Alanine aminotransferase (ALT) > 2.5 times the upper limit of normal (ULN) if no demonstrable liver metastases, or > 5 times ULN in presence of liver metastases
Liver function abnormalities as indicated by ongoing hepatic enzyme elevation (AST or ALT) >2 times upper limit of normal (ULN)
AST less than 5 times the upper limit of normal
Measurable disease, defined as presence of serum immunoglobulin M (IgM) with a minimum IgM level of > 2 times the upper limit of normal of each institution is required
Measurable disease, defined as presence of serum immunoglobulin M (IgM) with a minimum IgM level of > 2 times the upper limit of normal of each institution is required
For WM, serum immunoglobulin M (IgM) with a minimum IgM level of ? 2 times the upper limit of normal (ULN).
Direct bilirubin within =< 1.5 times the institutional upper limit of normal (ULN); for patients with known Gilbert syndrome, or if the elevation is believed to be leukemia related, the cut-off of =< 3.0 times the institutional ULN is allowable
INCLUSION - TREATMENT: AST less than 5 times the upper limit of normal
Alanine aminotransferase > 2.5 times the upper limit of normal (ULN) if no demonstrable liver metastases or > 5 times the ULN in the presence of liver metastases.
AST/ALT =< 1.5 times upper limit of normal\r\n* If transaminase elevation and/or bilirubin elevation is attributed to the presence of liver metastases, a total bilirubin =< 2.5 times the upper limit of normal and an AST and ALT =< 2.5 times the upper limit of normal are permissible; patients with an elevated bilirubin level that is attributed to an inherited disorder, such as Gilbert’s disease, may be enrolled at the discretion of the principal investigator
ALT and/or AST >2.5 times the upper limit of normal (ULN) if no demonstrable liver metastases or >5 times ULN in the presence of liver metastases
total bilirubin < 1.5 X (ULN) ; alanine aminotransferase (ALT), aspartate transaminase (AST) ? 2.5 times the upper limit of normal (ULN) if no liver involvement or ? 5 times the upper limit of normal with liver involvement.
Have adequate organ function, including: Absolute neutrophil count (ANC) at least 1.5 x 109/Liter (L), platelets at least 100 x 109/L, and hemoglobin at least 8 grams/deciliter (g/dL); bilirubin no more than 1.5 times upper limits of normal; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) no more than 2.0 times upper limits of normal; Serum creatinine no more than 1.5 times upper limits of normal or calculated creatinine clearance >45 milliliters/minute (mL/min)
ARM I&II: Transaminases =< times above the upper limits of the institutional normal
REP ELIGIBILITY: Serum ALT and AST less than three times the institutional upper limit of normal
CHEMOTHERAPY/CELL INFUSION ELIGIBILITY: Serum ALT and AST less than three times the institutional upper limit of normal
CHEMOTHERAPY/CELL INFUSION ELIGIBILITY: PT and PTT less than or equal to 1.5 times the institutional upper limit of normal
STUDY TREATMENT: Serum aminotransferase value less than 1.5 times the upper limit of the normal range
Liver aminotransferase levels greater than 3 times the laboratory's upper limit of normal (greater than 5 times the laboratory's upper limit of normal if the liver is known to be involved with tumor)
Transaminase levels </=2.5 times the upper limit of normal (ULN)
Alanine aminotransferase (ALT) >2.5 times the upper limit of normal (ULN) if no demonstrable liver metastases or >5 times ULN in the presence of liver metastases
Alanine aminotransferase > 2.5 times the upper limit of normal (ULN) if no demonstrable liver metastases or > 5 times ULN in the presence of liver metastases
Transaminases =< 2 times above the upper limits of the institutional normal
Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) values less than or equal to 2.5 times the upper limit of normal; patients with elevations of ALT or AST up to 10 times the upper limit of normal may be considered for participation if such elevations are thought to be due to liver involvement by malignancy; however, in these latter patients, if AST/ALT do not decrease to less than or equal to 2.5 times the upper limit of normal after induction chemotherapy, eligibility for the transplant (research) phase will be at the discretion of the PI
RESEARCH PHASE INCLUSION CRITERIA: In patients with suspected liver disease, AST and ALT must be =< 2.5 times institutional upper limit of normal (ULN)
Liver function criteria: AST and ALT =< 2.5 times the institutional upper limits of normal
Serum creatinine concentration, 1.5 times greater than the upper limit of laboratory normal ranges (ULN), except if related to ALL/LBL,
transaminases (AST or ALT) levels, 5 times greater than the ULN, except if related to ALL/LBL,
AST less than 5 times the upper limit of normal
Serum alanine transaminase (ALT) less than three times the upper limit of normal (Turnstile II)
AST/ALT ? 2.5 times upper limit of normal (ULN)
Liver enzymes less than three times the upper limit of normal
Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) values >= 2.5 times the upper limit of normal based on age-specific normal values; if the abnormal liver function is attributable to liver involvement by malignancy, patients may be eligible with serum ALT and AST values up to 5.0 times the upper limit of normal, provided the patient has no evidence of impending hepatic failure (encephalopathy or prothrombin time > 2 times the upper limit of normal)
Screening Laboratory Values Hemoglobin ? 9g/dL White blood cell count ? 3,500 cells/mm3 Absolute neutrophil count ? 1,500 cells/mm3 Total bilirubin ? 2 times upper limit of normal Serum AST and ALT ? 2.5 times upper limit of normal Serum creatinine concentration ? 2mg/mL Pregnancy test: negative for females of childbearing potential
acute hepatitis, chronic active hepatitis, liver cirrhosis; or an alanine aminotransferase level 3 times or more and/or bilirubin level 2 times or more higher the upper limit of the normal range;
AST/ALT ? 3 times institutional upper limit of normal (except in patients with leukemic infiltration of liver)
Evidence of abnormal liver function (serum ALT level(s) > 5 times upper limit of normal at screening or creatinine levels >2 times upper limit of normal at screening);
PT and PTT < 1.25 times the institutional upper limit of normal.
Adequate liver function defined by a bilirubin value ?2 times the upper limit of normal (ULN), and transaminases (AST and ALT) values ?2.5 times ULN
AST and/or ALT ?2.5 times upper limit of normal (ULN)
ALT/AST <2.5 times the upper limit of normal (ULN)
Renal and hepatic function values exceeding 2 times the upper normal value
At least one of the following clinical, laboratory, or imaging parameters:\r\n* Mild or moderate ascites\r\n* Serum bilirubin >= 3 mg/dl but less than 6 mg/dl\r\n* Aspartate aminotransferase (AST) > 5 times upper limit of normal (ULN) but =< 10 times ULN\r\n* Alanine aminotransferase (ALT) > 5 times upper limit of normal (ULN) but =< 10 times ULN\r\n* International normalized ratio for prothrombin time (INR) >1.5 but =< 2.5\r\n* Bland portal vein thrombosis (branch or main)\r\n* Functioning transjugular intrahepatic portosystemic shunt (TIPS) or surgical portosystemic shunt
AST > 10 times upper normal limit
ALT > 10 times upper normal limit
Serum ALT and AST less than three times the institutional upper limit of normal
Dysfunction of liver (ALT/AST > 5 times normal value, or bilirubin > 3 times normal value), or of renal function (creatinine clearance <30ml/min/1.73m2)
AST and ALT ? 2.5 times the upper limit of normal (ULN)
AST and ALT ? 2.5 times the upper limit of normal (ULN)
AST and ALT ? 5 times upper limit of normal (ULN)
Liver transaminases > 5-times the upper limit of normal
Measurable disease, defined as presence of serum immunoglobulin M (IgM) with a minimum IgM level of >= 2 times the upper limit of normal is required
Measurable disease, defined as presence of serum immunoglobulin M (IgM) with a minimum IgM level of > 2 times the upper limit of normal of each institution is required
AST ? 2.5 times upper limit of normal (ULN) (? 5 times ULN for patients with liver metastases);
Liver enzymes =< 2 times the upper limit of normal
Total bilirubin =< 1.5 x ULN (except for patients with liver metastases, ALT and/or ALT =< 5 times the upper limit of normal is accepted)
ALT > 2.0 times upper normal limit (unless due to chronic GVHD)
Liver function tests >= 2 times the institutional upper limits of normal
Transaminases < 3 times the upper limit of normal
Hepatic Function: Bilirubin ? 1.5 times institutional normal; SGPT (ALT) < 3 times institutional normal
Patients must have adequate bone marrow function (ANC = or > 1,500/mm^3 and platelet count of = or > 100,000/mm^3), adequate liver function (SGPT = or < 3 times upper limit of normal and alkaline phosphatase = or < 2 times upper limit of normal, bilirubin = or <1.5 mg/dl), adequate renal function (BUN and creatinine = or <1.5 times upper limit of normal) and normal serum amylase and lipase prior to starting therapy. Elevated cholesterol and triglycerides are not a contraindication to study enrollment, but should be managed as clinically appropriate by the treating physician.
Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) values less than or equal to 2.5 times the upper limit of normal; patients with elevations of ALT or AST up to 10 times the upper limit of normal 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 study
AST or ALT greater than 5 times upper limit of normal or greater than 250 U/l.
Transaminases > 3 times upper normal limit
Must have measurable disease, defined as presence of serum immunoglobulin M (IgM) with a minimum IgM level of ? 2 times the upper limit of each institution's normal value is required.
Total bilirubin < 2.5 times the upper limit of normal; in patients with liver metastasis, liver function tests should be < 5 times the upper limit of normal
Hepatic insufficiency (> 1.5 times the upper normal limit of transaminase levels)
Serum bilirubin levels =< 1.5 times the upper limit of the normal (ULN) range for the laboratory; higher levels are acceptable if these can be attributed to active hemolysis or ineffective erythropoiesis
Does the subject have an ALT < 3 times the upper limit of the laboratory reference range and total bilirubin < 1.5 mg/dL?
Subjects have adequate bone marrow, renal, and hepatic function as follows: Bone marrow: Absolute neutrophil count (ANC) >/= 1,500/mm3 Platelets >/= 100,000/mm3; Hemoglobin >/= 9.0 g/dL Renal function: Serum creatinine </= 1.5 times the upper limit of the institution's normal range Hepatic function: Bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) </= 1.5 times the upper limit of the institution's normal range. Subjects with liver metastasis may have an AST and ALT of </= 5.0 x the upper limit of normal.
INR and aPTT < 1.2 times upper limit of normal for age.
PT and aPTT each < 1.5 times the upper limit of normal.
Serum bilirubin greater than 1.25 times the upper limit of reference range (ULRR).
Elevated liver enzymes or bilirubin defined as 3 times the upper limits of normal
Measurable disease, defined as presence of serum immunoglobulin M (IgM) with a minimum IgM level of > 2 times the upper limit of normal of each institution is required
Unexplained persistent elevation of transaminases (> 3 times upper limits of normal)
SUB-STUDY I: Liver transaminases > 5 times the upper limit of normal
SUB-STUDY II: Liver transaminases > 5 times the upper limit of normal
SUB-STUDY III: Liver transaminases > 5 times the upper limit of normal
Liver transaminases > 5 times the upper limit of normal
Pre-treatment laboratory tests for patients receiving [18F]FMISO must be performed within 21 days prior to the FMISO scan; these laboratory tests must be less than 4.0 times below or above the upper or lower limit range for the respective laboratory test for entry into the study (unless not clinically relevant); for those patients receiving Coumadin or another anticoagulant the upper limit for prothrombin time or partial thromboplastin time must not exceed 6 times the upper limit of the normal range
Prothrombin time less than 2.5 times below or above the upper or lower limit range; for those patients receiving Coumadin or another anticoagulant the upper limit for prothrombin time must not exceed 6 times the upper limit of the normal range
Hepatic enzymes 5 times greater than the upper limits of normal
PT and PTT ? 1.5 times the upper limit of normal
Patients should have adequate hepatic function with a total bilirubin within normal range and serum glutamate oxaloacetate transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) < two times the upper limit of normal (ULN) for patients without liver metastasis and SGOT or SGPT < five times ULN for those with liver metastasis, and adequate renal function as defined by a serum creatinine within 1.5 times the upper limit of normal.
bilirubin ? 1.5 mg/dL; alanine aminotransferase (ALT), aspartate transaminase (AST) ? 2.5 times the upper limit of normal if no liver involvement or ? 5 times the upper limit of normal with liver involvement.