx_NEWLINE_xXSerum direct bilirubin < 2 mg/dl or serum total bilirubin =< 3; NOTE: the above stipulation for normal hepatic function does not apply if liver dysfunction is due to leukemia infiltrationXx_NEWLINE_xXObtained =< 48 hours prior to registration: Serum direct bilirubin < 2 mg/dL or serum total bilirubin =< 3Xx_NEWLINE_xXDirect or total bilirubin < 1.5 x ULN (unless related to Gilbert’s or Meulengracht’s syndrome); the values must be obtained within 48 hours prior to randomizationXx_NEWLINE_xXBilirubin =< 1.5 x ULN (CTCAE v 3.0 grade 1)Xx_NEWLINE_xXTotal bilirubin (=< 1.5 mg/dl) normal unless history of Gilbert’s syndromeXx_NEWLINE_xXObtained within 28 days prior randomization: total bilirubin must be =< 1.5 x ULN (upper limit of normal) for the lab unless the patient has a bilirubin elevation > 1.5 x ULN to 3 x ULN due to Gilbert’s disease or similar syndrome involving slow conjugation of bilirubin; andXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 x ULN), within 4 weeks of randomizationXx_NEWLINE_xXDirect bilirubin < 3.0 mg/dLXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN within 14 days prior to registration.Xx_NEWLINE_xXBilirubin =< 1.5 x ULNXx_NEWLINE_xXDirect bilirubin =< 2.0 mg/dLXx_NEWLINE_xXSerum total bilirubin =< 1.5 x upper limit of normal (ULN) (Note: in subjects with Gilbert’s syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is =< 1.5 x ULN, subject is eligible) within 90 days prior to Step 1 registrationXx_NEWLINE_xXTotal bilirubin =< 2.0 mg/dlXx_NEWLINE_xXTotal serum bilirubin ? ULN; or total bilirubin ? 3.0 × ULN with direct bilirubin within normal range in patients with documented Gilbert's Syndrome.Xx_NEWLINE_xXTotal bilirubin (T. bili) =< 1.3Xx_NEWLINE_xXObtained within 14 days prior to treatment start: Total serum bilirubin =< 1.5 x ULN; or total bilirubin (TBILI) =< 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert’s syndromeXx_NEWLINE_xXTotal bilirubin of ? 2.0 mg/dL (? 3.0 mg/dL for patients with known Gilbert's syndrome)Xx_NEWLINE_xXWithin 10 days of treatment initiation: Bilirubin =< 1.5 X IULN\r\n* Bilirubin > 1.5 x ULN is allowed in subjects with conjugated bilirubin disorder or Gilbert's syndromeXx_NEWLINE_xXBilirubin < 1.4 mg/dlXx_NEWLINE_xXWithin 21 days of treatment initiation:\r\nSerum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN; except subjects with known Gilbert’s syndromeXx_NEWLINE_xXBilirubin >1.5 mg/dL, except for Gilbert's Syndrome or hemolysis.Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) except subjects with documented Gilbert’s syndrome (> 5 x ULN) or liver metastasis, who must have a baseline total bilirubin =< 3.0 mg/dLXx_NEWLINE_xXTotal 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)Xx_NEWLINE_xXTotal bilirubin =< 2.0 mg/dL; in patients with Gilbert’s syndrome, total bilirubin >= 2.0 is permittedXx_NEWLINE_xXTotal bilirubin =< 1.5 X ULN (may not have abnormalities in both bilirubin and transaminases)Xx_NEWLINE_xXBilirubin =< 1.5 mg/dLXx_NEWLINE_xXBilirubin ? 1.5 × ULN unless evidence of Gilbert's disease in which case < 3 x ULNXx_NEWLINE_xXSerum bilirubin ? 1.5 x ULN, except in subjects with Gilbert's Syndrome who must have a total bilirubin < 3 mg/dLXx_NEWLINE_xXTotal bilirubin ? 1.5 × ULN (except in patients with Gilbert Syndrome who can have total bilirubin < 3.0 mg/dL). Direct bilirubin ? ULN for patients with total bilirubin levels >1.5 × ULN.Xx_NEWLINE_xXBilirubin < 1.5 × ULN except in patients with Gilbert's disease Renal FunctionXx_NEWLINE_xXTotal serum bilirubin ? 1.5 X ULNXx_NEWLINE_xXTotal bilirubin > 1.5 times ULN (patients with confirmed Gilbert's syndrome may be included in the study)Xx_NEWLINE_xXBilirubin =< 1.5 x ULN OR direct bilirubin of =< ULN for subjects with total bilirubin levels of > 1.5 x ULN obtained within 14 days prior to registrationXx_NEWLINE_xXWithin 14 days of treatment initiation: Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN (except in patients with Gilbert’s syndrome who may have total bilirubin < 3.0 mg/dL)Xx_NEWLINE_xXSerum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN (up to 14 days before treatment initiation)Xx_NEWLINE_xXTotal bilirubin =< 3.0 x ULN; if patient has known Gilbert’s syndrome direct bilirubin =< 1.5 x ULNXx_NEWLINE_xXBilirubin ? 1.5 x ULN (unless considered due to Gilbert's syndrome or hemolysis)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN OR, for subjected with total bilirubin levels > 1.5 x ULN, a direct bilirubin =< ULN must be met within 28 days of C1D1Xx_NEWLINE_xXBilirubin =< 2 x ULNXx_NEWLINE_xXWithin 14 days of treatment initiation:\r\nSerum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXTotal bilirubin ? 2 mg/dLXx_NEWLINE_xXSerum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXWithin 10 days of treatment initiation: Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXSerum total bilirubin ? ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dL (=< 2.0 in patients with known Gilbert's syndrome)Xx_NEWLINE_xXTotal bilirubin must be less than or equal to 1.5 x ULN (upper limit of normal) for the lab unless the patient has a bilirubin elevation greater than 1.5 x ULN to 3 x ULN due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin; andXx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 10 days of treatment initiationXx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXTotal bilirubin >1.5 x ULNXx_NEWLINE_xXSerum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 14 days of treatment initiationXx_NEWLINE_xXTotal bilirubin ? 1.5 × ULNXx_NEWLINE_xXCOHORT 1: Serum total bilirubin =< 1.5 X ULN unless considered due to leukemic organ involvement, Gilbert’s or hemolysis, OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN within 14 days of treatment initiationXx_NEWLINE_xXCOHORT 2: Serum total bilirubin =< 1.5 X ULN unless considered due to leukemic organ involvement, Gilbert’s or hemolysis, OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN within 14 days of treatment initiationXx_NEWLINE_xXTotal bilirubin ?2.0Xx_NEWLINE_xXBilirubin =< 1.5 x ULN (unless documented Gilbert's disease), within 14 days of registrationXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin > 1.5 x ULNXx_NEWLINE_xXSAFETY RUN-IN: Within 10 days of registration: Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXRANDOMIZED PHASE II CLINICAL TRIAL: Within 10 days of registration: Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXSerum total bilirubin ? 1.5 × ULN (On fractionation ? 90% of total bilirubin should be unconjugated. Total bilirubin must be <4 X ULN for patients with Gilbert's syndrome).Xx_NEWLINE_xXTotal bilirubin < 1.5 x upper limit of normal (ULN); or total bilirubin =< 3.0 x ULN or direct bilirubin =< 1.5 x ULN in patients with well-documented Gilbert’s syndromeXx_NEWLINE_xXTotal serum bilirubin =< 1.5 X ULN (except participants with Gilbert’s syndrome, who can have a total bilirubin [bili] < 5 X ULN), performed within 14 days of treatment initiationXx_NEWLINE_xXBilirubin ? 2.5 × ULN (? 4 × ULN for subjects with Gilbert's disease);Xx_NEWLINE_xXSerum bilirubin <1.5 mg/dL (except subjects with Gilbert's syndrome who may have total bilirubin <3.0 mg/mL)Xx_NEWLINE_xXSerum total bilirubin =< 1.5 x ULN ORXx_NEWLINE_xXDirect bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXTotal bilirubin and direct bilirubin =< ULNXx_NEWLINE_xXPatients with hyperbilirubinemia clinically consistent with an inherited disorder of bilirubin metabolism (e.g., Gilbert syndrome) will be eligible at the discretion of the principal investigator if total bilirubin is =< 1.5 X ULNXx_NEWLINE_xXTotal bilirubin <2.0 mg/dL unless elevated due to known Gilbert's syndrome.Xx_NEWLINE_xXTotal bilirubin =< 1.5 × ULNXx_NEWLINE_xXSerum total bilirubin > 1.5 mg/dL or > 3 × ULN for patients with hereditary benign hyperbilirubinemiaXx_NEWLINE_xXTotal bilirubin less than or equal to 1.5 X ULN except for unconjugated hyperbilirubinemia of Gilbert's syndromeXx_NEWLINE_xXTotal bilirubin < ULN; or total bilirubin =< 3.0 x ULN or direct bilirubin =< 1.5 x ULN in patients with well-documented Gilbert’s syndromeXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN; or =< 2 x ULN (if upon judgment of the treating physician, it is believed to be due to EMH related to MF)Xx_NEWLINE_xXSerum bilirubin levels ?2 x ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dLXx_NEWLINE_xXTotal bilirubin is no higher than the ULN;Xx_NEWLINE_xXBilirubin =< 3.0 mg/dL (unless due to Gilbert’s syndrome or hemolysis)Xx_NEWLINE_xXSerum direct bilirubin =< 2 mg/dL (unless history of Gilbert’s)Xx_NEWLINE_xXTotal serum bilirubin =< 2.0 mg/dLXx_NEWLINE_xXSerum bilirubin =< 1.5 x institutional ULNXx_NEWLINE_xXTotal bilirubin < 2 mg/dL (unless due to acute lymphoblastic leukemia [ALL])Xx_NEWLINE_xXSerum bilirubin > 1.5 × ULN; bilirubin up to 3 x ULN is permitted in individuals with documented liver involvement by lymphoma or if due to known Gilbert syndrome or other organ system that may place the patient at undue risk to undergo treatmentXx_NEWLINE_xXTotal bilirubin < 2.0 mg/dl (unless attributable to Gilbert's disease)Xx_NEWLINE_xXSerum bilirubin < 1.5 x the ULN for the reference lab;Xx_NEWLINE_xXTotal bilirubin =< 1.5 x the IULNXx_NEWLINE_xXBilirubin (total) >1.5x ULNXx_NEWLINE_xXBilirubin =< 1.5 x the upper limit of normal (ULN) within 7 days before the first dose of cabozantinib. For subjects with known Gilbert’s disease, bilirubin =< 3.0 mg/dLXx_NEWLINE_xXTotal bilirubin ? 1 X ULN (subjects with Gilbert’s disease can have bilirubin of up to 1.5 X ULN)Xx_NEWLINE_xXBilirubin < 1.5 mg/dlXx_NEWLINE_xXTotal bilirubin ?1.5 ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dL (=< 2.0 in patients with known Gilberts syndrome)Xx_NEWLINE_xXTotal bilirubin ? 1.5 mg/dL (upper limit of normal) except subject with documented Gilbert's syndrome (? 5 x ULN) or liver metastasis, who must have a baseline total bilirubin ? 3.0 mg/dLXx_NEWLINE_xXTotal bilirubin ? 1.5 x ULN or direct bilirubin ? ULN for subjects with total bilirubin > 1.5 x ULNXx_NEWLINE_xXWithin 10 (except as noted) days of planned treatment initiation: Serum bilirubin =< 1.5 x institutional ULN OR direct bilirubin =< ULN for patients with total bilirubin levels > 1.5 x ULNXx_NEWLINE_xXTotal bilirubin ?1.5 mg/dL unless elevated due to known Gilbert's syndrome.Xx_NEWLINE_xXObtained within 21 days prior to study registration: total bilirubin =< 2.0 g/dLXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN OR direct bilirubin =< 1 x ULNXx_NEWLINE_xXHave a total bilirubin level ?2.0 mg/dL (unless secondary to Gilbert syndrome, hemolysis, or leukemia)Xx_NEWLINE_xXSerum total bilirubin ? 2.0 mg/dL (34 ?mol/L). In the case of Gilbert's syndrome, or documented liver or pancreatic involvement by lymphoma, serum total bilirubin must be ? 5.0 mg/dL (86 ?mol/L).Xx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for patients with total bilirubin levels > 1.5 ULN.Xx_NEWLINE_xXtotal bilirubin must be ? ULN for the lab unless the patient has a bilirubin elevation > ULN to 1.5 x ULN due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin; andXx_NEWLINE_xXObtained within 14 days prior to C1D1: Total Bilirubin =< 1.5 x ULN, except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dLXx_NEWLINE_xXTotal serum bilirubin less than ULN.Xx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dl, except in subjects with Gilbert’s syndromeXx_NEWLINE_xXBilirubin less than or equal to 1.5 x the upper limit of normal (except subjects with Gilbert syndrome, who can have total bilirubin < 3 mg/dl)Xx_NEWLINE_xXObtained =< 21 days prior to registration: total bilirubin =< 2.0 mg/dL (if total is elevated check direct and if normal patient is eligible)Xx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dL or < 2 mg/dL if attributable to hepatic infiltration by neoplastic disease or Gilbert’s syndromeXx_NEWLINE_xXSerum bilirubin =< 2 x ULNXx_NEWLINE_xXTotal bilirubin > 1.5 x ULNXx_NEWLINE_xXTotal bilirubin ? 1.5 × institutional ULN (total bilirubin of ? 3 x institutional ULN in subjects with documented Gilbert's syndrome).Xx_NEWLINE_xXTotal serum bilirubin =< 1.5 x ULN unless the patient has documented Gilbert syndromeXx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dL (25.65 umol/L)Xx_NEWLINE_xXTotal bilirubin =< 2.4 mg/dL unless related to Gilbert’s disease or patient’s lymphomaXx_NEWLINE_xXTotal bilirubin < ULN; or total bilirubin =< 3.0 x ULN or direct bilirubin =< 1.5 x ULN in patients with well-documented Gilbert’s syndromeXx_NEWLINE_xXObtained =< 2 weeks prior to registration: Total bilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< upper limit of normal performed within 30 days prior to the date of registration (ULN, Note: In subjects with Gilbert’s syndrome, if total bilirubin is > ULN, measure direct and indirect bilirubin and if direct bilirubin is =< ULN, subject may be eligible)Xx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 10 days of treatment initiationXx_NEWLINE_xXTotal serum bilirubin > 2 mg/dLXx_NEWLINE_xXWithin 14 days of treatment registration: Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXObtained within 14 days prior to registration: Total bilirubin =< 1.5 ULN (unless documented Gilbert's disease)Xx_NEWLINE_xXTotal bilirubin < ULN; or total bilirubin =< 3.0 x ULN or direct bilirubin =< 1.5 x ULN in patients with well-documented Gilbert’s syndromeXx_NEWLINE_xXTotal bilirubin < institutional ULN within 14 days of enrollment to trialXx_NEWLINE_xXBilirubin ?2 x ULN (except subjects with Gilbert's syndrome, who must have total bilirubin < 3.0 mg/dL (<52 µmol/L))Xx_NEWLINE_xXBilirubin (total) within normal institutional limits (except subjects with Gilbert syndrome who must have total bilirubin < 3.0 mg/dL)Xx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dLXx_NEWLINE_xXtotal bilirubin ? 1.5 × upper limit of normal (ULN) OR direct bilirubin ? ULN for subjects with total bilirubin levels > 1.5 x ULN (except subject with Gilbert's Syndrome, who can have total bilirubin < 3.0 mg/dl)Xx_NEWLINE_xXTotal bilirubin ?1.5 mg/dL not related to hemolysis or Gilbert's diseaseXx_NEWLINE_xXTotal serum bilirubin ?1.5 x ULN. In subjects with Gilbert's syndrome, if total bilirubin is >1.5 × ULN, measure direct and indirect bilirubin and if direct bilirubin is ?1.5 × ULN, subject may be eligible)Xx_NEWLINE_xXTotal bilirubin ? 1.5 x institutional ULN. If total bilirubin is > ULN and < 1.5 x ULN, it must be non-rising for at least 7 days.Xx_NEWLINE_xXTotal bilirubin: =< 1.5 x ULN (in case of known Gilbert’s syndrome, < 2 x ULN is allowed) within 8 weeks of pre-registrationXx_NEWLINE_xXTotal bilirubin (TBL) ? 2.5 mg/dL, except for participants with Gilbert's syndrome.Xx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dL (=< 2.0 in participants with known Gilbert’s syndrome)Xx_NEWLINE_xXHepatic status: Serum total bilirubin ? 1 x upper limit of normal (ULN; in the case of known Gilbert's syndrome, a higher serum total bilirubin [< 1.5 x ULN] is allowed), aspartate aminotransferase and alanine aminotransferase ? 1.5 x ULN, and alkaline phosphatase ? 1.5 x ULN;Xx_NEWLINE_xXBilirubin =< 1.5 x ULN (unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin); bilirubin =< 3 x ULN is permissible if due to diseaseXx_NEWLINE_xXTotal bilirubin =< 2.0 mg/dL unless due to Gilbert’s syndrome, hemolysis, or ineffective hematopoiesisXx_NEWLINE_xXBilirubin =< 2.5 x ULN (=< 4 x ULN for subjects with Gilbert’s disease)Xx_NEWLINE_xXObtained =< 21 days prior to registration and confirmed prior to the first dose of study drug: Total bilirubin =< 1.5 mg/dL (if total is elevated check direct and if normal patient is eligible)Xx_NEWLINE_xXTotal bilirubin (TBL) < 2x ULN (unless Gilbert's disease or if liver involvement with lymphoma)Xx_NEWLINE_xXTotal bilirubin ?1.5 x ULNXx_NEWLINE_xXBilirubin =< 2.0 mg/dl, unless due to Gilbert’s, hemolysis or leukemic infiltrationXx_NEWLINE_xXTotal serum bilirubin ? 1.5 × upper limit of normal for the study site (ULN) (in patients with known Gilbert Syndrome, total bilirubin ? 3 × ULN, with direct bilirubin ? 1.5 × ULN)Xx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 14 days of treatment initiationXx_NEWLINE_xXTotal bilirubin ? 2.0 mg/dlXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional ULNXx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN within 14 days of treatment initiationXx_NEWLINE_xXTotal bilirubin =< 1.5 x the upper limits of normal (ULN), except for subjects with Gilbert Syndrome who can have bilirubin < 3Xx_NEWLINE_xXBilirubin =< 1.5 x ULN (unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin)Xx_NEWLINE_xXSerum bilirubin =< 1.5 x ULNXx_NEWLINE_xXBilirubin > 2.0 mg/dLXx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dLXx_NEWLINE_xXDirect bilirubin ? 1.5 mg/dL or total bilirubin ? 1.5 mg/dLXx_NEWLINE_xXDirect bilirubin ? 3.0 mg/dL (50 mmol/L)Xx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN unless due to Gilbert’s disease, hemolysis or leukemic infiltration OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 14 days of D1 of treatment under LCCC1522Xx_NEWLINE_xXTotal bilirubin =< 3 mg/dLXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN), except for patients with Gilbert’s syndrome, who may only be included if total bilirubin =< 3.0 x ULN or direct bilirubin =< 1.5 x ULN, at the screening visitXx_NEWLINE_xXTotal bilirubin ?1.5 × institutional ULNXx_NEWLINE_xXBilirubin =< 1.5 x ULNXx_NEWLINE_xXSerum total bilirubin =< 1.5 upper limit of normal (ULN) or, direct bilirubin =< ULN for participants with total bilirubin levels > 1.5 ULN (performed within 14 days of treatment initiation)Xx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN (performed within 28 days of treatment initiation)Xx_NEWLINE_xXTotal bilirubin ? 1.5 ULNXx_NEWLINE_xXBilirubin ?1.5 × institutional ULN.Xx_NEWLINE_xXSerum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXSerum total bilirubin > 1.5 mg/dL or > 3 × ULN for patients with hereditary benign hyperbilirubinemiaXx_NEWLINE_xXTotal bilirubin =< 1.5 x the upper limit of the normal range (ULN) except for previously documented Gilbert’s disease, defined as a mild unconjugated hyperbilirubinemia with no other identifiable cause and bilirubin values < 6 mg/dL; patients with hyperbilirubinemia secondary to presumed Gilbert’s disease who are being considered for enrollment in the study MUST have a fractionated bilirubin included in their screening labs when determining eligibilityXx_NEWLINE_xXSerum total bilirubin =<1.5 X institutional ULN OR direct bilirubin =< institutional ULN for subjects with total bilirubin levels > 1.5 institutional ULN, performed within 28 days of study registrationXx_NEWLINE_xXTotal bilirubin ? 1.5 × ULN or direct bilirubin ? ULN.Xx_NEWLINE_xXSerum bilirubin =< 1.0 x ULNXx_NEWLINE_xXTotal bilirubin ? 2Xx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dLXx_NEWLINE_xXARM 2 - A: Total bilirubin =< 2.0 mg/dLXx_NEWLINE_xXSerum bilirubin < 2 x ULNXx_NEWLINE_xXTotal bilirubin ?1.5× ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional ULNXx_NEWLINE_xXTotal bilirubin ? 1.5 x ULNXx_NEWLINE_xXTotal bilirubin ? 1.5mg/dl,Xx_NEWLINE_xXOBTAINED =< 7 DAYS PRIOR TO REGISTRATION: Total bilirubin =< ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 X ULNXx_NEWLINE_xXTotal bilirubin =< 2.0 mg/dl unless due to underlying conjugation disease such as Gilbert’sXx_NEWLINE_xXSerum total bilirubin =< 1.5 x IULN OR direct bilirubin =< IULN for patients with total bilirubin > 1.5 x IULNXx_NEWLINE_xXTotal bilirubin should be =< 2 x upper limit of normal (ULN) (patients with Gilbert's syndrome must have a total bilirubin less than 3.0 mg/dL)Xx_NEWLINE_xXBilirubin < 1.5 x ULN (unless bilirubin rise is due to Gilbert’s syndrome [as defined by > 80% unconjugated hyperbilirubinemia] or of non-hepatic origin)Xx_NEWLINE_xXTotal bilirubin =< 2.0 x ULNXx_NEWLINE_xXBilirubin =< 2.0 x ULN, (except patients with Gilbert’s syndrome, who must have a total bilirubin less than 3.0 mg/dL)Xx_NEWLINE_xXTotal bilirubin less than or equal to 2 mg/dl, except in patients with Gilbert’s syndrome, who must have a total bilirubin less than or equal to 3 mg/dlXx_NEWLINE_xXBilirubin up to 2.5 x ULN.Xx_NEWLINE_xXTotal bilirubin < 1.5 mg/dLXx_NEWLINE_xXTotal bilirubin =< 1.5 X ULN (unless there is lymphoma in the liver)Xx_NEWLINE_xXRETREATMENT WITH MODIFIED T-CELLS INCLUSION CRITERIA: Total bilirubin: =< 3 x ULN for age OR conjugated bilirubin =< 2 mg/dLXx_NEWLINE_xXTotal bilirubin =< to 1.5 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dlXx_NEWLINE_xXTotal bilirubin ?1.5 times the upper limit of normal (ULN) (in patients with known Gilbert Syndrome, a total bilirubin ?3.0 x ULN, with direct bilirubin ?1.5 x ULN)Xx_NEWLINE_xXTotal bilirubin =< 2.0 x institutional ULN, unless documented Gilbert’s syndromeXx_NEWLINE_xXBilirubin > 2.0Xx_NEWLINE_xXPART I: Total bilirubin =< 1.5 mg/dlXx_NEWLINE_xXPART II: Total bilirubin =< 1.5 x ULNXx_NEWLINE_xXHepatic: Total bilirubin =< upper limit of normal (ULN) for age, or if total bilirubin is > ULN, direct bilirubin is =< 1.4 mg/dLXx_NEWLINE_xXTotal bilirubin less than or equal to 1.5 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dlXx_NEWLINE_xXSerum total bilirubin =< 2 x ULN (except for patients with Gilbert’s Syndrome)Xx_NEWLINE_xXBilirubin =< 1.5 mg/dLXx_NEWLINE_xXBilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin less than or equal to 2 mg/dl, except in patients with Gilbert’s syndrome, who must have a total bilirubin less than or equal to 3 mg/dlXx_NEWLINE_xXBilirubin =< 2 unless consistent with Gilbert’s (total/direct > 5)Xx_NEWLINE_xXBilirubin =< 1.5 x ULNXx_NEWLINE_xXPerformed within 10 business days of treatment initiation with the exception of beta- HCG (72 hours), if applicable: Serum total bilirubin =< 1.5 X ULN or direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN.Xx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN (except subjects with Gilbert syndrome, who must have total bilirubin < 3.0 mg/dL) within 14 days prior to first dose of protocol-indicated treatment.Xx_NEWLINE_xXWithin 14 days of randomization: Bilirubin =< ULN (unless documented Gilbert's disease)Xx_NEWLINE_xXWithin 14 days of the first dose of study drug: Total bilirubin =< 1.5 x ULN (except patients with Gilbert syndrome who must have total bilirubin < 3.0 mg/dL)Xx_NEWLINE_xXSerum total bilirubin > 1.5 mg/dL or > 3 x ULN for patients with hereditary benign hyperbilirubinemiaXx_NEWLINE_xXTotal bilirubin =< 2.0 mg/dLXx_NEWLINE_xXAt time of registration and within 4 weeks prior to initiating on-protocol treatment: Total bilirubin =< 1.5 x ULN, OR direct bilirubin =< ULN for participants with total bilirubin levels >1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< to 2.0 mg/dl, except in patients with Gilbert’s syndrome, who must have a total bilirubin =< 3.0 mg/dl.Xx_NEWLINE_xXTotal bilirubin within normal institutional limits; for patients with Gilbert’s syndrome, total bilirubin =< 3.0 mg/dL.Xx_NEWLINE_xXHepatic: < 2 x ULN total serum bilirubin, unless there is congenital benign hyperbilirubinemia.Xx_NEWLINE_xXTotal bilirubin =< 2.0 mg/mlXx_NEWLINE_xXDirect bilirubin < 2.0 mg/dLXx_NEWLINE_xXARM I&II: Total bilirubin =< 1.5 mg/dlXx_NEWLINE_xXTotal bilirubin < 1.5 X ULNXx_NEWLINE_xXBilirubin ?1.5x the upper limit of normal (ULN). For subjects with documented Gilbert's disease, bilirubin ?3.0 mg/dL. For subjects with documented liver metastases, bilirubin ? 2.5x ULN.Xx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN (unless Gilbert’s syndrome or disease infiltration of the liver is present, who may be included if total bilirubin =< 3.0 x ULN or direct bilirubin =< 1.5 x ULN)Xx_NEWLINE_xXWithin 10 days prior to the start of study treatment: Total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for participants with total bilirubin levels > 1.5 x ULNXx_NEWLINE_xXTotal bilirubin ? 1.5 x ULN OR in subjects with Gilbert’s syndrome, a total bilirubin ? 3.0 x ULNXx_NEWLINE_xXTotal bilirubin =< 2.0 mg/dl, except in patients with Gilbert’s Syndrome, who must have a total bilirubin < 3.0 mg/dlXx_NEWLINE_xXBilirubin < 2.0 mg/dLXx_NEWLINE_xXBilirubin ? 2.0 mg/mlXx_NEWLINE_xXTotal bilirubin ?1.5 times the ULN (or ?3 x ULN, if patient has Gilbert syndrome)Xx_NEWLINE_xXSerum bilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin < 1.5 x ULN (or =< 3 x ULN for patients with documented Gilbert syndrome)Xx_NEWLINE_xXA bilirubin of less than or equal to 1.5 mg/dL, excluding patients with Gilbert's diseaseXx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 28 days of treatment initiationXx_NEWLINE_xXPerformed within 10 days of treatment initiation: Serum total bilirubin ? 1.2 X ULN OR in case of Gilbert’s disease an elevated total bilirubin is allowed if direct bilirubin is ? 40% of totalXx_NEWLINE_xXDirect bilirubin must be < 2 mg/dL unless the elevation is known to be due to Gilbert syndrome within 3 days prior to enrollment.Xx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, should be performed within 10 days of treatment initiationXx_NEWLINE_xXBilirubin > 1.15 mg/dLXx_NEWLINE_xXBilirubin =< 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL).Xx_NEWLINE_xXObtained within 28 days prior to registration: Bilirubin =< 1.5 x upper limit of normal (ULN) (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)Xx_NEWLINE_xXWithin 7 days of enrollment and with 24 h of starting lymphodepleting chemotherapy: Total bilirubin =< 1.5 X ULN.Xx_NEWLINE_xXTotal bilirubin =<1.5 x ULN (excepting Gilbert’s syndrome)Xx_NEWLINE_xXTotal serum bilirubin =< 1.5 x ULNXx_NEWLINE_xXWithin 28 days prior to treatment start: Total bilirubin =< 1.5 x upper limit of normal (ULN) (Note: In subjects with Gilbert’s syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is =< 1.5 x ULN, subject may be eligible)Xx_NEWLINE_xXSTRATUM A: Total bilirubin =< ULN or if > ULN then direct bilirubin =< 1.5 x ULNXx_NEWLINE_xXSTRATUM B: Total bilirubin =< ULN; or if > ULN then direct bilirubin =< 1.5 x ULNXx_NEWLINE_xXSTRATUM C: Total bilirubin =< ULN; or if > ULN then direct bilirubin =< 1.5 x ULNXx_NEWLINE_xXBilirubin =< 1.5 x ULN, (Patients with documented Gilbert’s syndrome and conjugated bilirubin within the normal range may be allowed into the study; in this event, it will be documented that the patient was eligible based on\r\nconjugated bilirubin levels)Xx_NEWLINE_xXSerum total bilirubin =< 1.5 x institutional ULN (except subjects with Gilbert’s syndrome, who must have normal direct bilirubin)Xx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 10 days of treatmentXx_NEWLINE_xXTotal bilirubin < 1.5 x institutional normal limits (subjects with known Gilbert syndrome are eligible with total bilirubin < 3.0 mg/dL).Xx_NEWLINE_xXDirect bilirubin > 2.0 mg/dLXx_NEWLINE_xXBilirubin =< 1.5 x ULN OR in subjects with Gilbert’s syndrome, a total bilirubin =< 3.0 x ULNXx_NEWLINE_xXSerum total bilirubin ? 1.5 X ULN OR direct bilirubin ? ULN for subjects with total bilirubin levels > 1.5 ULN within 21 days of treatment initiationXx_NEWLINE_xXSerum bilirubin ?1.5 × ULN (Grade ? 1).Xx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN within 21 days of treatment initiationXx_NEWLINE_xXTotal serum bilirubin ? 1.5 x ULN (in subjects with known Gilbert Syndrome, a total bilirubin ? 3.0 x ULN, with direct bilirubin ? 1.5 x ULN)Xx_NEWLINE_xXPerformed within 10 days of treatment initiation: serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXTotal bilirubin less than or equal to 2 mg/dl, except in patients with Gilbert’s syndrome, who must have a total bilirubin less than or equal to 3 mg/dlXx_NEWLINE_xXSerum bilirubin < 1.5 x upper limit of normal (ULN); Note: In subjects with Gilbert’s syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is =< 1.5 x ULN, subject may be eligibleXx_NEWLINE_xXBilirubin: =< 1.5 x ULN (except for subjects with Gilbert’s Syndrome or of non-hepatic cause)Xx_NEWLINE_xXSerum total bilirubin =< 1.5 times upper limit of normal (ULN) OR direct bilirubin =< ULN for subjects with total bilirubin >= 1.5 x ULNXx_NEWLINE_xXShould be performed within 30 days of treatment initiation: serum total bilirubin ? 1.5 X ULN OR direct bilirubin ? ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 X institutional ULNXx_NEWLINE_xXWithin 28 days of cycle 1 day 1: Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN (performed within 10 days of treatment initiation)Xx_NEWLINE_xXTotal Serum Bilirubin ? 1.5 x ULN (< 3.0 mg/dL if subject has Gilbert's syndrome)Xx_NEWLINE_xXWithin 5 days prior to the start of study treatment: Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN.Xx_NEWLINE_xXCOHORT 1: HORMONE RECEPTOR POSITIVE BREAST CANCER: Total bilirubin < 1.5 X ULN, unless known diagnosis of Gilbert’s syndrome, where bilirubin =< 5 mg/dL will be permitted; Gilbert’s syndrome will be defined as elevated unconjugated bilirubin, with conjugated (direct) bilirubin within the normal range and less than 20% of the total; total bilirubin will be permitted up to 5 mg/dL, if patients have historical readings consistent with the definition of Gilbert’s syndrome prior to entering studyXx_NEWLINE_xXCOHORT 2: TRIPLE NEGATIVE BREAST CANCER: Total bilirubin < 1.5 X ULN, unless known diagnosis of Gilbert’s syndrome, where bilirubin =< 5 mg/dL will be permitted; Gilbert’s syndrome will be defined as elevated unconjugated bilirubin, with conjugated (direct) bilirubin within the normal range and less than 20% of the total; total bilirubin will be permitted up to 5 mg/dL, if patients have historical readings consistent with the definition of Gilbert’s syndrome prior to entering studyXx_NEWLINE_xXCOHORT 3: ENDOMETRIAL CANCER: Total bilirubin < 1.5 X ULN, unless known diagnosis of Gilbert’s syndrome, where bilirubin =< 5 mg/dl will be permitted; Gilbert’s syndrome will be defined as elevated unconjugated bilirubin, with conjugated (direct) bilirubin within the normal range and less than 20% of the total; total bilirubin will be permitted up to 5 mg/dL, if patients have historical readings consistent with the definition of Gilbert’s syndrome prior to entering studyXx_NEWLINE_xXObtained within 14 days prior to randomization/registration: total Bilirubin =< 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL)Xx_NEWLINE_xXBilirubin =< 1.5 x IULNXx_NEWLINE_xXBilirubin 1.5-2 x IULNXx_NEWLINE_xXBilirubin < 1.5 mg/dLXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN), except patients with Gilbert’s syndrome in whom total bilirubin must be < 3.0 mg/dL, within 2 weeks of registrationXx_NEWLINE_xXTotal bilirubin ? 1.5 mg/dl, except in subjects with Gilbert's syndrome.Xx_NEWLINE_xXbilirubin <= 1.5 x ULN* * Unless considered to be due to leukemic organ involvement i. Subjects who are < 75 years of age may have a bilirubin of <= 3.0 x ULNXx_NEWLINE_xXTotal bilirubin < 2.5 ULN. Subjects with a known history of Gilberts Disease and an isolated elevation of indirect bilirubin are eligible.Xx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN (patients with Gilbert’s syndrome may have serum bilirubin > 1.5 x ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) for age\r\n* Temozolomide should not be administered if total bilirubin is > 2.0 mg/dl or SGPT(ALT) > 2.5 x ULNXx_NEWLINE_xXTotal bilirubin ? 2x the institutional ULN with the exception of patients with Gilbert syndrome; patients with Gilbert syndrome may be included if their total bilirubin is ? 3.0x ULN and direct bilirubin is ? 2x ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN\r\n* Except in the case of Gilbert disease, in which case total bilirubin must be =< 3 x ULNXx_NEWLINE_xXTotal serum bilirubin ? 1.5 x ULN, (except for patients with known Gilbert's Syndrome ? 3 x ULN is permitted)Xx_NEWLINE_xXObtained within 28 days prior to the first dose of cabozantinib: bilirubin =< 1.5 x the upper limit of normal (ULN). For subjects with known Gilbert’s disease, bilirubin =< 3.0 mg/dL.Xx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)Xx_NEWLINE_xXBilirubin less than or equal to 1.5 x the upper limit of normal (except subjects with Gilbert syndrome, who can have total bilirubin < 3 mg/dl)Xx_NEWLINE_xXBilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin > ULN (NOTE: in subjects with Gilbert’s syndrome, if total bilirubin is > ULN, measure direct and indirect bilirubin and if direct bilirubin is within normal range, subject may be eligible) orXx_NEWLINE_xXDirect bilirubin =< 2.0 mg/dL in the absence of suspected Gilbert’s disease (if Gilbert’s disease is suspected, the total bilirubin must be =< 3.0 mg/dL)Xx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN (upper limit of normal) except subject with documented Gilbert's syndrome (=< 5 x ULN) or liver metastasis, who must have a baseline total bilirubin =< 3.0 mg/dLXx_NEWLINE_xXTotal bilirubin ? ULN (except in patients who have Gilbert’s syndrome or patients with recently placed stents for biliary obstruction when bilirubin should be < 1.5 X ULN) obtained ? 14 days prior to randomizationXx_NEWLINE_xXBilirubin less than or equal to 1.5 x the upper limit of normal (except subjects with Gilbert syndrome, who can have total bilirubin < 3 mg/dl)Xx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin ? ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 14 days of treatment initiationXx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 28 days of treatment initiationXx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dLXx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXSerum bilirubin =< 1.0 x ULNXx_NEWLINE_xXDirect bilirubin (bili) =< 40% if total bili > ULN in patients with Gilbert’s syndromeXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 x ULNXx_NEWLINE_xXSerum total bilirubin =< 1.5 x ULNXx_NEWLINE_xXSerum bilirubin < 1.8Xx_NEWLINE_xXBilirubin =< 1.5 mg/dL (OR in patients with Gilbert’s syndrome, a total bilirubin =< 3.0) (within 16 days before starting therapy)Xx_NEWLINE_xXWithin 4 weeks before enrollment: Total bilirubin =< 2.5 x ULN; except if the elevation is due to Gilbert's syndromeXx_NEWLINE_xXSerum bilirubin ? 1.5 x institutional ULN (in subjects with Gilbert’s syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin and patient is eligible if direct bilirubin ? 1.5 x ULN)Xx_NEWLINE_xXTo be performed within 14 days of treatment initiation: serum total bilirubin ? 1.5 x ULN OR direct bilirubin ? ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXBilirubin =< 1.5 x ULN.Xx_NEWLINE_xXTotal bilirubin =< 2.0 mg/dL, except in patients with Gilbert’s syndrome, who must have a total bilirubin =< 3.0 mg/dLXx_NEWLINE_xXTotal bilirubin =< 2 mg/dL; for subjects with known Gilbert’s disease, bilirubin =< 3.0 mg/dLXx_NEWLINE_xXObtained =< 14 days prior to registration: Total bilirubin =< 1.5 x upper limit of normal (ULN) (in patients with well-documented Gilbert’s syndrome and the total bilirubin is grade 1, then direct bilirubin value must be =< 1.0 mg/dL)Xx_NEWLINE_xXWithin 10 days of treatment initiation: Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN.Xx_NEWLINE_xXWithin 10 days of treatment initiation: Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXTotal serum bilirubin < 1.5 x ULN, unless the patient has documented Gilbert syndromeXx_NEWLINE_xXWithin 14 days of treatment initiation: Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 10 days of treatment initiationXx_NEWLINE_xXPerformed within 10 days of treatment initiation: Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXSerum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN.Xx_NEWLINE_xXTotal bilirubin =< 3.0 mg/dLXx_NEWLINE_xXTotal bilirubin ? 3.0 mg/dLXx_NEWLINE_xXWithin 7 days of registration: Total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 x ULNXx_NEWLINE_xXObtained =< 14 days prior to registration: Serum total bilirubin =< 1.5 X upper limit of normal (ULN) or direct bilirubin =< (ULN) for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXWithin 14 days of the first dose of the study drugs: Total bilirubin =< 1.5 mg/dl.Xx_NEWLINE_xXWithin 10 days prior to on-study date: Serum total bilirubin ? 1.5 X ULN ORXx_NEWLINE_xXSerum total bilirubin\t ? 2 mg/dl (biliary stent is allowed) within 10 days prior to “on study” statusXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL) within 14 days of registrationXx_NEWLINE_xXTotal bilirubin =< 2 mg/dL or direct bilirubin =< ULN for those with total bilirubin > 2 x ULN; subjects with Gilbert syndrome will be eligible if total bilirubin is < 3.0 mg/dLXx_NEWLINE_xXBilirubin =< 3.0 mg/dL (obtained within three days prior to study treatment)Xx_NEWLINE_xXDirect or conjugated bilirubin < 3 mg/dlXx_NEWLINE_xXTotal bilirubin > 3 mg/dlXx_NEWLINE_xXWithin 28 days prior to enrollment: Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin >= 1.5 ULNXx_NEWLINE_xXTotal bilirubin < 3.0 g/dl OR < 5.0 g/dl if Gilbert’s syndrome or disease infiltration of the liver is presentXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN within 14 days of study registration (except subjects with Gilbert Syndrome who must have total bilirubin < 3.0 mg/dl).Xx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for patients with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN (except if the patient has Gilbert’s syndrome who can have total bilirubin =< 2 x ULN) must be met during screening (within 21 days) and also prior to study drug administration on cycle 1 day 1Xx_NEWLINE_xXWithin 10 days of treatment initiation: Serum total bilirubin =< 1.5 X ULNXx_NEWLINE_xXObtained within 21 days prior to randomization/registration: Total bilirubin =< 1.5 x ULN (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL).Xx_NEWLINE_xXTotal bilirubin ? 1.5 × upper limit of normal (ULN) OR direct bilirubin ? ULN for subjects with total bilirubin levels > 1.5 x ULNXx_NEWLINE_xXWithin 14 days prior to registration: Bilirubin =< 1.5 x ULN; for patients with Gilbert's syndrome, bilirubin =< 3 x ULN is acceptableXx_NEWLINE_xXWithin 10 days of treatment initiation: Serum total bilirubin ? 1.5 X ULN OR direct bilirubin ? ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXTotal Bilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal serum bilirubin =< 1.5 x ULN (=< 3 x ULN or direct bilirubin =< 1.5 x ULN if known Gilbert’s syndrome)Xx_NEWLINE_xXSerum total bilirubin ? 1.5 X ULN OR direct bilirubin ? ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dl, except in subjects with Gilbert’s syndromeXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULNXx_NEWLINE_xXSerum total bilirubin =< 1.5 x ULN or direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 x ULNXx_NEWLINE_xXSerum bilirubin =< 1.0 x ULNXx_NEWLINE_xXTotal bilirubin =<1.5 X institutional ULN (or =< 3 X institutional ULN for patients with documented Gilberts syndrome) (unless dysfunction is secondary to lymphoma involvement)Xx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN (performed within 10 days of treatment initiation)Xx_NEWLINE_xXWithin 14 days of the first dose of study drug: Total bilirubin =< 1.5 mg/dlXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN (In the expansion cohort, subjects with Gilbert’s syndrome [hereditary indirect hyperbilirubinemia] who must have a total bilirubin of =< 3 x ULN).Xx_NEWLINE_xXPerformed within 10 days of treatment initiation: Serum total bilirubin =< 1.5 X ULNXx_NEWLINE_xXREP ELIGIBILITY: Total bilirubin less than or equal to 2.0 mg/dL, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dLXx_NEWLINE_xXCHEMOTHERAPY/CELL INFUSION ELIGIBILITY: Total bilirubin less than or equal to 2.0 mg/dL, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dLXx_NEWLINE_xXWithin 7 days before the first dose of study treatment: Bilirubin =< 1.5 x the upper limit of normal (ULN); for subjects with known Gilbert’s disease, bilirubin =< 3.0 mg/dLXx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXSerum total bilirubin =< 1.5 X upper limit of normal (ULN) OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXSerum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 10 days of treatment initiationXx_NEWLINE_xXSerum total bilirubin =< 3 mg/dL (performed within 14 days of treatment initiation)Xx_NEWLINE_xXSerum bilirubin > 1.5 x ULN; patients with known Gilbert’s disease who have a serum bilirubin level =< 3 x ULN may be enrolledXx_NEWLINE_xXObtained =< 14 days prior to registration: Total bilirubin =< 1.5 x the upper limit of the normal range (ULN) or if total bilirubin is > 1.5 x ULN, the direct bilirubin must be =< 2.0 mg/dLXx_NEWLINE_xXPatients with bilirubin levels > 2 mg/dLXx_NEWLINE_xXBilirubin =< 1.5 x ULN (unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin)Xx_NEWLINE_xXObtained =< 28 days prior to registration: Total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for patients with total bilirubin levels > 1.5 x ULNXx_NEWLINE_xXTotal bilirubin within normal institutional limits except in patients with Gilbert’s syndrome who must have a total bilirubin < 3.0 mg/dLXx_NEWLINE_xXPerformed within 7 days of treatment initiation: Total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXTotal bilirubin =< to 1.5 mg/dL, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dLXx_NEWLINE_xXTotal bilirubin < 2.0 mg/dL (? 3.0 mg/dL for patients with known Gilbert's syndrome)Xx_NEWLINE_xXPerformed within 14 days of treatment initiation: Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin >= 1.5 ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dL within 30 days of registrationXx_NEWLINE_xXTotal bilirubin: =< 3 x upper limit of normal (ULN) for age OR direct bilirubin =< 2 mg/dlXx_NEWLINE_xXTotal bilirubin ?1.5 times the ULN, or direct bilirubin <ULN for patients with total bilirubin levels >1.5xULN;Xx_NEWLINE_xXTotal bilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal serum bilirubin =< 1.5 ULNXx_NEWLINE_xXSerum bilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin (except patients with Gilbert’s Syndrome, who are eligible for the study but exempt from the total bilirubin eligibility criterion) =< 2.0 mg/dl within 14 days prior to Step 2 registration andXx_NEWLINE_xXBilirubin =< 1.5 mg/dlXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin ? 1.5 x ULN (AST, ALT, and total bilirubin ? 3 × ULN in subjects with documented Gilbert’s syndrome or hyperbilirubinemia clearly attributed to lymphoma involvement of the liver)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) (except subjects with Gilbert syndrome who can have total bilirubin < 3.0 mg/dL)Xx_NEWLINE_xXBilirubin =< 1.5 x ULNXx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXTotal bilirubin ?1.5 × ULN except for unconjugated hyperbilirubinemia or Gilbert's syndromeXx_NEWLINE_xXTotal bilirubin (T bili) =< 1.5 mg/dL except for patients with Gilbert’s syndrome or hemolysisXx_NEWLINE_xXSerum total bilirubin =< 1.5 x ULN or =< 3 x ULN if patient has Gilberts disease OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 14 days of treatment initiationXx_NEWLINE_xXSerum total bilirubin =< 1.5 x ULN, performed within 10 days of treatment initiation OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN; for subjects with Gilbert’s disease =< 3 mg/dLXx_NEWLINE_xXPatients must have adequate organ and bone marrow function within 14 days prior to registration, as defined by: total bilirubin total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (except patients with Gilbert syndrome or liver metastasis, who can have total bilirubin =< 3.0 x ULN)Xx_NEWLINE_xXTotal serum bilirubin =< 1.5 mg/dlXx_NEWLINE_xXSerum bilirubin < 1.5 x ULNXx_NEWLINE_xXBilirubin =< 2 mg/dLXx_NEWLINE_xXSubjects with Gilbert’s syndrome, confirmed by genotyping or Invader UGTIA1 molecular assay prior to study entry, must have total bilirubin < 3.0 times ULNXx_NEWLINE_xXA total bilirubin =< 1.5 ULNXx_NEWLINE_xXBilirubin =< 1.5 x ULN (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)Xx_NEWLINE_xXTotal bilirubin =< 2.0 mg/dlXx_NEWLINE_xXSerum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXTotal bilirubin > or = 1.5 x ULN, unless due to Gilbert’s disease.Xx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN obtained =< 14 days prior to registrationXx_NEWLINE_xXbilirubin ? 1.5 x ULN;Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN), except patients with Gilbert's syndrome in whom total bilirubin must be < 3.0 mg/dL, within 2 weeks of registration (except where specified otherwise)Xx_NEWLINE_xXTotal bilirubin (Bili T) =< 1.5 x ULN (although patients with Gilbert syndrome can have total bilirubin < 3.0 mg/dL), within 30 days before study registrationXx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dlXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL) within 14 days prior to first doseXx_NEWLINE_xX(For both cohorts A and B): Total serum bilirubin =< 2.0 mg/dLXx_NEWLINE_xXSerum total bilirubin =< 1.5 x ULN (subjects with Gilbert syndrome can have a total bilirubin < 3 mg/dL), performed within 14 days of protocol registrationXx_NEWLINE_xXPerformed within 10 days of treatment initiation: Serum total bilirubin =< 2.0 x ULN (unless considered due to Gilbert’s disease or leukemia disease) or direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXTotal serum bilirubin =< 1.5 x ULN unless the patient has documented Gilbert syndrome. If organ function abnormalities are considered due to tumor, total serum bilirubin must be =< 2 x ULNXx_NEWLINE_xXSerum total bilirubin >= 1.5 x ULN OR direct bilirubin >= ULN for patients with total bilirubin levels > 1.5 x ULNXx_NEWLINE_xXBilirubin =< 5 x ULNXx_NEWLINE_xXBilirubin =< 1.5 x ULNXx_NEWLINE_xXHepatic impairment, defined as total bilirubin > 1.5 x institutional ULN (patients with benign hyperbilirubinemia [e.g., Gilbert’s syndrome] are eligible) orXx_NEWLINE_xXTotal serum bilirubin =< 1.5 x ULNXx_NEWLINE_xXSerum total bilirubin =< 1.5 x upper limit of normal (ULN) OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXBilirubin =< 1.6 mg/dL (except patients with Gilbert’s syndrome, who must have a total bilirubin less than 3.0 mg/dL) obtained < 4 weeks prior to starting treatmentXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN), except for patients with Gilbert’s syndrome who may be included if total bilirubin =< 3.0 x ULN or direct bilirubin =< 1.5 x ULNXx_NEWLINE_xXDirect bilirubin =< 2.0 mg/100 mlXx_NEWLINE_xXWithin 28 days prior to registration for protocol therapy: Serum total bilirubin => 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXTotal bilirubin ? 1.5x institutional ULNXx_NEWLINE_xXTotal bilirubin <1.5 x ULNXx_NEWLINE_xXPerformed within 10 days of treatment initiation: Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXObtained within 14 days of randomization: Total bilirubin =< 1.5 x ULN (except subjects with Gilbert Syndrome who must have total bilirubin < 3.0 mg/dL)Xx_NEWLINE_xXDirect bilirubin =< 2.0 mg/dLXx_NEWLINE_xXDetermined within 3 weeks of treatment initiation: Serum bilirubin =< 1.5 x upper limit of normal (ULN) OR direct bilirubin =< ULN for a subject with total bilirubin level > 1.5 x ULNXx_NEWLINE_xXbilirubin ? 1.5 × ULN* ° Subjects who are < 75 years of age may have bilirubin of ? 3.0 × ULNXx_NEWLINE_xXTotal bilirubin < 2 mg/dlXx_NEWLINE_xXTotal bilirubin =< 2 mg/dLXx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN; unless due to Gilbert’s disease or hemolysisXx_NEWLINE_xXTotal bilirubin =< 1.5 X ULN.Xx_NEWLINE_xXTotal bilirubin > 1.5 x ULN (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)Xx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN within 14 days of treatment initiationXx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXTotal bilirubin =< ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dL, except in subjects with Gilbert’s Syndrome in whom total bilirubin must be =< 3.0 mg/dLXx_NEWLINE_xXSerum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXTotal bilirubin less than or equal to 2.0 mg/dlXx_NEWLINE_xXBilirubin =< 1.5 x ULN (unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin)Xx_NEWLINE_xXSerum total bilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< 2.5 x ULN prior to biopsyXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) (except patients with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL)Xx_NEWLINE_xXTotal bilirubin < 2.0Xx_NEWLINE_xXSerum bilirubin =< 1.8Xx_NEWLINE_xXBilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< 2.5 mg/dl within 30 days of enrollment to studyXx_NEWLINE_xXWithin 10 days of treatment initiation: Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXTotal bilirubin: =< 1.5 X ULN (isolated bilirubin > 1.5 X ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%)Xx_NEWLINE_xXWithin 14 days prior to the first study treatment (cycle 1, day 1): Total bilirubin =< 1.5 x upper limit of normal (ULN) with the following exception:\r\n* Patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled\r\n* Direct bilirubin =< ULN for patients with total bilirubin levels > 1.5 x ULNXx_NEWLINE_xXFULL STUDY INCLUSION CRITERIA: Total bilirubin =< 1.5 x the upper limit of normal (ULN); documented Gilbert syndrome is allowed if total bilirubin is mildly elevated (< 6 mg/dL)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)Xx_NEWLINE_xXBilirubin =< 1.5 mg/dLXx_NEWLINE_xXTotal bilirubin ? 1.5 mg/dlXx_NEWLINE_xXTotal bilirubin ? 1.5 x the upper limit of normal (ULN), unless suspected to have Gilbert's disease. For newly diagnosed AML patients < 75 years of age, total bilirubin ? 3 x ULN; for ? 75 years of age, total bilirubin ? 1.5 x ULN.Xx_NEWLINE_xXDirect bilirubin ? 2.0 × the upper limit of laboratory normal (ULN). (NOTE: direct bilirubin will only be determined if total bilirubin is ? 2.0 × ULN)Xx_NEWLINE_xXWithin 14 days of treatment initiation: Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXTotal bilirubin =< 2.0 mg/dL\r\n* If Gilbert's disease is suspected and total bilirubin > 2.0 mg/dL, direct bilirubin must be =< 2.0 mg/dLXx_NEWLINE_xXSerum total bilirubin =< 1.5 X institutional ULN OR direct bilirubin =< institutional ULN for subjects with total bilirubin levels > 1.5 institutional ULN, performed within 14 days of registrationXx_NEWLINE_xXTotal bilirubin ? 1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN; (in patients with well documented Gilbert’s syndrome, total bilirubin =< 3 x ULN with direct bilirubin within normal range)Xx_NEWLINE_xXTotal bilirubin < 1.5 x ULNXx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dLXx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dl within 14 days prior to study entryXx_NEWLINE_xXWithin 14 days prior to planned start of treatment: Total serum bilirubin =< 2.2 mg/dLXx_NEWLINE_xXTotal bilirubin =< 1.5 X upper limit of normal (ULN) (or total bilirubin =< 3.0 X ULN with direct bilirubin =< 1.5 X ULN in patients with well-documented Gilbert’s syndrome) obtained =< 14 days prior to registrationXx_NEWLINE_xXPerformed within 10 days of treatment initiation: Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXTotal bilirubin < 2.0 mg/dl-exception permitted in patients with Gilbert’s syndromeXx_NEWLINE_xXTotal bilirubin ?1.5 x ULN (does not include patients with Gilbert's Disease)Xx_NEWLINE_xXBilirubin > 2 x ULNXx_NEWLINE_xXBilirubin < 2.5 mg/dL (unless due to Gilbert's disease)Xx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULNXx_NEWLINE_xXDirect bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXTotal bilirubin =< 2.5 x normal prior to biopsyXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN) (except patients with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL), within 14 days prior to treatmentXx_NEWLINE_xXTotal bilirubin =< 3 x ULN in patients with documented Gilbert’s syndrome (unconjugated hyperbilirubinemia) or in the presence of liver metastasesXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)Xx_NEWLINE_xXSerum total bilirubin =< 2.0 X ULN (performed within 28 days of registration)Xx_NEWLINE_xXSerum total bilirubin =< 1.5 x ULN or direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 x ULN performed within 10 days of treatment initiationXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN; subjects with Gilbert’s syndrome should have direct bilirubin within normal institutional limitsXx_NEWLINE_xXTotal bilirubin level ? 1.5 x ULN, except for patients with known Gilbert's syndrome (confirmed by the UGT1A1 polymorphism analysis), who are excluded if total bilirubin>3.0 x ULN or direct bilirubin > 1.5 x ULNXx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXDirect bilirubin =< 1.5 x ULN except for i) patients with documented Gilbert’s syndrome for whom any bilirubin value is allowed and ii) for patients with asymptomatic hyperbilirubinemia (liver transaminases and alkaline phosphatase within normal range)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN.Xx_NEWLINE_xXBilirubin =< 2.0 mg/dlXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL) or =< 2 x ULN if lenalidomide is being prescribed; should be obtained within 21 days prior to enrollmentXx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXSerum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXSerum bilirubin =< 1.5 x institutional ULNXx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN or direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN (within 10-15 days of treatment initiation)Xx_NEWLINE_xXTotal bilirubin =< ULN for the laboratoryXx_NEWLINE_xXSerum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for patients with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXTotal serum bilirubin =< 1.5 x ULN; for patients with well documented Gilbert’s syndrome, total bilirubin =< 3 x ULN with direct bilirubin within normal rangeXx_NEWLINE_xXTotal bilirubin >1.5 times ULN, except for patients with Gilbert's syndrome who are excluded if total bilirubin >3.0 x ULN or direct bilirubin >1.5 x ULNXx_NEWLINE_xXSerum total bilirubin =< 1.5 x ULN, within 14 days start of study startXx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN within 16 days of treatment initiationXx_NEWLINE_xXSerum total bilirubin =< 1.5 × upper limit of normal (ULN) (Note: In subjects with Gilbert’s syndrome, if total bilirubin is > 1.5 × ULN, measure direct and indirect bilirubin and if direct bilirubin is =< 1.5 × ULN, subject may be eligible)Xx_NEWLINE_xXTotal bilirubin < 1.5 X ULN, unless known diagnosis of Gilbert‘s syndrome, where bilirubin =< 5 mg/dl will be permitted; Gilbert’s syndrome will be defined as elevated unconjugated bilirubin, with conjugated (direct) bilirubin within the normal range and less than 20% of the total; total bilirubin will be permitted up to 5 mg/dl, if patients have historical readings consistent with the definition of Gilbert’s syndrome prior to entering studyXx_NEWLINE_xXTotal serum bilirubin =< 1.5 x ULN; or total bilirubin =< 3 x ULN with direct bilirubin within normal range in patients with well documented Gilbert’s syndromeXx_NEWLINE_xXBilirubin =< 1.5 x ULN (unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin, in which case the total bilirubin should be < 3 x ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dlXx_NEWLINE_xXTotal bilirubin less than or equal to 1.5 x ULNXx_NEWLINE_xXTotal serum bilirubin < ULN; or total bilirubin ? 3.0 × ULN with direct bilirubin within normal range in patients with well-documented Gilbert's SyndromeXx_NEWLINE_xXTotal bilirubin =< 2 mg/dL, or direct bilirubin =< ULN for those with total bilirubin > 2 x ULN performed within 7 days of treatment initiationXx_NEWLINE_xXSubjects with total bilirubin > 2.0 mg/dL at day 1 are not eligible for enrollmentXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULNXx_NEWLINE_xXSerum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, during screening and on cycle 1, day 1Xx_NEWLINE_xXTotal bilirubin < 1.5 mg/dL (or =< 3.0 mg/dL in patients with Gilbert syndrome)Xx_NEWLINE_xXBilirubin: =< 1.5 x ULN (except for subjects with Gilbert’s syndrome or of non-hepatic origin)Xx_NEWLINE_xXSerum bilirubin < 1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< 2.0 mg/dL unless due to known Gilbert’s disease obtained =< 14 days prior to registration\r\n* NOTE: If total bilirubin is > 2 mg/dL, a direct bilirubin should be performed and must be < 1.5 mg/dL for Gilbert’s to be diagnosedXx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN within 14 days of treatment initiationXx_NEWLINE_xXA bilirubin of up to 2.0 mg/dL, excluding patients with Gilbert's diseaseXx_NEWLINE_xXBilirubin ? 2.0 x ULN, (except patients with Gilbert's Syndrome, who must have a total bilirubin less than 3.0 mg/dL)Xx_NEWLINE_xXEXCEPTIONS:\r\n* Total bilirubin >= 5 mg/dL in patients with Gilbert's syndrome as defined by > 80% unconjugated\r\n* Total bilirubin >= 7.5 with direct fraction > 0.7 if patient is receiving a protease inhibitor at the time of initial evaluation\r\n* Hepatic dysfunction attributed to lymphoma, KSHV-MCD, or KICSXx_NEWLINE_xXTotal Bilirubin =< 1.5 x ULN (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)Xx_NEWLINE_xXSerum total bilirubin =< ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > ULN (performed within 10 days of treatment initiation)Xx_NEWLINE_xXObtained within 14 days prior to registration; total bilirubin ? ULNXx_NEWLINE_xXTotal bilirubin > 1.5 x ULN (Patients with a history of Gilbert's syndrome may participate if total bilirubin is less than or equal to 1.5 x ULN and the AST/ALT and alkaline phosphatase meet the protocol-specified levels for eligibility)Xx_NEWLINE_xXBilirubin =< 1.5 x ULN (unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin)Xx_NEWLINE_xXTotal bilirubin > 5Xx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< 2 mg/dL, except for patient's with Gilbert's syndromeXx_NEWLINE_xXBilirubin =< 1.5 x ULN; for subjects with documented/suspected Gilbert’s disease, bilirubin =< 3 x ULNXx_NEWLINE_xXSerum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULNXx_NEWLINE_xXWithin 10 days of treatment initiation: Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 X ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dLXx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dLXx_NEWLINE_xXPHASE II: Total bilirubin =< 1.5 mg/dLXx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dL, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dLXx_NEWLINE_xXSerum total bilirubin: =< 1.5 X ULN OR direct bilirubin =< ULN for participants with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXTotal bilirubin less than or equal to 2 mg/dL (> 2 mg/dL permitted if the patient has evidence of Gilbert’s disease based upon prior bilirubin elevation or genetic testing)Xx_NEWLINE_xXAspartate aminotransferase (AST) or alanine aminotransferase (ALT) >= 2.5 x ULN; Note: in subjects with Gilbert’s syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is =< 1.5 x ULN, subject may be eligibleXx_NEWLINE_xXTotal serum bilirubin =< 2.0 x ULN (except if Gilbert’s disease)Xx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dL x upper limit of normal (ULN) (except subjects with Gilbert syndrome who can have total bilirubin =< 3.0 mg/dL)Xx_NEWLINE_xXBilirubin =< 1.0 x ULN (exceptions for Gilbert’s syndrome)Xx_NEWLINE_xXCompleted within 10 days of SBRT treatment initiation: Serum total bilirubin =< 1.5 X ULN ORXx_NEWLINE_xXCompleted within 10 days of SBRT treatment initiation: Direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXBilirubin =< 2 X ULN (3 X if known history of Gilbert's syndrome)Xx_NEWLINE_xXTotal bilirubin =< to 1.5 mg/dL, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dLXx_NEWLINE_xXTotal serum bilirubin =< 1.5 x upper limit of normal (ULN) OR direct bilirubin =< ULN if total bilirubin levels > 1.5 x ULNXx_NEWLINE_xXTotal bilirubin is less than or equal to ULN, except the case in which the elevated total bilirubin is not a sign of liver disease, such as the Gilbert Syndrome, in which case a total bilirubin less than or equal to 2 x ULN is acceptableXx_NEWLINE_xXTotal bilirubin ? 2 × ULNXx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXSerum total bilirubin =< 1.5 x ULN or direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN within 14 days of treatment initiationXx_NEWLINE_xXBilirubin =< 2 x ULN (except subjects with Gilbert’s syndrome, who must have total bilirubin < 3.0 mg/dL)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) except subjects with documented Gilbert’s syndrome (> 3 x ULN), who must have a baseline total bilirubin =< 3.0 mg/dLXx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN within 14 days prior to registrationXx_NEWLINE_xXSerum bilirubin < 3 x ULNXx_NEWLINE_xXBilirubin =< 1.5 mg/dL (excluding Gilbert’s syndrome)Xx_NEWLINE_xXWithin 14 days prior to registration: Total bilirubin =< 1.5 x ULN (except in patients with Gilbert’s disease)Xx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dL, unless hyperbilirubinemia is attributable solely to Gilbert’s syndromeXx_NEWLINE_xXBilirubin > 1.5 x upper limit of normal (ULN), except for patients with known Gilbert syndrome who are excluded if total bilirubin > 3.0 x ULN or direct bilirubin > 1.5 x ULNXx_NEWLINE_xXTotal bilirubin < 2 mg/dlXx_NEWLINE_xXPART 2 GROUP 1 INCLUSION CRITERIA: Total serum bilirubin (sum of conjugated + unconjugated) =< 1.5x upper limit of normal (ULN), except for subjects with Gilbert’s Syndrome who may be included if total bilirubin is =< 3.0 x ULN and direct bilirubin is =< 1.5 x ULNXx_NEWLINE_xXPART 2 GROUP 2A INCLUSION CRITERIA: Total serum bilirubin (sum of conjugated + unconjugated) =< 1.5x ULN, except for subjects with Gilbert’s Syndrome who may be included if total bilirubin is =< 3.0 x ULN and direct bilirubin is =< 1.5 x ULNXx_NEWLINE_xXPART 2 GROUP 3 INCLUSION CRITERIA: Total serum bilirubin (sum of conjugated + unconjugated) =< 1.5x ULN, except for subjects with Gilbert’s Syndrome who may be included if total bilirubin is =< 3.0 x ULN and direct bilirubin is =< 1.5 x ULNXx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXTotal bilirubin =< 2 x ULN (except patients with documented Gilbert’s syndrome)Xx_NEWLINE_xXTotal bilirubin =< to 1.5 mg/dl, except in patients with Gilbert’s Syndrome who must have a total bilirubin less than 3.0 mg/dlXx_NEWLINE_xXTotal serum bilirubin levels < 1.5 x ULN (note: in subjects with Gilbert’s syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is =< 1.5 x ULN, subject may be eligible)Xx_NEWLINE_xXPHASE II SCLC: Total bilirubin =< 1.5 x ULN (unless Gilbert’s disease)Xx_NEWLINE_xXUROTHELIAL CARCINOMA EXPANSION COHORT: Total bilirubin =< 1.5 x ULN (=< 3 x ULN for subjects with Gilbert’s disease)Xx_NEWLINE_xXmCRPC EXPANSION COHORT: Total bilirubin =< 1.5 x ULN (=< 3 x ULN for subjects with Gilbert’s disease)Xx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 10 days of treatment initiationXx_NEWLINE_xXTotal bilirubin ? 1 x ULN (unless elevated due to Gilbert's syndrome or extrahepatic source as denoted by increased indirect bilirubin fraction. Subjects with ?1 x ULN will be tested for direct bilirubin fraction so that the indirect fraction can be calculated).Xx_NEWLINE_xXTotal bilirubin =< 1.5 X ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN, except for patients with Gilbert’s syndrome who may be included if total bilirubin =< 3.0 x ULN and direct bilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) or =< 3 x ULN for patients with Gilbert’s disease (in patients [pts] with elevated total bilirubin due to increased indirect bilirubin, pts with direct bilirubin =< 1.5 x ULN are eligible)Xx_NEWLINE_xXBilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin < 1.5 X institutional normal limits (subjects with known Gilbert syndrome are eligible with total bilirubin < 3.0 mg/dL)Xx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXTotal bilirubin =< 3 mg/dL unless due to Gilbert’s syndrome, hemolysis, or ineffective hematopoiesisXx_NEWLINE_xXDirect bilirubin >= 2.0 mg/dL not related to hemolysis or Gilbert’s diseaseXx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dL (25.65 umol/L)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN), except for patients with Gilbert’s syndrome or documented hepatic involvement with lymphoma who may be included if bilirubin =< 3.0 x ULN or direct bilirubin =< 1.5 x ULNXx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXSerum bilirubin =< 1.5 x ULNXx_NEWLINE_xXSerum total bilirubin =< 1.5 x upper limit of normal (ULN) (note: in subjects with Gilbert’s syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is =< 1.5 x ULN, subject may be eligible)Xx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXBilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dLXx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN or direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN (except for subjects with Gilbert Syndrome, who may have total bilirubin < 3.0 mg/dl) or direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 X ULNXx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULNXx_NEWLINE_xXBilirubin > 3.0 mg/dLXx_NEWLINE_xXTotal bilirubin less than or equal to 2.0 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dlXx_NEWLINE_xXPerformed 28 days prior to study registration up to the first dose of study drug: serum total bilirubin =< 1.5 X ULN (except for subjects with Gilbert syndrome, who may have total bilirubin < 3.0 mg/dl) or direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN, except subjects with Gilbert’s syndrome or liver metastases, who must have a baseline total bilirubin =< 3.0 mg/dLXx_NEWLINE_xXTotal serum bilirubin ? 1.5 x ULN (? 3.0 x ULN if Gilbert’s disease)Xx_NEWLINE_xXWithin 10 days of treatment initiation: Serum total bilirubin =< 1.5 X ULN (=< 3 X ULN if Gilbert’s syndrome) OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 10 days of treatment initiationXx_NEWLINE_xXBilirubin < 1.5 mg/dL (except for Gilbert’s syndrome which will allow bilirubin =< 2.0 mg/dL)Xx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN (within 28 days of treatment initiation)Xx_NEWLINE_xXTotal bilirubin =< 2.0 mg/dL (unless previously diagnosed with Gilbert’s syndrome)Xx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dL (except Gilbert’s syndrome or known hemolysis or leukemic infiltration) obtained =< 7 days prior to registrationXx_NEWLINE_xXTotal bilirubin above 2.5 ULN in the absence of hemolysis or diagnosis of Gilbert’s syndromeXx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dlXx_NEWLINE_xXPerformed within 14 days (+3 working days) of treatment initiation: Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXTotal bilirubin =< 2 mg/dL (unless directly attributable to lymphoma)Xx_NEWLINE_xXTotal bilirubin less than or equal to 2.0 mg/dlXx_NEWLINE_xXTotal bilirubin =< 1.5 upper limit of normal unless the patient is receiving a protease inhibitor known to be associated with increased bilirubin (e.g. atazanavir), in which case total bilirubin =< 7.5 mg/dL with direct fraction =< 0.7Xx_NEWLINE_xXTotal bilirubin > 2 X upper limit of normal (ULN) , or direct bilirubin > 2.0 mg/dL (except patients with Gilbert’s syndrome, then total bilirubin greater than 2 X ULN allowed in the absence of other hepatic signs or symptoms)Xx_NEWLINE_xXTotal serum bilirubin ? 1.5 x ULNXx_NEWLINE_xXBilirubin less than or equal to 2.0 mg/dlXx_NEWLINE_xXSerum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXBilirubin =< 1.5 x ULNXx_NEWLINE_xXBilirubin less than or equal to 1.5 mg/dl (unless due to Gilbert’s syndrome)Xx_NEWLINE_xXObtained =< 14 days prior to registration: Total bilirubin =< 1.5 mg/dL or direct bilirubin =< 1.0 mg/dL for patients with Gilbert’s syndromeXx_NEWLINE_xXSerum total bilirubin =< 1.5 mg/dLXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN; subjects with Gilbert’s syndrome should have direct bilirubin within normal institutional limitsXx_NEWLINE_xXbilirubin ? 1.5 x ULNXx_NEWLINE_xXTotal bilirubin < 2.0 mg/dl with the exception of patients with Gilbert syndrome; patients with Gilbert syndrome may be included if their total bilirubin is >= 3.0 x upper limit of normal (ULN) and direct bilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN except in patients with documented Gilbert’s syndrome or liver metastasis, who must have a baseline total bilirubin =< 3.0 mg/dlXx_NEWLINE_xXSerum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXTotal bilirubin =< to 1.5 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dlXx_NEWLINE_xXTotal bilirubin =< 1.5 × ULN and < 2 mg/dl\r\n* Note: patients who have a total bilirubin level > 1.5 × ULN will be allowed if their indirect bilirubin level is =< 1.5 × ULNXx_NEWLINE_xXDirect bilirubin < 1.5 mg/dl, unless due to Gilbert’s or secondary to hemolysisXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN; except subjects with Gilbert syndrome who can have total bilirubin < 3.0 mg/dL) obtained within 14 days of first treatmentXx_NEWLINE_xXPerformed within 14 days of treatment initiation: Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXTotal bilirubin > 1.5 x ULN, except for patients with Gilbert's syndrome who are excluded if total bilirubin > 3.0 x ULN or direct bilirubin > 1.5 x ULN.Xx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL) obtained within 14 days prior to randomization/registrationXx_NEWLINE_xXTotal bilirubin < ULN; or total bilirubin =< 3.0 x ULN or direct bilirubin =< 1.5 x ULN in patients with well documented Gilbert’s syndromeXx_NEWLINE_xXTotal bilirubin levels =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN) (except patients with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x ULNXx_NEWLINE_xXBilirubin =< 2 x ULNXx_NEWLINE_xXDirect bilirubin =< 2.0 mg/dlXx_NEWLINE_xXCAPMATINIB INCLUSION CRITERIA: Total bilirubin =< 1.5 x upper limit of normal (ULN); patients with Gilbert’s syndrome may be included if total bilirubin =< 3 x ULN or direct bilirubin =< 1.5 x ULNXx_NEWLINE_xXCERITINIB INCLUSION CRITERIA: Total bilirubin =< 1.5 x upper limit of normal (ULN); patients with Gilbert’s syndrome may be included if total bilirubin =< 3 x ULN and direct bilirubin =< 1.5 x ULNXx_NEWLINE_xXREGORAFENIB INCLUSION CRITERIA: Total bilirubin =< 1.5 x upper limit of normal (ULN); patients with Gilbert’s syndrome may be included if total bilirubin =< 3 x ULN or direct bilirubin =< 1.5 x ULNXx_NEWLINE_xXENTRECTINIB INCLUSION CRITERIA: Total bilirubin =< 1.5 x upper limit of normal (ULN); patients with Gilbert’s syndrome may be included if total bilirubin =< 3 x ULN or direct bilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin >= 2 x ULNXx_NEWLINE_xXTotal or direct bilirubin =< 1.5 mg/dLXx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXBilirubin =< 1.5 x ULN unless known to have Gilbert’s syndrome or elevated bilirubin resulting from hemolysisXx_NEWLINE_xXTotal serum bilirubin =< 1.5 x upper limit of normal (ULN) (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)Xx_NEWLINE_xXPHASE I: Bilirubin < 1.5 x ULNXx_NEWLINE_xXPHASE II: Bilirubin < 1.5 x ULNXx_NEWLINE_xXSerum bilirubin =< 1.8Xx_NEWLINE_xXWithin 14 days prior to registration: Total bilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin < 1.5 mg/dL.Xx_NEWLINE_xXTotal bilirubin =< 2.0 mg/dl (except for patients in whom hyperbilirubinemia is attributed to Gilbert’s syndrome)Xx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXTotal bilirubin =< 1.6 mg/dLXx_NEWLINE_xXSerum bilirubin =< 1.5 x ULNXx_NEWLINE_xXSerum bilirubin =< 2.0 x ULNXx_NEWLINE_xXSerum bilirubin less than or equal to 1.5 x ULNXx_NEWLINE_xXBilirubin =< 1.5 x ULN (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)Xx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dL (25.65 mol/L)Xx_NEWLINE_xXTotal bilirubin > 2 x institutional ULN (except for known Gilbert’s syndrome/familial non-hemolytic jaundice)Xx_NEWLINE_xXBilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN), except for patients with Gilbert’s syndrome who may be included if total bilirubin =< 3.0 x ULN or direct bilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 X normal institutional limits (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)Xx_NEWLINE_xXTotal bilirubin ? 1.5 x ULN for age, direct bilirubin ? ULN for ageXx_NEWLINE_xXBilirubin =< 2.0 mg/dLXx_NEWLINE_xXSerum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXWithin 3 months of registration: Bilirubin =< 1.5 x upper limit of normal (ULN); in subjects with Gilbert’s syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin; if direct bilirubin is =< 1.5 x ULN, subject may be eligibleXx_NEWLINE_xXTotal serum bilirubin ?1.5 × ULN, unless due to Gilbert's syndromeXx_NEWLINE_xXTotal bilirubin ? 1.5 ULNXx_NEWLINE_xXBilirubin less than 1.5 x ULN (CTCAE Grade 1)Xx_NEWLINE_xXTotal bilirubin concentration < 1.5 x the ULNXx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN (patients who do not meet this criteria must have a direct\r\nbilirubin =< 1.5 X ULN)Xx_NEWLINE_xXWithin 14 days prior to study entry: Bilirubin =< 1.5 x upper limit of normal (ULN); except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dLXx_NEWLINE_xXTotal bilirubin =< 1.5 X ULNXx_NEWLINE_xXTotal bilirubin < 1.5 x ULNXx_NEWLINE_xXTotal bilirubin < 3 mg/dLXx_NEWLINE_xXTotal bilirubin =< 2.0 mg/dLXx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN ORXx_NEWLINE_xXDirect bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXTotal bilirubin =< 2.5 x the institutional ULNXx_NEWLINE_xXARM A COHORT 1: Total bilirubin =< 1.5 x ULNXx_NEWLINE_xXARM B COHORT 3: Total bilirubin =< 1.5 x IULNXx_NEWLINE_xXARM C COHORT 4: Total bilirubin =< 2 X IULNXx_NEWLINE_xXDirect bilirubin > 2 x ULNXx_NEWLINE_xXTotal bilirubin =< 3.0 mg/dlXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic originXx_NEWLINE_xXTotal bilirubin =< 2.0 mg/dLXx_NEWLINE_xXPHASE II COLORECTAL CANCER COHORT 6 (MEDI+C ONLY):\r\nTotal bilirubin =< 1.5 X ULN; for subjects with documented/suspected Gilbert’s disease, bilirubin =< 3 X ULNXx_NEWLINE_xXBilirubin < 1.5 mg/dL, with the exception of patients thought to have Gilbert’s syndrome, who may have a total bilirubin above 1.5 mg/dLXx_NEWLINE_xXTotal bilirubin < 3 x IULNXx_NEWLINE_xXBilirubin (total) < 2.0 ml/dl within 14 days of study entryXx_NEWLINE_xXSerum bilirubin =< 2 x ULNXx_NEWLINE_xXTotal bilirubin ? 1.5 x ULN orXx_NEWLINE_xXDirect bilirubin ? ULN for subjects with total bilirubin levels > 1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN for the laboratory\r\n* Exception: if a patient has documented Gilbert’s syndrome and a total bilirubin is > 1.5 x ULN, the total bilirubin requirement may be waived provided the direct bilirubin is within normal limits (WNL) for the laboratoryXx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dl, unless increase is due to hemolysis or congenital disorderXx_NEWLINE_xXBilirubin less than or equal to 3.0 mg/dLXx_NEWLINE_xXTotal serum bilirubin =< 1.5 x ULN (in patients with known Gilbert syndrome, a total bilirubin =< 3.0 x ULN, with direct bilirubin =< 1.5 x ULN)Xx_NEWLINE_xXTotal serum bilirubin =< 2.0 mg/dLXx_NEWLINE_xXADDITIONAL CRITERIA FOR STUDY CONTINUATION: Total bilirubin =< 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin =< 2.0 x ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x the institutional ULNXx_NEWLINE_xXPerformed within 28 days prior to study registration up to the first dose of study drug: Serum total bilirubin =< 1.5 X ULN or direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXTotal bilirubin =< 2.5 mg/dLXx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXTotal bilirubin > 3 mg/dLXx_NEWLINE_xXTotal bilirubin < 2.0 mg/dLXx_NEWLINE_xXTotal bilirubin < 1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULNXx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN or direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 10 days of treatment initiationXx_NEWLINE_xXTotal serum bilirubin =< 1.5 x ULN (=< 3 x ULN for Gilbert’s syndrome)Xx_NEWLINE_xXSerum bilirubin =< 1.0 x ULNXx_NEWLINE_xXBilirubin =< 1.5 mg/dLXx_NEWLINE_xXFor Part A participants: total bilirubin concentration =< 2 x the institutional ULN for ageXx_NEWLINE_xXFor Part B participants: total bilirubin concentration =< 1.5 x the institutional ULN for ageXx_NEWLINE_xXBilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< 5.0 mg/dLXx_NEWLINE_xXBilirubin >= 1.5 mg/dLXx_NEWLINE_xXTotal bilirubin < 1.5 x ULN for ageXx_NEWLINE_xXBilirubin =< 2 x ULN (must be within 7 days of MLA)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dLXx_NEWLINE_xXSerum total bilirubin =< 1.5 x ULNXx_NEWLINE_xXPerformed within 10 days of treatment initiation; serum total bilirubin ? 1.5 X ULN or direct bilirubin ? ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXSerum total bilirubin less than 2.5 mg/dl; patients with elevations of serum total bilirubin up to 10 mg/dl may be considered for participation if such elevations are thought to be due to liver involvement by malignancy; however, in these latter patients, if the bilirubin (BR) level does not decrease to less than or equal to 2.5 mg/dl after induction chemotherapy, eligibility for the transplant (research) phase will be at the discretion of the PIXx_NEWLINE_xXHas total bilirubin < 1.5 mg/dL, serum albumin > 3.0 gm/dL, AST and ALT < 1.5 ULN or < 3 x ULN for subjects with known hepatic metastasesXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN for the laboratory at the time of enrollment, all forms of biliary stents allowedXx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dLXx_NEWLINE_xXPatients with Gilbert syndrome are excluded from the requirement of a normal bilirubin but they must have an indirect bilirubin of < 6 mg/dl, and a direct bilirubin of < 0.5 mg/dl in order to be eligible; (Gilbert syndrome is found in 3-10% of the general population and is characterized by mild, chronic hyperbilirubinemia in the absence of liver disease or overt hemolysis)Xx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXTotal bilirubin =< 2.5 mg% (unless from Gilbert’s disease or disease-related)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x ULNXx_NEWLINE_xXBilirubin less than or equal to 2 mg/dLXx_NEWLINE_xXTotal bilirubin < 1.5 mg/dlXx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXELIGIBILITY CRITERIA FOR T-CELL PRODUCT INFUSION: Total bilirubin: =< 3 x ULN for age OR conjugated bilirubin =< 2 mg/dLXx_NEWLINE_xXRETREATMENT WITH MODIFIED T CELLS: Total bilirubin: =< 3 x ULN for age OR conjugated bilirubin =< 2 mg/dLXx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXBilirubin =< 1.5 mg/dLXx_NEWLINE_xXTotal bilirubin =< 1.6 mg/dL prior to biopsyXx_NEWLINE_xXWithin 4 days prior to the first dose of cabozantinib: Bilirubin =< 1.5 x the upper limit of normal (ULN) (for subjects with known Gilbert’s disease, bilirubin =< 3.0 mg/dL)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x IULNXx_NEWLINE_xXTotal bilirubin =< 3 mg/dLXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN), except for patients with Gilbert’s syndrome who may be included if total bilirubin =< 3.0 x ULN or direct bilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin (T-Bil) =< 1.5 X ULN (prior diagnosis or past history consistent with Gilbert's syndrome is an exception)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)Xx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dL, unless increase is due to hemolysis or congenital disorderXx_NEWLINE_xXPART 2: Total serum bilirubin must be < 3 mg/dL unless the elevation is thought to be due to Gilbert’s disease or hemolysisXx_NEWLINE_xXDirect bilirubin < 1 mg/dlXx_NEWLINE_xXBilirubin > 1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< 2.0 mg/dL; (does NOT apply to patients with Gilbert’s syndrome)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN (isolated bilirubin > 1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x ULNXx_NEWLINE_xXBilirubin =< 1.5 x ULN or =< 3 x ULN for subjects with documented/suspected Gilbert’s diseaseXx_NEWLINE_xXTotal bilirubin less or equal to 2 mg/dlXx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dl within 14 days of the first dose of study drugXx_NEWLINE_xXBilirubin < 1.5 mg/dLXx_NEWLINE_xXTotal bilirubin =< 3Xx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic originXx_NEWLINE_xXBilirubin =< 1.5 x ULNXx_NEWLINE_xXWithin 2 weeks of enrollment: Bilirubin =< 2.0 mg/dlXx_NEWLINE_xXTotal bilirubin =< 1.5 x IULNXx_NEWLINE_xXTotal bilirubin =< 2.0 mg/dlXx_NEWLINE_xXbilirubin ? 1.5 x ULNXx_NEWLINE_xXBilirubin =< 2.5 mg/dLXx_NEWLINE_xXTotal bilirubin less than or equal to 1.5 x normal for ageXx_NEWLINE_xXTotal bilirubin >= 1.5 mg/dL and not related to hemolysis or Gilbert's disease; patients with total bilirubin >= 1.5 mg/dL to 3 mg/dL are eligible if at least 75% of the bilirubin is indirectXx_NEWLINE_xXTotal bilirubin =< 2 mg/dLXx_NEWLINE_xXWithin 30 days of first vaccination: Total bilirubin =< 1.5 mg/dlXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< to 1.5 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dlXx_NEWLINE_xXTotal bilirubin =< 2.0 mg/dLXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< 3.0Xx_NEWLINE_xXTotal bilirubin < 3.0 mg/dl (if total bilirubin is >= 3.0 patient is eligible if direct bilirubin is within normal limits)Xx_NEWLINE_xXTotal bilirubin =< 2.5 mg/dLXx_NEWLINE_xXBilirubin (Gilbert's Disease) =< 3.0 mg/dLXx_NEWLINE_xXTotal bilirubin ? 3.0 mg/dLXx_NEWLINE_xXBilirubin =< 2 mg/dLXx_NEWLINE_xXTotal serum bilirubin > 1.5 mg/dlXx_NEWLINE_xXSerum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for patients with total bilirubin level 1.5 ULNXx_NEWLINE_xXTotal bilirubin =< to 1.5 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dlXx_NEWLINE_xXTotal bilirubin =< 2.0 mg/dL (=< 3.0 mg/dL for patients with known Gilbert’s syndrome), unless these are thought to be due to AMLXx_NEWLINE_xXTotal bilirubin =< 2 mg/dLXx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXBilirubin =< 1.5 mg/dLXx_NEWLINE_xXBilirubin =< 1.5 X ULNXx_NEWLINE_xXTotal serum bilirubin =< 1.5 mg/dl (patients with total bilirubin > 1.5 mg/dL eligible only with Gilbert’s syndrome)Xx_NEWLINE_xXDirect bilirubin =< 2.0 mg/dlXx_NEWLINE_xXTotal serum bilirubin =< 2.0 mg/dLXx_NEWLINE_xXTotal bilirubin < 2 mg/dLXx_NEWLINE_xXSerum bilirubin > 2.0 mg/dl that is not due to Gilbert’s syndrome or hemolysisXx_NEWLINE_xXSerum direct bilirubin =< 2 mg/dL (34 umol/L)Xx_NEWLINE_xXBilirubin =< 2.0 x ULN, (except patients with Gilbert’s Syndrome, who must have a total bilirubin less than 3.0 mg/dL)Xx_NEWLINE_xXTotal bilirubin > 1.5 x ULN (or > 3 x ULN for patients with documented Gilbert syndrome)Xx_NEWLINE_xXSerum bilirubin =< 2.0 g/dLXx_NEWLINE_xXTotal bilirubin >= 1.5 x ULN (subjects with Gilbert's syndrome can have bilirubin of up to 1.5 x ULN), ORXx_NEWLINE_xXTotal bilirubin =< ULNXx_NEWLINE_xXBilirubin =< 1.5 mg/dLXx_NEWLINE_xXTotal bilirubin =< 2.0 mg/dLXx_NEWLINE_xXTotal bilirubin =< to 1.5 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dlXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN (patient with diagnosed Gilbert’s syndrome and normal direct bilirubin will be allowed)Xx_NEWLINE_xXTotal serum bilirubin > 1.5 mg/dlXx_NEWLINE_xXTotal bilirubin less than or equal to 2.0 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dl (Turnstile II)Xx_NEWLINE_xXTotal bilirubin > 1.5×ULNXx_NEWLINE_xXDirect bilirubin < 1.6 (unless related to Gilbert’s disease or medications)Xx_NEWLINE_xXTotal bilirubin < 2 mg/dLXx_NEWLINE_xXBilirubin equal or less than 1.5 mg/dl except for Gilbert’s diseaseXx_NEWLINE_xXTotal bilirubin =< 2 mg/dlXx_NEWLINE_xXTotal bilirubin =< 2 mg/dlXx_NEWLINE_xXTotal bilirubin =< 2 mg/dLXx_NEWLINE_xXSerum bilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal or direct bilirubin =< 1.5 mg/dL (if not due to the leukemia itself or known Gilbert’s syndrome) (as documented by treating physician)Xx_NEWLINE_xXBilirubin > 3.0 mg/dLXx_NEWLINE_xXTotal serum bilirubin > 2 mg/dLXx_NEWLINE_xXTotal bilirubin =< 2.0 mg/dlXx_NEWLINE_xXBilirubin =< 1.5 mg/dl (unless Gilbert's syndrome)Xx_NEWLINE_xXBilirubin =< 2.0 mg/dlXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN for the laboratory (total bilirubin criteria may be waived if a patient has documented Gilbert’s disease)Xx_NEWLINE_xXTotal bilirubin =< 3.0Xx_NEWLINE_xXBilirubin =< 3.0 mg/dLXx_NEWLINE_xXDirect bilirubin of =< 2 mg/dLXx_NEWLINE_xXTotal bilirubin of < 2 mg/dl unless due to hemolysis, leukemia organ infiltration, or Gilbert’s syndromeXx_NEWLINE_xXSerum bilirubin =< 1.8Xx_NEWLINE_xXSerum bilirubin < ULN (exception of Gilbert disease)Xx_NEWLINE_xXTotal bilirubin < 2.0 mg/dl, unless a diagnosis of Gilbert’s diseaseXx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dLXx_NEWLINE_xXTotal bilirubin less than or equal to 2.0 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dl (Turnstile II)Xx_NEWLINE_xXTotal bilirubin =< 2 x ULN (except patients with documented Gilbert's syndrome)Xx_NEWLINE_xXSerum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for patients with total bilirubin levels > 1.5 x ULNXx_NEWLINE_xXBilirubin < 2 mg/dLXx_NEWLINE_xXTotal bilirubin less than or equal to 1.5Xx_NEWLINE_xXBilirubin =< 1.5 x ULN, (except patients with Gilbert’s syndrome, who must have a total bilirubin less than 3.0 mg/dL)Xx_NEWLINE_xXTotal bilirubin less than or equal to 3.0Xx_NEWLINE_xXSerum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for patients with total bilirubin levels > 1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< 3.0Xx_NEWLINE_xXTotal bilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< 2 X ULN (exceptions may apply to benign non-malignant indirect hyperbilirubinemia such as Gilbert syndrome)Xx_NEWLINE_xXTotal bilirubin =< 2 mg/dLXx_NEWLINE_xXBilirubin =< 2 mg/dLXx_NEWLINE_xXTotal bilirubin > 2.0 mg/dlXx_NEWLINE_xXTotal bilirubin < 2.5 x the institutional ULNXx_NEWLINE_xXBilirubin =< 1.5 x upper limit of normal unless the patient is receiving protease inhibitor therapy (e.g. indinavir, ritonavir, nelfinavir, or atazanavir) known to be associated with increased bilirubin, in which case total bilirubin =< 7.5 mg/dL with direct fraction =< 0.7 mg/dLXx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dl, except in patients with Gilbert’s syndrome, who must have a total bilirubin =< 3.0 mg/dlXx_NEWLINE_xXBilirubin < 1.5 mg/dL with the exception of patients thought to have Gilbert’s syndrome, who may have a total bilirubin above 1.5 mg/dLXx_NEWLINE_xXTotal bilirubin =< 2.5 x the institutional ULN, measured prior to conditioning chemotherapyXx_NEWLINE_xXSerum total bilirubin =< 1.5 x institutional ULN (Note: In subjects with Gilbert’s syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is =< 1.5 x ULN, subject may be eligible)Xx_NEWLINE_xXTotal serum bilirubin >2.5 × upper limit of normal (ULN; except for subjects with Gilbert's Syndrome for whom direct bilirubin is <2.5 × ULN), or liver cirrhosis, or chronic liver disease Child-Pugh Class B or C.Xx_NEWLINE_xXBilirubin =< 1.5 mg/dLXx_NEWLINE_xXTotal bilirubin > 1.5 x ULN, except for patients with Gilbert's syndrome who are excluded if total bilirubin > 3.0 x ULN or direct bilirubin > 1.5 x ULNXx_NEWLINE_xXHave a total bilirubin level ?2.0 mg/dL (unless secondary to Gilbert syndrome, hemolysis, or leukemia)Xx_NEWLINE_xXBilirubin =< 1.5 x institutional ULN (unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin)Xx_NEWLINE_xXBilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin >= 2.0 mg/dl in the absence of a history of Gilbert's diseaseXx_NEWLINE_xXBilirubin < 1.5 mg/dlXx_NEWLINE_xXSerum bilirubin =< 1.8Xx_NEWLINE_xXBilirubin =< 1.95 mg/dLXx_NEWLINE_xXTotal serum bilirubin > 1.5 mg/dlXx_NEWLINE_xXTotal bilirubin < 3 mg/dlXx_NEWLINE_xXSerum bilirubin =< 1.8Xx_NEWLINE_xXBilirubin =< 3.0 mg/dL (unless due to Gilbert’s syndrome or hemolysis)Xx_NEWLINE_xXSerum total bilirubin < 2.5 mg/dlXx_NEWLINE_xXBilirubin =< 2.0 mg/dl, unless known Gilbert's syndromeXx_NEWLINE_xXSerum total bilirubin > 2.5 mg/dl; if the abnormal liver function is attributable to liver involvement by malignancy, patients may be eligible with serum total bilirubin up to 5.0 mg/dl, provided the patient has no evidence of impending hepatic failure (encephalopathy or prothrombin time > 2 times the upper limit of normal)Xx_NEWLINE_xXPatients must have bilirubin =< 1.5 mg/dlXx_NEWLINE_xXBilirubin =< 2 unless consistent with Gilbert’s (total/direct > 5)Xx_NEWLINE_xXTotal serum bilirubin > 1.5 mg/dlXx_NEWLINE_xXBilirubin =< 2.5 mg/dLXx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dL or direct bilirubin =< 1.0 mg/dL for patients with Gilberts syndromeXx_NEWLINE_xXSerum bilirubin =< 2.0Xx_NEWLINE_xXTotal bilirubin =< 2.0 x ULN for ageXx_NEWLINE_xXTotal bilirubin =< 2 mg/dL unless hemolysis or Gilbert’s diseaseXx_NEWLINE_xXBilirubin < 1.5 mg/dLXx_NEWLINE_xXHepatic Parameters: Total Bilirubin </= ULN; Alkaline Phosphatase </= 2 x ULN; AST and ALT </= 2 x ULN If the patient has a history of Gilbert's Syndrome, check direct and indirect bilirubin. If in the judgment of the attending medical oncologist it is safe to treat the patient, the patient will be considered eligible for this criteria.Xx_NEWLINE_xXTotal bilirubin =< 2x normalXx_NEWLINE_xXThe total serum bilirubin =< 2.5 mg/dLXx_NEWLINE_xXSerum bilirubin > 3.0 mg/dl\r\n* In some cases where there is an elevated bilirubin, and the tumor may be isolated from a vascular standpoint, treatment may proceedXx_NEWLINE_xXSerum bilirubin > 3.0 mg/dl; * In some cases where there is an elevated bilirubin, and the tumor may be isolated from a vascular standpoint, treatment may proceedXx_NEWLINE_xXDirect bilirubin >= 3.1 mg/dlXx_NEWLINE_xXBilirubin =< 2.0 mg/100 mlXx_NEWLINE_xXTotal bilirubin =< 2.0 mg/dlXx_NEWLINE_xXTotal bilirubin =< 2.0 mg/dlXx_NEWLINE_xXTotal bilirubin less than or equal to 2.0 mg/dl, except in patients with Gilbert's syndrome who must have a total bilirubin less than 3.0 mg/dl (Turnstile II - Chemotherapy/Cell Infusion - Inclusion Criteria)Xx_NEWLINE_xXBilirubin < 2.0Xx_NEWLINE_xXBilirubin < 2.0 mg/dl, or total bilirubin =< 4.5 mg/dl with direct fraction =< 0.3 mg/dl in patients for whom these abnormalities are felt to be due to protease inhibitor therapyXx_NEWLINE_xXBilirubin < 1.5 mg/dlXx_NEWLINE_xXTotal serum bilirubin?1.5 x ULN, (except for patients with known Gilbert's Syndrome?3 x ULN is permitted)Xx_NEWLINE_xXSerum total bilirubin ? 1.5 X ULN OR direct bilirubin ? ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXTotal bilirubin < 3 x ULN (except if confirmed history of Gilbert's disease)Xx_NEWLINE_xXSerum total bilirubin ? 1.5 x ULN OR o Direct bilirubin ? ULN for subjects with total bilirubin >1.5 x ULNXx_NEWLINE_xXtotal bilirubin ? 1.5 × ULN,Xx_NEWLINE_xXTotal bilirubin (<=) 2* ULN or direct bilirubin level (<=) 2.0* ULNXx_NEWLINE_xXSerum total bilirubin =< 1.2 X ULN OR in case of Gilbert’s disease an elevated total bilirubin is allowed if direct bilirubin is =< 40% of total, should be performed within 10 days of treatment initiationXx_NEWLINE_xXTotal serum bilirubin concentration >3.0 mg/dL UNLESS attributed to GvHDXx_NEWLINE_xXbilirubin < 1.5 ULN, excluding Gilbert's syndromeXx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXTotal bilirubin within normal institutional limits (patients with Gilbert's syndrome must have a total bilirubin < 3.0 mg/dL)Xx_NEWLINE_xXTotal bilirubin < 2.0 x ULNXx_NEWLINE_xXTotal bilirubin =< upper limit of normal (ULN) except in patients with Gilbert’s syndrome; patients with Gilbert’s syndrome may enroll if direct bilirubin =< 1.5 x ULN (repeat if more than 3 days before the first dose)Xx_NEWLINE_xXAlanine transaminase ALT >3x upper limit of normal (ULN) AND bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)Xx_NEWLINE_xXTotal bilirubin >1.5 mg/dLXx_NEWLINE_xXTotal bilirubin ?1.5 mg/dL.Xx_NEWLINE_xXSerum total bilirubin =< 1.5 X upper limit of normal (ULN) or direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXTotal bilirubin within the reference range during screening evaluationXx_NEWLINE_xXTotal bilirubin > 2 mg/dL, except for patients with Gilbert's syndrome who are excluded if total bilirubin > 3.0 x ULN or direct bilirubin > 1.5 x ULNXx_NEWLINE_xXTotal bilirubin ? 2 mg/dL (except in patients with Gilbert's Syndrome)Xx_NEWLINE_xXTotal bilirubin ? 2 mg/dL (except in patients with Gilbert's Syndrome)Xx_NEWLINE_xXBilirubin level < 1.5 x ULNXx_NEWLINE_xXTotal bilirubin ? 1.5 × (< 3 mg/dL for subjects with Gilbert's disease)Xx_NEWLINE_xXSerum total bilirubin <2.0 mg/dL (34 µmol/L)Xx_NEWLINE_xXTotal bilirubin ?2mg/dlXx_NEWLINE_xXTotal serum bilirubin ? 1.5 × ULN.Xx_NEWLINE_xXTotal bilirubin > ULN (except in patients diagnosed with Gilbert's disease).Xx_NEWLINE_xXTotal bilirubin =< 2.2 mg/dLXx_NEWLINE_xXTotal Bilirubin ? 1.0 x ULN (unless elevated secondary to benign conditions such as Gilbert's disease)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x the institutional ULNXx_NEWLINE_xXSerum bilirubin within normal range (or =< 1.5 x ULN if liver metastases are present; or total bilirubin =< 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert Syndrome)Xx_NEWLINE_xXTotal bilirubin must be less than 2 mg/dl (unless due to CLL involvement of liver or a known history of Gilbert’s disease)Xx_NEWLINE_xXBilirubin < 1.5 x ULN; transaminases < 3 x ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin ?1.5 x ULNXx_NEWLINE_xXHepatic function: total bilirubin ? 1.5 x ULN (Common Terminology Criteria for AEs [CTCAE] v4.0 grade 1) except patients with Gilbert's disease (up to 5.0 mg/dL). Aspartate aminotransferase (AST) and alkaline phosphatase ? 2.5 x ULN.Xx_NEWLINE_xXSubjects with adequate organ system functions as defined follows: Absolute neutrophil count (ANC) >=1.0 X 10^9/L; Hemoglobin >=8.0 g/dL; Platelets>= 50 X 10^9/L; Total bilirubin <=1.5X Upper limit of normal (ULN). Isolated bilirubin >=1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percent); Alanine aminotransferase (ALT) <=2.5X ULN; Estimated glomerular filtration rate (eGFR) >=30 milliliter per minute per 1.73 meter square (mL/min/m^2); Spot urine (albumin/creatinine ratios [spot urine]) < 500 milligram per gram (mg/g) (56 mg per millimoles [mg/mmol]); Left ventricular ejection fraction (LVEF) >= 45 percent.Xx_NEWLINE_xXTotal bilirubin ? 1.5 x upper limit of normal (ULN) (except patients with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL)Xx_NEWLINE_xXWithin 14 days prior to registration: Total serum bilirubin level =< 1.5 x ULN; direct bilirubin =< ULN for subjects with total bilirubin > 1.5 x ULN (patients with isolated indirect bilirubin elevations and a history of Gilbert’s syndrome are eligible)Xx_NEWLINE_xXSerum bilirubin within normal limits (WNL) or =< 1.5 x ULN in patients with liver metastases; or total bilirubin =< 3.0 x ULN with direct bilirubin WNL in patients with well documented Gilbert’s syndromeXx_NEWLINE_xXWithin 14 days prior to randomization: Total bilirubin must be =< 1.5 x upper limit of normal (ULN) for the lab or direct bilirubin =< ULN for patients with bilirubin levels > 1.5 x ULNXx_NEWLINE_xXTotal bilirubin <1.5 x ULNXx_NEWLINE_xXSerum total bilirubin =< 1.5Xx_NEWLINE_xXTotal bilirubin < 1.5 x ULNXx_NEWLINE_xXTotal bilirubin ? 1.5 x ULN (excepting Gilbert’s syndrome)Xx_NEWLINE_xXSerum total bilirubin ? 1.5 X ULN OR direct bilirubin ? ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXWithin 14 days of first dose of study drug: Bilirubin =< 1.5 x ULN (< 2 x ULN if hyperbilirubinemia is due to Gilbert’s syndrome)Xx_NEWLINE_xXTotal bilirubin < 1.5 X upper limit of normal (ULN) (in women with prior documented bilirubin elevations consistent with Gilbert’s syndrome, total bilirubin up to 3 X ULN will be allowed)Xx_NEWLINE_xXSerum bilirubin ? 1.5 x ULN, with the exception of patients with known Gilbert disease: serum bilirubin level ? 3 x ULNXx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXBilirubin =< 1.5 X ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULNXx_NEWLINE_xXREGISTRATION TO TREATMENT (STEP 1): Serum total bilirubin =< 1.5 X ULN OR direct bilirubin \r\n=< ULN for subjects with total bilirubin levels > 1.5 X ULN, within 14 days prior to first dose of pembrolizumabXx_NEWLINE_xXREGISTRATION TO TREATMENT (STEP 2): Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 X ULN, within 14 days prior to first dose of pembrolizumabXx_NEWLINE_xXBilirubin must be =< 1.5 x ULN, except participants with Gilbert’s syndrome where bilirubin must be =< 2.0 x ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dL, except in subjects with Gilbert’s syndrome in whom total bilirubin must be =< 3.0 mg/dLXx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dL, except in subjects with Gilbert’s syndrome in whom total bilirubin must be =< 3.0 mg/dL.Xx_NEWLINE_xXWithin 14 days of study drug(s) initiation: Serum bilirubin within normal limits (WNL) or =< 1.5 x ULN in patients with liver metastases; or total bilirubin =< 3.0 x ULN with direct bilirubin WNL in patients with well documented Gilbert’s syndrome.Xx_NEWLINE_xXSerum total bilirubin ? 1.5 x ULNXx_NEWLINE_xXFor high risk and very high risk CLL-IPI (Arms A and B) only; obtained ? 30 days prior to randomization: Total bilirubin ? 1.5 x upper limit of normal (ULN) (or total bilirubin ? 3.0 x ULN with direct bilirubin ? 1.5 x ULN in patients with well-documented Gilbert’s syndrome)Xx_NEWLINE_xXTotal bilirubin ? 1.5 x of institutional ULN within 14 days prior to registrationXx_NEWLINE_xXTotal serum bilirubin ? 1.5 x ULN; in subjects with known or suspected Gilbert’s syndrome, if total bilirubin is > 1.5 x ULN, direct bilirubin is ? 1.5 x ULNXx_NEWLINE_xXBilirubin =< ULN, if total bilirubin is > ULN, measure direct/indirect bilirubin to evaluate for Gilbert’s Syndrome (if direct bilirubin is within normal range, subject may be eligible)Xx_NEWLINE_xXTotal bilirubin ? 1.5 ULN OR direct bilirubin ? ULN if total bilirubin > 1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< institutional upper limit of normal (ULN) (unless due to known Gilbert’s syndrome or compensated hemolysis directly attributable to CLL); patients with Gilbert’s syndrome may enroll if direct bilirubin =< 1.5 x ULN of the direct bilirubin; elevated indirect bilirubin due to post-transfusion hemolysis is allowedXx_NEWLINE_xXSerum total bilirubin ? 1.5 X ULN within 7 days of treatment initiation\r\n* Direct bilirubin ? ULN for subjects with total bilirubin levels > 1.5 ULN within 7 days of treatment initiationXx_NEWLINE_xXRENAL COHORT: Laboratory values as follows within 4 days before the first dose of daratumumab: bilirubin ? 1.5 x upper limit of normal (ULN); for subjects with known Gilbert’s disease, bilirubin ? 3.0 mg/dLXx_NEWLINE_xXBLADDER: Clinical laboratory values at screening: bilirubin ? 1.5 x the ULN; for subjects with known Gilbert’s disease, bilirubin ? 3.0 mg/dLXx_NEWLINE_xXWithin 7 days before the first dose of cabozantinib: Bilirubin =< 1.5 x the upper limit of nomal (ULN); for subjects with known Gilbert’s disease, bilirubin =< 3.0 mg/dLXx_NEWLINE_xXTotal bilirubin =< to 2.0 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dlXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN =< 14 days prior to registrationXx_NEWLINE_xXAll screening labs should be performed within 14 days (+3 working days) of treatment initiation: serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN;Xx_NEWLINE_xXTotal bilirubin </= 1.5 x ULN except in patients with documented Gilbert’s syndrome or liver metastasis, who must have a baseline total bilirubin 3.0 mg/dl within 3 weeks prior to initial treatmentXx_NEWLINE_xXTotal serum bilirubin > 1.5 x ULN (patients with Gilbert’s disease may be included if their total bilirubin is =< 3.0 mg/dL).Xx_NEWLINE_xXSerum total bilirubin ? 1.5 X ULN OR direct bilirubin ? ULN for patients with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXWithin 10 days of treatment initiation: total bilirubin =< 1.5 x ULN (3 X ULN if a exists a history of Gilbert syndrome) or direct bilirubin >= ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXENROLLMENT: Adequate liver function, defined as: total bilirubin =< 2 mg/dlXx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 28 days of treatment initiationXx_NEWLINE_xXTotal serum bilirubin must be < 3mg/dL unless the elevation is thought to be due to Gilbert’s disease or hemolysisXx_NEWLINE_xXBilirubin less than or equal to 1.5 x ULN (unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin)Xx_NEWLINE_xXWithin 10 days of treatment initiation: Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< 2 x ULN or =< 3 x ULN if Gilbert's disease).Xx_NEWLINE_xXSerum bilirubin < 1.5 mg/dl unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin.Xx_NEWLINE_xXAt cycle 1 day 1 pre-dosing: Total bilirubin level >= 1.5 x ULN, (except for Gilbert syndrome: direct bilirubin >= 1.5 x ULN)Xx_NEWLINE_xXTotal serum bilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN; if liver metastases or metabolic disorder such as Gilbert’s syndrome, then =< 2.5 x ULNXx_NEWLINE_xXSerum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXSerum total bilirubin < 1.5 mg/dLXx_NEWLINE_xXTotal serum bilirubin =< 1.5 x ULNXx_NEWLINE_xXBilirubin (total) =< 1.7 mg/dLXx_NEWLINE_xXBilirubin =< 2.0 mg/dLXx_NEWLINE_xXTotal bilirubin =< 2.0 mg/dLXx_NEWLINE_xXTotal bilirubin ?1.5 × ULN or total bilirubin of ?2 mg/dL, whichever is higher.Xx_NEWLINE_xXTotal bilirubin > 1.5 × ULN; > 3 × ULN with direct bilirubin > 1.5 × ULN in presence of Gilbert's disease.Xx_NEWLINE_xXDirect bilirubin < 1.4 mg/dL (23.9 micromoles/L); Note: a total bilirubin of < 1.4 mg/dL (23.9 micromoles/L) is acceptable to meet this requirementXx_NEWLINE_xXSerum total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (patients with Gilbert's syndrome with a total bilirubin < 3.0 mg/dL)Xx_NEWLINE_xXSerum total bilirubin =< 1.5 x upper limit of normal (ULN) OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 x ULN obtained =< 28 days prior to registrationXx_NEWLINE_xXTotal serum bilirubin >2.5 ULN (except for subjects with Gilbert's Syndrome for whom direct bilirubin is <2.5×ULN), or liver cirrhosis or chronic liver disease Child-Pugh Class B or C.Xx_NEWLINE_xXWithin 28 days of study registration: Bilirubin =< 1.5 times the upper institutional limits of normal (ULN); patients with a history of Gilbert's syndrome may be enrolled if the total bilirubin is < 3 mg/dL with a predominance of indirect bilirubin; if the total bilirubin is > 1.5 x the institutional ULN, direct and indirect bilirubin will be measured and if direct bilirubin is =< 1.5 x the institutional ULN, the patient will be eligible to participateXx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXTotal bilirubin =< grade 1\r\n* Note: If total bilirubin is 2 to 3 mg/dL, but direct bilirubin is normal, then the patient will be considered eligibleXx_NEWLINE_xXTotal serum bilirubin =< 1.5 times upper limit of normal (ULN) (=< grade 1); if total bilirubin is 2 to 3 mg/dL, but direct bilirubin is normal, then the patient will be considered eligibleXx_NEWLINE_xXTotal serum bilirubin =< 1.5 x ULN\r\n* NOTE: if total bilirubin is 2-3 mg/dL, but direct bilirubin is normal, then the patient will be considered eligibleXx_NEWLINE_xXBilirubin =< grade 1\r\n* If bilirubin is 2-3 mg/dL, but direct bilirubin is normal then patient will be considered eligibleXx_NEWLINE_xXTotal bilirubin must be =< ULN (upper limit of normal) for the lab unless the patient has a bilirubin elevation > ULN to 1.5 x ULN due to Gilbert’s disease or similar syndrome involving slow conjugation of bilirubin within 28 days before randomizationXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN except subjects with normal direct bilirubin or those with known Gilbert’s syndromeXx_NEWLINE_xXTotal bilirubin < 2.0 mg/dlXx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN (performed within 10 days of treatment initiation)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN for the laboratory; Note: Patients with known Gilbert’s syndrome are not eligible for this studyXx_NEWLINE_xXSerum total bilirubin: =< 1.5 X ULN ORXx_NEWLINE_xXDirect bilirubin: =< ULN for patients with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN unless if evidence of indirect hyperbilirubinemia due to for example Gilbert’s syndromeXx_NEWLINE_xXARM A: obtained =< 14 days prior to registration: \r\n* Total bilirubin =< 1.5 x ULNXx_NEWLINE_xXARM B: obtained =< 14 days prior to registration: \r\n* Total bilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN (patients with Gilbert’s syndrome may have serum bilirubin > 1.5 ULN)Xx_NEWLINE_xXTotal bilirubin\r\n* If no known liver metastases:\r\n** Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (except subjects with Gilbert syndrome, who may have total bilirubin < 3.0 mg/dl)\r\n* If known metastasis:\r\n** Total bilirubin =< 5 ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)Xx_NEWLINE_xXBilirubin less than or equal to 1.5 x the upper limit of normal (except subjects with Gilbert syndrome, who can have total bilirubin < 3 mg/dl)Xx_NEWLINE_xXObtained within 30 days prior to registration: Bilirubin 1.5 =< (ULN)\r\n* Except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dLXx_NEWLINE_xXTotal bilirubin < 3 x ULN for ageXx_NEWLINE_xXTotal serum bilirubin of =< 1.5 x institutional ULNXx_NEWLINE_xXSerum total bilirubin < 2 mg/dl (except if known Gilbert syndrome AND normal transaminases)Xx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXBilirubin =< 1.5 x ULN (=< 3 x ULN for patients with Gilbert syndrome)Xx_NEWLINE_xXTotal bilirubin =< 2 mg/dl (biliary stent is allowed)Xx_NEWLINE_xXTotal serum bilirubin =< 1.5 x ULN (in patients with known Gilbert syndrome, a total bilirubin =< 3.0 x ULN, with direct bilirubin =< 1.5 x ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN unless Gilbert’s syndrome of disease infiltration of the liver is presentXx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dLXx_NEWLINE_xXSerum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 10 days of treatment initiationXx_NEWLINE_xXTotal bilirubin (TBil) and direct bilirubin (DBil) =< ULN with an exception of patients with confirmed Gilbert’s syndrome; for patients with confirmed Gilbert’s syndrome, the TBil should be =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin > 2 mg/dL (in the absence of Gilbert’s disease)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN) (except patients with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)Xx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXTotal bilirubin < 2.0mg/dL unless due to Gilbert’s diseaseXx_NEWLINE_xXSerum total bilirubin =< 1.5 X upper limit of normal (ULN) or direct bilirubin =< ULN for patients with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXSerum total bilirubin =< 1.5 x institutional ULN (=< 3 x institutional ULN for Gilbert’s syndrome) OR direct bilirubin =< institutional ULN for subjects with total bilirubin levels > 1.5 institutional ULNXx_NEWLINE_xXTotal bilirubin ? 2.0 mg/dL not related to hemolysis or Gilbert's disease.Xx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dL or direct bilirubin =< 0.4 mg/dLXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) or if total bilirubin is > 1.5 x ULN the direct bilirubin must be =< 1.5 x ULN (=< 0.45 mg/dL)Xx_NEWLINE_xXTotal bilirubin =< 2 x ULN (patients with Gilbert syndrome may be included at the discretion of the principal investigator [PI] or where hemolysis has been excluded)Xx_NEWLINE_xXDirect bilirubin < 1.4 mg/dL (23.9 micromoles/L); note: a total bilirubin of < 1.4 mg/dL (23.9 micromoles/L) is acceptable to meet this requirementXx_NEWLINE_xXTotal bilirubin =< 2.0 mg/dLXx_NEWLINE_xXBilirubin =< 2.5 x ULNXx_NEWLINE_xXBilirubin =< 2.0 mg/dLXx_NEWLINE_xXBilirubin =< 2.0 mg/dlXx_NEWLINE_xXBilirubin < 1.5 x upper limit of normal (ULN), for patients with Gilbert syndrome, direct bilirubin will be measured instead of total bilirubinXx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN; patients with Gilbert’s syndrome must have a total bilirubin < 3.0 mg/dLXx_NEWLINE_xXWithin 14 days of registration: Total bilirubin =< 2.0 mg/dLXx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXTotal bilirubin within =< 1.5 normal institutional limits (patients with Gilbert’s syndrome with total bilirubin up to 2.5 mg/dL is allowed)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for participants with total bilirubin levels > 1.5 x ULN, specimens must be collected within 10 days prior to the start of study treatmentXx_NEWLINE_xXWithin 30 days prior to treatment initiation: Serum total bilirubin =< 1.5 X institutional ULN OR direct bilirubin =< institutional ULN for subjects with total bilirubin levels > 1.5 institutional ULNXx_NEWLINE_xXBilirubin =< 2.0 mg/dL within 2 weeks before baselineXx_NEWLINE_xXTotal bilirubin =< 2mg/dL.Xx_NEWLINE_xXTotal bilirubin =< upper limit of normal (ULN) (except for patients with Gilbert’s syndrome who may only be included if the total bilirubin is =< 3.0 x institutional ULN or direct bilirubin =< 1.5 x ULN)Xx_NEWLINE_xXSerum bilirubin =< 1.5 x ULN, (except patients with Gilbert’s syndrome, who must have a total bilirubin less than 3.0 mg/dL)Xx_NEWLINE_xXTotal bilirubin < 2.0 mg/dlXx_NEWLINE_xXBilirubin =< 1.5 mg/dlXx_NEWLINE_xXPretreatment serum bilirubin =< 2.5 x institutional ULN orXx_NEWLINE_xXTotal bilirubin < 4.5 mg/dl with direct fraction =< 0.3 mg/dl in patients for whom these abnormalities are felt to be due to protease inhibitor therapyXx_NEWLINE_xXTotal bilirubin < 3 x ULNXx_NEWLINE_xXSerum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXTotal bilirubin < 1.5 X ULN; patients with Gilbert's disease are exempt from this criteriaXx_NEWLINE_xXTotal bilirubin =< ULN; or total bilirubin =< 3.0 x ULN or direct bilirubin in patients with well-documented Gilbert’s syndromeXx_NEWLINE_xXTotal bilirubin =< 2 mg/dl unless high indirect bilirubin is due to a congenital disorderXx_NEWLINE_xXTotal bilirubin =< upper limit of normal (ULN) for age, or if total bilirubin is > ULN, direct bilirubin is =< 1.4 mg/dL, andXx_NEWLINE_xXTotal bilirubin =< ULN; or total bilirubin =< 3.0 x ULN with direct bilirubin =< 1.5 ULN n patients with well documented Gilbert’s syndromeXx_NEWLINE_xXPretreatment serum bilirubin =< 2.5 x ULN or total bilirubin < 4.5 mg/dl with direct fraction =< 0.3 mg/dl in patients for whom these abnormalities are felt to be due to protease inhibitor therapyXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN for the laboratory (total bilirubin criteria may be waived if a subject has documented Gilbert’s syndrome)Xx_NEWLINE_xXDirect bilirubin =< 2mg/dLXx_NEWLINE_xXBilirubin =<1.5 x ULNXx_NEWLINE_xXBilirubin =< 1.5 x ULNXx_NEWLINE_xXBilirubin =< 2 mg/dl, within 14 days prior to registrationXx_NEWLINE_xXTotal bilirubin =< 1.5 x IULNXx_NEWLINE_xXTotal bilirubin < upper limit of normal (ULN) or up to 2 x ULN if patient has clinically documented Gilbert’s syndrome (elevated unconjugated bilirubin from decreased UDP glucuronosyltransferase 1 family, polypeptide A1 [UGT1A1] activity)Xx_NEWLINE_xXTotal bilirubin less than or equal to 2.0 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dlXx_NEWLINE_xXBilirubin =< 1.6 mg/dL (except patients with Gilbert’s syndrome, who must have a total bilirubin less than 3.0 mg/dL)Xx_NEWLINE_xXBilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin: =< 2.0 mg/dLXx_NEWLINE_xXBilirubin =< 1.5 ULNXx_NEWLINE_xXSerum bilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< 2.0 mg/dlXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin must be =< upper limit of normal (ULN) for the lab unless the patient has a bilirubin elevation > ULN to 1.5 x ULN due to Gilbert’s disease or similar syndrome involving slow conjugation of bilirubinXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN) (isolated bilirubin > 1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%)Xx_NEWLINE_xXBilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< 2 mg/dL (=< 3 mg/dL in case of Gilbert's syndrome)Xx_NEWLINE_xXDirect bilirubin =< 1 mg/dLXx_NEWLINE_xXTotal bilirubin < 2.0 mg/dLXx_NEWLINE_xXBilirubin =< 1.5 mg/dl, in patients with Gilbert's syndrome, a total bilirubin =< 3.0 mg/dLXx_NEWLINE_xXTotal bilirubin =< to 2.0 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dlXx_NEWLINE_xXDirect bilirubin > 1.5 mg/dLXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< 2.5 mg% (unless from Gilbert’s disease or disease-related)Xx_NEWLINE_xXBilirubin =< 1.5 x ULNXx_NEWLINE_xXSerum bilirubin < 2 x ULN for patients with liver metastases and =< 1.5 x ULN for patients without liver metastases, (except patients with Gilbert's syndrome, who must have a total bilirubin < 3.0 mg/dL)Xx_NEWLINE_xXTotal bilirubin less than or equal to 2.0 mg/dL, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dLXx_NEWLINE_xXBilirubin < 1.5 mg/dLXx_NEWLINE_xXTotal bilirubin less than or equal to 2.0 mg/dL, except in patients with Gilbert's syndrome who must have a total bilirubin less than 3.0 mg/dLXx_NEWLINE_xXTotal bilirubin less than or equal to 2.0 mg/dL, except in patients with Gilbert's syndrome who must have a total bilirubin less than 3.0mg/dLXx_NEWLINE_xXTotal bilirubin ? 2 times ULN            \r\n* Patients with documented diagnosis of Gilbert syndrome resulting in elevated total bilirubin levels will be eligible, provided all other eligibility criteria are met\r\n* Patients with a total bilirubin of 2-3 mg/dL and direct (conjugated) bilirubin in the normal range will be eligible, provided all other eligibility criteria are metXx_NEWLINE_xXTotal bilirubin =< 4.0 mg/dlXx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dLXx_NEWLINE_xXTotal bilirubin =< 1.5 x IULNXx_NEWLINE_xXSerum bilirubin =< 1.5 x ULN in patients with known Gilbert syndrome, total bilirubin =< 3 x ULN, with direct bilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal serum bilirubin < 2.5 x ULNXx_NEWLINE_xXBilirubin =< 1.5 mg/dlXx_NEWLINE_xXBilirubin =< 2.0 mg/dLXx_NEWLINE_xXBilirubin < 2.0 mg/dLXx_NEWLINE_xXBilirubin < 2.0 mg/dLXx_NEWLINE_xXBaseline total bilirubin > 1.5 x ULNXx_NEWLINE_xXSerum total bilirubin < 2 mg/dl; patients with Gilbert syndrome are excluded from the requirement of a normal bilirubinXx_NEWLINE_xXBilirubin =< 2 x ULNXx_NEWLINE_xXTotal bilirubin < 1.5 mg/dLXx_NEWLINE_xXTotal bilirubin =< 2.0 mg/dlXx_NEWLINE_xXBilirubin =< 2 x ULN (except subjects with Gilbert syndrome who must have total bilirubin < 3.0 mg/dL)Xx_NEWLINE_xXBilirubin =< 2 x ULN (except subjects with Gilbert’s syndrome, who must have total bilirubin < 3.0 mg/dL)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dLXx_NEWLINE_xXTotal bilirubin must be =< 1.5 mg/dL except in patients with Gilbert’s syndrome (as defined by > 80% unconjugated bilirubin) it must be < 5 mg/dlXx_NEWLINE_xXBilirubin < 1.5 mg/dL, with the exception of patients thought to have Gilbert's syndrome, who may have a total bilirubin above 1.5 mg/dLXx_NEWLINE_xXBilirubin =< 1.5 mg/dLXx_NEWLINE_xXTotal bilirubin < 1.5Xx_NEWLINE_xXNo history of severe prior or ongoing chronic liver disease; total bilirubin =< 2.0 mg/dlXx_NEWLINE_xXTotal bilirubin =< 2.2 mg/dLXx_NEWLINE_xXTotal bilirubin >= 1.5 mg/mlXx_NEWLINE_xXTotal bilirubin < 1.5 x IULNXx_NEWLINE_xXSerum total bilirubin ? 1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< 2.0 x ULN; in the setting of metastatic disease to the liver, total bilirubin =< 2.5 x ULN; if a patient is known or suspected to have Gilbert’s disease, total bilirubin up to =< 2.5 x ULN is allowedXx_NEWLINE_xXTotal bilirubin =< 5 mg/dLXx_NEWLINE_xXTotal bilirubin <1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 ULN (CTCAE grade 1)Xx_NEWLINE_xXTotal serum bilirubin ?1.5×ULN.Xx_NEWLINE_xXBilirubin =< 1.5 mg/dLXx_NEWLINE_xXBilirubin =< 1.5 mg/dL within four weeks prior to randomizationXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal serum bilirubin ? 1.5 x ULN (CTCAE Grade ? 1);Xx_NEWLINE_xXTotal serum bilirubin ?2.0 x ULN unless the subject has documented Gilbert syndrome;Xx_NEWLINE_xXTotal bilirubin =< 2.0 mg/dLXx_NEWLINE_xXBilirubin less than or equal to 1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dL (25.65 umol/L) (except patients with Gilbert's disease)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (IULN) (except Gilbert’s syndrome, who must have a total bilirubin < 3.0 mg/dL) be obtained within 42 days prior to registrationXx_NEWLINE_xXBilirubin < 2.0 mg/dL;Xx_NEWLINE_xXTotal bilirubin ? 1.5 x ULN.Xx_NEWLINE_xXTotal bilirubin ? 1.5 x ULN.Xx_NEWLINE_xXBilirubin ? 2.0 mg/dl with the exception of patients with Gilbert-Meulengracht syndrome; patients with Gilbert-Meulengracht syndrome may be included if their total bilirubin is ? 3.0 x ULN and direct bilirubin ? 1.5 x ULNXx_NEWLINE_xXHepatic: alanine aminotransferase (ALT), and aspartate aminotransferase (AST) > 2.5 x ULN, total serum bilirubin > 1.5 x ULN (patients with Gilbert's Disease may be included if their total bilirubin is ?3.0 mg/dL)Xx_NEWLINE_xXSerum total bilirubin ? 1.5 x ULN (except in subjects with Gilbert's who may have serum bilirubin < 3.0 x ULN),Xx_NEWLINE_xXBilirubin ?1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin, such as hemolysis)Xx_NEWLINE_xXTotal bilirubin < 1.5 X upper limit of normal (ULN); or < 3 x institutional ULN for Gilbert’s syndrome or HIV protease inhibitors; or < 5 x ULN and direct bilirubin < 0.7 mg/dL for patients on atazanavir containing HIV regimenXx_NEWLINE_xXTotal bilirubin =< 2.0mg/dLXx_NEWLINE_xXTotal serum bilirubin <=1.5 * ULNXx_NEWLINE_xXTotal bilirubin =< 1.0 X ULN (institutional); for patients with Gilbert syndrome, the direct bilirubin should be within the institutional normal rangeXx_NEWLINE_xXBilirubin ? 1.5 mg/dlXx_NEWLINE_xXBilirubin ? 1.5 mg/dlXx_NEWLINE_xXTotal bilirubin =< 1.5 X ULNXx_NEWLINE_xXBilirubin less than 1.5 mg/dL; (except in patients with Gilbert's syndrome, who must have a total bilirubin less than 3.0 mg/dL)Xx_NEWLINE_xXTotal bilirubin ? 1.5 upper limit of normal (ULN), except for participants with Gilbert's syndrome as defined by > 80% unconjugated bilirubin and total bilirubin ? 6 mg/dLXx_NEWLINE_xXBilirubin =< 1.2Xx_NEWLINE_xXTotal bilirubin: serum bilirubin within normal limits (WNL) or =< 1.5 x ULN in patients with liver metastases; or total bilirubin =< 3.0 x ULN with direct bilirubin WNL in patients with documented Gilbert’s syndromeXx_NEWLINE_xXTotal bilirubin within 1.5 x ULN, except those with Gilberts syndrome for whom this must be <3 x ULNXx_NEWLINE_xXSerum total bilirubin > 1.5 × ULN or > 3.0 mg/dL for subjects with documented Gilbert's syndromeXx_NEWLINE_xXTotal serum bilirubin ? 2.0 × ULN (unless the subject has documented Gilbert Syndrome)Xx_NEWLINE_xXBilirubin < 2.0 mg/dL.Xx_NEWLINE_xXHepatic: alanine aminotransferase (ALT), and aspartate aminotransferase (AST) > 2.5 x ULN, total serum bilirubin > 1.5 x ULN (patients with Gilbert's Disease may be included if their total bilirubin is ? 3.0 mg/dL).Xx_NEWLINE_xXBilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin less than or equal to 2 mg/dLXx_NEWLINE_xXSerum bilirubin > 2.0 mg/dl (except in the case of Gilbert syndrome or ongoing hemolytic anemia)Xx_NEWLINE_xXTotal bilirubin =< 1 x upper limit of normal (ULN); or total bilirubin =< 3.0 x ULN with direct bilirubin =< 1.5 x ULN in patients with well-documented Gilbert’s syndrome, obtained =< 21 days prior to registrationXx_NEWLINE_xXMF PATIENTS: Direct bilirubin =< 1.5 x ULNXx_NEWLINE_xXHepatic: alanine aminotransferase (ALT), and aspartate aminotransferase (AST) > 2.5 x Upper Limit of Normal (ULN), total serum bilirubin > 1.5 x ULN (patients with Gilbert's Disease may be included if their total bilirubin is ?3.0 mg/dL)Xx_NEWLINE_xXBilirubin < ULNXx_NEWLINE_xXSerum bilirubin =< 2.0 x ULN (except patients with Gilbert’s syndrome, who must have a total bilirubin less than 3.0 mg/dL)Xx_NEWLINE_xXBilirubin > 2 mg/dl (total) except > 5 mg/dl in patients with Gilbert’s syndrome as defined by > 80% unconjugatedXx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dlXx_NEWLINE_xXWithin 56 days prior to randomization: Serum total bilirubin < 3.0 mg/dLXx_NEWLINE_xXBilirubin =< 1.5 x ULNXx_NEWLINE_xXSerum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXTotal Bilirubin: ?1.5xULN OR Direct bilirubin ?ULN for subjects with total bilirubin levels >1.5xULNXx_NEWLINE_xXSerum total bilirubin ?1.5 x ULN (unless subject had documented Gilbert's Syndrome)Xx_NEWLINE_xXTotal bilirubin ? 2.0 X ULN, or ? 3.0 X ULN (for patients with Gilbert's Syndrome)Xx_NEWLINE_xXTotal bilirubin ? 1.5 × ULN. Patients with liver lesions who do not have hepatocellular carcinoma and who have a total bilirubin ? 2.0 x ULN may be eligible if agreed upon by the investigator and medical monitor for the sponsor.Xx_NEWLINE_xXTotal bilirubin =< 2 mg/dLXx_NEWLINE_xXtotal serum bilirubin ?2.5 × ULN or ?5 × ULN in cases of Glibert's Syndrome or liver involvement by lymphomaXx_NEWLINE_xXTotal bilirubin ? 3.0 x ULNXx_NEWLINE_xXPatients must have a total bilirubin level ? 1.5 x ULN (? 2 x ULN if it is non-rising for a period of 10 days prior to initiation of therapy).Xx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dLXx_NEWLINE_xXTotal bilirubin ? 2.0 mg/dL not related to Gilbert's disease or hemolysis.Xx_NEWLINE_xXTotal bilirubin =< 2.5 x the institutional ULNXx_NEWLINE_xXTotal bilirubin =< 3.0 mg/dlXx_NEWLINE_xXBilirubin ? 2.5 mg/dLXx_NEWLINE_xXTotal bilirubin < 1.5 x ULN unless the patient has Gilbert’s syndrome, in which case total (T) bilirubin < 2.5 x ULN requiredXx_NEWLINE_xXTotal bilirubin =< 2.0 mg/dLXx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dlXx_NEWLINE_xXTotal bilirubin ? 1.5 × ULN.Xx_NEWLINE_xXBilirubin =< 2 x ULN (except subjects with Gilbert’s syndrome, who must have total bilirubin < 3.0 mg/dL)Xx_NEWLINE_xXTotal bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXBilirubin < 1.5 x ULN unless bilirubin is due to Gilbert’s syndrome, documented liver involvement with lymphoma, or of non-hepatic origin, in which case bilirubin should not exceed 3 g/dLXx_NEWLINE_xXBilirubin within normal limits (except subjects with Gilbert's syndrome, who must have a total bilirubin < 3.0 mg/dL)Xx_NEWLINE_xXTotal bilirubin <=1.5*ULN;Xx_NEWLINE_xXTotal bilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin ?1.5 mg/dLXx_NEWLINE_xXBilirubin ? 1.5 × ULN except for cases of documented or suspected Gilbert's disease, in which bilirubin must be ? 5 × ULNXx_NEWLINE_xXBilirubin =< 1.5 x ULN (except for patients with Gilbert’s syndrome, who must have a total bilirubin =< 3 mg/dL)Xx_NEWLINE_xXTotal bilirubin <upper limit of normal (ULN) except in participants with Gilbert's syndrome. Participants with Gilbert's syndrome may enroll if direct bilirubin <=1.5*ULN of the direct bilirubin.Xx_NEWLINE_xXSerum total bilirubin =< 1.5 x ULNXx_NEWLINE_xXBilirubin =< 1.5 x ULN; for patients with Gilbert's syndrome, bilirubin =< 3.0 mg/dL is acceptableXx_NEWLINE_xXSerum bilirubin WNL or ?1.5 x the ULN in patients with liver metastases; or total bilirubin ?3.0 x ULN with direct bilirubin WNL in patients with well documented Gilbert's Syndrome.Xx_NEWLINE_xXTotal bilirubin ? 1.5 × ULN. Patients with liver lesions who do not have hepatocellular carcinoma and who have a total bilirubin < 2.0 x ULN may be eligible if agreed upon by the investigator and medical monitor for the sponsor.Xx_NEWLINE_xXBilirubin ?1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin, such as hemolysis)Xx_NEWLINE_xXSerum total bilirubin > 1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN (unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin); if considered related to ASM/MCL =< 3 x ULNXx_NEWLINE_xXSerum total bilirubin ? 1.5 X ULNXx_NEWLINE_xXWithin 14 days of study start: Serum total bilirubin =< 1.5 x ULNXx_NEWLINE_xXDirect bilirubin (bili) < 3 x ULNXx_NEWLINE_xXTotal bilirubin < 2.0 mg/dLXx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN or direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXTotal bilirubin (except patients with Gilbert’s syndrome, who are eligible for the study but exempt from the total bilirubin eligibility criterion) =< 2.0 mg/dlXx_NEWLINE_xXSerum total bilirubin =< 2.0 mg/dLXx_NEWLINE_xXSerum bilirubin =< 1.5 x ULN or =< 3.0 x ULN for patients with Gilbert syndrome or documented hepatic involvementXx_NEWLINE_xXTotal bilirubin ? 3 x ULN, (except patients with Gilbert's Syndrome, who must have a total bilirubin less than 3.0 mg/dL)Xx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXBilirubin less than or equal to 1.5 x ULNXx_NEWLINE_xXTotal bilirubin less than or equal to 2.0 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dlXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 x IULNXx_NEWLINE_xXTotal bilirubin < 1.5 x ULN (except for subjects with documented Gilbert's syndrome)Xx_NEWLINE_xXTotal bilirubin =< 2 x ULN (except patients with documented Gilbert’s syndrome)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN for the labXx_NEWLINE_xXTotal bilirubin =< 2.5 mg/dl (unless the patient has a history of Gilbert’s syndrome)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institution’s ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN (except subjects with Gilbert Syndrome who must have total bilirubin < 3.0 mg/dL)Xx_NEWLINE_xXDirect bilirubin ? 2.0 x ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dLXx_NEWLINE_xXBilirubin < 1.5 mg/dLXx_NEWLINE_xXSerum bilirubin =< 2 x ULNXx_NEWLINE_xXSerum direct bilirubin =< 1.5 x ULN; if considered related to ASM/MCL =< 3 x ULNXx_NEWLINE_xXTotal bilirubin > 2.0 mg/dl, except in patients with Gilbert's syndrome whose total bilirubin must not exceed 3.0 mg/dl) deemed by investigator to be irreversibleXx_NEWLINE_xXTotal bilirubin > 2.0 mg/dl, except in patients with Gilbert's syndrome whose total bilirubin must not exceed 3.0 mg/dl)Xx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dL (< 3 mg/dL for patients with Gilbert’s syndrome)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN for age ANDXx_NEWLINE_xXBilirubin =< 1.5 x ULNXx_NEWLINE_xXBilirubin less than or equal to 3.0 mg/dLXx_NEWLINE_xXTotal serum bilirubin =< 1.5 × the ULN; for subjects with known Gilbert’s disease or similar syndrome with slow conjugation of bilirubin, total bilirubin =< 3.0 mg/dLXx_NEWLINE_xXTotal bilirubin =< 2 mg/dLXx_NEWLINE_xXPatients must have adequate organ and marrow function defined as: absolute neutrophil count (ANC) >/= 1,000/mL, platelets >/=75,000/mL; creatinine clearance >/= 35 ml/min; total bilirubin </= 2 X ULN (exceptions may apply to benign non-malignant indirect hyperbilirubinemia such as Gilbert syndrome); ALT (SGPT) and or AST (SGOT) </= 5 X ULN Exception for patients with liver metastasis: total bilirubin </= 3 x ULN; ALT (SGPT) </= 8 X ULN; Fasting lipid profile: cholesterol </= 350 mg/dL; triglycerides </= 400 mg/dL Corrected calcium >/= 8.4 mg/dL; phosphorus >/= 2.5 mg/dL for denosumabXx_NEWLINE_xXTotal Bilirubin ? 2.0 X ULNXx_NEWLINE_xXBilirubin =< 3.0 mg/dl, unless considered due to tumorXx_NEWLINE_xXTotal bilirubin =< 1.5 x institution's ULNXx_NEWLINE_xXIf the patient is to be treated with cisplatin, the serum bilirubin of =< 2.0 mg%Xx_NEWLINE_xXTotal bilirubin =< 2 x ULN (except patients with documented Gilbert's syndrome)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN (< 3 mg/dL for subjects with Gilbert's disease)Xx_NEWLINE_xXPatients with known Gilbert disease who have serum bilirubin level ? 3 x ULN may be enrolled.Xx_NEWLINE_xXTotal bilirubin =< 2.0 mg/dL, unless due to Gilbert’s diseaseXx_NEWLINE_xXSerum total bilirubin =< 1.5 x upper limit of normal (ULN) OR direct bilirubin =< ULN if total bilirubin levels > 1.5 x ULN (within 14 days prior to day 1 of protocol therapy)Xx_NEWLINE_xXTotal Serum Bilirubin ? 1.5 x ULN (< 3.0 mg/dL if subject has Gilbert's syndrome)Xx_NEWLINE_xXBilirubin ?1.5 × institutional ULN;Xx_NEWLINE_xXTotal bilirubin ? 1.5 × ULN (except in patients with Gilbert Syndrome who can have total bilirubin < 3.0 mg/dL).Xx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN (performed within 10 days of treatment initiation)Xx_NEWLINE_xXSerum total bilirubin ? 1.5 x Institutional ULNXx_NEWLINE_xXTotal bilirubin =< IULN; or total bilirubin =< 3.0 x IULN or direct bilirubin =< 1.5 ULN in patients with well documented Gilbert’s syndromeXx_NEWLINE_xXTotal bilirubin < 2.0 mg/ dlXx_NEWLINE_xXSerum bilirubin ? 1.5 x ULN, except in patients with Gilbert's Syndrome who must have a total bilirubin < 3 mg/dLXx_NEWLINE_xXSerum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 10 days of treatment initiationXx_NEWLINE_xXTotal bilirubin ? 1.5 x ULNXx_NEWLINE_xXTotal bilirubin > 1.5 x ULN, except for patients with Gilbert's syndrome who are excluded if total bilirubin > 3.0 x ULN or direct bilirubin > 1.5 x ULNXx_NEWLINE_xXTotal serum bilirubin =< 2.0 mg/dLXx_NEWLINE_xXTotal serum bilirubin within ULNXx_NEWLINE_xXBilirubin < 2.0 mg/dlXx_NEWLINE_xXBilirubin =< 1.5 x ULN OR in subjects with Gilbert’s syndrome, a total bilirubin =< 3.0 x ULNXx_NEWLINE_xXBilirubin =< 3.0 mg/dL (unless due to Gilbert’s syndrome or hemolysis)Xx_NEWLINE_xXAdvanced bilirubin levels > 3 mg/dlXx_NEWLINE_xXTotal bilirubin ? 1.5X ULNXx_NEWLINE_xXTotal-value bilirubin (TBil) and direct bilirubin (DBil) =< ULN with an exception of patients with confirmed Gilbert’s syndrome; for patients with confirmed Gilbert’s syndrome, the TBil should be =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin <1.5 x the institutional ULN, unless the subject has documented unconjugated bilirubin disorder such as Gilbert's syndrome.Xx_NEWLINE_xXSerum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXTotal bilirubin < ULN; or total bilirubin =< 3.0 x ULN or direct bilirubin =< 1.5 x ULN in patients with well-documented Gilbert’s syndrome.Xx_NEWLINE_xXRequired Initial Laboratory Values: Leukocytes ?2000/ µl Hemoglobin >9.0 g/dL Platelets ?100,000/ µl ANC ?1,500/mcL Serum creatinine ? 1.5 x ULN or creatinine clearance (CrCl) ? 40 mL/min (if using the Cockcroft-Gault formula below): Female CrCl = (140 - age in years) x weight in kg x 0.85 72 x serum creatinine in mg/dL Male CrCl = (140 - age in years) x weight in kg x 1.00 Total Bilirubin <1.5 mg/dl (except for subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dl) SGOT (AST) <2.5 x ULN ALP <2.5 x ULN in absence of liver metastases (<5 x ULN if liver metastases present PTT <1.5 x ULNXx_NEWLINE_xXBilirubin less than or equal to 2.0 mg/dlXx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dL (if total is elevated check direct and if normal patient is eligible), obtained =< 21 days prior to registration and confirmed prior to the first dose of study drugXx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dlXx_NEWLINE_xXWithin 14 days prior to registration: total bilirubin =< 1.5 x institutional ULN (except participants with Gilbert syndrome, who can have total bilirubin =< 3.0 x institutional ULN with direct bilirubin that is within institutional ULN)Xx_NEWLINE_xXSerum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for participants with total bilirubin levels > 1.5 ULN (within 14 days of treatment initiation)Xx_NEWLINE_xXTotal Bilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal serum bilirubin =< ULN (or =< 1.5 x ULN if documented hepatic involvement; or total bilirubin =< 3 x ULN with direct bilirubin =< 1.5 ULN in patients with documented Gilbert’s syndrome)Xx_NEWLINE_xXBilirubin =< 1.5 mg/dLXx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dlXx_NEWLINE_xXSerum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, should be performed within 28 days of treatment initiation, unless otherwise indicatedXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN) (except patients with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)Xx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXBilirubin =< 1.5 mg/dL (OR in patients with Gilbert’s syndrome, a total bilirubin =< 3.0) (within 16 days before starting therapy)Xx_NEWLINE_xXObtained =< 7 days prior to registration:\r\nTotal bilirubin =< 1.5 x ULN (does not apply to patients with isolated hyperbilirubinemia [e.g., Gilbert’s disease], in that case direct bilirubin should be =< 2 x ULN)Xx_NEWLINE_xXAbsolute neutrophil count (ANC) >=1.5 X 10^9/liter (L), Hemoglobin >=9 grams (g)/deciliter (dL) (subjects that required transfusion or growth factor need to demonstrate stable hemoglobin for 7 days of 9 g/dL), Platelets >=100 X 10^9/L, prothrombin time (PT)/ international normalized ratio (INR) and partial thromboplastin time (PTT) - <=1.5 X upper limit of normal (ULN); Hepatic - Albumin >=2.5 g/dL, Total bilirubin <=1.5 X ULN (isolated bilirubin >1.5 X ULN is acceptable if bilirubin is fractionated and direct bilirubin <35% or subject has a diagnosis of Gilbert's syndrome), Alanine aminotransferase (ALT) <=2.5 x ULN OR <5 x ULN is acceptable for subjects with documented liver metastases/tumor infiltration; Renal - Creatinine <=1.5 X ULN OR Creatinine clearance [either directly measured or calculated by Cockcroft-Gault formula] >=40 milliliter (mL)/minute (min); Cardiac - Ejection fraction >=50% by echocardiogram or multigated acquisition scan (MUGA), Troponin (T) <=ULN, Potassium >=Lower limit of normal (LLN) and <=ULN, Magnesium >=LLNXx_NEWLINE_xXTotal bilirubin =< 2.0. mg/dL or < 2.5 mg/dL if attributable to hepatic infiltration by neoplastic disease or Gilbert’s syndromeXx_NEWLINE_xXSerum bilirubin =< 2.5 x ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal serum bilirubin =< 1.5 x ULNXx_NEWLINE_xXSerum bilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) except subject with documented Gilbert’s syndrome (=< 5 x ULN) or liver metastasis, who must have a baseline total bilirubin =< 3.0 mg/dLXx_NEWLINE_xXTotal bilirubin ? 1.5 x ULNXx_NEWLINE_xXBilirubin < 1.5 x ULN unless bilirubin is due to Gilbert’s syndrome, documented liver involvement with lymphoma, or of non-hepatic origin, in which case bilirubin should not exceed 3 g/dLXx_NEWLINE_xXIn the case of Gilberts syndrome, or documented liver or pancreatic involvement by lymphoma, the requirement for total bilirubin is =< 5.0 mg/dLXx_NEWLINE_xXTotal bilirubin (TBL) > 2 x ULNXx_NEWLINE_xXHepatic total bilirubin =< 1.5 X ULN (isolated bilirubin > 1.5 X ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%)Xx_NEWLINE_xXWithin 4 weeks of administration of study therapy: Serum total bilirubin =< 1.5 x ULN or direct bilirubin =< ULN for patients with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXBilirubin =< 2 mg/dL, unless due to chronic GVHDXx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXTotal bilirubin =< 2 mg/dl unless high indirect bilirubin is due to a congenital disorderXx_NEWLINE_xXHas adequate hepatic function defined as total bilirubin ?1.5 mg/dL, unless associated with hepatobiliary metastases or Gilbert syndrome, then total bilirubin or ? 2 ULN. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ? 2.5 × upper limit of normal (ULN) or ? 5 x ULN for subjects with known hepatic metastases.Xx_NEWLINE_xXSerum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 28 days of treatment initiationXx_NEWLINE_xXBilirubin levels >= 1.5 institutional ULNXx_NEWLINE_xXSerum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 x ULNXx_NEWLINE_xXSerum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN (excepting Gilbert's syndrome)Xx_NEWLINE_xXTotal bilirubin =< ULN (except subjects with Gilbert syndrome who must have total bilirubin < 3.0 mg/dl)Xx_NEWLINE_xXBilirubin =< 1.5 mg/dl (unless Gilbert's syndrome)Xx_NEWLINE_xXBilirubin > 3 x ULN that cannot be attributed to NSCLC metastasisXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN; for participants with Gilbert’s disease =< 3.0 mg/dLXx_NEWLINE_xXBilirubin > 2.5 x ULNXx_NEWLINE_xXBilirubin ?1.5 x ULNXx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXTotal bilirubin =< 1.5mg/dL (in patients with known Gilbert’s syndrome direct bilirubin =< 1.5 x upper limit of normal [ULN] will be used as organ function criteria, instead of total bilirubin)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional ULNXx_NEWLINE_xXTotal bilirubin ? 1.5 × ULNXx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXSerum total bilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< 2.0 mg/dLXx_NEWLINE_xXtotal bilirubin ? 1.5 × upper limit of normal (ULN) OR direct bilirubin ? ULN for subjects with total bilirubin levels > 1.5 x ULNXx_NEWLINE_xXTotal bilirubin < 2.0 mg/dl-exception permitted in patients with Gilbert’s syndromeXx_NEWLINE_xXSerum total bilirubin < 2 x ULN (except patients with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)Xx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 14 days prior to registrationXx_NEWLINE_xXWithin 14 days of treatment initiation: Serum total bilirubin =< 1.5 X institutional ULN OR direct bilirubin =< institutional ULN for subjects with total bilirubin levels > 1.5 institutional ULNXx_NEWLINE_xXTotal bilirubin within normal limits (WNL) for the institution, unless the bilirubin abnormality is considered due to Gilbert's syndrome.Xx_NEWLINE_xXSerum total bilirubin ? 1.5 x ULNXx_NEWLINE_xXPerformed within 28 days of radiation therapy: Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXTotal bilirubin =< 2.0 mg/dl-exception permitted in participants with Gilbert’s syndromeXx_NEWLINE_xXBilirubin less than or equal to 1.5 ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN) (except patients with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)Xx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 28 days of treatment initiationXx_NEWLINE_xXbilirubin less than or equal to 1.5 × ULN for all subjects age 75 and older* Subjects who are less than 75 years of age must have a bilirubin of less than 3.0 × ULN * Unless considered due to leukemic organ involvement. Note: Subjects with Gilbert's Syndrome may have a bilirubin greater than 1.5 × ULN per discussion between the investigator and AbbVie medical monitor.Xx_NEWLINE_xXSerum total bilirubin =< 1.5 x ULN (direct bilirubin =< ULN if total bilirubin [bili] > 1.5 x ULN)Xx_NEWLINE_xXTotal serum bilirubin =< 2 mg/dLXx_NEWLINE_xXBilirubin =< 1.5 x ULNXx_NEWLINE_xXObtained =< 21 days prior to registration: Total bilirubin =< 2.0 mg/dL (if total is elevated check direct and if normal patient is eligible)Xx_NEWLINE_xXTotal bilirubin levels ? 1.5 x upper limit of normal [ULN] (except for patients with Gilbert's Syndrome, who must have a total bilirubin of less than 3.0 mg/dL)Xx_NEWLINE_xXBilirubin =< 2.0 mg/dl within 21 days prior to study registration unless patient has Gilbert’s syndromeXx_NEWLINE_xXBilirubin =< 1.5 ULNXx_NEWLINE_xXBilirubin =< 1.5 x ULNXx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin >= 1.5 ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional ULNXx_NEWLINE_xXSerum total bilirubin =< 1.5 x upper limit of normal (ULN) OR direct bilirubin =< ULN for patients with total bilirubin levels > 1.5 x ULN (labs should be performed within 14 days of treatment initiation)Xx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dlXx_NEWLINE_xXDirect bilirubin < 2.0 mg/dlXx_NEWLINE_xXBilirubin =< 1.5 mg/dlXx_NEWLINE_xXBilirubin =< 3.0 mg/dLXx_NEWLINE_xXTotal bilirubin =< upper limit of normal (ULN) except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dLXx_NEWLINE_xXSerum bilirubin within normal range (or =< 1.5 x ULN if liver metastases are present; or total bilirubin =< 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert syndrome)Xx_NEWLINE_xXTotal bilirubin > 1.0 x ULNXx_NEWLINE_xXSerum bilirubin =< 1.5 x ULN (except patients with Gilbert’s syndrome who must have a total bilirubin of < 3 times ULN)Xx_NEWLINE_xXTotal serum bilirubin =< 1.5 x ULN; patients with Gilbert’s syndrome with baseline serum bilirubin exceeding this limit are allowed to participateXx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dL (exception: patients with documented Gilbert’s syndrome are allowed to participate despite elevated bilirubin)Xx_NEWLINE_xXDirect bilirubin > 1.5 x ULN unless due to hemolysis or Gilbert’s syndromeXx_NEWLINE_xXBilirubin < 1.5 mg/dl (OR in patients with Gilbert’s syndrome, a total bilirubin =< 3.0 mg/dL)Xx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dL (except Gilbert’s syndrome or known hemolysis or leukemic infiltration)Xx_NEWLINE_xXTotal bilirubin ?1.5 x ULNXx_NEWLINE_xXBilirubin =< 2.5 x ULN (except for patients with Gilbert’s syndrome, who must have a total bilirubin =< 3 mg/dL)Xx_NEWLINE_xXTotal bilirubin =< 2 x upper limit of normal (ULN), unless patient has a documented history of Gilbert’s disease, then direct bilirubin =< 1.0 mg/dLXx_NEWLINE_xXBilirubin =< 2.0 x ULN, (except patients with Gilbert's syndrome, who must have a total bilirubin less than 3.0 mg/dL)Xx_NEWLINE_xXSerum bilirubin =< 1.5 times the upper institutional limits of normal (ULN); patients with a history of Gilbert’s syndrome may be enrolled if the total bilirubin is < 3 mg/dL with a predominance of indirect bilirubinXx_NEWLINE_xXDirect bilirubin ? 2.0 x ULNXx_NEWLINE_xXBilirubin < 2.0 x ULN, unless subject has Gilbert’s diseaseXx_NEWLINE_xXTotal bilirubin =< 2.0; exception for patients with liver metastasis: total bilirubin =< 3 x ULNXx_NEWLINE_xXTotal serum bilirubin ?1.5 x ULN (<3.0 x ULN for participants with Gilbert syndrome)Xx_NEWLINE_xXTotal bilirubin < 2.0 mg/dLXx_NEWLINE_xXSerum bilirubin =< 1.5 times the upper institutional limits of normal (ULN); patients with a history of Gilbert's syndrome may be enrolled if the total bilirubin is < 3 mg/dL with a predominance of indirect bilirubinXx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dLXx_NEWLINE_xXTotal serum bilirubin =< 2.0 x ULNXx_NEWLINE_xXTotal bilirubin =< 5.0 mg/dLXx_NEWLINE_xXBilirubin =< 1.5 mg/dLXx_NEWLINE_xXTotal serum bilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< 2.5 x upper limit of normal (ULN) unless due to Gilbert's disease; for those with a total bilirubin > 2.5 x ULN, a direct bilirubin should be performed and must be < 1.5 mg/dL for Gilbert's to be diagnosed; if value is higher due to hepatic involvement by CLL, patient is eligibleXx_NEWLINE_xXTotal bilirubin < 2.0 mg/dL unless due to Gilbert’s disease, hemolysis or leukemiaXx_NEWLINE_xXBilirubin >= 3 x ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 institutional ULNXx_NEWLINE_xXTotal bilirubin level ?1.5 × ULN.Xx_NEWLINE_xXAbnormal glucuronidation of bilirubinXx_NEWLINE_xXBilirubin < 2.0 mg/dLXx_NEWLINE_xXCOHORT A: Bilirubin =< 1.5 x ULN (except patients with Gilbert's syndrome, who must have a total bilirubin less than 3.0 mg/dL)Xx_NEWLINE_xXCOHORT B: Bilirubin =< 1.5 x ULN (except patients with Gilbert's syndrome, who must have a total bilirubin less than 3.0 mg/dL)Xx_NEWLINE_xXSerum total bilirubin =< 2.5 mg/dL; Note, patients with Gilbert’s syndrome may have elevated bilirubin at baseline prior to diagnosis with AML or MDS; patients with Gilbert’s syndrome are included if their total bilirubin is =< 2 times their baseline total bilirubinXx_NEWLINE_xXSerum total bilirubin > 2.5 mg/dL; Note, patients with Gilbert’s syndrome may have elevated bilirubin at baseline prior to diagnosis with AML or MDS; patients with Gilbert’s syndrome are excluded if their total bilirubin is > 2 times their baseline total bilirubinXx_NEWLINE_xXBilirubin must not be more than 1.5 x ULN (does not apply to patients with Gilbert’s disease)Xx_NEWLINE_xXTotal bilirubin ? 1.5 x ULNXx_NEWLINE_xXSerum total bilirubin > 2.0 mg/dLXx_NEWLINE_xXTotal bilirubin within normal ranges unless associated with hepatobiliary metastases or Gilbert syndrome, then total bilirubin ? 2 x ULNXx_NEWLINE_xXTotal bilirubin < 1.5 mg/dlXx_NEWLINE_xXTotal bilirubin > 2 x ULNXx_NEWLINE_xXTotal bilirubin ? 1.5 × ULNXx_NEWLINE_xXTotal bilirubin levels < 1.5 X ULNXx_NEWLINE_xXTotal bilirubin within normal institutional limits (isolated bilirubin > 1.5 × institutional ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN (tested within 14 days prior to registration)Xx_NEWLINE_xXTotal bilirubin ? 1.5 × institutional ULN except in the presence of Gilbert SyndromeXx_NEWLINE_xXTotal serum bilirubin ? 1.5 x institutional ULNXx_NEWLINE_xXBilirubin =< 1.8 mg/dL within 4 weeks of enrollmentXx_NEWLINE_xXWithin 30 days prior to initiation of protocol treatment: Bilirubin =< 1.5 mg/dL\r\n* Subjects with documented Gilbert’s disease may have bilirubin up to 2.5 mg/dLXx_NEWLINE_xXBilirubin =< 1.5 mg/dlXx_NEWLINE_xXAlanine aminotransferase ? 5 × ULN and total bilirubin < 2.0 mg/dL (or < 3.0 mg/dL for subjects with Gilbert's syndrome or leukemic infiltration of the liver)Xx_NEWLINE_xXBilirubin =< 2 mg/dl within 30 days prior to registrationXx_NEWLINE_xXTotal bilirubin =< upper limit of normal (ULN) except in patients with Gilbert's syndrome; patients with Gilbert's syndrome may enroll if direct bilirubin =< 1.5 x ULN of the direct bilirubinXx_NEWLINE_xXTotal bilirubin > 2.0 mg/dL (or > 3.0 mg/dL in participants with documented Gilbert syndrome)Xx_NEWLINE_xXBilirubin < 1.5 x ULN 9unless bilirubin rise is due to Gilbert's syndrome or of nonhepatic origin)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN, except subjects with Gilbert’s syndrome who can have total bilirubin =< 3.0 mg/dLXx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dLXx_NEWLINE_xXTotal bilirubin =< 2.0 x ULNXx_NEWLINE_xXBilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< 3.0 mg/dLXx_NEWLINE_xXSerum direct bilirubin < 2 mg/dL (34 Omol/L) within 7 days of time of consentXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional ULNXx_NEWLINE_xXSerum bilirubin =< 1.5 x institutional ULNXx_NEWLINE_xXTotal bilirubin < 1.5 x ULN; concomitant elevations in bilirubin above 1.0 x ULN are not permittedXx_NEWLINE_xXTotal bilirubin =< ULN (patient’s with Gilbert’s syndrome are eligible, even if total bilirubin is > ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dlXx_NEWLINE_xXTotal bilirubin =< 2.0 mg/dl, except in cases of Gilbert’s diseaseXx_NEWLINE_xXTotal bilirubin =< 2.5 mg/dlXx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dlXx_NEWLINE_xXBilirubin =< 1.5 mg/dL (OR in patients with Gilbert's syndrome, a total bilirubin =< 3.0) (within 16 days before starting therapy)Xx_NEWLINE_xXTotal bilirubin within normal institutional limits; for patients with Gilbert's syndrome, total bilirubin =< 3.0 mg/dLXx_NEWLINE_xXTotal bilirubin =< grade 3Xx_NEWLINE_xXBilirubin =< 1.5 x ULNXx_NEWLINE_xXSerum bilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< 1.2 mg/dL; for patients with Gilbert syndrome, the direct bilirubin should be within the institutional normal rangeXx_NEWLINE_xXBilirubin =< 2 x ULN (must be within 7 days of MLA)Xx_NEWLINE_xXTotal bilirubin =< 3.0 mg/dLXx_NEWLINE_xXSerum bilirubin =< 2.5 x ULNXx_NEWLINE_xXBilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< 3.0 mg/dL and no evidence of bile obstructionXx_NEWLINE_xXBilirubin < 2.0 mg/100 mlXx_NEWLINE_xXBilirubin =< 3 x ULNXx_NEWLINE_xXBilirubin >= 3 x ULN (unless Gilbert’s syndrome)Xx_NEWLINE_xXTotal bilirubin =< 3 mg/dLXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULNXx_NEWLINE_xXSerum bilirubin =< 1.5 x ULN andXx_NEWLINE_xXTotal bilirubin =< 2 mg/dl; patients with biliary obstruction can join if bilirubin corrects to required limit after adequate biliary drainageXx_NEWLINE_xXTotal bilirubin < 2 X ULN (except for subjects with documented Gilbert’s syndrome who can have total bilirubin < 3.0 mg/dl)Xx_NEWLINE_xXBilirubin < 1.5 x ULNXx_NEWLINE_xXTotal or direct bilirubin =< 1.5 mg/dLXx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dLXx_NEWLINE_xXTotal bilirubin =< 2 x ULN (except for patients with uridine diphosphate glucuronosyltransferase 1A1 [UGT1A1] promoter polymorphism, i.e. Gilbert syndrome, confirmed by genotyping or invader UGT1A1 molecular assay prior to study enrollment; patients enrolled with Gilbert syndrome must have total bilirubin < 3 ULN)Xx_NEWLINE_xXSerum bilirubin within normal range (or =< 1.8 x ULN if liver metastases are present; or total bilirubin =< 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert syndrome)Xx_NEWLINE_xXObtained =< 7 days prior to registration: Total bilirubin =< 1.5 x ULN (does not apply to patients with isolated hyperbilirubinemia [e.g., Gilbert’s disease], in that case direct bilirubin should be =< 2 x ULN)Xx_NEWLINE_xXObtained within 2 weeks from study entry: Total bilirubin =< 1.5 x upper limit of normal (ULN) (patients with known Gilbert syndrome, a total bilirubin =< 3.0 x ULN, with direct bilirubin =< 1.5 x ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dlXx_NEWLINE_xXBilirubin =< 1.5 x ULNXx_NEWLINE_xXSerum bilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin < or equal to 1.5 × ULNXx_NEWLINE_xXTotal bilirubin ? 1.5 × ULN.Xx_NEWLINE_xXTotal bilirubin =< 2.0 mg/dlXx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dLXx_NEWLINE_xXTotal bilirubin >= 3 x ULNXx_NEWLINE_xXTotal serum bilirubin < 1.5, unless there is congenital benign hyperbilirubinemiaXx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dLXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin < 2.0 mg/dlXx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dLXx_NEWLINE_xXTotal bilirubin =< 2.0 mg/dLXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< 3.0 mg/dL (or direct bilirubin < 1 mg/dL)Xx_NEWLINE_xXTotal bilirubin =< 2.0 mg/dLXx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dLXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN (patients with elevated bilirubin due to Gilbert's disease will not be excluded)Xx_NEWLINE_xXTotal bilirubin =< 2 x ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 x IULNXx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dLXx_NEWLINE_xXDirect bilirubin ? 1.5 x ULN except for i) patient with documented Gilbert's syndrome for whom any bilirubin value is allowed and ii) for patients with asymptomatic hyperbilirubinemia (liver transaminases and alkaline phosphatase within normal range)Xx_NEWLINE_xXTotal serum bilirubin < 1.5 mg/dLXx_NEWLINE_xXSerum total bilirubin < 2.0 mg/dL, patients with Gilbert's Syndrome should contact the medical monitorXx_NEWLINE_xXSerum bilirubin =< 1.5 x ULN (unless Gilbert’s syndrome and evidence of hemolysis)Xx_NEWLINE_xXTotal serum bilirubin must be < 3 mg/dL unless the elevation is thought to be due to Gilbert's disease or hemolysisXx_NEWLINE_xXTotal bilirubin > 3 mg/dLXx_NEWLINE_xXTotal bilirubin ? 2.0 × ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dL (unless benign congenital elevated bilirubin)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x institution's ULNXx_NEWLINE_xXTotal bilirubin concentration < 1.5 x the institutional ULNXx_NEWLINE_xX< 2.0 total serum bilirubin (unless secondary to hemolysis)Xx_NEWLINE_xXTotal bilirubin < 3 x ULNXx_NEWLINE_xXDirect bilirubin less than or equal to 3.0 mg/dLXx_NEWLINE_xXSerum bilirubin =< 1.5 X ULNXx_NEWLINE_xXTotal serum bilirubin =< 1.5 mg/dLXx_NEWLINE_xXBilirubin =< 1.5 ULN, (except patients with Gilbert’s syndrome, who must have a total bilirubin less than 3.0 mg/dL)Xx_NEWLINE_xXHepatic: < 1.5 total serum bilirubin, unless there is congenital benign hyperbilirubinemiaXx_NEWLINE_xXTotal bilirubin < 2.0Xx_NEWLINE_xXTotal bilirubin =< ULNXx_NEWLINE_xXBilirubin =< 5 x ULNXx_NEWLINE_xXTotal bilirubin >3 x ULN.Xx_NEWLINE_xXTotal bilirubin ? 1.5 ULNXx_NEWLINE_xXTotal bilirubin =< 2 x ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 X ULN; patients with increased bilirubin due to Gilberts disease will not be excluded, if increased bilirubin is the only protocol exclusion criteria metXx_NEWLINE_xXTotal bilirubin =<1.5 x ULN unless increase is due to Gilbert’s disease or similar syndrome involving slow conjugation of bilirubinXx_NEWLINE_xXBilirubin =< 2.0 mg/dLXx_NEWLINE_xXTotal bilirubin =< 2.0 mg/dL (unless MCL related or attributable to Gilbert’s disease)Xx_NEWLINE_xXSerum bilirubin =< 1.5 x ULNXx_NEWLINE_xXBilirubin of < 3 mg/dlXx_NEWLINE_xXBilirubin =< 1.5 x ULN, CTCAE grade 1Xx_NEWLINE_xXTotal bilirubin =< 3 mg/dLXx_NEWLINE_xXTotal bilirubin < 1.5 mg/dLXx_NEWLINE_xXBilirubin =< 3.0 x ULN, (except patients with Gilbert’s syndrome, who must have a total bilirubin less than 3.0 mg/dL)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< 2.5 x normal prior to biopsyXx_NEWLINE_xXSerum bilirubin < 2 mg/dL (unless due to Gilbert's syndrome)Xx_NEWLINE_xXBilirubin < 3.0 mg/dlXx_NEWLINE_xXBilirubin =< 2.0 x ULN, (except patients with Gilbert’s syndrome, who must have a total bilirubin less than 3.0 mg/dL)Xx_NEWLINE_xXTotal bilirubin <1.6 mg/mlXx_NEWLINE_xXTotal Bilirubin >1.5x ULN (except subjects with Gilbert syndrome, total bilirubin <3.0 mg/dL)Xx_NEWLINE_xXTotal bilirubin =< to 1.5 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dlXx_NEWLINE_xXTotal bilirubin =< 1.5 X ULN (except in patients with Gilbert's)Xx_NEWLINE_xXSerum bilirubin =< 1.5 x ULNXx_NEWLINE_xXBilirubin: ~ 2.0 x ULN (except for subjects with Gilbert’s syndrome, who must have a total bilirubin of less than 3.0 mg/dL)Xx_NEWLINE_xXBilirubin =< 1.5 mg/dLXx_NEWLINE_xXTotal bilirubin >= 1.5 mg/dL and not related to hemolysis or Gilbert's disease; patients with total bilirubin >= 1.5 mg/dL to 3 mg/dL are eligible if at least 75% of the bilirubin is indirectXx_NEWLINE_xXSerum bilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 X ULNXx_NEWLINE_xXAspartate aminotransferase (AST) and alanine aminotransferase (ALT) ?3 × the upper limit of normal (ULN) and total bilirubin ?1.5 × ULN. If the total bilirubin is elevated between 1.5 x and 3 x ULN, patients with a direct bilirubin ? 1.5 X ULN are eligible during the Phase II portion.Xx_NEWLINE_xXTotal bilirubin =< 2 mg/dl (biliary stent is allowed)Xx_NEWLINE_xXBilirubin =< 2.0 mg/100 mlXx_NEWLINE_xXTotal bilirubin =< 1.5 X institutional ULNXx_NEWLINE_xXTotal bilirubin < 1.5 x ULN\r\n* Does not apply to patients with isolated hyperbilirubinemia (e.g., Gilbert's disease) grade < 3Xx_NEWLINE_xXBilirubin < 2.0 mg/dl (unless attributed to Gilbert's disease)Xx_NEWLINE_xXTotal serum bilirubin =< 2.0 x ULNXx_NEWLINE_xXBilirubin =< 2.0 mg/dLXx_NEWLINE_xXElevation of bilirubin to > 3 mg/dlXx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dl, within 14 days of registrationXx_NEWLINE_xXBilirubin < 2.0 mg/dLXx_NEWLINE_xXTotal bilirubin =< 2.0 mg/dlXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULNXx_NEWLINE_xXBilirubin < 1.5Xx_NEWLINE_xXTotal bilirubin < 2.5 mg/dL (unless documented Gilbert’s syndrome)Xx_NEWLINE_xXBilirubin > 1.5Xx_NEWLINE_xXTotal bilirubin =< 3 mg/dLXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin less than or equal to 2.0 mg per dLXx_NEWLINE_xXBilirubin =< 1.5 x ULNXx_NEWLINE_xXARM B: Total bilirubin =< 1.5 X ULN (in patients with known Gilbert syndrome a total bilirubin =< 3.0 x ULN with direct bilirubin =< 1.5 X ULN)Xx_NEWLINE_xXBilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin < 1.5 mg/dlXx_NEWLINE_xXTotal bilirubin less than or equal to 1.5 x ULNXx_NEWLINE_xXException for patients with liver metastasis: total bilirubin =< 3 x ULNXx_NEWLINE_xXTotal bilirubin of =< 1.5 mg/dlXx_NEWLINE_xXBilirubin =< 1.5 times ULN (if total bilirubin elevated, but direct is within normal limits [WNL], patient is eligible)Xx_NEWLINE_xXSerum total bilirubin =< 1.5 x ULN or direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 x ULNXx_NEWLINE_xXTotal bilirubin < 2 mg/dLXx_NEWLINE_xXSerum bilirubin < 1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dl unless felt secondary to Gilbert's diseaseXx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dLXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN); in patients with known Gilbert's syndrome direct bilirubin =< 1.5 x ULN will be used as organ function criteria, instead of total bilirubinXx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dLXx_NEWLINE_xXTotal bilirubin =< 2.0; exception for patients with liver metastasis: total bilirubin =< 3 x ULNXx_NEWLINE_xXTotal bilirubin =< 2.0Xx_NEWLINE_xXSerum bilirubin <2x ULNXx_NEWLINE_xXBilirubin < 2.5 ULNXx_NEWLINE_xXSerum total bilirubin < 1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULNXx_NEWLINE_xXHepatic: < 1.5 total serum bilirubin, unless there is congenital benign hyperbilirubinemiaXx_NEWLINE_xXSerum total bilirubin =< 2.0Xx_NEWLINE_xXTotal bilirubin ? 2 x ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) appropriate for age (except for patients with Gilbert’s syndrome, who must have a total bilirubin < 3 mg/dL) within 30 days prior to registrationXx_NEWLINE_xXTotal serum bilirubin =< 1.5 x ULN (=< 3 x ULN with direct bilirubin within normal range in patients with documented hepatic involvement, well documented Gilbert's syndrome)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x ULNXx_NEWLINE_xX=< 10 days prior to enrollment/randomization: Total bilirubin =< 1.5 mg/dlXx_NEWLINE_xXWithin 8 weeks of randomization: Serum bilirubin =< 1.5 times the upper institutional limits of normal (ULN); patients with a history of Gilbert’s syndrome may be enrolled if the total bilirubin is < 3 mg/dL with a predominance of indirect bilirubinXx_NEWLINE_xXTotal bilirubin ?1.5 x ULN, except in patients with Gilbert's Syndrome who must have a total bilirubin <3 mg/dL (51.3 ?mol/L)Xx_NEWLINE_xXTotal bilirubin ? 1.5 × upper limit of normal (ULN) OR direct bilirubin ? ULN for subjects with total bilirubin levels > 1.5 x ULNXx_NEWLINE_xXBilirubin > 1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin)Xx_NEWLINE_xXSerum total bilirubin =< 1.5 x ULN (1.5 mg/dL or 25.65 umol/L) OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN; except patients with Gilbert's disease (=< 3 x ULN)Xx_NEWLINE_xXTotal bilirubin <1.5 x ULN, except for patients with Gilbert's disease who are eligible if total bilirubin ? 3mg/dL.Xx_NEWLINE_xXBilirubin < 1.5x ULN (except for patients with Gilbert's disease, for whom the upper acceptable limit of serum bilirubin is 3mg/dL)Xx_NEWLINE_xXAdequate hepatic and renal function laboratory values within 14 days prior to registration: Total bilirubin =< 1.5 mg/dL except for patients with a history of elevated total bilirubin, such as in Gilbert'sXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< 3.0Xx_NEWLINE_xXBilirubin =< 2.0 mg/dLXx_NEWLINE_xXBilirubin =< 2.0 mg/dLXx_NEWLINE_xXBilirubin =< 2.0 mg/dLXx_NEWLINE_xXBilirubin =< 2 mg/dLXx_NEWLINE_xXTotal bilirubin =< 3.0 mg/dLXx_NEWLINE_xXBilirubin =< 2.0 mg/dLXx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULNXx_NEWLINE_xXSerum total bilirubin =< 1.5 x ULNXx_NEWLINE_xXBilirubin < 2.0 mg/100 mlXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin < 2.0 mg/dl except < 5 mg/dL in patients with Gilbert’s (as defined as > 80% unconjugated hyperbilirubinemia without other known cause); unless impairment due to organ involvement by lymphomaXx_NEWLINE_xXSerum bilirubin > 2 mg/dl (unless due to Gilbert’s syndrome)Xx_NEWLINE_xXBilirubin ? 1.5 × ULN except for subjects with documented Gilbert's disease, ? 2.5 × ULN;Xx_NEWLINE_xXTotal bilirubin =< 2 X ULN, except for patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dl (part 1 & 2)Xx_NEWLINE_xXTotal bilirubin > 1.5 x ULN at screeningXx_NEWLINE_xXTotal bilirubin less than or equal to 1.5 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dlXx_NEWLINE_xXBilirubin =< 1.5 X upper limit of normal (ULN) unless the patient is receiving protease inhibitor therapy (i.e. indinavir, ritonavir, nelfinavir, and atazanavir) known to be associated with increased bilirubin: in this case total bilirubin =< 7.5 mg/dl and the direct fraction is =< 0.7 mg/dlXx_NEWLINE_xXTotal bilirubin =< 2.0 mg/dL obtained =< 14 days prior to registration (if total is elevated check direct and if normal patient is eligible)Xx_NEWLINE_xXSerum direct bilirubin < 1.5 mg/dL (unless Gilbert's syndrome)Xx_NEWLINE_xXSerum total bilirubin >2.0 mg/dL (with the exception of Gilbert's Syndrome)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN (< 3.0 x ULN in the presence of Gilbert’s disease)Xx_NEWLINE_xXTotal bilirubin all < 2.5 x the institutional ULNXx_NEWLINE_xXTotal bilirubin concentration < 3 X the institutional ULNXx_NEWLINE_xXDirect bilirubin > 0.5mg/dLXx_NEWLINE_xXSerum total bilirubin less than 2.5 mg/dl; patients with elevations of serum total bilirubin up to 10 mg/dl may be considered for participation if such elevations are thought to be due to liver involvement by malignancy; however, in these latter patients, if these values do not decrease to less than or equal to 2.5 times the upper limit of normal during induction chemotherapy, such patients will not be eligible for the transplant phase of the protocol, and will thus be taken off studyXx_NEWLINE_xXTotal bilirubin =< 1.5Xx_NEWLINE_xXPatient has total bilirubin > 2.5 mg/dL.Xx_NEWLINE_xXBilirubin < 1.5 mg/dlXx_NEWLINE_xXBilirubin =< 2.0Xx_NEWLINE_xXBilirubin =< 1.5 mg/dl (total) except < 5 mg/dl in patients with Gilbert’s syndrome as defined by > 80% unconjugatedXx_NEWLINE_xXTotal bilirubin ?1.5 x ULN (except for subjects with documented Gilbert's syndrome)Xx_NEWLINE_xXBilirubin levels greater than 3 mg/dlXx_NEWLINE_xXSerum total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (isolated total bilirubin > 1.5 institutional ULN is acceptable if bilirubin is fractionated and direct bilirubin is < 35%)Xx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXTotal serum bilirubin ? 2.0 × ULN (unless the subject has documented Gilbert Syndrome)Xx_NEWLINE_xXTotal bilirubin ? 1.5× ULN (or ? 3× ULN, with direct bilirubin ?1.5 × ULN, in patients with known Gilbert syndrome).Xx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN or direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic originXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN unless the patient has documented Gilbert syndromeXx_NEWLINE_xXIf organ function abnormalities are considered due to leukemic infiltration, total bilirubin must be =< 2 x ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dlXx_NEWLINE_xXTotal bilirubin =< 2Xx_NEWLINE_xXDirect bilirubin =< 1.4 mg/dL (if total bilirubin > 1.4 mg/dL)Xx_NEWLINE_xXTotal serum bilirubin < 1.5 x ULN, unless there is congenital benign hyperbilirubinemiaXx_NEWLINE_xXSerum bilirubin ? 2 x ULN unless due to Gilbert's syndrome or hemolysis or considered to be related to leukemia;Xx_NEWLINE_xXSerum total bilirubin of at least 3 mg/dLXx_NEWLINE_xXBilirubin =< 1.5Xx_NEWLINE_xXTotal bilirubin values <1.5 x ULN unless the bilirubin is principally unconjugated (in the context of hemolysis) or there is documented Gilbert's disease.Xx_NEWLINE_xXSerum direct bilirubin < 1.5 mg/dL (unless Gilbert's syndrome)Xx_NEWLINE_xXDirect bilirubin less than 3.0, indirect bilirubin less than 4.0Xx_NEWLINE_xXPatient has > 1.5 x ULN total bilirubinXx_NEWLINE_xXTotal bilirubin ? 1.5x ULN for age. If the total bilirubin is elevated, patient will still be eligible if the conjugated (direct) serum bilirubin ? ULN for age.Xx_NEWLINE_xXTotal bilirubin =< 1.2 mg/dL (except patients with Gilbert’s syndrome)Xx_NEWLINE_xXBilirubin =< 1.5 mg/dlXx_NEWLINE_xXTotal bilirubin < 1.5 × ULN (except for subjects with documented Gilbert's syndrome)Xx_NEWLINE_xXTotal bilirubin =< 3 x ULN (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN unless bilirubin rise is considered to be the result of leukemic involvement by the PIXx_NEWLINE_xXTotal bilirubin must be 1.5 ULN with the following exception: Patients with known Gilbert disease who have serum bilirubin level 3 ULN may be enrolled.Xx_NEWLINE_xXTotal serum bilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin < 1.5 mg/dL or UNLXx_NEWLINE_xXSerum bilirubin =< 2.0 (unless hemolysis or Gilbert disease)Xx_NEWLINE_xXTotal bilirubin =< ULNXx_NEWLINE_xXTotal bilirubin =< 2 mg/dLXx_NEWLINE_xXBilirubin =< 1.5 x ULN, except in cases of patients with Gilbert’s disease, where =< 4 x ULN will be allowedXx_NEWLINE_xXBilirubin < 3 mg/dl unless due to diseaseXx_NEWLINE_xXSerum direct bilirubin less than 1 mg/dl (unless due to Gilbert’s syndrome or hemolysis)Xx_NEWLINE_xXBilirubin > 3.0 mg/dlXx_NEWLINE_xXBilirubin ?1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin).Xx_NEWLINE_xXSerum bilirubin within normal range (or =< 1.5 x ULN if liver metastases are present; or total bilirubin =< 3.0 x ULN with direct bilirubin within normal range in patients with well-documented Gilbert Syndrome)Xx_NEWLINE_xXBilirubin: =< 2.0 x ULN (except for subjects with Gilbert’s syndrome, who must have a total bilirubin of less than 3.0 mg/dL)Xx_NEWLINE_xXTotal bilirubin < 2 x ULNXx_NEWLINE_xXTotal bilirubin ? 1.5 x ULNXx_NEWLINE_xXTotal bilirubin ? 1.5 x ULNXx_NEWLINE_xXSerum bilirubin levels =< 1.5 mg/dL except for patients with Gilbert’s syndromeXx_NEWLINE_xXTotal bilirubin < 2.5 mg/dlXx_NEWLINE_xXFor patients with Gilbert's syndrome total bilirubin > 2.5 x ULNXx_NEWLINE_xXBilirubin for Gilbert’s =< 3.0 mg/dlXx_NEWLINE_xXTotal bilirubin should be =< 1.5 x upper limit of normal (ULN); if, however, the elevated bilirubin is felt to be secondary to atazanavir therapy, participants will be allowed to enroll on protocol if the total bilirubin is =< 3.5 mg/dL provided that the direct bilirubin is normalXx_NEWLINE_xXTotal bilirubin must be =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< to 2.0 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dlXx_NEWLINE_xXTotal bilirubin =< 2.0 x ULN, unless elevated bilirubin is attributable to Gilbert’s syndrome or to HIV medications (e.g., indinavir, tenofovir, atazanavir)Xx_NEWLINE_xXSerum bilirubin < 1.5 x ULNXx_NEWLINE_xXTotal bilirubin ?1.5 x ULN, unless secondary to Gilbert's diseaseXx_NEWLINE_xXTotal serum bilirubin > 2.0 mg/dlXx_NEWLINE_xXTotal bilirubin =< to 1.5 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dlXx_NEWLINE_xXSerum bilirubin =< ULNXx_NEWLINE_xXBilirubin less than or equal to 1.5 mg/dL; even if organ function abnormalities are considered due to tumor, the upper limit for bilirubin is less than or equal to 2.0 mg/dL (unless due to hemolysis or Gilbert’s disease, i.e. mainly indirect bilirubin)Xx_NEWLINE_xXSerum total bilirubin < 2 mg/dl; patients with Gilbert syndrome are excluded from the requirement of a normal bilirubinXx_NEWLINE_xXBilirubin < 1.5 mg/dl except for Gilbert’s diseaseXx_NEWLINE_xXTotal bilirubin > 1.5 x ULNXx_NEWLINE_xXTotal bilirubin ?1.5 mg/dLXx_NEWLINE_xXSerum total bilirubin =< 1.5 x ULN OR total bilirubin =< 4.0 ULN with direct bilirubin =< 1.5 x ULN in patients with well documented Gilbert syndromeXx_NEWLINE_xXTotal bilirubin < 2.0 mg/dLXx_NEWLINE_xXTotal bilirubin ? 1.5 times the upper limit of normal (ULN); for patients with hepatocellular carcinoma only, total bilirubin ? 3 mg/dL (i.e. Child-Pugh Score for bilirubin is no greater than 2).Xx_NEWLINE_xXTotal bilirubin =< 2.0 mg/dLXx_NEWLINE_xXTotal bilirubin =< 2.5 mg/dLXx_NEWLINE_xXTotal bilirubin =< 1.5 x the upper limit of normal (ULN); for subjects with known Gilbert's disease, bilirubin =< 3.0 mg/dLXx_NEWLINE_xXTotal bilirubin =< 2.0 mg/dlXx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dlXx_NEWLINE_xXTotal Bilirubin < 1.5 x ULNXx_NEWLINE_xXTotal serum bilirubin ? 1.5 x ULNXx_NEWLINE_xXBilirubin < 1.5 mg/dlXx_NEWLINE_xXTotal bilirubin ?1.5 x ULNXx_NEWLINE_xXTotal bilirubin: see guidelines for individual cohortsXx_NEWLINE_xXSerum total bilirubin =< 2.0 mg/dLXx_NEWLINE_xXBilirubin <1.5 mg/dL or direct bilirubin <1.0 mg/dLXx_NEWLINE_xXTotal bilirubin less than or equal to 1.5 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dlXx_NEWLINE_xXTotal bilirubin =< 3 mg/dlXx_NEWLINE_xXTotal bilirubin < 1.5 x ULN (except subjects with Gilbert syndrome who can have total bilirubin < 3.0 mg/deciliter) should be obtained with 28 days prior to randomizationXx_NEWLINE_xXBilirubin =< 1.5 x upper limit of normal (ULN) (CTCAE v4.03 grade 1; in patients with known Gilbert syndrome, a total bilirubin =< 3.0 x ULN, with direct bilirubin =< 1.5 x ULN)Xx_NEWLINE_xXTotal bilirubin >1.5x ULN (unless due to Gilbert's Syndrome)Xx_NEWLINE_xXSerum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN within 7 days of treatment initiationXx_NEWLINE_xXSerum total bilirubin < 1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< 2 mg/dLXx_NEWLINE_xXBilirubin =< 1.5 mg/dLXx_NEWLINE_xXTotal bilirubin >2.5 mg/dLXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN); for subjects with known Gilbert’s disease or similar syndrome with slow conjugation of bilirubin, total bilirubin =< 3.0 mg/dLXx_NEWLINE_xXSerum bilirubin < 1.5 x ULN unless due to Gilbert's syndrome. o Serum bilirubin ? 1.0 x ULN unless due to Gilbert's syndrome, Treatment Arm B only (CC-122 in combination with ibrutinib)Xx_NEWLINE_xXTotal bilirubin <1.5 mg/dl, except in subjects with Gilbert's syndromeXx_NEWLINE_xXTotal bilirubin must be =< the upper limit of normal (ULN) for the lab unless the patient has a grade 1 bilirubin elevation (> ULN to 1.5 x ULN) resulting from Gilbert’s disease or similar syndrome due to slow conjugation of bilirubin; andXx_NEWLINE_xXSerum bilirubin =< 1.5 x ULN (unless secondary to Gilbert's disease)Xx_NEWLINE_xXTotal bilirubin ?2 mg/dLXx_NEWLINE_xXDirect bilirubin ? 2.0 x ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 x upper limit of normal (ULN) unless due to Gilbert’s disease; if total bilirubin is > 1.5 x ULN, a direct bilirubin should be performed and must be < 1.5 mg/dL for Gilbert’s to be diagnosedXx_NEWLINE_xXBilirubin ? 1.5 x the ULNXx_NEWLINE_xXBilirubin =< 1.5 ULN, (except patients with Gilbert’s syndrome, who must have a total bilirubin less than 3.0 mg/dL)Xx_NEWLINE_xXDirect bilirubin =< 1.5 x the upper limit of normal (ULN); for subjects with known Gilbert’s disease, direct bilirubin =< 3.0 mg/dLXx_NEWLINE_xXBilirubin =< 1.5 ULN (subjects with documented diagnosis of Gilbert’s syndrome are eligible provided total bilirubin < 3.0 x ULN)Xx_NEWLINE_xXTotal bilirubin >ULN: Subjects with Gilbert's syndrome are allowed if total bilirubin is <3.0 mg/dL and direct bilirubin is ?ULN,Xx_NEWLINE_xXTotal bilirubin =< upper limit of normal (ULN) for age, or if total bilirubin is > ULN, direct bilirubin is =< 1.5 mg/dLXx_NEWLINE_xXTotal serum bilirubin ? ULN unless due to Gilbert's Syndrome;Xx_NEWLINE_xXSerum total bilirubin ? 1.5 x the ULN.Xx_NEWLINE_xXTotal bilirubin ?3.0 mg/dLXx_NEWLINE_xXDirect bilirubin less than or equal to 3.0 mg/dLXx_NEWLINE_xXTotal bilirubin =< upper limit of normal (ULN) for age, or if total bilirubin is > ULN, direct bilirubin is =< 1.4 mg/dl andXx_NEWLINE_xXtotal bilirubin of ? 2.0 mg/dl (? 3.0 mg/dl for patients with known Gilbert's syndrome)Xx_NEWLINE_xXPatient must have adequate hepatic function documented by a total bilirubin of ? 2.0 mg/dl (? 3.0 mg/dl for patients with known Gilbert's syndrome) and ALT and AST ? 3 times the ULN for the reference lab.Xx_NEWLINE_xXPatient's total bilirubin must be ? 1.5 x ULN.Xx_NEWLINE_xXTotal bilirubin =< 2.5 mg/dLXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULNXx_NEWLINE_xXSerum total bilirubin > 1.5 mg/dL or > 3 × ULN for patients with hereditary benign hyperbilirubinemiaXx_NEWLINE_xXTotal serum bilirubin =< 2.0 x ULNXx_NEWLINE_xXNormal total serum bilirubinXx_NEWLINE_xXBilirubin =< 1.5 x ULNXx_NEWLINE_xXSerum total bilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dL (unless there is a known history of Gilbert's syndrome)Xx_NEWLINE_xXSerum bilirubin =< 1.5 x ULN (patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled)Xx_NEWLINE_xXBilirubin =< 2 x ULNXx_NEWLINE_xXBilirubin ? 1.5 × ULN except for cases of documented or suspected Gilbert's disease, in which bilirubin must be ? 5 × ULNXx_NEWLINE_xXTotal bilirubin < 3 x ULN, exception is elevated indirect bilirubin attributed to Gilbert’s syndrome or hemolysisXx_NEWLINE_xXTotal bilirubin ? 1.5 x ULNXx_NEWLINE_xXTotal bilirubin ? 1.5x institutional ULNXx_NEWLINE_xXSerum bilirubin 1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin)Xx_NEWLINE_xXBilirubin ?1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin)Xx_NEWLINE_xXTotal bilirubin >1.0 x ULN.Xx_NEWLINE_xXTotal bilirubin < 2.0 mg/dL, except when the patient is known to have Gilbert’s syndrome, the total bilirubin can be =< 3.0 mg/dLXx_NEWLINE_xXTotal bilirubin ? 1.5 × ULN except in cases of Gilbert's disease and liver metastases.Xx_NEWLINE_xXTotal bilirubin =< to 1.5 mg/dL, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dLXx_NEWLINE_xXSerum total bilirubin >1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dLXx_NEWLINE_xXTotal bilirubin ? 1.5 X ULN. Patients with elevated bilirubin known to be due to Gilbert's disease may be enrolled after approval from the medical monitor, andXx_NEWLINE_xXDirect bilirubin equal to or less than 2.0 mg/dLXx_NEWLINE_xXTotal bilirubin =< 2.5 mg/dlXx_NEWLINE_xXPerformed within 10 days of treatment initiation: Serum total bilirubin =< 1.5 x upper limit of normal (ULN) OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXTotal bilirubin =< ULNXx_NEWLINE_xXParticipants with moderate hepatic impairment: total bilirubin must be > 1.5 to 3 x ULN with any ALT level.Xx_NEWLINE_xXParticipants with severe hepatic impairment: total bilirubin must be > 3 x ULN with any ALT level.Xx_NEWLINE_xXTotal bilirubin ? 1.5 × institutional ULN [? 2.0 x ULN in presence of liver metastases] within 14 days prior to randomization.Xx_NEWLINE_xXTotal bilirubin =< 2.0 x ULNXx_NEWLINE_xXTotal bilirubin < 1.5 x ULN for age or normal conjugated bilirubinXx_NEWLINE_xXBilirubin =< 1.5 x ULNXx_NEWLINE_xXBilirubin < 1.5 × ULN.Xx_NEWLINE_xXTotal bilirubin =< ULNXx_NEWLINE_xXBilirubin ? 1.5 × ULN except for cases of documented or suspected Gilbert's disease, in which bilirubin must be ? 5 × ULNXx_NEWLINE_xXTotal serum bilirubin < 1.5x institutional ULNXx_NEWLINE_xXTotal bilirubin ? 1.5 × ULN except subjects with documented Gilbert's syndrome (> 3 × ULN) or liver metastasis, who must have a baseline total bilirubin ? 3.0 mg/Xx_NEWLINE_xXSerum bilirubin levels =< 1.5 mg/dL except for patients with Gilbert’s syndromeXx_NEWLINE_xXTotal bilirubin ? 1.5 x the upper limit of normal (ULN). Mildly elevated total bilirubin (< 6 mg/dL) is allowed if Gilbert's syndrome is documented.Xx_NEWLINE_xXSerum bilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin < 1.5 mg/dlXx_NEWLINE_xXBilirubin and total bilirubin levels =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< 2.0 mg/dLXx_NEWLINE_xXTotal bilirubin >= 1.5 × the ULN for the institutionXx_NEWLINE_xXSerum bilirubin < 1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< 2.0 mg/dL (excluding Gilbert’s syndrome), unless due to lymphomaXx_NEWLINE_xXTotal bilirubin (TBili) <1.5 x ULNXx_NEWLINE_xXAbnormal liver function tests: Serum aspartate transaminase (AST/SGOT) or alanine transaminase ( ALT/SGPT) 2 x upper limit of normal (ULN). Serum bilirubin. Total bilirubin > 2.0 mg/dL (34 µmol/L), conjugated bilirubin > 0.8 mg/dL.Xx_NEWLINE_xXSerum bilirubin < 2 x ULNXx_NEWLINE_xXTotal bilirubin < 4.0 mg/dlXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< 2.5 mg/dLXx_NEWLINE_xXTotal bilirubin > 1.5× the ULN for the institution, unless considered due to Gilbert's SyndromeXx_NEWLINE_xXTotal bilirubin =< 2.0 mg/dL unless due to Gilbert’s syndrome, hemolysis, or ineffective hematopoiesisXx_NEWLINE_xXTotal bilirubin ?3.0 mg/dLXx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dL; in patients with known Gilbert’s syndrome, direct bilirubin =< 1.5 x upper limit of normal (ULN) will be used as organ function criteria, instead of total bilirubinXx_NEWLINE_xXBilirubin ? 1.5 x ULNXx_NEWLINE_xXtotal bilirubin ?1.5 X institutional ULN unless due to Gilbert's syndrome, controlled autoimmune hemolytic anemia or immune thrombocytopeniaXx_NEWLINE_xXTotal bilirubin ?2.0 times the ULN for the institution, unless considered due to Gilbert's syndrome;Xx_NEWLINE_xXTotal bilirubin ?1.5 x ULNXx_NEWLINE_xXSerum bilirubin =< 1.5 x ULNXx_NEWLINE_xXMust have total serum bilirubin ? 3 mg/dlXx_NEWLINE_xXBilirubin ?1.5 mg/dLXx_NEWLINE_xXBilirubin less than 1.5 mg/dL; (except in patients with Gilbert's syndrome, who must have a total bilirubin less than 3.0 mg/dL)Xx_NEWLINE_xX< 1.5 total serum bilirubin, unless there is congenital benign hyperbilirubinemiaXx_NEWLINE_xXTotal bilirubin < 1.5 mg/dlXx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dlXx_NEWLINE_xXBilirubin =< 1.6 mg/dLXx_NEWLINE_xXTotal bilirubin ? 1.5 × ULN OR direct bilirubin ? 1 × ULNXx_NEWLINE_xXTotal bilirubin ? 1.5 × ULN except in patients with Gilbert's syndrome. Patients with Gilbert's syndrome may enroll if direct bilirubin ? 1.5 × ULN of the direct bilirubin.Xx_NEWLINE_xXTotal bilirubin ?2 x ULN (?5 x ULN if considered due to Gilbert's syndrome or hemolysis)Xx_NEWLINE_xXTotal bilirubin =< 2 X ULN unless related to antiretroviral use (e.g., atazanavir and indinavir), then the direct bilirubin must be =< 2 X ULNXx_NEWLINE_xXTotal bilirubin =< to 1.5 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dlXx_NEWLINE_xXTotal bilirubin less than or equal to 2 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3 mg/dlXx_NEWLINE_xXSerum bilirubin =< 1.5 x ULNXx_NEWLINE_xXBilirubin ? 1.5 x ULNXx_NEWLINE_xXTotal bilirubin < 2.0Xx_NEWLINE_xXBilirubin > 2.0Xx_NEWLINE_xXConjugated bilirubin </= 1.5 mg/dL (or total bilirubin </= 2.5 mg/dL)Xx_NEWLINE_xXBilirubin levels < 1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin < 1.5 x ULN (< 3.0 x ULN for subjects with documented Gilbert's Disease or for whom the indirect bilirubin level suggests an extrahepatic source of elevation);Xx_NEWLINE_xXTotal bilirubin =< 1.5 x ULNXx_NEWLINE_xXSerum bilirubin =< 1.5 x ULNXx_NEWLINE_xXBilirubin =< 1.5 mg/dLXx_NEWLINE_xXBilirubin =< 1.50 mg/dLXx_NEWLINE_xXTotal bilirubin < 1.5 mg/dlXx_NEWLINE_xXTotal bilirubin < 3.0 mg/dlXx_NEWLINE_xXPatient has > 1.5 x ULN total bilirubin, unless history of Gilbert's syndromeXx_NEWLINE_xXAdequate hepatic function as evidenced by the following serum chemistry values: total bilirubin, ULN. If total bilirubin is greater than (>) ULN, measure indirect bilirubin to evaluate for Gilbert's syndrome (if direct bilirubin is within normal range, participant may be eligible) ALP 2.5 x ULN; Trabectedin: if the ALP is >2.5 x ULN, then an ALP liver fraction or 5-nucleotidase must be obtained and ULN, AST and ALT 2.5 ULNXx_NEWLINE_xXDocumentation of inclusion criteria adequate organ function as evidenced by the following peripheral blood counts or serum chemistry values: hemoglobin 9 gram per deciliters (g/dL), absolute neutrophil count (ANC) 1,500/L, platelet count 100,000/L, serum creatinine 1.5*the upper limit of normal (ULN), creatine phosphokinase (CPK) 2.5*ULN and adequate hepatic function as evidenced by the following serum chemistry values: total bilirubin, ULN. If total bilirubin is greater than (>) ULN, measure indirect bilirubin to evaluate for Gilbert's syndrome (if direct bilirubin is within normal range, participant may be eligible) ALP <= 2.5*ULN; Trabectedin: if the ALP is >2.5*ULN, then an ALP liver fraction or 5-nucleotidase must be obtained and ULN, AST and ALT 2.5 ULN will be reviewed by the Sponsor before enrollment in the OEP may occurXx_NEWLINE_xXBilirubin =< 3.0 mg/dL (unless due to Gilbert’s syndrome or hemolysis)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN for ageXx_NEWLINE_xXBilirubin =< 3.0 x ULN (except patients with Gilbert's syndrome, who must have a total bilirubin less than 3.0 mg/dL)Xx_NEWLINE_xXSerum total bilirubin > 2.0 mg/dLXx_NEWLINE_xXTotal bilirubin =< 3 mg/dlXx_NEWLINE_xXTotal bilirubin =< 2.0 mg/dlXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin < 2.0 mg/dL or < 1.50 x ULN for the institution whichever is higherXx_NEWLINE_xXTotal bilirubin ?1.5 X ULN unless considered due to Gilbert's syndromeXx_NEWLINE_xXTotal bilirubin ?1.5X ULN, unless considered due to Gilbert's syndromeXx_NEWLINE_xXTotal bilirubin ?2X ULN, unless considered due to Gilbert's syndromeXx_NEWLINE_xXTotal bilirubin ?2X ULN, unless considered due to Gilbert's syndromeXx_NEWLINE_xXTotal bilirubin > 1.5 x ULN (unless due to lymphoma or isolated, predominantly indirect hyperbilirubinemia due to Gilbert's syndrome)Xx_NEWLINE_xXBilirubin > 2.0 mg/dL (26 umol/L)Xx_NEWLINE_xXALT < 3 times ULN and bilirubin < 1.5 mg/dLXx_NEWLINE_xXBilirubin less than or equal to 1.5 x ULNXx_NEWLINE_xXTotal bilirubin > 2x ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 X ULNXx_NEWLINE_xXBilirubin =< 1.5 mg/dl (unless Gilbert's syndrome)Xx_NEWLINE_xXTotal bilirubin < 1.5 X ULN mg/dlXx_NEWLINE_xXBilirubin < 5 ULNXx_NEWLINE_xXBilirubin < 1.5 ULNXx_NEWLINE_xXBilirubin < 1.5 x ULNXx_NEWLINE_xXSerum direct bilirubin =< 2.0 mg/dlXx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dlXx_NEWLINE_xXTotal Bilirubin > 2 mg/dLXx_NEWLINE_xXTotal bilirubin =< 2.0Xx_NEWLINE_xXTotal bilirubin < 2 × upper limit of normal, direct bilirubin < 2.0 mg/dL.Xx_NEWLINE_xXTotal serum bilirubin ? 2.0 mg/dLXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN; (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)Xx_NEWLINE_xXTotal bilirubin < 2 mg/dLXx_NEWLINE_xXSerum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXBilirubin < 1.5 x ULNXx_NEWLINE_xXTotal bilirubin less than or equal to 2.0 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dlXx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dLXx_NEWLINE_xXBilirubin > 1.5 x upper limit normal (ULN), except for patients with known Gilbert syndrome who are excluded if total bilirubin > 3.0 x ULN or direct bilirubin > 1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< 2.0 x ULNXx_NEWLINE_xXTotal bilirubin =< to 1.5 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dlXx_NEWLINE_xXTotal bilirubin =< 2.5 mg/dlXx_NEWLINE_xXTotal bilirubin =< to 1.5 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dlXx_NEWLINE_xXBilirubin less than or equal to 1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN, except for patients with Gilbert’s syndrome who may be included if total bilirubin =< 3.0 x ULN OR direct bilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal serum bilirubin < 1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< 2 x ULN, or < 5 ULN if Gilbert’s diseaseXx_NEWLINE_xXTotal serum bilirubin > 2 mg/dLXx_NEWLINE_xXBilirubin =< 2.0 x ULN, (except patients with Gilbert’s syndrome, who must have a total bilirubin less than 3.0 mg/dL)Xx_NEWLINE_xXBilirubin > 1.6 mg/dLXx_NEWLINE_xXSerum total bilirubin =< ULN or 1.5 x ULN if liver metastases are present or total 3 x ULN with direct bilirubin =< ULN in patients with well documented Gilbert syndromeXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN for ageXx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dL unless due to Gilbert’s diseaseXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULNXx_NEWLINE_xXBilirubin =< 2.0 mg/dLXx_NEWLINE_xXBilirubin > 1.5 X ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dLXx_NEWLINE_xXBilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXTotal serum bilirubin <1.5 × ULN andXx_NEWLINE_xXPerformed within 10 days of treatment initiation: Total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for patients with total bilirubin levels > 1.5 x ULNXx_NEWLINE_xXTotal bilirubin ? 1.5 x ULN (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)Xx_NEWLINE_xXTotal serum bilirubin =< 1.5 mg/dLXx_NEWLINE_xXSerum total bilirubin =< 1.5 x upper limit of normal (ULN) (except in subjects with Gilbert’s syndrome who have a total bilirubin > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is =< 1.5 x ULN, subject may be eligible)Xx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dL X ULN unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic originXx_NEWLINE_xXSerum total bilirubin =< 2 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 2 ULN (performed within 10 days of treatment initiation)Xx_NEWLINE_xXSerum bilirubin =< 2.0 x ULN with the following exception: patients with known Gilbert’s disease should have a serum bilirubin =< 3 x ULN (obtained within 28 days prior to the first study treatment)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN.Xx_NEWLINE_xXTotal bilirubin > 1.5 x ULNXx_NEWLINE_xXSerum bilirubin =< 2.0Xx_NEWLINE_xXTotal bilirubin >= 2 x IULNXx_NEWLINE_xXBilirubin =< 3.0 mg/dL (unless due to Gilbert’s syndrome or hemolysis)Xx_NEWLINE_xXBilirubin > 1 x ULN for the laboratoryXx_NEWLINE_xXTotal bilirubin < 3 x ULNXx_NEWLINE_xXTotal bilirubin >= 1.5 x ULN 14 days prior to study enrollmentXx_NEWLINE_xXSerum direct bilirubin >= 1 mg/dl (except Gilbert's syndrome or hemolysis)Xx_NEWLINE_xXHepatic: < 1.5 total serum bilirubin, unless there is congenital benign hyperbilirubinemiaXx_NEWLINE_xXBilirubin > 2Xx_NEWLINE_xXBilirubin level >= 3.7 mg/dL.Xx_NEWLINE_xXTotal bilirubin < 2.5 mg/dL unless the increase in bilirubin is attributable to Gilbert‘s syndromeXx_NEWLINE_xXBilirubin > 10.0Xx_NEWLINE_xXTotal bilirubin =< 10 x ULNXx_NEWLINE_xXBilirubin =< 2.5 mg/dL, except for patients with Gilbert’s syndrome or hemolysisXx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dLXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULNXx_NEWLINE_xXBilirubin =< 1.5 x ULN (unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin)Xx_NEWLINE_xXBilirubin =< 1.5 x ULN (except subjects with Gilbert’s syndrome who must have total bilirubin =< 3.0 mg/dL), obtained within 14 days of the first dose of study drugXx_NEWLINE_xXBilirubin =< 2.0 x ULN (unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXTotal bilirubin >1.5 × ULN; >3 × ULN with direct bilirubin, >1.5 × ULN in the presence of Gilbert's DiseaseXx_NEWLINE_xXTotal bilirubin =< 2, unless due to Gilbert’s diseaseXx_NEWLINE_xXTotal serum bilirubin =< 1.5 mg/dl (patients with total bilirubin > 1.5 mg/dL eligible only with Gilbert’s syndrome)Xx_NEWLINE_xXTotal bilirubin =< 2 x ULN (in the expansion cohort, patients with Gilbert’s syndrome [hereditary indirect hyperbilirubinemia] who must have a total bilirubin of =< 3 x ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dLXx_NEWLINE_xXTotal bilirubin < 2.0 mg/dl-exception permitted in participants with Gilbert’s syndromeXx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dLXx_NEWLINE_xXSerum total bilirubin ? 2.0 x ULNXx_NEWLINE_xXSerum bilirubin < institutional ULN (in patients with Gilbert’s disease, direct bilirubin < institutional ULN)Xx_NEWLINE_xXA total bilirubin of less than 2.5 mg/dL, unless these values are due to underlying hematologic malignancyXx_NEWLINE_xXTotal bilirubin equal to or less than 2 mg/dlXx_NEWLINE_xXSerum total bilirubin =< 3Xx_NEWLINE_xXTotal bilirubin =< 3.0 mg/dL (bilirubin =< 1.5 x ULN)Xx_NEWLINE_xXSerum bilirubin ? 1.5 times the upper limits of normal. Subjects with a history of Gilbert's syndrome may be enrolled if the total bilirubin is < 3 mg/dL with an indirect bilirubin of > 1.5 mg/dLXx_NEWLINE_xXTotal bilirubin < 2.0 mg/dl, unless hepatic dysfunction is a manifestation of cGVHD; for patients in whom a diagnosis of hemolysis or Gilbert’s is made, the total bilirubin is allowed to be elevatedXx_NEWLINE_xXA bilirubin of up to 2.0 mg/dL, excluding patients with Gilbert’s diseaseXx_NEWLINE_xXTotal bilirubin =< 3.0 mg/dLXx_NEWLINE_xXTotal bilirubin < 2.0 mg/dlXx_NEWLINE_xXTotal bilirubin ? 1.5 ULN of institution's rangeXx_NEWLINE_xXBilirubin < 2 x ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional upper limit of normal (ULN) Note: Higher total bilirubin levels (=< 3 mg/dL) can be allowed if due to known benign liver condition, i.e. Gilbert’sXx_NEWLINE_xXTotal bilirubin =< 1.5 mg/dl within 90 days of enrollmentXx_NEWLINE_xXBilirubin < 2.5Xx_NEWLINE_xXTotal bilirubin (bili) =< 1.5 x ULN orXx_NEWLINE_xXTotal bilirubin > 1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< 2.0 mg/dlXx_NEWLINE_xXTotal bilirubin ?1.5 mg/dLXx_NEWLINE_xXTotal bilirubin =< 2 x institutional ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 x institutional ULNXx_NEWLINE_xXTotal bilirubin =< 2.0, within 30 days prior to enrollmentXx_NEWLINE_xXBilirubin > 1.5 x ULN (CTCAE grade 2)Xx_NEWLINE_xXTotal bilirubin =< 2.5 mg/dl (unless the patient has a history of Gilbert’s syndrome)Xx_NEWLINE_xXTotal bilirubin =< 2 x institutional ULN obtained =< 45 days prior to randomizationXx_NEWLINE_xXTotal serum bilirubin =< 2.0 mg/dLXx_NEWLINE_xXSerum bilirubin ? 1.5 x ULN.Xx_NEWLINE_xXTotal bilirubin < 1.5 x ULNXx_NEWLINE_xXBilirubin =< 1.5 mg/dlXx_NEWLINE_xXTotal bilirubin < 1.5 mg/dlXx_NEWLINE_xXT. bilirubin < 2 mg/dl (Patients with Gilbert Syndrome total bilirubin <3xULN and direct bilirubin ? 35%)Xx_NEWLINE_xXTotal bilirubin £ 1.5 × ULNXx_NEWLINE_xXDirect serum bilirubin ? 1.5 x ULNXx_NEWLINE_xXTotal bilirubin < 1.5 x ULN for ageXx_NEWLINE_xXTotal bilirubin > 2.0 mg/dLXx_NEWLINE_xXTotal bilirubin < ULN; or total bilirubin =< 3.0 x ULN or direct bilirubin =< 1.5 x ULN in patients with well- documented Gilbert’s syndromeXx_NEWLINE_xXSerum bilirubin =< institution ULN (except for subjects with Gilbert’s Disease who are eligible despite elevated serum bilirubin level)Xx_NEWLINE_xXTotal bilirubin =< 2.0 mg/dlXx_NEWLINE_xXTotal bilirubin within 2 x ULNXx_NEWLINE_xXTotal bilirubin < 5 X institutional ULNXx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 10 days of treatment initiationXx_NEWLINE_xX- Total bilirubin < 1.5 x ULN (< 3 x ULN in patients with known/suspected Gilbert's disease)Xx_NEWLINE_xXTotal bilirubin less than or equal to 1.5 x ULNXx_NEWLINE_xXTotal bilirubin < 3 x ULNXx_NEWLINE_xXBilirubin < 1.5 x ULN (unless Gilbert’s is suspected in which case total bilirubin < 3 x ULN)Xx_NEWLINE_xXTotal bilirubin < 3.0Xx_NEWLINE_xXBilirubin < 1.5 x ULNXx_NEWLINE_xXSubjects must have a serum direct bilirubin < 2.0 mg/dL unless related to Gilbert’s syndrome of hemolysis; if the total bilirubin =< 2.0, direct bilirubin does not need to be drawnXx_NEWLINE_xXBilirubin > 1.4 mg/dlXx_NEWLINE_xXBilirubin (total) > 1.5 x ULNXx_NEWLINE_xXTotal serum bilirubin =< 1.5 x ULN (if documented Gilberts syndrome =< 3 x ULN) obtained =< 14 days prior to registrationXx_NEWLINE_xXTotal bilirubin ?1.5 x ULN, except in subjects with documented Gilbert's Syndrome, who must have a total bilirubin ?3 x ULNXx_NEWLINE_xXTotal bilirubin ? 1.5 mg/dLXx_NEWLINE_xXTotal bilirubin < 1.5 x ULN (if thought to be > 1.5 x ULN due to Gilbert’s disease or the patient’s AML, must discuss with the principal investigator [PI])Xx_NEWLINE_xXTotal serum bilirubin < 1.5 x ULN or total bilirubin =< 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert’s syndrome or hemolysis or who required regular blood transfusionsXx_NEWLINE_xXTotal bilirubin =< 2.0 mg/dLXx_NEWLINE_xXBilirubin < 2.0 mg/dLXx_NEWLINE_xXBilirubin < 2.0 mg/ dLXx_NEWLINE_xXTotal bilirubin < 1.5 X ULNXx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, obtained =< 30 days prior to registrationXx_NEWLINE_xXSerum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 10 days of treatment initiationXx_NEWLINE_xXTotal bilirubin =< 1.5 x ULNXx_NEWLINE_xXTotal serum bilirubin =< 1.5 x ULNXx_NEWLINE_xXSerum total bilirubin ? 2.5 mg/dL (43 ?mol/L), except for subjects with Gilbert's syndrome.Xx_NEWLINE_xXTotal serum bilirubin < 2.0 mg/dL, within 2 weeks prior to study startXx_NEWLINE_xXSerum bilirubin =< 4.0 x ULN or LLN (except for patients with Gilbert’s disease)Xx_NEWLINE_xXTotal bilirubin =< 2 mg/dLXx_NEWLINE_xXBilirubin > 1.5 x ULNXx_NEWLINE_xXTotal bilirubin < 1.5 mg/dLXx_NEWLINE_xX- Total bilirubin < 1.5 x ULN (< 3 x ULN in patients with known/suspected Gilbert's disease)Xx_NEWLINE_xXBilirubin > 1.5 x ULNXx_NEWLINE_xXBilirubin > 1.5 x ULNXx_NEWLINE_xXTotal bilirubin ?1.5×ULN.Xx_NEWLINE_xXSerum bilirubin =< 1.5 x institutional ULNXx_NEWLINE_xXTotal Bilirubin <4.0 mg/dlXx_NEWLINE_xXBilirubin > 1.6 mg/dLXx_NEWLINE_xXTotal bilirubin within the normal range at the screening visitXx_NEWLINE_xXGreater than 3 x the ULN for total bilirubin (except for known cases of Gilbert’s syndrome, where the levels of conjugated bilirubin must be less than 3 x the ULN)Xx_NEWLINE_xXTotal bilirubin =< 1.5 x ULN mg/dLXx_NEWLINE_xXTotal bilirubin ? 1.5 x ULN.Xx_NEWLINE_xXDirect bilirubin ? 1.5 x ULN except for i) patients with documented Gilbert's syndrome for whom any bilirubin value is allowed and ii) for patients with asymptomatic hyperbilirubinemia (liver transaminases and alkaline phosphatase within normal range).Xx_NEWLINE_xXTotal bilirubin >1.5 x ULN (unless Gilbert's syndrome or extrahepatic source as denoted by increased indirect bilirubin fraction)Xx_NEWLINE_xXBilirubin > 1.5 mg/dLXx_NEWLINE_xXSerum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXTotal bilirubin =< 2.0 mg/dL (except patients with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)Xx_NEWLINE_xXTotal bilirubin ? 1.5 x ULNXx_NEWLINE_xXSerum total bilirubin =< 1.5 X upper limit of normal (ULN) (=< 3 X ULN if Gilbert’s syndrome) OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xXSerum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 10 days of protocol enrollmentXx_NEWLINE_xXSerum total bilirubin =< 1.5 X upper limit of normal (ULN) (=< 3 X ULN if Gilbert’s syndrome) OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULNXx_NEWLINE_xX