Total bilirubin =< 1.5 x normal institutional limits; this will not apply to patients with confirmed Gilbert’s syndrome (persistent or recurrent hyperbilirubinemia [predominantly unconjugated bilirubin] in the absence of evidence of hemolysis or hepatic pathology), who will be allowed in consultation with their physician
Serum bilirubin less than two times the institutional upper limits of normal (ULN); higher levels are acceptable if these can be attributed to active hemolysis, ineffective erythropoiesis, or Gilbert’s disease
Total bilirubin =< 1.5 x upper limit of normal (ULN); NOTE: exceptions can be granted from principal investigator (PI) for instances of Gilbert’s disease, and/or primarily indirect bilirubinemia, if due to recent transfusion and/or hemolysis
NOTE: exceptions can be granted from PI for instances of Gilbert’s disease, and/or primarily indirect bilirubinemia, if due to recent transfusion and/or hemolysis
Bilirubin =< 3.0 mg/dL (unless due to Gilbert’s syndrome or hemolysis)
Total bilirubin =< 2.0 mg/dL unless due to Gilbert’s syndrome, hemolysis, or ineffective hematopoiesis
Bilirubin =< 2.0 mg/dl, unless due to Gilbert’s, hemolysis or leukemic infiltration
Serum bilirubin =< 1.5 x institutional upper limit of normal (ULN); this will not apply to subjects with confirmed Gilbert’s syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with the study sponsor
Bilirubin =< 3.0 mg/dL (unless due to Gilbert’s syndrome or hemolysis) for patients receiving MAC, RIC or RIC-MMF and bilirubin =< 5.0 mg/dL for patients receiving IOC (unless due to Gilbert’s syndrome or hemolysis)
Should be performed within 10 days of treatment initiation: serum bilirubin ? 1.5 x institutional upper limit of normal (ULN); this will not apply to subjects with confirmed Gilbert’s syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician
Total serum bilirubin < 2 x upper limit of normal (ULN), unless due to Gilbert’s syndrome, hemolysis or the underlying leukemia approved by the principal investigator (PI)
Direct bilirubin ? 2 X institutional upper limit of normal (ULN) (unless due to known Gilbert’s syndrome or compensated hemolysis directly attributable to CLL)
Serum bilirubin =< 1.5 x institutional upper limit of normal (ULN); this will not apply to subjects with confirmed Gilbert’s syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician
Within 7 days (+ 3 day window) of enrollment: Serum bilirubin =< 1.5 x the institutional ULN, or =< 3 x ULN if confirmed Gilbert’s syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology)
Serum bilirubin =< 1.5 x institutional upper limit of normal (ULN); (this will not apply to subjects with confirmed Gilbert's syndrome [persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology], who will be allowed only in consultation with their physician)
Serum bilirubin =< 1.5 x institutional upper limit of normal (ULN). This will not apply to subjects with confirmed Gilbert’s syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician.
Total bilirubin (T bili) =< 1.5 mg/dL except for patients with Gilbert’s syndrome or hemolysis
Serum bilirubin =< 1.5 x institutional upper limit of normal (ULN); this will not apply to subjects with confirmed Gilbert’s syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician
Serum bilirubin =< 1.5 x institutional upper limit of normal (ULN). This will not apply to subjects with confirmed Gilbert’s syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician
Serum bilirubin =< 1.5 x institutional upper limit of normal (ULN). This will not apply to subjects with confirmed Gilbert’s syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only upon treating physician, principal investigators (PI) or co-PIs approval
Serum bilirubin =< 1.5 x institutional upper limit of normal (ULN). (This will not apply to subjects with confirmed Gilbert’s syndrome [persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology], who will be allowed only in consultation with their physician)
Serum bilirubin =< 1.5 x institutional upper limit of normal (ULN) within 28 days prior to study registration; this will not apply to subjects with confirmed Gilbert’s syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician
Direct bilirubin =< 2 X institutional upper limit of normal (ULN) (unless due to known Gilbert’s syndrome or compensated hemolysis directly attributable to CLL)
Total bilirubin =< 1.5 x the upper limit of normal (patients with confirmed Gilbert’s syndrome (persistent or recurrent hyperbilirubinemia in the absence of evidence of hemolysis or hepatic pathology) will be allowed to enroll after discussion with the principal investigator if total bilirubin is =< 3 x the upper limit of normal)
Transaminases < 5 x upper limit of normal (ULN) and total bilirubin =< 2.5 mg/dL except for patients with Gilbert’s syndrome or hemolysis
Serum bilirubin =< 1.5 x institutional upper limit of normal (ULN); this will not apply to subjects with confirmed Gilbert’s syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician
Bilirubin =< 2.5 x institutional upper limit of normal (IULN) unless elevation is thought to be due to hepatic infiltration by AML, Gilbert’s syndrome, or hemolysis (assessed within 14 days prior to registration)
Serum bilirubin =< 1.5 x institutional upper limit of normal (ULN); this will not apply to subjects with confirmed Gilbert’s syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician
Total bilirubin within normal institutional limits unless thought due to hemolysis or to Gilbert’s syndrome
Patients with Gilbert’s syndrome will be eligible for the study; a diagnosis of Gilbert’s syndrome will be based on the exclusion of other diseases based on the following criteria:\r\n* Unconjugated hyperbilirubinemia noted on several occasions\r\n* No evidence of hemolysis (normal hemoglobin, reticulocyte count, and lactate dehydrogenase [LDH])\r\n* Normal liver function tests\r\n* Absence of other diseases associated with unconjugated hyperbilirubinemia
Total bilirubin =< 3 mg/dL unless due to Gilbert’s syndrome, hemolysis, or ineffective hematopoiesis
Direct bilirubin >= 2.0 mg/dL not related to hemolysis or Gilbert’s disease
Bilirubin =< 2 times institutional upper limit of normal unless elevation is thought to be due to hepatic infiltration by AML, Gilbert’s syndrome, or hemolysis (assessed within 10 days prior to study day 0)
Transaminases =< 5 x upper limit of normal (ULN) and total bilirubin =< 2.5 mg/dL except for patients with Gilbert’s syndrome or hemolysis
Serum bilirubin =< 1.5 x institutional upper limit of normal (ULN); this will not apply to subjects with confirmed Gilbert’s syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician
Total bilirubin =< 1.5 mg/dL (except Gilbert’s syndrome or known hemolysis or leukemic infiltration) obtained =< 7 days prior to registration
Total bilirubin above 2.5 ULN in the absence of hemolysis or diagnosis of Gilbert’s syndrome
Direct bilirubin < 1.5 mg/dl, unless due to Gilbert’s or secondary to hemolysis
Bilirubin =< 1.5 x ULN unless known to have Gilbert’s syndrome or elevated bilirubin resulting from hemolysis
Bilirubin =< 1 .5 x upper limit of normal (ULN) unless elevation is thought to be due to Gilbert’s syndrome, hemolysis, or hepatic infiltration by the hematologic malignancy
Patients with active hemolysis should be excluded
Total bilirubin =< 1.5 mg/dl, unless increase is due to hemolysis or congenital disorder
Total bilirubin =< 1.5 mg/dL, unless increase is due to hemolysis or congenital disorder
PART 2: Total serum bilirubin must be < 3 mg/dL unless the elevation is thought to be due to Gilbert’s disease or hemolysis
Serum bilirubin > 2.0 mg/dl that is not due to Gilbert’s syndrome or hemolysis
Total bilirubin of < 2 mg/dl unless due to hemolysis, leukemia organ infiltration, or Gilbert’s syndrome
Total serum bilirubin < 2 x upper limit normal (unless due to hemolysis, Gilbert’s syndrome, or ineffective erythropoiesis)
Total bilirubin =< 1.5 x upper limit of normal (ULN) (unless considered due to Gilbert’s syndrome or hemolysis)
Bilirubin =< 3.0 mg/dL (unless due to Gilbert’s syndrome or hemolysis)
Total bilirubin =< 2 mg/dL unless hemolysis or Gilbert’s disease
Total bilirubin =< 1.5 x normal institutional limits; this last criterion will not apply to patients with confirmed Gilbert’s syndrome (persistent or recurrent hyperbilirubinemia [predominantly unconjugated bilirubin] in the absence of evidence of hemolysis or hepatic pathology), who will be allowed in consultation with their physician
Bilirubin ? 2.5 x institutional upper limit of normal (IULN) unless elevation is thought to be due to hepatic infiltration by AML, Gilbert’s syndrome, or hemolysis (assessed within 14 days prior to study day 0)
Total 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 allowed
Total serum bilirubin must be < 3mg/dL unless the elevation is thought to be due to Gilbert’s disease or hemolysis
Serum bilirubin =< 1.5 x institutional upper limit of normal (ULN); (this will not apply to subjects with confirmed Gilbert’s syndrome [persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology], who will be allowed only in consultation with their physician)
Direct bilirubin ?2 X institutional ULN (unless due to known Gilbert's syndrome or compensated hemolysis directly attributable to CLL)
Patients with uncontrolled immune hemolysis or thrombocytopenia (positive direct antiglobulin test in absence of hemolysis is not an exclusion)
Indirect hyperbilirubinemia due to Gilbert’s disease or hemolysis is permitted
Poor liver function defined as bilirubin >= 2 mg/dl (not due to hemolysis, Gilbert’s or primary malignancy) or
Bilirubin < 2.0 x ULN unless subject has Gilbert’s disease, low-grade hemolysis, or liver involvement with lymphoma
Patients must have a total bilirubin =< 2.0 x institutional upper limit of normal (IULN) within 14 days prior to registration, unless the elevation is due primarily to elevated unconjugated hyperbilirubinemia secondary to Gilbert’s syndrome or hemolysis and not to liver dysfunction
Total bilirubin =< 2.0 x IULN within 14 days prior to registration, unless the elevation is due primarily to elevated unconjugated hyperbilirubinemia secondary to Gilbert’s syndrome or hemolysis and not to liver dysfunction
Bilirubin =< 2.5 x institutional upper limit of normal (IULN) unless elevation is thought to be due to hepatic infiltration by AML, Gilbert’s syndrome, or hemolysis (assessed within 14 days prior to study day 0)
Bilirubin =< 1.5 x upper limits of normal (unless due to liver involvement, hemolysis, or Gilbert’s disease)
Bilirubin =< 3.0 mg/dL (unless due to Gilbert’s syndrome or hemolysis)
Total bilirubin < 2 X institutional upper limit of normal (ULN) unless predominantly indirect and therefore likely due to hemolysis or Gilbert’s syndrome
Direct bilirubin > 1.5 x ULN unless due to hemolysis or Gilbert’s syndrome
Total bilirubin =< 1.5 mg/dL (except Gilbert’s syndrome or known hemolysis or leukemic infiltration)
Total bilirubin < 2.0 mg/dL unless due to Gilbert’s disease, hemolysis or leukemia
Serum bilirubin =< 1.5 x ULN (unless Gilbert’s syndrome and evidence of hemolysis)
< 2.0 total serum bilirubin (unless secondary to hemolysis)
Serum bilirubin =< 1.5 x institutional upper limit of normal (ULN); this will not apply to subjects with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician
Serum bilirubin =< 1.5 x institutional upper limit of normal (ULN); this will not apply to patients with confirmed Gilbert’s syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology)
Patients must have a total bilirubin =< 2.1 mg/dL within 72 hours of initiating the induction cycle, unless the elevation is due primarily to elevated unconjugated hyperbilirubinemia secondary to Gilbert’s syndrome or hemolysis or non-hepatic origin, and not to liver dysfunction
Serum bilirubin =< 2.0 (unless hemolysis or Gilbert disease)
Serum direct bilirubin less than 1 mg/dl (unless due to Gilbert’s syndrome or hemolysis)
Total bilirubin =< 1.5 × upper limit of normal (ULN) for the laboratory unless resulting from hemolysis
Serum bilirubin =< 1.5 x upper limit of normal (ULN) unless elevation is considered to be secondary to Gilbert’s syndrome, hemolysis, or hepatic infiltration by AML
Bilirubin greater than 1.5 mg/dl (>26 µmol/L) unless elevation is thought to be due to hepatic infiltration by AML, Gilbert syndrome, or hemolysis.
Total bilirubin < 3 x ULN, exception is elevated indirect bilirubin attributed to Gilbert’s syndrome or hemolysis
Total bilirubin =< 2.0 mg/dL unless due to Gilbert’s syndrome, hemolysis, or ineffective hematopoiesis
Bilirubin =< 2 x institutional upper limit of normal (IULN) unless elevation is thought to be due to hepatic infiltration by AML, Gilbert’s syndrome, or hemolysis (assessed within 7 days prior to study day 1)
Bilirubin =< 3.0 mg/dL (unless due to Gilbert’s syndrome or hemolysis)
Serum bilirubin levels =< 1.5 mg/dL; higher levels are acceptable if these can be attributed to active hemolysis or ineffective erythropoiesis
Serum bilirubin =< 1.5 x institutional upper limit of normal (ULN); this will not apply to subjects with confirmed Gilbert’s syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician and the study principal investigator (PI)
Bilirubin =< 3.0 mg/dL (unless due to Gilbert’s syndrome or hemolysis)
Bilirubin =< 2.5 mg/dL, except for patients with Gilbert’s syndrome or hemolysis
Total 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 elevated
Known history of hemolysis and/or methemoglobinemia
Iron (Fe) phosphatase =< 5 x upper limit of normal and total bilirubin =< 2.5 mg/dL except for patients with Gilbert’s syndrome or hemolysis
Subjects 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 drawn
Total serum bilirubin ? 1.5 x ULN regardless of liver involvement secondary to tumor. Higher levels are acceptable if these can be attributed to active hemolysis or ineffective erythropoiesis.