Total bilirubin =< 1.5 x upper limit of normal (ULN) for age
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (however, patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled)
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)
PARTICIPANTS 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 enrollment
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (however, patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled), within 2 weeks of randomization
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) within 30 days of day 1 of study; NOTE: patients with elevated bilirubin secondary to Gilbert’s disease are eligible to participate in the study
Total bilirubin must be < 1.5 x the upper limit of normal, unless the elevation of bilirubin is thought to be secondary to Gilbert’s syndrome or combined antiretroviral therapy (cART); if, however, the elevated bilirubin is felt to be secondary to antiretroviral therapy, the total bilirubin must be =< 3.5 mg/dL, provided that the direct bilirubin is normal and the aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x the upper limit of normal; also, if the elevated bilirubin is thought to be secondary to cHL the same criteria for hyperbilirubinemia should be applied; however 1 prior cycle of cyclophosphamide is permitted in attempt to make the participant eligible; patients should not be excluded from study participation unless dosing cannot be safely established
Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age
Total bilirubin =< 1.5 x upper limit of normal (ULN) for age, and
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)
Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age
Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age
Total bilirubin =< 1.5 x upper limit of normal (ULN) (except in patients with Gilbert‘s syndrome who must have total bilirubin =< 3.0 x ULN)
Total bilirubin =< 1.5 x the institutional upper limit of normal (ULN), within 28 days prior to administration of study treatment
Total bilirubin =< 1.5 x upper limit of normal (ULN) for age
Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age
Total bilirubin =< 1.5 x the institutional upper limit of normal (ULN)
Bilirubin (sum of conjugated + unconjugated) =< upper limit of normal (ULN) for age
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Within 28 days prior to registration: Total bilirubin =< 2.0 x institutional upper limit of normal (IULN) or for documented/suspected Gilbert’s disease, total bilirubin =< 3.0 x IULN
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Bilirubin =< 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 therapy
Total bilirubin =< 1.5 x upper limit of normal (ULN) (except in subjects with Gilbert syndrome who must have a total bilirubin < 3.0 x ULN)
Serum bilirubin =< institutional upper limit of normal (IULN) within 28 days prior to sub-study registration; for patients with liver metastases, bilirubin must be =< 5 x IULN
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) (or =< 2.5 x upper limit of normal [ULN] with Gilbert’s syndrome)
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin < 1.5 x institutional upper limit of normal (=< 3 mg/dL in case of Gilbert’s syndrome)
Total 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 registration
Total bilirubin =< 2.5 x institutional upper limit of normal (IULN) (except patients with Gilbert’s syndrome) within 28 days prior to registration
Total bilirubin =< institutional upper limit of normal (ULN) or =< 1.5 X institutional ULN (if the patient has liver metastases)
Total bilirubin =< 1.5 x upper limit of normal (ULN) except in the case of Gilbert disease
Total bilirubin =< 1.5 x upper limit of normal (ULN); unless patient has Gilbert disease
Total bilirubin =< 1.5 x upper limit of normal (ULN) for age
Total bilirubin =< the upper limit of normal (ULN) within 4 weeks prior to randomization
Total 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 registration
Within less than or equal to 14 days prior to registration: Total serum bilirubin =< institutional upper limit of normal (ULN)
Bilirubin =< 1.5 x normal
Total bilirubin =< 1.5 x upper limit of normal (ULN) for age
Total bilirubin =< 1.5 x upper limit of normal (ULN) for age
Total bilirubin =< 1.5 x upper limit of normal (ULN) for age, and
Bilirubin =< 1.5 x upper limit of normal (ULN)
Direct bilirubin =< 3 x upper limit of normal (ULN) for age, and
Total bilirubin =< 1.5 x upper limit of normal (ULN) for age
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) obtained =< 21 days prior to registration
Total bilirubin =< 1.5 x upper limit of normal (ULN) unless isolated hyperbilirubinemia attributed to Gilbert’s syndrome
Total or direct bilirubin =< 1.5 x upper limit of normal (ULN) for age, and
Bilirubin =< 1.5 upper limit of normal (ULN)
Obtained within 28 days prior to registration: Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) (or =< 3.0 x IULN with Gilbert's syndrome)
Total bilirubin =< 1.5 x upper limit of normal (ULN) for age
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN), within 21 days prior to registration
Total bilirubin < 2 x the institutional upper limit of normal (ULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) (except Gilbert's syndrome, who must have a total bilirubin < 3.0 mg/dL)
Total bilirubin =< 1.5 x upper limit of normal (ULN) within 28 days prior to step 1 registration
Total bilirubin =< 1.5 x upper limit of normal (ULN) within 28 days prior to step 3 registration
Direct bilirubin =< 3 x upper limit of normal (ULN), unless suspected leukemic involvement of the liver
Total bilirubin =< 1.5 x upper limit of normal (ULN), except for patients with known Gilbert’s syndrome
Bilirubin less than or equal to 1.5 x upper limit of normal (ULN) (CTCAE grade 1)
Total bilirubin =< 1.5 x upper limit of normal (ULN) for age
Bilirubin < 1.5 times institutional upper limit of normal, within 21 days prior to study entry
Patients with solid tumors: bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age
Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age
Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age
Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age
Bilirubin =< 1.5 upper limit of normal (ULN)
Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age
Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age
Total bilirubin =< 1.5 x upper limit of normal (ULN) (however, patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled)
Total bilirubin =< 5 x upper limit of normal (ULN) for age
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Direct bilirubin < 2.0 x upper limit of normal (ULN)
Total bilirubin ? 1.5 x upper limit of normal (ULN) for age AND
Total bilirubin =< 2.0 x upper limit of normal (ULN), within 14 days of registration
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN), measured within 28 days prior to administration of study treatment
Total bilirubin < 1.5 X institutional upper limit of normal; for patients with Gilbert syndrome, the direct bilirubin should be within the institutional normal range
Total bilirubin < 1.5 x upper limit of normal
Total bilirubin =< 1.5 times upper limit of normal (ULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN), documented within 14 days of registration
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin ? 1.5 x upper limit of normal (ULN) for age AND
Total 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/dL
Total bilirubin =< 1.5 x the upper limit of normal
Serum total bilirubin =< 1.5X the institutional upper limit of normal (ULN)
Total bilirubin =< 1.5 x the upper limit of normal
Total bilirubin =< 1.5 x institutional upper limit of normal
Total bilirubin =< 1.5 times the institutional upper limit of normal (ULN), unless elevated secondary to lymphomatous involvement of liver or biliary system, or due to other HIV medications (e.g., indinavir, tenofovir, or atazanavir); if secondary to lymphomatous involvement, an initial upper limit of total bilirubin 5 mg/dL (85.5 uM/L) should be utilized - for direct bilirubin > 1.2 mg/dL (20.5 uM/L)
Total bilirubin =< 2 mg/dL or =< 1.5 times upper limit of normal (ULN)
Total bilirubin (T. Bili) =< 1.5 X upper limit of normal (ULN)
Total bilirubin =< 2 x institutional upper limit of normal for age
Bilirubin =< 2.0 x upper limit of institutional normal value
Bilirubin =< 1.5 times the upper limit of normal (x ULN).
Total bilirubin =< 1.5 x upper limit of normal (ULN); patients with Gilbert’s Syndrome must have bilirubin =< 3 x ULN (for treatment phase)
Total bilirubin =< 1.5 times institutional upper limit of normal (ULN)
Measured within 28 days prior to registration: total bilirubin =< 1.5 x institutional upper limit of normal (ULN). In the case of known Gilbert’s syndrome, a higher serum total bilirubin (< 2 × ULN) is allowed.
Obtained =< 21 days prior to registration: Total Bilirubin =< 1.5 x upper limit of normal (ULN)\r\n* NOTE: For bilirubin elevation 1 to 1.5 x ULN, alanine aminotransferase (ALT) above 1.5 x ULN (upper limit of normal) is not permitted\r\n* NOTE: For bilirubin elevation 1 to 1.5 x ULN, aspartate aminotransferase (AST) above 1.5 x ULN (upper limit of normal) is not permitted
Obtained =< 21 days prior to registration: Alanine amino transferase (ALT) < 2.5 X ULN, with normal bilirubin; NOTE: Concomitant elevations in bilirubin and ALT above 1.5 x ULN (upper limit of normal) is not permitted
Obtained =< 21 days prior to registration: Aspartate aminotransferase (AST) < 2.5 X ULN, with normal bilirubin; NOTE: Concomitant elevations in bilirubin and AST above 1.5 x ULN (upper limit of normal) is not permitted
Serum total bilirubin =< 1.5 x upper limit of normal (ULN) or =< 3 x ULN for patients with Gilbert’s disease
Total bilirubin =< 1.5 x institutional upper limit of normal
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (IULN)
Bilirubin =< 1.5 x the upper limit of normal (ULN); for subjects with known Gilbert’s disease, bilirubin =< 3.0 mg/dL
Total bilirubin level =< 1.5 x the upper limit of normal (ULN) range
Total bilirubin < 1.5 x upper limit of normal (ULN) (or < 3 x ULN for subjects with Gilbert's syndrome)
Total bilirubin =< upper limit of normal (ULN)
Total bilirubin =< institutional upper limit of normal
Patients with bilirubin =< 2 x upper limit of normal
Obtained =< 14 days prior to registration: Direct bilirubin =< 1.5 x upper limit of normal (ULN)
Total Bilirubin ? 1.5 x upper limit of normal (ULN), or patients diagnosed with Gilberts syndrome, that have been reviewed and approved by the medical monitor.
Total bilirubin within normal institutional limits (unless patient has Gilbert’s syndrome in which total bilirubin should be =< 2 x upper limit of normal [ULN])
Total bilirubin =< 1.5 x upper limit of normal (ULN) for age
Bilirubin 1.5 times upper limit of normal
Total bilirubin < 2 x the institutional upper limit of normal (ULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN) or 3 x ULN for Gilbert's disease
Bilirubin ? 1.5 times upper limit of normal (x ULN); if liver metastases are present, then ? 2 x ULN is allowed. Criteria does not apply to subjects with Gilbert's syndrome diagnosed as per institutional guidelines.
Total bilirubin at most1.5 x the upper limit of the normal range (ULN), except Gilbert's disease
Total bilirubin < 1 times the upper limit of normal
Total bilirubin =< 1.5 x institutional upper limit of normal OR > 1.5 x institutional upper limit of normal allowed if direct bilirubin is within normal range
Total bilirubin =< 1.5 x institution's upper limit of normal
Total bilirubin =< 1.5 x institutional upper limit of normal
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (however, patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled)
Total bilirubin =< 1.5 x institutional upper limit of normal
Total bilirubin =< 2.5 times upper limit of normal AND
Total or direct bilirubin ? 1.5 times upper limit of normal (x ULN); does not apply to subjects with Gilbert's syndrome diagnosed as per institutional guidelines.
Total bilirubin < 1.5 X upper limit of normal unless known diagnosis of Gilbert’s disease
Total bilirubin =< 1.5 X institutional upper limit of normal
Total bilirubin =< 1.5 x upper limit of normal (ULN) except patients with documented Gilbert’s syndrome (=< 3 x ULN)
Bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin concentration =< 1.5 x the institutional upper limit of normal for age
Total bilirubin =< 2 x upper limit of normal (ULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN)
total bilirubin ? 3 times the upper limit of normal (ULN)
Total bilirubin =< 2.0 × the upper limit of the normal range (ULN)
Serum bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin =< 1.5 x institutional upper limit of normal, unless due to Gilbert’s syndrome
Total bilirubin less than or equal to the institution's upper limit of normal
Serum bilirubin < 1.5 x the upper limit of normal (ULN) or < 5 x the ULN if secondary to liver metastasis
Serum bilirubin ? 1.5 x upper normal limit (UNL) except patients with Gilbert's syndrome
Total bilirubin =< 1.25 x institutional upper limit of normal (ULN), with the exception of < 2.9 mg/dL for patients with Gilbert’s disease
Total bilirubin ?1.5 × the upper limit of normal (ULN) (subjects with Gilbert's Syndrome are allowed if direct bilirubin is within normal limits);
Total bilirubin =< 1.5 mg/dL x the upper limit of normal (ULN), within 14 days before the first dose of cabozantinib
Total bilirubin less than 1.5 x upper normal limit (UNL)
Serum total bilirubin =< 1.5 x institutional upper limit of normal (ULN) OR serum direct bilirubin =< 2 x institutional ULN
Total bilirubin =< 1.5 X the institutional upper limit of normal (ULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Serum bilirubin =< 1.5 × upper limit of normal (ULN); bilirubin =< 3 x ULN is permitted in individuals with documented liver involvement by lymphoma or if due to known Gilbert syndrome
Total bilirubin =< 1.5 x institutional upper limit of normal OR > 1.5 x institutional upper limit of normal allowed if direct bilirubin is within normal range
Total bilirubin =< 1.5 x upper limit of normal (ULN) (unless hepatic dysfunction is caused by cGVHD)
Serum total bilirubin =< 2.0 times the upper limit of normal
Total bilirubin =< 1.5 x upper limit of normal (ULN) (or =< 2.5 x ULN for subjects with asymptomatic Gilbert’s syndrome)
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) or within 3 x the ULN for patients with Gilbert disease
Total serum bilirubin =< 1.5 x upper limit of normal (ULN), unless due to Gilbert’s syndrome
Total bilirubin =< 2 X institutional upper limit of normal (ULN) (documented within 28 days of registration)
Total bilirubin =< 1.5 x upper limit of normal
Bilirubin =< 1.5 x upper limit of normal range
Total bilirubin =< 1.3 mg/dl (institutional upper limit of normal)
Bilirubin < 1.5 times the upper limit of normal (ULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)
TREATMENT: Bilirubin =< 2 x upper limit of normal
Total bilirubin less than or equal to 1.5 x upper limit of normal (ULN)for age, and
Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age
Bilirubin less than 3 times the upper limit of normal
Total bilirubin =< 1.5 x upper limit of normal (ULN) or if total bilirubin is > 1.5 x ULN, the direct bilirubin must be normal obtained =< 14 days prior to registration
Patients with bilirubin =< 3 x normal
Bilirubin =< 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/dL
Hepatic: aspartate transaminase (AST)/alanine transaminase (ALT) ?2.5 x upper limit of normal (ULN); total or conjugated bilirubin ?1.5 x ULN
Total bilirubin =<1.5 x institutional upper limit of normal (ULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN).
Bilirubin < 1.5 mg/dL, ALT < 3 x upper limit of normal
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)
Have a serum total bilirubin ?1.5 × ULN (upper limit of normal).
Serum bilirubin ? 1.5 × upper limit of normal (ULN) or ? 2 x ULN if patient is known to have Gilbert’s disease as the only underlying hepatic disorder
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)
Total bilirubin ? 1.5 x institutional upper limit of normal
Serum bilirubin < 2 x upper limit of normal (ULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (however, patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled)
Total bilirubin =< 1.5 times the institutional upper limit of normal (ULN) OR direct bilirubin =< the normal in subjects with total bilirubin > 1.5 times the ULN
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)\r\n* Note: Patients with Gilbert’s syndrome with a total bilirubin =< 2.0 times ULN and direct bilirubin within normal limits are permitted
Total bilirubin =< 1.25 x institutional upper limit
Total bilirubin ? 2 times upper limit of normal (ULN). (Participants with known Gilbert's disease who has serum bilirubin ? 3 × ULN may be enrolled).
Total bilirubin ? 2 × the upper limit of the normal range (ULN)
Direct bilirubin =< 1.5 x institutional upper limit of normal (ULN)
Total bilirubin ?1.5 times the upper limit of normal (ULN) except for unconjugated hyperbilirubinemia of Gilbert's syndrome;
ENROLLMENT TO THE DOSE ESCALATION, EXPANSION AND PART II: Total bilirubin =< 2 X institutional upper limit of normal (ULN)
EXPANDED ACCESS COHORT: Total bilirubin =< 2 x institutional upper limit of normal (ULN)
Total bilirubin < 3.0 x ULN (upper limit of normal)
total bilirubin ? 1.5 institutional 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
Total serum bilirubin =< 1.5 x upper limit of normal (ULN) OR if hepatic involvement by lymphoma: =< 3 x ULN for Gilbert's disease or documented hepatic involvement by lymphoma
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)
Patients with bilirubin ? 2 x upper limit of normal
Total bilirubin =< 2 x upper limit of normal (ULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)
INCLUSION - TREATMENT: Bilirubin less than 3 times the upper limit of normal
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN), completed within 14 days prior to the date of registration
Total bilirubin ? 1.5 x upper limit of institutional normal (ULN), unless due to Gilbert's syndrome
Total bilirubin =< 1.5 times upper limit of normal (ULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (or 2.0 x ULN in patients with documented Gilbert’s syndrome)
Total bilirubin =< 1.5 X upper limit of normal (ULN), with exception of patients with Gilbert syndrome
Total bilirubin =< 1.2 X institutional upper limit of normal (ULN) OR =< 3.0 X institutional ULN if the patient has Gilbert's syndrome
Total bilirubin =< institutional upper limit of normal (IULN) or total bilirubin =< 3.0 x IULN with direct bilirubin within normal range in patients with documented Gilbert’s syndrome
Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age
Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age
Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age
Total bilirubin=< 1.5 x upper limit of normal (ULN) (if, however, the participant has Gilbert’s disease or unconjugated hyperbilirubinemia that is considered to be secondary to with atazanavir or indinavir therapy, then the total bilirubin must be =< 3 x ULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN), unless due to Gilbert’s syndrome or hemolysis, in which case =< 3.0 x ULN is allowed
Total bilirubin < 1.5 times upper limit of normal for age and documented within 14 days prior to registration and within 14 days prior to the start of treatment
Liver function: total bilirubin < 2x the upper limit of normal and alanine aminotransferase (ALT)/aspartate aminotransferase (AST) < 2.5x the upper normal limit (Patients with Gilbert's Disease are permitted to exceed the defined bilirubin value of 2x the upper limit of normal, however measurements of direct bilirubin should be done to confirm this diagnosis).
Total bilirubin =< 1.5 within 30 days prior to registration\r\n* It is highly recommended but not required that total bilirubin be =< 1.5 upper limit of normal
Documented within 14 days of registration: Total bilirubin < 1.5 times upper limit of normal for age
Bilirubin =< 1.5 x upper limit of normal (ULN), within 14 days prior to registration
Bilirubin < 2.5 times institutional upper limit of normal (ULN)
Total bilirubin within normal institutional limits (WLN) or =< 1.5 x upper limit of normal (ULN) in patients with liver metastases; or total bilirubin =< 3 x ULN with direct bilirubin WLN in patients with well documented Gilbert’s syndrome
Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age
Total bilirubin =< 1.5 x upper limit of normal (ULN), determined within 14 days of registration
Total bilirubin =< 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 aspartate aminotransferase (AST) and alanine aminotransferase (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
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
INCLUSION - INFUSION: Patients with bilirubin ? 3 x upper limit of normal
Serum bilirubin =< 2 x upper limit of normal (ULN)
Total bilirubin =< upper limit of normal (ULN)
Adequate hepatic function (total bilirubin ? 1.5 × upper limit of normal [ULN] for the institution; aspartate transaminase (AST) and alanine transaminase (ALT) ? 2.5 × ULN.
Total bilirubin (except for Gilbert’s syndrome) =< 2.5 x upper limit of normal (ULN)
Total bilirubin >1.5 times upper limit of normal (ULN)
Within 28 days of study registration: Total bilirubin =< 1.5 x upper limit of normal (ULN) for age
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)
Total bilirubin =< 1.2 x institutional upper limit of normal\r\n* With the exception of candidates with a diagnosis of Gilbert’s disease in which case the total bilirubin may extend up to 1.5 x institutional upper limit of normal
TREATMENT INCLUSION: Bilirubin 1.5 times or less than the upper limit of normal
Obtained =< 35 days prior to registration: total or direct bilirubin < 2 x institutional upper limit of normal (ULN)
Total bilirubin ? 1.5 x institutional upper limit of normal (ULN) (or ? 2.5 x ULN with Gilbert’s disease) within 28 days prior to registration
Bilirubin =< upper limit of institutional normal
Total bilirubin < 2 x upper normal limit
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) within 14 days prior to start of protocol therapy.
Total serum bilirubin <1.5 X upper limit of normal (ULN)
Total bilirubin ? 1.5 × upper limit of normal (ULN)
Total or direct bilirubin ? 2 times upper limit of normal (x ULN); does not apply to subjects with Gilbert's syndrome diagnosed as per institutional guidelines.
Total bilirubin =< 1.5 x institution’s upper limit of normal (ULN)
Total bilirubin =< 1.5 x the upper limit of the normal range (ULN)
Total bilirubin =< 1.5 X MSKCC upper limit of normal
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.
Total 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 eligibility
Adequate organ function within 14 days of study registration including:\r\n* Total bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN); no prior history of Gilbert’s syndrome
Total bilirubin < 1.5 times upper limit of institutional normal
Total bilirubin =< 2.0 x institution’s upper limit of normal (ULN)
Within 14 days prior to registration: Total bilirubin < 1.5 x institutional upper limit of normal (ULN)
Bilirubin > 1.5 x the upper limit of normal
Bilirubin ? 2X upper limit of normal
Total bilirubin ?2.0 x the upper limit of normal or <3.0 xULN if patient has a history of Gilbert's syndrome
Bilirubin ? 2 x upper limit of normal
Total bili ? 1.5 x upper limit or normal
Total bilirubin level =< 1.5 x institutional upper limit of normal (ULN)
PHASE I: Total bilirubin =< 1.5 times upper limit of normal (ULN)
PHASE IB: Total bilirubin =< 1.5 times upper limit of normal (ULN)
Serum bilirubin < 1.5 x upper limit of normal (ULN) (except for patients with documented Gilbert’s disease)
Total bilirubin =< 1.5 x institutional upper limit of normal
Total bilirubin =< 1.5 upper limit of normal (ULN), with the exception of patients with Gilbert syndrome
Total bilirubin >1.5 x upper limit of normal (ULN). For patients with Gilbert's syndrome, total bilirubin >2.5 x ULN.
Total bilirubin =< 1.5 times institutional upper limit of normal (ULN)
INCLUSION CRITERIA FOR STRATUM C: Total bilirubin =< 1.5 times institutional upper limit of normal (ULN)
Serum bilirubin =< 2.0 x upper limit of institutional normal
Total 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 =< upper limit of normal (obtained =< 14 days prior to registration)
Total bilirubin =< 2 x upper limit of normal (ULN) (except in the case of subjects with documented Gilbert’s disease >= 3 x ULN)
Total bilirubin ? 1.5 x the upper limit of the normal range (ULN).
Total 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)
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) OR direct bilirubin =< IULN for patients with total bilirubin > 1.5 x IULN
ELIGIBILITY CRITERIA AT TIME OF TREATMENT: Patients with bilirubin ? 3 x upper limit of normal
Total bilirubin =< 1.5 times upper limit of institutional normal (ULN) for age
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)
Patients with bilirubin ? 2x upper limit of normal
Total bilirubin < 1.5 times upper limit of normal except for known conjugation diseases such as Gilbert’s; direct bilirubin is not an inclusion criteria
Total bilirubin =< 2.5 times upper limit of normal
Total bilirubin =< 1.5 X institutional upper limit of normal
total bilirubin ? 2 times the upper limit of normal (ULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Bilirubin ? 1.5 times the upper limit of normal (ULN),
Serum bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin =< 1.5 institutional upper limit of normal (IULN)
Total bilirubin (TBL) > 2.5 times the upper limit of normal at the screening visit
Total bilirubin < 3.0 times the institutional upper limit of normal (ULN)
Bilirubin ? 2 times the upper limit of normal
Total bilirubin < 1.5 x upper limit of normal (ULN) within four weeks of enrollment
Total bilirubin: =< 3 X upper limit of normal (ULN) for age OR conjugated bilirubin =< 2 mg/dl
Total bilirubin =< 2 x upper limit of normal (ULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN) for age
Total bilirubin =< 2 x upper limit of normal (ULN)
Serum total bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN) for age; participants with biliary or hepatic primaries with bilirubin values greater than 1.5 x ULN may be enrolled on study if all other eligibility criteria are met
Obtained =< 14 days prior to registration: Total bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin < 2.0 times the institutional upper limit of normal (ULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)
Total bilirubin =< 1.5 X upper limit of normal (ULN)
Bilirubin < 1.5 x upper limit of normal (ULN)
Total bilirubin =< 1.5 x institutional upper limit of normal
Serum total bilirubin: =< 1.5 x upper limit of normal (ULN)
Bilirubin =< 1.5 x institutional upper limit of normal (ULN)
Total bilirubin =< upper limit of normal (ULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN) for age
Serum creatinine, total bilirubin, ALT/SGPT </= 2.0 x upper limit of normal
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Serum bilirubin > 1.5 x upper limit of normal (ULN)
Total bilirubin =< 1.5 X institutional upper limit of normal
Bilirubin ? 1.5 x upper limit of normal
Total bilirubin =< 1.5 times the upper limit of the reference range
Total bilirubin level =< 1.5 x upper limit of normal (ULN) or in patients with Gilbert’s syndrome, a total bilirubin of =< 3.0
Total bilirubin =< 1.5 x institutional upper limit of normal, unless related to leukemic infiltration or hemolysis
Total bilirubin =< 1.5 x upper limit of normal (ULN) for age
Total bilirubin < 1.5 x upper limit of reference range (< 3 x upper limit of reference range in patients with Gilbert's disease)
Total bilirubin =< 1.5 X institutional upper limit of normal (ULN) unless due to indirect hyperbilirubinemia related to Gilbert's syndrome or hemolysis, or to disease infiltration
Total bilirubin =< upper limit of normal (ULN) (except in Gilbert’s syndrome)
Total bilirubin =< 1.5 x upper limit of normal (ULN) with the following exception: patients with known Gilbert disease who have serum indirect bilirubin level =< 3 X ULN may be enrolled.
TREATMENT WITH SJCAR19: Total bilirubin =< 3 times the upper limit of normal for age, except in subjects with Gilbert’s syndrome
Total serum bilirubin =< 1.5 times upper limit of normal (ULN).
Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age.
Total bilirubin ? 1.5 x upper limit of normal (ULN) (Patients with documented diagnosis of Gilbert syndrome are eligible if total bilirubin < 3.0 x ULN)
Total bilirubin =< 1.5 times upper limit of normal (ULN).
Total bilirubin =< 1.5 x upper limit of normal (ULN) (unless Gilbert’s disease), =< 5 days prior to C1D1
Bilirubin =< 1.5 × upper limit of normal (ULN) obtained within 14 days prior to initiating study treatment.
Total bilirubin level =< 1.5 × the upper limit of normal (ULN).
Total bilirubin =< 3 X upper limit of normal (ULN), unless attributable to Gilbert syndrome
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)
Total bilirubin ? 2 x upper limit of normal (ULN) for age
Obtained ? 14 days prior to registration: Total bilirubin ? 1.5 x upper limit of normal (ULN)
Serum bilirubin >= 1.5 x upper limit of normal (ULN), patients with Gilbert’s syndrome and a total bilirubin of < 3 times ULN are permitted)
Total serum bilirubin of =< 1.5 x institutional upper limit of normal (ULN)
Total bilirubin ? 1.5 x institutional upper limit of normal (IULN)
Serum bilirubin =< 2.0 × the upper limit of normal (ULN).
Total Bilirubin ? 1.5 x upper limit of normal (ULN), or patients diagnosed with Gilbert's syndrome, that have been reviewed and approved by the medical monitor
Serum bilirubin < 2 x upper limit of normal.
Total bilirubin =< 1.5 x upper limit of normal (ULN) unless due to Gilbert’s syndrome, in which case the direct bilirubin must be =< 1.5 X ULN, obtained =< 14 days prior to registration
Total bilirubin < 1.5 x upper limit of normal (ULN)
Direct bilirubin =< 2 x upper limit of normal (ULN) unless deemed to be related to underlying leukemia.
Total bilirubin ? 1.5 × upper limit of normal (ULN) (unless indirect bilirubin is elevated due to Gilbert's syndrome or hemolysis)
Total bilirubin =< 3 x upper limit of normal (ULN)
Bilirubin greater than 1.5 times the upper limit of normal (ULN)
Obtained =< 14 days prior to registration: Total bilirubin =< 1.5 x upper limit of normal (ULN) or direct bilirubin =< ULN
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 upper limit of normal (ULN) (within 14 days of PET imaging)
Total bilirubin level =< 1.5 x upper limit of normal (ULN)
Obtained 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)
Total bilirubin =< 2 x institutional upper limit of normal (IULN)
Within 28 days prior to registration: Bilirubin =< 1.5 x upper limit of normal (ULN)
Bilirubin < 1.5 X upper limit of normal (ULN)
Total bilirubin within 1.5 x the upper limit of normal institutional limits; patients with elevation of unconjugated bilirubin alone, as in Gilbert's disease, are eligible, performed within 14 days prior to day 1 of protocol therapy
Total bilirubin less than 2 mg/dL or 1.5 times upper limit of normal (ULN)
Total bilirubin ? 2.0 times the upper limit of normal (ULN) of each institution with the following exception: patients with Gilbert Disease serum bilirubin > 3 x ULN.
Bilirubin less than or equal to 2.5 x the upper limit of normal (ULN) (excluding Gilbert's syndrome)
Total bilirubin level =< 1.5 x the upper limit of normal (ULN).
Total bilirubin =< 1.5 times the institutional upper limit of normal.
Bilirubin < 1.5 x institutional upper limit of normal (ULN) or < 3 x ULN in patients with Gilbert's disease or liver involvement
Total bilirubin =< 1.5 x upper limit of normal (ULN).
Serum bilirubin =< 1.5 times upper-limit of normal (ULN) (measured within 28 days of registration)
Total bilirubin =< 1.5 times upper limit of normal (unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin)
Bilirubin < 1.5 x upper limit of normal (ULN)
Total bilirubin ? 1.5 x upper limit of normal (ULN) (patients with Gilbert’s syndrome may have serum bilirubin ? 3 x ULN)
Total Bilirubin (sum of conjugated + unconjugated) ? 1.5 x upper limit of institutional normal and
Total bilirubin =< 1.5 times the upper limit of normal (ULN)
Total bilirubin =< 2 x upper limit of normal (ULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) (except Gilbert’s syndrome, who must have a total bilirubin < 3.0 mg/dL)
Adequate hepatic function including total bilirubin < 2 x upper limit of normal (ULN) unless increase is due to Gilbert’s disease or leukemic involvement
Total bilirubin =< 1.5 X institutional upper limit
STUDY TREATMENT: Total bilirubin =< 1.5 × upper limit of normal (ULN) within 14 days prior to the first study treatment with the following exception:\r\n* Patients with known Gilbert's disease who have serum bilirubin level =< 3 × ULN may be enrolled.
Total bilirubin =< 1.5 times upper limit of normal (x ULN).
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)
Total bilirubin ? institutional upper limit of normal (IULN); patients with Gilbert’s syndrome may enroll if direct bilirubin ? 1.5 x IULN
Total 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
Within 28 days prior to administration of study treatment: Total bilirubin =< 1.5 x the institutional upper limit of normal (ULN)
Bilirubin (sum of conjugated + conjugated) =< 1.5 x upper limit of normal (ULN) for age
Total bilirubin =< 2 X institutional upper limit of normal (IULN)
Total bilirubin ? 1.5 x ULN (upper limit of normal)
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (however, patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled)
Total bilirubin =< 1.5 x institutional upper limit of normal
Total bilirubin =< 2.5 x institutional upper limit of normal
Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age
Total bilirubin (sum of conjugated + unconjugated) ?1.5 x upper limit of normal (ULN) for age
Total bilirubin =< institutional upper limit of normal (except for patients with Gilberts' syndrome who must have normal direct bilirubin)
Total bilirubin =< 1.5 x institutional upper limit of normal
Within two weeks prior to enrollment: Total bilirubin =< 1.5 times the upper limit of normal
Total 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 ULN
Total bilirubin < 1.5 times upper limit of normal for age, within 14 days of registration and within 7 days of the start of treatment
Total bilirubin =< 1.5 x ULN (upper limit of normal)
Serum bilirubin =< 2 x the upper limit of normal (ULN) (except for patients with Gilbert’s disease)
Total bilirubin =< 1.5 x the upper limit of normal (ULN)
Obtained 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.
To be performed within 14 days prior to day 1 of protocol therapy: total serum bilirubin =< 2 x upper limit of normal (ULN)
Total bilirubin (Tbili) > 1.5 times the upper limit of normal at the screening visit
Total bilirubin =< 3 X upper limit of normal (ULN) (except subjects with Gilbert syndrome, who can have total bilirubin up to 3.5 X ULN)
Within 4 weeks of day 1: Total bilirubin =< upper limit of normal (ULN)
Bilirubin < 1.5 x upper limit of normal
Total 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/dL
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Bilirubin >= 2 X institutional upper limit of normal
Total bilirubin =< 1.5 x upper limit of normal (ULN); =< 3 x ULN for patients with known Gilbert disease.
Total bilirubin < 1.5 times upper limit of normal (ULN) unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin
Within 3 days before the first dose of study drug: total bilirubin < upper limit of normal (ULN)
Total bilirubin: =< 3 x upper limit of normal (ULN) for age OR conjugated bilirubin =< 2 mg/dl
Total bilirubin =< 2 x upper limit of normal (ULN)
Total bilirubin (sum of conjugated + unconjugated) =< 1.5 x institutional upper limit of normal for age
Total bilirubin =< 1.5 x upper limit of normal (ULN), unless due to Gilbert’s disease obtained =< 14 days prior to registration
Total bilirubin > 3 x institutional upper limit of normal (ULN) (unless documented Gilbert’s syndrome)
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (or =< 2.0 x ULN in patients with documented Gilbert’s syndrome)
Total bilirubin below the upper limit of normal (ULN), excluding patients with Gilbert’s syndrome
Bilirubin ?1.5 times the upper limit of normal (ULN) unless due to Gilbert Syndrome
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin level ? 1.5 × the upper limit of normal (ULN) range
Total bilirubin =< 2 X upper limit laboratory normal (ULN); subjects with non-clinically significant elevations of bilirubin due to Gilbert’s disease are not required to meet these criteria
Total bilirubin level =< 1.5 x institutional upper limit of normal (ULN)
Serum bilirubin =< 1.5 x institutional upper limit of normal (ULN) (except patients with Gilbert’s syndrome, who can have total bilirubin < 3 mg/DL)
Bilirubin =< 1.5 times upper limit of normal for age
Serum conjugated (direct) bilirubin < 2 x upper limit of normal for age as per local laboratory
Total bilirubin =< 2.0 x upper limit of normal within 14 days of treatment initiation
Bilirubin =< 1.5 times the upper limit of normal (ULN) for the institution (for patients with known Gilbert's disease: bilirubin =< 3 x ULN) within 14 days of study registration
Total bilirubin ? 1.5 x institutional upper limit of normal (IULN) (unless due to diagnosis of Gilbert’s syndrome)
Total bilirubin < 1.5 x upper limit of normal (ULN) \r\n* For patients with Gilbert’s syndrome total bilirubin < 3.0 x ULN
Total bilirubin =< 1.5 x the institutional upper limit of normal (ULN).
Total bilirubin =< 1.5 x the upper limit of normal (ULN), obtained within 7 days prior to first study treatment
Total bilirubin =< 1.5 x the upper limit of the normal range (ULN)
Serum bilirubin =< 1.5 times upper limit of normal (prior to biopsy)
Serum bilirubin =< 1.5 x upper limit of normal (ULN).
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Within 7-10 days of study drug administration: Total bilirubin < 3 X upper limit of normal (ULN) for age
Total bilirubin < 1.5 x institutional upper limit of normal OR > 1.5 x institutional upper limit of normal allowed if direct bilirubin is within normal range.
Bilirubin < 2 x upper limit of normal (ULN)
Total bilirubin concentration of =< 1.5 x the upper limit of normal (ULN) range
Within 7 days prior to administration of study treatment: Total bilirubin =<1.5 x institutional upper limit of normal (ULN) (except for patients with known Gilbert’s disease).
Total serum bilirubin =< 2 x upper limit of normal (ULN), unless due to Gilbert’s syndrome.
Total bilirubin =< 1.5 times upper limit of normal (ULN)
Bilirubin =< 2.0 x upper limit of normal (ULN)
Serum bilirubin =< 1.5 x institutional upper limit of normal (ULN)
Total bilirubin ? 1.5 X upper limit of normal (ULN) for current age (? 3 X ULN if increase in bilirubin is attributable to Gilbert's Syndrome)
Total bilirubin ? 1.5 X the upper normal limit of institution's normal range
Total bilirubin =< upper limit of normal (ULN) unless elevation is thought to be due to Gilbert’s syndrome
Total bilirubin > 2 times the upper limit of normal OR in patients with Gilbert’s syndrome, a total bilirubin > 3.0
Obtained with 21 days of registration: total bilirubin =< 3 x the upper limit of normal (ULN)
Bilirubin =< 1.5 x institutional upper limit of normal
Bilirubin (sum of conjugated + unconjugated) ?1.5 times the upper limit of normal (ULN) for age.
Total bilirubin: =< 3 x upper limit of normal (ULN) for age OR conjugated bilirubin =< 2 mg/dl
Total bilirubin ? 3 times the upper limit of normal (ULN)
Bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin =< 1.5 X institutional upper limit of normal
Total bilirubin within normal institutional limits (patients with confirmed Gilbert’s syndrome with a total bilirubin =< 2.0 x upper limit of normal [ULN], may be included in this study)
Total bilirubin < 1.5x upper limit of normal (ULN) unless increase is due to Gilbert’s disease or leukemic involvement
Within 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/dL
Total bilirubin =< 1.5 x upper limit of normal (ULN) (results within 7 days before study drug administration)
Total bilirubin =< 1.5 x upper limit of normal (ULN) for age, and
Total bilirubin =< 1.5 x the upper normal limit of institution's normal range, at the time of enrollment; for subjects with liver metastases, total bilirubin > 1.5 - 3.0 x the upper normal limit of institution's normal range are acceptable as long as there is no persistent nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, or eosinophilia
Total bilirubin < 2.5 x upper limit of institutional normal reference range; patients with known Gilbert disease who have serum bilirubin =< 3 x upper limit of normal (ULN) may be enrolled
Serum bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) except for patients with bilirubin elevation due to Gilbert's disease or of non-hepatic origin who will be allowed to participate, provided bilirubin is =< 3 x institutional ULN.
Total bilirubin =< 1.5 X institution upper limit of normal
Total bilirubin =< 1.5 x upper limit of normal (ULN) with the following the exception that patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled
Total bilirubin =< 1.5 times the upper limit of the institutional normal values
Total bilirubin level ? 1.5 × the upper limit of normal (ULN) range
No more than 14 days prior to registration: Total bilirubin =< 1.5 X institutional upper limit of normal
Total serum bilirubin within 1.5 x upper limit of normal (ULN)
Bilirubin < 1.5 times the upper limit of normal (ULN)
Bilirubin < 1.5 x institutional upper limit of normal (ULN) or < 3 x ULN in patients with Gilbert's disease or liver involvement
Total bilirubin: =< 3 x upper limit of normal (ULN) for age OR direct bilirubin =< 2 mg/dl
Bilirubin =< 1.5 X institutional upper limit of normal
Obtained within 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: 1) patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled
Serum bilirubin =< 1.5 x institutional upper limit of normal (ULN)
Bilirubin < 1.5 x upper limit of normal (ULN) unless believed due to leukemic infiltration
Within 14 days of the first study treatment: Total bilirubin level =< 1.5 x the upper limit of normal (ULN) range
Total bilirubin =< 1.5 x upper limit of normal (ULN) (except subjects with Gilbert syndrome who can have total bilirubin < 3.0 mg/dL)
Within 14 days prior to registration: Bilirubin =< 1.5 x the upper limit of normal (ULN)
Serum bilirubin > 1.5 times the upper limit of normal (ULN) (except patients with Gilbert’s syndrome: total bilirubin of > 3 x ULN) at the time of screening
Total serum bilirubin =< 2 x upper limit of normal (ULN), unless due to Gilbert’s syndrome.
Total bilirubin (except for Gilbert’s syndrome) =< 2.5 x upper limit of normal (ULN)
Total bilirubin =< 1.5 x institutional upper limit of normal within normal
Within 14 days prior to cycle 1 day 1 of treatment: Bilirubin =< 1.5 x upper limit of normal (ULN) (subjects with known Gilbert’s disease who have serum bilirubin =< 3.0 x ULN may be enrolled)
Total bilirubin =< 2 x institutional upper limit of normal (ULN) (after the HDT/ASCT)
Total Bilirubin =< 1.5 x the upper limit of normal (ULN)
Serum bilirubin =< 1.5 x upper limit of normal (ULN) or =< 3 x ULN for patients with Gilbert’s disease
Bilirubin =< 1.5 times the upper limit of normal (ULN)
Serum bilirubin =< 1.5 x upper normal limit (UNL), except patients with Gilbert's syndrome
Total bilirubin =< 2.5 X institutional upper limit of normal
Total bilirubin < 3 x the upper limit of normal (ULN)
Total 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)
Bilirubin > 1.5 times the upper limit of the normal range (ULN)
Total bilirubin =< 2 x upper limit of normal (ULN)
Total bilirubin < 1.5 x institutional upper limit of normal (with the exception of those with Gilbert syndrome
Total bilirubin =< 1.5 x institutional upper limit of normal
Bilirubin >= 2 X institutional upper limit of normal
Total bilirubin =< 1.5 upper limit of normal (ULN)
Total serum bilirubin within 1.5 x upper limit of normal (ULN)
Bilirubin =< to 2.0 x normal.
Total Bilirubin =< upper limit of normal [ULN]
Within 4 weeks prior to the registration: bilirubin =< 1.5 X upper limit of normal
Total bilirubin =< upper limit of normal (ULN)
Hepatic impairment, defined as total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (patients with benign hyperbilirubinemia [e.g., Gilbert’s syndrome] are eligible) or
Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age within 14 days of registration
Serum total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (for patients with a diagnosis of Gilbert’s syndrome, direct bilirubin =< 1.5 x ULN)
Serum bilirubin =< 1.5 x institutional upper limit of normal (ULN) (unless Gilbert's disease in which case total bilirubin =< 3 x institutional ULN)
Total bilirubin =< 1.5 x institution’s upper limit of normal
Total bilirubin =< 1.5 x the upper limit of normal range (ULN)
Total bilirubin greater than 2.5 times the upper limit of normal
Total bilirubin =< 1.5 x upper limit of normal (ULN) unless elevation due to Gilbert’s syndrome obtained =< 7 days prior to registration
Total bilirubin level =< 1.5 x the upper limit of normal (ULN) range
Total bilirubin =< 1.5 x upper limit of normal (ULN) (unless related to Gilbert’s or Meulengracht’s syndrome)
Total bilirubin =< 2 x upper limit of normal (ULN)
Total bilirubin < 1.5 x upper limit of normal
Total bilirubin ? 2.0 x institution’s upper limit of normal
Total bilirubin =< 1.5 X upper limit of normal (ULN) (patients with diagnosed Gilbert’s syndrome will not be excluded if their direct bilirubin is within normal institutional limits)
Total bilirubin level =< 1.5 x the upper limit of normal range (ULN)
Total bilirubin < 1.5 x institutional upper limit of normal
Total bilirubin =< 1.5 times the institutional upper limit of normal (ULN) (or =< 3 times ULN in case of liver metastasis or Gilbert syndrome)
Serum bilirubin =< 2 x the upper limit of normal (ULN) (except for patients with Gilbert’s disease)
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN), measured within 28 days prior to administration of study treatment
Total bilirubin < 1.5 x institutional upper limit of normal (ULN) for age and weight
Bilirubin > upper limit of normal (ULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN) (except patients with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL)
Total bilirubin =< 1.5 x upper limit of normal (ULN), unless due to Gilbert’s disease obtained =< 14 days prior to registration
Serum bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin level =< 1.5 x upper limit of normal (ULN)
Total bilirubin =< 2.0 x institutional upper limit of normal (IULN)
Serum bilirubin =< 1.5 x institutional upper limit of normal (ULN) unless diagnosed with Gilbert’s syndrome.
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
FULL 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)
Total bilirubin =< 2.0 x institutional upper limit of normal ([ULN]; unless attributable to Gilbert’s disease or other causes of inherited indirect hyperbilirubinemia, at which point total bilirubin must be =< 4.0 x ULN)
Bilirubin =< 2 x upper limit of normal (ULN)
Total serum bilirubin =< upper limit of normal (ULN); or total bilirubin =< 3.0 x ULN with direct bilirubin within normal range in patients with documented Gilbert’s syndrome
Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (unless due to Gilbert’s disease or disease-related hemolysis, then =< 3.0 x ULN)
Total bilirubin =< 1.5 ULN (upper limit of normal), unless due to Gilbert’s syndrome
Total bilirubin ?1.5 x the upper limit of normal (ULN)
Bilirubin =< 1.5 x upper limit of normal (ULN) (obtained within 28 days prior to first study treatment)\r\n* Subjects with known Gilbert’s disease should have a serum bilirubin =< 3 x ULN
Total bilirubin must be less than or equal to (<=) 1.5 * the upper limit of normal (ULN).
Total bilirubin =< 1.5 x the institutional upper limit of normal (ULN)
Total bilirubin < 1.5 x upper limit of normal (ULN) (except in patients diagnosed with Gilbert’s disease)
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin with 1.5 x the upper limit of normal (ULN) institutional limits; patients with elevation of unconjugated bilirubin alone, as in Gilbert's disease, are eligible
LYMPHODEPLETION: Bilirubin =< 1.5 x upper limit of normal (ULN) unless attributed to Gilbert’s syndrome, obtained within 72 hrs prior to procurement
Obtained =< 14 days prior to registration: Total bilirubin =< 1.5 x upper limit of normal (ULN) unless due to Gilbert’s syndrome
Total bilirubin less than 1.5 x upper limit of normal (ULN)
Total bilirubin ? 1.5 x upper limit of normal (ULN) within 14 days prior to the first study treatment (cycle 1, day 1) with the following exception:\r\n* Patients with known Gilbert disease who have serum bilirubin level ? 3 x ULN may be enrolled
Total bilirubin =< 2.5 x institutional upper limit of normal
Total bilirubin =< 1.5 x upper limit of normal (ULN), obtained =< 14 days prior to registration
Obtained =< 7 days prior to registration: Total bilirubin =< 1.5 x upper limit normal (ULN)
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 =< institutional upper limit of normal (ULN) (except in patients with Gilbert's syndrome; patients with Gilbert's syndrome may enroll if direct bilirubin is =< 1.5 x ULN
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Serum bilirubin =< 1.5 x institutional upper limit of normal (ULN)
Total serum bilirubin =< 1.5 times upper limit of normal (ULN)
Bilirubin less than or equal to 1.5 x upper limit of normal (ULN) (unless bilirubin rise is due to Gilbert’s syndrome or B-ALL or non-hepatic origin)
Bilirubin =< 1.5 x upper limit of normal (ULN) unless due to Gilbert’s syndrome
Total bilirubin < 2x institutional upper limit of normal (ULN) within 7 days prior to starting the study drug;
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)
Total bilirubin =< 2 x institutional 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
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin =< 2.5 x normal prior to biopsy
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), within 14 days prior to treatment
Total bilirubin =< 1.5 x the upper normal limit of institution's normal range; for subjects with liver metastases, total bilirubin > 1.5 - 3.0 x the upper normal limit of institution's normal range are acceptable as long as there is no persistent nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, or eosinophilia
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Bilirubin < 2 x upper limit of normal (ULN) and
Total bilirubin =< 1.5 times upper limit of (institutional/central) normal (patients with Gilbert’s syndrome total bilirubin must be =< 4 times institutional upper limit of normal)
Total bilirubin less than or equal to 1.5 x upper limit of normal (ULN)
Bilirubin < 1.5 x the upper limit of normal (ULN)
Total bilirubin =< 1.5 times upper limit of normal (ULN) at the screening visit unless an alternate nonmalignant etiology exists (e.g., Gilbert’s disease)
Total bilirubin =< 1.5 times upper limit of normal (ULN) at the screening visit unless an alternate nonmalignant etiology exists (eg, Gilbert’s disease)
Total bilirubin =< 1.5 times upper limit of normal (x ULN) (=< 3 x ULN if considered to be due to leukemic involvement or Gilbert’s syndrome)
Total Bilirubin =< institutional upper level of normal (ULN) at cycle 1 day 1 of TPF
Bilirubin =< 3 times upper limit of normal (CTCAE grade 2 baseline)
Total bilirubin =< 1.5 times upper limit of normal (ULN)
Total bilirubin > 1.5 x the upper limit of normal (ULN) for age
Total bilirubin =< upper limit of normal (ULN)
Serum bilirubin < 2 x upper limit of normal
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Bilirubin (total) > 1.5 times the upper limit of normal
Total bilirubin =< institutional upper limit of normal (IULN)
Serum bilirubin > upper limit of normal (ULN)
Serum bilirubin =< 1.5 x institutional upper limit of normal (ULN)
Total bilirubin =< 1.5 x the upper limit of the normal range (ULN)
Total bilirubin =< 1.5 × institutional upper limit of normal (except for patients with Gilbert disease)
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)
Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age
Total bilirubin =< 1.5 x upper limit of normal (ULN) or =< 3 × ULN in the case of suspected/documented Gilbert’s syndrome
Total bilirubin =< 2 times the upper limit of normal (ULN) (or =< 3.0 x ULN if deemed to be elevated due to Gilbert’s disease or leukemia)
Total bilirubin =< 1.5 x upper normal limit if documented hepatic involvement with lymphoma, or =< 5 x upper normal limit if history of Gilbert’s disease
Total bilirubin within 2 x upper limit of normal
Total bilirubin =< 1.5 times the institutional upper limit of normal (ULN) (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)
Bilirubin =< 2 x the upper limit of normal (except Gilbert’s syndrome)
Total bilirubin > 1.5 x upper limit of normal (ULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN) except for patients with known Gilbert syndrome
Serum bilirubin =< 1.5 x upper limit of normal (ULN); for patients with Gilbert’s disease, serum bilirubin up to =< 3 x ULN is allowed provided normal direct bilirubin
Serum total bilirubin: ? 1.5 x upper limit of normal (ULN)
Total bilirubin =< 1.5 X upper limit of normal (ULN), with the exception of patients with Gilbert syndrome who are required to have =< 3 X ULN
Completed within 60 days of surgery: Total bilirubin < 1.5 times the upper limit of institutional normal value
Serum bilirubin =< 3 times the upper limit of normal (ULN) (within 14 days prior to registration)
Total bilirubin < 3.0 x the upper limit of normal (ULN) for age (patients who have been diagnosed with Gilbert’s disease are allowed to exceed this limit)
Serum bilirubin =< 1.5 x upper limit of normal (ULN) (institutional upper limit of normal)
Total bilirubin =< 1.5 x upper limit of normal (ULN) for the laboratory
Total bilirubin; if cirrhosis present: part of Child Pugh requirement; if no cirrhosis: bilirubin should be =< 2 x upper limit of normal (ULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN); for subjects with documented/suspected Gilbert's disease, bilirubin =< 3 x ULN
Total 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/dL
Total bilirubin < 2.0 x upper limit of normal (ULN)
Bilirubin < 2.5 x upper limit of normal (ULN)
Total bilirubin =< 2.0 x upper limit of normal (ULN) (unless elevated bilirubin is related to Gilbert syndrome), within 14 day prior to registration
Bilirubin =< 3 x upper limit of normal (ULN)
Have AST, ALT, GGT, and AP that are ?2.5*upper limit of normal (ULN) and normal bilirubin (total and direct) regardless of liver involvement.
Bilirubin =< 3 times the upper limit of normal for age
Total bilirubin =< 1.5 x upper limit of normal (ULN) (unless due to Gilbert syndrome, in which case it should be =< 3.0 x ULN)
Total bilirubin =< 1.5 x institutional upper limit of normal
Total bilirubin =< 2 mg/dL; serum transaminases less than two times the institutional upper limit of normal (< 2 x upper limit of normal [ULN])
Total bilirubin < 2.0 x institutional upper limit of normal (ULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN) for age, and
PHASE I: Total bilirubin =< 1.5 x upper limit of normal (ULN) (unless Gilbert’s disease)
Bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin < 2.0 X upper limit of normal (ULN)
Concentrations of total serum bilirubin within 1.5 x upper limit of normal (ULN)
Total bilirubin =< institutional upper limit of normal (IULN)
Total bilirubin within 1.5 x the upper limit of normal institutional limits; patients with elevation of unconjugated bilirubin alone, as in Gilbert's disease, are eligible
Total bilirubin =< 1.5 x upper limit of normal (< 3 x ULN if Gilbert’s disease)
Serum bilirubin < 1.5 x upper limit of normal values
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Serum bilirubin =< 1.5 x institutional upper limit of normal (ULN)
Transaminases =< 5 x upper limit of normal (ULN) and total bilirubin =< 2.5 mg/dL except for patients with Gilbert’s syndrome or hemolysis
Total bilirubin < 1.25 x institutional upper limit of normal
Hepatic: total bilirubin =< 1.5 x upper limit of normal (ULN)
Bilirubin > upper limit of normal (ULN)
Total bilirubin =< 2 x institutional upper limit of normal
Total bilirubin =< 2 x institutional upper limit of normal (ULN)
Total bilirubin =< institutional upper limit of normal (ULN)
Total bilirubin > 1.5 x upper limit of normal (ULN) (unless evidence of Gilbert’s disease)
Total bilirubin with normal institutional limits; NOTE: for this study, subjects with bilirubin levels > 1.5 upper limit of normal (ULN) are excluded from this enrollment in this study
Bilirubin levels > 1.5 institutional upper limit of normal (IULN)
Serum bilirubin < 1.5 x institutional upper limit of normal (IULN) (except for patients with known Gilbert’s disease)
Obtained =< 14 days prior to registration: Total bilirubin =< institutional upper limit of normal (ULN)
PRIOR TO CELL PROCUREMENT: Bilirubin ? 1.5 times the upper limit of normal (ULN)
PRIOR TO INFUSION OF ATLCAR.CD30 CELLS: Bilirubin ? 1.5 times the upper limit of normal (ULN)
Total bilirubin < 1.5 x upper limit normal (ULN)
Total bilirubin =< to 1.5 X upper limit of normal (ULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)
Serum bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)
Total bilirubin < 1.5 x institutional upper limit of normal (IULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN), in case of Gilbert's syndrome, =< 2 x ULN within 30 days prior to C1D1
Total serum bilirubin =< 1.5 x upper limit of normal (ULN) unless attributable to Gilbert’s syndrome
Total bilirubin =< 3 x institutional upper limit of normal, unless there is a known history of Gilbert’s disease
Total bilirubin < 1.5 x institutional upper limit of normal (ULN)
Total bilirubin ? 2 times the upper limit of normal (ULN) unless due to Gilbert's disease
Total bilirubin ?1.5 x upper limit of normal (ULN) (except patients with documented Gilbert's syndrome);
Total bilirubin > 1.5 x upper limit of normal (ULN)
Total bilirubin less than 1.5 X institutional upper limit of normal (IULN) except in patients with Gilbert’s syndrome who must have a total bilirubin less than 2.5 X IULN
Total bilirubin: =< 1.5 upper limit of normal (ULN)
Total serum bilirubin =< 1.5 x upper limit of normal (ULN), OR in patients with Gilbert’s syndrome, a total bilirubin =< 3.0
Total bilirubin =< 1.5 x upper limit of normal
Total bilirubin =< 1.5 x international upper limit of normal (IULN) OR direct bilirubin =< IULN for patients with total bilirubin > 1.5 x IULN
DONOR: Total bilirubin =< 2x institutional upper limit of normal
Total bilirubin =< 2 x institutional upper limit of normal
Serum bilirubin < 1.5 x upper limit of normal (ULN) except in patients with Gilbert’s syndrome as defined by > 80% unconjugated bilirubin
Total bilirubin =< 1.5 x the upper limit of normal
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) OR direct bilirubin =< IULN for patients with total bilirubin > 1.5 x IULN
Serum total bilirubin =< 1.5 x upper limit of normal (ULN) or =< 3 x ULN for patients with Gilbert’s disease
Total bilirubin =< 1.5 x upper limit of normal (ULN) for the laboratory
Total bilirubin =< 1.5 x the upper limit of the normal range (ULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Total serum bilirubin =< 1.5 X upper limit of normal (ULN)
Total bilirubin =< international upper limit of normal (IULN)
Total bilirubin =< 2.0 X institutional upper limit of normal
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)
Serum bilirubin ? 1.5 x institutional upper limit of normal (ULN)
Total bilirubin within 1.5 x institutional level of normal or direct bilirubin =< upper limit of normal (ULN) for patient with total bilirubin levels > 1.5 ULN
Total bilirubin > 1.5 x upper limit of normal (ULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)
Total bilirubin =< 1.5 x the upper limit of the normal range (ULN) unless related to disease or patient known to have underlying Gilbert’s disease
Total bilirubin =< 2.0 x upper limit of normal (ULN)
Total serum bilirubin =< 1.5 x upper limit of normal (ULN) (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)
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
Serum total bilirubin > 1.5 times the upper limit of normal (ULN);
Bilirubin ? 2 times upper limit of normal
Within 14 days of first dose of study drug administration: Total bilirubin =< 1.5 times the institutional upper limit of normal (ULN) (or =< 3 times ULN in case of liver metastasis)
Total bilirubin =< 1.5 times upper limit of normal (ULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN) with the following exception: patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled
Serum total bilirubin =< 2.0 x upper limit normal (ULN) or =< 3.0 x ULN if deemed to be elevated due to leukemia
Total bilirubin =< 2 x institutional upper limit of normal (ULN) (except for known Gilbert’s syndrome/familial non-hemolytic jaundice)
Serum bilirubin =< 1.5 x upper limit of normal
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin =< 2 x institutional upper limit of normal
Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age within 7 days prior to enrollment
Bilirubin =< 1.5 x upper limit of normal (ULN); for subjects with Gilbert’s disease =< 3.0 mg/dL
Total bilirubin > 1.5 times upper limit of normal (ULN) unless an alternate nonmalignant etiology exists (e.g., Gilbert's disease)
Total bilirubin =< 2 x upper limit of normal (ULN) (unless related to lymphoma or Gilbert’s disease) OR =< 5 x ULN for subjects with documented or suspected Gilbert’s disease, or related to involvement of the liver by the lymphoma, obtained =< 7 days prior to registration
Total bilirubin < 1.5 upper limit of normal (ULN)
Total bilirubin =< 1.5 x the upper limit of the normal range (ULN)
Direct bilirubin =< 1.5 x institutional upper limit of normal (ULN)
Bilirubin =< 1.5 times upper limit of normal (ULN)
Within 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/dL
Serum bilirubin =< 2 x upper limit of normal, unless proven to be due to disease involvement
Total bilirubin of =< 1.5 times upper limit of normal (exception is made for patients with Gilbert’s syndrome who may be considered eligible if total bilirubin is < 3 times upper limit of normal)
ARM B COHORT 2: Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)
Total bilirubin =< 1.5 x upper limit of reference range ( < 3 x upper limit of reference range in patients with Gilbert’s disease)
Total bilirubin =< 1.5 X institutional upper limit of normal (ULN) (measured within 28 days prior to administration of study treatment)
Total bilirubin < 1.5 x the upper limit of normal (ULN)
Hepatic: Serum/plasma total bilirubin ?1.5 x upper limit of normal (ULN) with the exception of <2.9 mg/dL for patients with Gilbert's disease, ALT (SGPT) and AST (SGOT) ?2.5 x ULN.
Total bilirubin > 1.5 x upper limit of normal (ULN)
Documented bilirubin and hepatic transaminases of =< 2.5 x upper limit of normal (ULN)
Total bilirubin =< 1.5 upper limit of normal (ULN)
Adequate liver function: Alanine transaminase (ALT) < 2 x ULN and bilirubin < 1.5 x Upper Limit of Normal (ULN), (or if bilirubin is between 1.5 - 2 x ULN, they must have a normal conjugated bilirubin).
AT THE TIME OF INFUSION: Bilirubin ? 3 x normal
Total bilirubin =< 2 times upper limit of normal (x ULN) (3 x ULN if considered to be due to leukemia involvement or Gilbert’s syndrome)
Total bilirubin < 1 x upper limit of normal (ULN)
bilirubin less than or equal 1.5 times the upper limit of normal (ULN).
Total serum bilirubin =< 1.5 times the upper limit of normal
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin =< 2.5 x institutional upper limit of normal
Total bilirubin =< 1.5 x upper limit of normal (ULN); for patients with Gilbert’s disease, total bilirubin up to =< 3 x ULN is allowed provided normal direct bilirubin
Total bilirubin >= 1.5 x the upper limit of the normal range (ULN)
Bilirubin (sum of conjugated + unconjugated) less than 1.5 x upper limit of normal (ULN) for age
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin =< 2.5 × institutional upper limit of normal
Serum bilirubin =< 2 x upper limit of normal (ULN)
Total bilirubin =< 2 times upper limit of normal (x ULN) (=< 3 x ULN if considered to be due to leukemic involvement or Gilbert’s syndrome)
Total bilirubin =< 1.5 x the upper limit of normal (ULN) unless considered due to Gilbert’s syndrome
Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age
Bilirubin =<1.5 x upper limit of normal (ULN)
Total bilirubin ? 1.5 x the upper limit of the normal range (ULN)
Total bilirubin =< 1.5 X upper limit of normal OR in patients with Gilbert’s syndrome, a total bilirubin =< 3.0
TREATMENT: Bilirubin < 3 × upper limit of normal (ULN)
Total bilirubin (Tbili) < 1.6 x upper limit of normal (ULN)\r\n* Except subjects with known Gilbert’s syndrome
Total bilirubin < 3 the upper limit of normal (ULN), except patients who are assigned to receive docetaxel must have liver function tests (serum transaminases, bilirubin) that are within 1.5 x the ULN
Bilirubin (sum of conjugated + unconjugated) ? 1.5 x upper limit of normal (ULN) for age.
Total bilirubin =< 2.5 x institutional upper limit of normal
Total bilirubin level =< 1.5 x institutional upper limit of normal (ULN)
Total bilirubin < 2.0 x the upper limit of normal and direct bilirubin within normal limits
EXCLUSION CRITERIA FOR ADDITIONAL PTCy-MILs INFUSION AT RELAPSE: Total bilirubin > 3 times the upper limit of normal (ULN)
Total bilirubin =<1.5 x the upper limit of the normal range (ULN)
Total bilirubin =< 2 x upper limit of normal (ULN)
Total bilirubin >1.5 x upper limit of normal (ULN). For patients with Gilbert's syndrome total bilirubin >2.5 x upper limit of normal (ULN)
Total bilirubin must be less than or equal to (<=) 1.5* the upper limit of normal (ULN).
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin < 3 x upper limit of normal (ULN)
Total bilirubin < 1.5 X upper limit of normal (ULN)
Total bilirubin: =< 3 x upper limit of normal (ULN) for age OR conjugated bilirubin =< 2 mg/dl
Within 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)
TREATMENT: Patients with bilirubin ? 2 x upper limit of normal
Serum bilirubin =< 2 x upper limit of normal (ULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN), unless due to Gilbert’s syndrome (< 5 if liver involvement with primary tumor)
Total bilirubin =< 1.5 x upper limit of normal (ULN), obtained within 30 days of study registration
Serum total bilirubin within normal range (or =< 1.5 x upper limit of normal [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), obtained =< 14 days prior to registration
Total bilirubin within normal range; for patients with liver metastases, serum bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin must be less than or equal to 1.5 x upper limit of normal (ULN), and
Within 21 days prior to course 1 day 1 (C1D1): Total bilirubin < 2 times the upper limit of normal (ULN)
Total bilirubin < 2 times upper limit of normal (unless due to Gilbert’s syndrome), performed within 28 days prior to registration
Patients must have bilirubin < 1.5 x normal
Total bilirubin =< 1.5 x upper limit of normal (ULN), =< 1.8 x ULN with liver metastases
Total bilirubin =< institutional upper limit of normal obtained no more than 28 days prior to the start of neoadjuvant endocrine therapy
Serum bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin =< upper limit of normal (ULN)
Total bilirubin > 1.5 x the upper limit of normal (ULN)
Total bilirubin less than or equal to 1.5 x normal for age
Total bilirubin =< 1.5 x institutional upper limit of normal
Total bilirubin < 1.5 x upper limit of normal (ULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)
Serum total bilirubin < 2.0 x ULN (upper limit of normal)
Bilirubin =< 1.5 x upper limit of normal (ULN)
Serum bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin =< 1.5 times the institutional upper limit of normal
Serum total bilirubin < or = to 1.5 X the upper limit of normal (ULN)
Serum bilirubin within (or under) normal limits (OR total bilirubin =< 3.0 x institutional upper limit of normal [IULN] with direct bilirubin within normal range in patients with well documented Gilbert syndrome)
Total bilirubin >= 2 x the upper limit of normal
Serum total bilirubin =< 1.5 x upper limit of normal (ULN) (except for patients with documented Gilbert's syndrome)
Serum bilirubin of =< 1.5 × upper limit of normal
Serum bilirubin within normal range (or =< 1.5 x upper limit normal [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)
Total bilirubin =< 1.5 times the upper limit of normal (ULN) (to be performed within 7 days prior to start of study treatment)
Bilirubin =< 1.5 times the upper limit of normal (ULN); this value must be obtained within two weeks before protocol entry
Serum direct bilirubin =< 2.0 x ULN (upper limit of normal)
Total bilirubin < 1.5 x institutional upper limit of normal OR > 1.5 x institutional upper limit of normal allowed if direct bilirubin is within normal range
Total bilirubin =< 1.5 x upper limit of normal (ULN) OR 3 x ULN for Gilbert’s disease
Bilirubin < 2.5 times institutional upper limit of normal (ULN)
Total bilirubin > 1.5 x upper limit of normal (ULN) unless related to Gilbert's syndrome or hemolysis
Serum total bilirubin =< 1.5 x ULN (upper limit of normal)
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (patients with Gilbert’s syndrome may have serum bilirubin > 1.5 × ULN)
Serum bilirubin =< twice the upper limit of normal
Total bilirubin =< upper normal limit (obtained =< 7 days prior to registration)
Total bilirubin =< 1.5 X institutional upper limit of normal (except for patients with documented Gilbert’s disease)
B. Hepatic: Serum total bilirubin ?2.5 x upper limit of normal (ULN), ALT (SGPT) and AST (SGOT) ?2.5 x ULN.
Serum bilirubin < 2x upper limit of normal (ULN)
Bilirubin =< 1.5 x the upper limit of normal (ULN); for subjects with known Gilbert’s disease, bilirubin =< 3.0 mg/dL
Total bilirubin < 2.0 times the institutional upper limit of normal (ULN)
Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Total serum bilirubin =< 1.5 x upper limit of normal (ULN)
Within 14 days prior to registration: Serum total bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin =< 3 times the upper limit of normal if patient had recent biliary stenting and a falling trend in bilirubin is demonstrated such that capecitabine treatment is deemed feasible per the treating medical oncologist, total bilirubin =< 1.5 times the upper limit of normal if no biliary stenting was done
Bilirubin =< 1.5 times upper limit of normal
Conjugated (direct) bilirubin less than 2 x upper limit of normal
Bilirubin =< 2 x upper limit of normal (ULN) (unless documented Gilbert’s syndrome, for which bilirubin =< 3 x upper limit of normal [ULN] is permitted) obtained within 2 weeks prior to registration
RANDOMIZED PHASE II (ARMS K AND L): Bilirubin =< 2 x upper limit of normal (ULN) (unless documented Gilbert’s syndrome, for which Bilirubin =< 3 x upper limit of normal [ULN] is permitted); obtained within 2 weeks prior to registration
Total bilirubin =< 1.5 x upper limit of normal OR in patients with Gilbert’s syndrome, a total bilirubin =< 3.0
Bilirubin =< 1.5 x the upper limit of normal
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN); and
Total bilirubin < 1.5 x upper limit of normal (ULN) AND
Serum total bilirubin =< 2.0 x ULN (upper limit of normal)
Bilirubin less than 3 times the upper limit of normal
Bilirubin =< 2x upper limit of normal
Total bilirubin =< 1.5 x institutional upper limit of normal
Within 14 days of enrollment: Total bilirubin level > 1.5 x upper limit or normal (ULN)
Total bilirubin < 1.5 times upper limit of normal
Total bilirubin =< 2 x upper limit of normal (ULN)
Bilirubin =< 3 times the upper limit of normal for age
Total bilirubin < 1.5 x upper limit of normal (ULN) (Gilbert's allowed 3 x ULN)
Total bilirubin =< 2 mg/dl or =< 2.5 x upper limit of normal (ULN) for age (unless Gilbert's syndrome)
Bilirubin =< 3 x upper limit of normal (ULN)
Total bilirubin =< 2 x upper limit laboratory normal (ULN); subjects with non-clinically significant elevations of bilirubin due to Gilbert’s disease are not required to meet these criteria
Total bilirubin =< 2 times the upper limit of normal (ULN)
Adequate organ function defined as: bilirubin <2x upper limit of normal (ULN) (unless associated with Gilbert's syndrome), and ALT or AST <2.5x ULN.
Total bilirubin =< 1.5 x upper limit of normal (ULN) or direct bilirubin =< ULN
Total bilirubin less than 2 x upper limit of normal
Bilirubin < 1.5 x upper limit of normal (ULN)
Serum bilirubin =< 2 x upper limit of normal
Total serum bilirubin < 2 x upper limit normal (unless due to hemolysis, Gilbert’s syndrome, or ineffective erythropoiesis)
Bilirubin less than or equal to 2 x upper limit of normal
Bilirubin =< 1.5 times the upper limit of the normal range (ULN)
Total bilirubin < 1.5 times upper limit of normal
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin =< 1.5 times the upper limit of normal (ULN)
Bilirubin (total) < 1.5 X upper limit of normal (ULN)
Total bilirubin < 2.0 times the institutional upper limit of normal (ULN)
Total bilirubin =< 2 x upper limit of normal (ULN), within 14 days prior to study entry
Bilirubin =< 3 x upper limit of normal
Bilirubin (sum of conjugated + unconjugated) < 1.5 x upper limit of normal (ULN)
Total (T.) bilirubin =< 3 X upper limit of normal (ULN)
Hepatic (bilirubin < 2 x upper limit of normal [ULN]) or
Bilirubin =< 1.5 fold the upper limit of normal
Total bilirubin =< 1.5 x upper limit of normal (ULN) (unless considered due to Gilbert’s syndrome or hemolysis)
Bilirubin =< 2.5 X the upper normal limit of institution's normal range
Bilirubin =< 1.5 x normal
Bilirubin =< 1.5 times the upper limit of normal (ULN); this value must be obtained within four weeks before protocol entry
Total bilirubin =< 1.5 x upper limit of normal
Total serum bilirubin =< 1.5 x upper limit of normal (ULN), unless due to Gilbert's syndrome
Total bilirubin =< 1.5 times institutional upper limit of normal (ULN)
Total bilirubin =< 1.5 x local institutional upper limit of normal (ULN)\r\n* If elevated total bilirubin is due Gilbert’s disease or disease-related hemolysis then total bilirubin =< 3.0 x local institutional ULN
Total bilirubin =< 1.5 x upper limit of normal (ULN) or =< 3 x ULN if documented hepatic involvement with lymphoma, or =< 5 x ULN if history of Gilbert's syndrome, without use of growth factor support for 1 week
Total bilirubin =< 1.5 × the upper limit of the normal range (ULN) obtained =< 14 days prior to registration
Obtained =< 28 days prior to randomization:\r\nTotal bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin < 1.5 x upper limit normal
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin =< 1.5 times upper limit of normal for age
Serum total bilirubin =< 1.5 X upper limit of normal (ULN)
Total bilirubin of =< 1.5 x upper limit of normal (ULN)
Patients with total bilirubin >= 2.0 times upper limit of normal unless felt to be related the underlying leukemia by the treating physician or hemolysis or Gilbert's disease
Patient must have adequate hepatic function as defined by total bilirubin < 2.5 x IULN (institutional upper limit of normal)
Serum bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin =< 2 x institutional upper limit of normal
Serum total bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin =< 2 x institutional upper limit of normal for age
Bilirubin 1.5 times or less than the upper limit of normal
Direct bilirubin > 3x upper limit of normal
Total bilirubin =< 1.5 times upper limit of normal range
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin must be < 2 x institutional upper limit of normal (ULN)
Bilirubin =< 3 x upper limit of normal
Serum bilirubin =< 2 x the institutional upper limit of normal (ULN)
Total bilirubin =< 2x normal
Total bilirubin < 1.5 x normal
Bilirubin < 5 x upper limit of normal
Bilirubin < 5 x normal
Bilirubin < 1.5 x upper limit of normal
Liver function: bilirubin > 1.5x upper limit of normal (ULN) and SGOT (AST) > 2.5x ULN.
Total bilirubin greater the upper limit of normal (ULN; unless the subject has documented Gilbert's syndrome).
Total bilirubin < 1.5 x upper limit of normal (ULN)
Bilirubin (sum of conjugated + unconjugated) ?1.5 × upper limit of normal (ULN) for age
Obtained =< 14 days prior to registration: Total bilirubin =< 1.5 x upper limit of normal (ULN)
Bilirubin < 4 times the upper limit of institutional normal
Hepatic-bilirubin > 2 X upper limit of normal (ULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Direct bilirubin ? 2x upper limit of normal (ULN)
Total 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 Upper limit of normal (ULN) to 3 x ULN due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin; and
Serum bilirubin < 1.5 times the upper limit of normal (ULN); unless due to Gilbert’s syndrome (in which < 2 times ULN acceptable)
Total bilirubin =< 2 times the upper limit of normal (ULN) (except patients with Gilbert’s syndrome who must have a total bilirubin of < 3 times ULN)
Total bilirubin < 1.5 x upper limit of normal (ULN); NOTE: concomitant elevations in bilirubin above 1.0 x ULN is not permitted
Bilirubin =< to 2.0 x normal
Bilirubin =< 1.5 times (x) upper limit of normal (ULN) (except patients with Gilbert’s syndrome, who must have a total bilirubin less than 3.0 mg/dL)
Total Bilirubin =< institutional upper level of normal (ULN)
Total bilirubin: < 1.5 x institutional upper limit of normal
Total bilirubin within institutional normal range
Total bilirubin ? 2.0 x the upper limit normal
total bilirubin: ?2 x upper normal limit (UNL) (patients with Gilbert's disease are eligible, hyperbilirubinemia is intermittent & indirect)
Total bilirubin =< 1.5 x upper limit of normal (ULN) for age
Total bilirubin ?1.5x upper limit of normal (ULN)
Total bilirubin ? 1.5 × institutional upper limit of normal (ULN) (however, patients with known Gilbert’s disease who have serum bilirubin level ? 3 × ULN may be enrolled)
Total bilirubin ? 1.5 x upper limit of normal (ULN) (except patients with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL)
Serum total bilirubin > 1.5 x upper limit of normal
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) within 28 days prior to administration of study treatment.
Total bilirubin =< 1.5 X institutional upper limit of normal
To be performed within 14 days prior to day 1 of protocol therapy: total bilirubin =< 1.5 x upper limit of normal (ULN) (=< for Gilbert's syndrome or documented hepatic involvement by lymphoma)
Within 28 days prior to administration of study treatment: Total bilirubin ? 1.5 x institutional upper limit of normal (ULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)
Total bilirubin ?1.5 × upper limit of normal (ULN)
Total bilirubin =< 1.5 x the upper limit of normal (ULN)
Total bilirubin ? 2 times the upper limit of normal (ULN) unless due to Gilbert's disease
AST, ALT, and total bilirubin ? 3x upper limit of normal;
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)
Total bilirubin =<1.5 x institutional upper limit of normal (IULN)
Total bilirubin =< 1.5 x normal for age
Within 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: Patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled.
Total serum bilirubin =< 1.5 X upper limit of normal (ULN)
Total bilirubin =< 1.5 times upper limit of normal (ULN) within 28 days prior to registration.
Total bilirubin =< 1.5 X upper limit of normal (ULN)
Bilirubin (sum of conjugated + unconjugated) ? 1.5 x upper limit of normal (ULN) for age
Obtained ? 14 days prior to registration: total bilirubin ? 1.5 x upper limit of normal (ULN) unless due to Gilbert’s syndrome, in which case the direct bilirubin must be ? 1.5 x ULN
Total bilirubin =< 2 x upper limit of normal (ULN) (unless elevated bilirubin is related to Gilbert syndrome).
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) (except participants with Gilbert’s Syndrome who must have normal direct bilirubin)
Within 14 days prior to first dose of study drug treatment: Serum bilirubin =< 1.5 x the upper limit of normal (ULN); patients with known Gilbert’s disease may have a bilirubin =< 3.0 x ULN
RENAL 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/dL
Bilirubin ? 1.0 x upper limit of normal (ULN)
Total bilirubin (TBL) =< 1.5 x upper limit of normal (ULN) except patients with documented Gilbert's syndrome (> 3 x ULN), within 28 days of day 0.
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)
Bilirubin < 2 x the upper limit of normal (except patients with Gilbert Syndrome in whom bilirubin level of > 2 x upper normal limit will be allowed)
Within 14 days of study registration: Total bilirubin =< 3 x upper limit of institutional normal (ULN)
Non-fasting bilirubin =< 1.5 X the upper normal limit of institution's normal range
Within 14 days prior to day 1 of protocol therapy unless otherwise stated: Total bilirubin =< 1.5 X upper limit of normal (ULN) OR if Gilbert’s syndrome =< 3.0 X ULN
Bilirubin < 3 times the upper limit of institutional normal
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Obtained =< 21 days prior to registration: Total bilirubin =< institutional upper limit of normal (ULN)
Total bilirubin < 1.5 times upper limit of normal
Serum bilirubin =< 1.5 x institutional upper limit of normal (ULN) unless diagnosed with Gilbert’s syndrome.
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)
Serum bilirubin =< 2.5 x institutional upper limit of normal (ULN)
Total bilirubin =< 2.5 X institutional upper limit of normal or =< 3 in subjects with Gilbert’s syndrome
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Serum total bilirubin and liver enzymes are 2 times the upper limit of normal
Liver function tests performed within 3 weeks prior to starting study therapy must have total bilirubin =< 1.5 x upper limit of normal (ULN)
Bilirubin =< 1.5 x upper limit of normal
Total bilirubin =< 1.5 times upper limit of normal (ULN)
Total bilirubin =< 1.5 × institutional upper limit of normal (ULN), unless known Gilbert’s syndrome has been diagnosed
Total bilirubin =< 1.5 X institutional upper limit of normal (ULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN; unless attributable to Gilbert’s disease or other causes of inherited indirect hyperbilirubinemia, at which point total bilirubin must be =< 2.5 x ULN)
Total bilirubin <=<1.5 x the upper limit of normal unless considered due to Gilbert's syndrome
Bilirubin < 1.5 times upper limit of normal
Total bilirubin =< 1.5 times upper limit of normal (ULN)
Total bilirubin =< 1.5 times upper limit of normal (ULN)
Obtained =< 7 days prior to registration: Total bilirubin =< 1.5 times the upper limit of normal (ULN) except for unconjugated hyperbilirubinemia of Gilbert’s syndrome
Total bilirubin within institutional upper limit of normal
Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin =< 1.5 x ULN (institutional upper limit of normal) (patients with Gilbert’s syndrome may have direct bilirubin > 2.5 x ULN)
Total bilirubin within normal ranges unless associated with hepatobiliary metastases or Gilbert syndrome, then total bilirubin =< 2 x upper limit of normal (ULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN), obtained within 14 days prior to the first study treatment (cycle 1, day 1) with the following exception:\r\n* Patients with known Gilbert disease who have total bilirubin level =< 3 x ULN may be enrolled
Total bilirubin =< 1.5 times institutional upper limit of normal (ULN)
To be performed within 28 days prior to day 1 of protocol therapy: Total serum bilirubin < upper limit of normal (ULN)
Total bilirubin < 4 x institutional upper limit of normal (ULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)
Serum total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (patients with Gilbert's syndrome with a total bilirubin < 3.0 mg/dL)
Within 7 days prior to study registration: Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age
Total bilirubin =< 1.5 times upper limit of normal (ULN)
Bilirubin =< 1.5 x institutional upper limit of normal (ULN)
Total bilirubin =< 2.0 x institutional upper limit of normal (ULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN), obtained =< 7 days prior to registration
Total bilirubin =< 1.5 x upper limit of normal (ULN); except in case of Gilbert’s disease
Total 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 eligible
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN) for age
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN), (except for patients with known Gilbert’s syndrome who must have normal direct bilirubin)
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (however, patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled)
Total bilirubin =< 2.5 x institutional upper limit of normal (ULN)
Total bilirubin level >= 1.5 times the upper limit of normal (ULN) (except patients with Gilbert syndrome, who are excluded if total bilirubin >= 3 times ULN), or
Direct bilirubin =< 1.5 x upper limit of normal (ULN) for age, and
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)
Total bilirubin < 1.5 x upper limit of normal (ULN)
Bilirubin =< 2 x upper limit of normal (ULN), obtained within 14 days prior to registration for protocol therapy
Total bilirubin =< 1.5 x upper limit of normal
Total bilirubin =< institutional upper limit of normal (ULN)
Total bilirubin < 2.5 upper limit of normal (ULN)
TUMOR BIOPSY SEQUENCING: Total bilirubin < 1.5 x institutional upper limit of normal
TREATMENT: Total bilirubin < 1.5 x institutional upper limit of normal
Total bilirubin < 2 x institutional upper limit of normal (ULN) within 14 days prior to registration
Total bilirubin =< 1.5 times upper limit of normal (ULN) for age
Total bilirubin =< 1.5 x upper limit of institutional normal
Bilirubin < 3 x upper limit of normal (ULN)
Total bilirubin =< 5 x upper limit of normal (ULN)
Total bilirubin =< 1.5 x the upper limit of normal (ULN)
Measured within 28 days prior to administration of study treatment: Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN), obtained =< 14 days prior to registration
Total bilirubin =< 2 x upper limit of normal (ULN)
Total bilirubin within normal institutional limits; EXCEPTION: subjects with known Gilbert's disease: total bilirubin =< 3 x institutional upper limit of normal (ULN)
Within 28 days prior to administration of therapy: Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)
Bilirubin (total) < 1.5 X upper limit of normal (ULN)
Total bilirubin =< 2 x upper limit of normal (ULN)
Total bilirubin =< the institutional upper limit of normal
Total bilirubin =< 1.5 x upper limit of normal unless clearly related to Gilbert’s disease, hemolysis or leukemic infiltrate
Direct bilirubin < 1.5 x upper limit of normal (ULN) for age and institution
Total bilirubin below normal institutional upper limit of normal (ULN)
Total bilirubin within =< 1.5 times the upper limit of normal (ULN) institutional limits
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)
Total bilirubin =< 1.5 mg/dL x the institutional upper limit of normal
Serum bilirubin greater than 3 times the upper limit of normal, unless attributed to Gilbert’s syndrome
Serum direct bilirubin < 2 x institutional upper limit of normal
Secondary Registration: total serum bilirubin =< 1.5 x institutional upper limit of normal
Serum bilirubin =< 1.5 x institutional upper limit of normal (ULN) except subjects with known Gilbert’s syndrome
Total bilirubin < 2 X institutional upper limit of normal (ULN)
Total bilirubin greater than 1.5 x the institutional upper limit of normal (ULN)
Total bilirubin < 1.5 times upper limit of institutional normal
Total serum bilirubin =< 1.0 x institutional upper limit of normal
Total bilirubin =< upper limit of normal (ULN)
Total bilirubin =< 1.5 x the upper limit of normal (ULN); for subjects with known Gilbert’s disease, =< 3 mg/dl
Total bilirubin < 1.5 x upper limit of normal (ULN) for age
Total bilirubin =< 1.5 x upper normal limit (ULN)
Bilirubin < 1.5 x upper limit of normal (ULN), for patients with Gilbert syndrome, direct bilirubin will be measured instead of total bilirubin
Total bilirubin =< 2 x institutional upper limit of normal
Total bilirubin =< 1.5 x upper limit of normal for age
Total bilirubin =< 1.5 x upper limit of normal (ULN) (unless Gilbert’s syndrome or disease infiltration of the liver is present)
Total bilirubin < 1.5 x institutional upper limit of normal (bilirubin < 3 x institutional upper limit of normal for Gilbert’s syndrome)
Serum bilirubin =< institutional upper limit of normal (IULN); for patients with liver metastases, bilirubin must be =< 5 x IULN obtained within 28 days prior to Step 2 re-registration
Bilirubin < 1.5 x upper limit of normal (ULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin < 1.5 x upper limit of normal (ULN) for age
Total bilirubin =< 1.5 x upper limit of normal (ULN) for age, and
Total bilirubin =< institutional upper limit of normal
Bilirubin =< 2 x upper limit of normal (ULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Non-fasting direct bilirubin =< 1.5 × the upper normal limit of institution's normal range
Total bilirubin =< 1.5 times upper limit of normal (ULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN) (except for patients with well-documented Gilbert’s syndrome) (obtained =< 14 days prior to registration)
Total bilirubin =< 1.5 X institutional upper limit of normal
Total bilirubin: =< 2 x institutional upper limit of normal (ULN)
Serum bilirubin =< institutional upper limit of normal (IULN); for patients with liver metastases, bilirubin must be =< 5 x IULN within 28 days prior to Step 2 re-registration
Total bilirubin =< 1.5 times the upper limit of normal (ULN)
Serum bilirubin =< institutional upper limit of normal (IULN); for patients with liver metastases, bilirubin must be =< 5 x IULN within 28 days prior to step 2 re-registration
Total bilirubin =< upper limit of normal (or =< 1.5 x upper limit of normal if live metastases are present; or total bilirubin =< 3.0 x upper limit of normal with direct bilirubin within normal range in patients with well documented Gilbert’s syndrome, which is defined as presence of several episodes of unconjugated hyperbilirubinemia with normal results from complete blood count [CBC] count [including normal reticulocyte count and blood smear], normal liver function test results, and absence of other contributing disease processes at the time of diagnosis)
Total bilirubin =< 1.5 x institutional upper limit of normal
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
Total bilirubin =< 1.5 x upper limit of normal (ULN) for age
Total bilirubin =< 1.5 x institutional upper limit of normal
Total bilirubin < 2 times the upper limit of normal (ULN) (except patients with Gilbert’s syndrome who must have a total bilirubin of < 3 times ULN)
Bilirubin =< 1.5 x upper limit of normal (ULN)
Within 14 days of subject registration: Total bilirubin within normal range or =< 1.5 X institutional upper limit of normal (IULN) if liver metastases are present or total bilirubin =< 3.0 X IULN with direct bilirubin within normal range in subjects with well-documented Gilbert’s syndrome, which is defined as presence of unconjugated hyperbilirubinemia with normal results from complete blood count (CBC) (including normal reticulocyte count and blood smear), normal liver function test results and absence of other contributing disease processes at the time of diagnosis
Total 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)
Total bilirubin =< 1.5 institutional upper limit of normal (ULN)
PHASE II: Total bilirubin =< 1.5 institutional upper limit of normal (ULN)
Serum total bilirubin < 1.5 x upper limit or normal (ULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN) for the institution
Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age
Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age
Serum bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin < 1.5 x institutional upper limit of normal with direct bilirubin within normal limits except for participants with Gilbert’s disease
Total bilirubin =< 2 X institutional upper limit of normal
Patients on Part A and Part B: bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age
Bilirubin < 1.5 x ULN of the institutional normal reference range
Total bilirubin =< 1.5 x the upper limit of the normal range (ULN) within 14 days of enrollment
Total bilirubin < 1.5 x institutional upper limit of normal
Total bilirubin =< 1.5 x upper limit of normal (ULN) for age
Total bilirubin =< 1.5 x institutional upper limit of normal
Total bilirubin =< 1.5 x institutional upper limit of normal
Total bilirubin < 1.5 x institutional upper limit of normal (bilirubin < 3 × institutional upper limit of normal for Gilbert’s syndrome)
Bilirubin =< 1.5 x institutional upper limit of normal (ULN) except subjects with known Gilbert’s syndrome, within 2 weeks of the first dose of study treatment
Serum bilirubin =< 1.5 x institutional upper limit of normal (ULN) except subjects with known Gilbert’s syndrome
Bilirubin < 1.5 x upper limit of normal (ULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin =< 2 x upper limit of normal (ULN)
Serum bilirubin < 1.5 times the institutional upper limit of normal
Total bilirubin =< 1.5 × upper limit of normal (ULN)
Total serum bilirubin of less than 3 times the upper limit of normal
Bilirubin less than 3 times the upper limit of normal
Total bilirubin =< 2 x institutional upper limit of normal (ULN)
Serum bilirubin =< 1.5 x upper limit of normal (ULN) (=< 3.0 if Gilbert’s syndrome)
Bilirubin (total) less than or equal to the upper limit of normal; an exception to this may be allowed for participants with Gilbert’s syndrome with prior approval by the protocol chair
Total bilirubin =< 1.5 x institutional upper limit of normal, measured within 28 days prior to administration of study treatment
Bilirubin less than 1.5 x upper limit of normal (ULN)
Bilirubin =< 2 x upper limit of normal value
Total bilirubin =< 1.5 institutional upper limit of normal (ULN)
Total bilirubin =< 1.5 X institutional upper limit of normal
Total bilirubin =< 2 mg/dL or =< 1.5 times upper limit of normal (ULN)
Total bilirubin < 1.5 x upper limit of normal (ULN)
Total bilirubin < 2.5 x institutional upper limit of normal (ULN)
Total bilirubin =< 1.5 times institutional upper limit of normal (ULN)
PHASE II: Total bilirubin =< 1.5 times institutional upper limit of normal (ULN)
Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age
Total bilirubin > 2 x upper limit of normal (ULN) (except in the case of subjects with documented Gilbert’s disease > 3 x ULN)
Total bilirubin < 1.5 x institutional upper limit of normal (ULN)
Direct bilirubin =< 1.5 X upper limit of normal (ULN) (subjects with Gilbert’s syndrome and elevations of indirect bilirubin only are eligible)
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Serum bilirubin >= 1.5 x upper limit of normal (ULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)
Total bilirubin < 1.5 x institutional upper limit of normal (ULN) (except for patients with Gilbert's syndrome and elevations of indirect bilirubin)
Total bilirubin < 1.5 x upper limit of normal assessed within seven (7) days prior to the start of therapy
Total bilirubin =< 1.5 x upper limit of normal (ULN) for age
Bilirubin =< 1.5 times upper limit of normal
Total bilirubin =< 1.5 x institutional upper limit of normal
Serum bilirubin =< 1.5x upper limit of normal
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)
Total bilirubin (TB) =< 1.5 x upper limit of normal (ULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age
Total bilirubin =< 1.5 X upper limit of normal (ULN)
Bilirubin =< 3 x upper limit of normal
Total bilirubin below the upper limit of normal (ULN)
Bilirubin less than 3 times the upper limit of normal
Total bilirubin > 1.5 x institutional upper limit of normal (ULN) (patients with benign hyperbilirubinemia [e.g., Gilbert’s syndrome] are eligible), within 21 days of initiation of protocol therapy
Obtained within 28 days prior to registration: Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)
Bilirubin =< 2 x institutional upper limit of normal (ULN); these results must be obtained within 28 days prior to registration
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (or =< 2.5 x ULN with Gilbert’s disease)
Subject has adequate liver function, which is defined as: • Total bilirubin is ? 2 mg/dL unless the increase in bilirubin is attributable to Gilbert's Syndrome • AST is ? 3.0 x upper normal limit (ULN) for age. For the purpose of this study, the ULN for AST is 50 U/L. • ALT is ? 3.0 x upper normal limit (ULN) for age. For the purpose of this study, the ULN for ALT is 45 U/L.
Total bilirubin ? 1.5 × upper limit of normal range except in cases of Gilbert's disease and liver metastases.
Total bilirubin < 1.5 times the institutional upper limit of normal (ULN); subjects with Gilbert’s syndrome and total bilirubin >= 1.5 times the upper limit of normal are eligible to participate
Total bilirubin =< 2 x institutional upper limit of normal (IULN) (unless due to Gilbert syndrome) within 42 days prior to registration
Total bilirubin < 1.5 times the upper limit of normal (ULN) unless due to Gilbert’s disease or hemolysis
Bilirubin > 1.5 x institutional upper limit of normal (ULN) (patients with benign hyperbilirubinemia [e.g., Gilbert's syndrome] are eligible) or
Total bilirubin =< 1.5 x upper limit of normal (ULN) (or =< 3.0 mg/dL if known Gilbert’s syndrome)
Bilirubin =< 1.5 times upper limit of normal (ULN)
Total 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 registration
Serum bilirubin =< 1.5 x upper limit of normal (ULN) unless attributable to Gilbert's syndrome
Total bilirubin < 1.5 x institutional upper limit of normal (ULN)
CLINICAL/LABORATORY CRITERIA: Total bilirubin =< 1.5 x institutional upper limit of normal (IULN); these results must be obtained within 28 days prior to registration
Total serum/plasma bilirubin ?1.5 times the upper limit of normal (ULN).
If no known liver metastases: total bilirubin < 1.5 x institutional upper limit of normal (ULN); if known liver metastases, then: total bilirubin < 2.5 x ULN
Total bilirubin =< 1.5 x upper limit of normal (ULN) (patients with Gilbert’s syndrome may have serum bilirubin > 1.5 ULN)
Performed within 14 days of patient registration: Total bilirubin within normal range or =< 1.5 x institutional upper limit of normal (IULN) if liver metastases are present or total bilirubin =< 3.0 x IULN with direct bilirubin within normal range in patients with well documented Gilbert’s syndrome, which is defined as presence of several episodes of unconjugated hyperbilirubinemia with normal results from complete blood count (CBC) (including normal reticulocyte count and blood smear), normal liver function test results, and absence of other contributing disease processes at the time of diagnosis
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) except in the case of patients with Gilbert’s disease
Total 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/dL
Serum bilirubin up to 1.2 x upper limit of normal
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (or =< 2.0 x ULN in patients with documented Gilbert's syndrome)
Bilirubin ? 1.5 times upper limit of normal (CTCAE Grade 2 baseline)
Bilirubin =< 1.5 times upper limit of normal
Bilirubin less than or equal to 1.5 x institutional/laboratory upper limit of normal (ULN)
Total bilirubin =< 2.0 x upper limit of normal (ULN)
Total bilirubin within institutional upper limit of normal (IULN)
Serum bilirubin =< institutional upper limit of normal (IULN) within 28 days prior to RE-TREATMENT registration; for patients with liver metastases, bilirubin must be =< 5 x IULN
Bilirubin ? 1.5 x upper limit of normal (ULN) except for unconjugated hyperbilirubinemia or Gilbert's syndrome;
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)
Total bilirubin =< 1.5 x institutional upper limit of normal; unless due to Gilbert’s syndrome
Bilirubin =< 1.5 times the institutional limit of normal
Bilirubin* within normal range
Total bilirubin < 2 x institutional upper limit of normal (ULN)
Within 14 days prior to registration: Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)
AMKL PATIENTS: Total bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin ? 1.5 times the upper limit of normal;
Total bilirubin =< institutional upper limit of normal (IULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN) or if total bilirubin is > 1.5 x ULN, the direct bilirubin must be normal
Total bilirubin < 1.5 x of institutional upper limit of normal (ULN)
Serum bilirubin < 1.5x upper limit of normal
Total bilirubin =< 1.5 x upper limit of normal in the absence of Gilbert’s disease; for patients with Gilbert’s syndrome: direct bilirubin =< 1.5 x upper limit of normal
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 must be less than or equal to 1.5 x upper limit of normal (ULN); and
SUB-PROTOCOL AIM A: Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)
Serum bilirubin < 1.5 x institutional upper limit of normal (ULN)
Total bilirubin within upper limit of normal (ULN),
Serum bilirubin at least 1.5 × upper limit of normal (ULN) or at least 3 × ULN if Gilbert's disease is documented
Total bilirubin <1.5 X institutional upper limit of normal (ULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN) (unless Gilbert’s syndrome or disease infiltration of the liver is present)
Total bilirubin < 1.5 x upper limit of normal (ULN) or normal direct bilirubin if the patient has Gilberts
Total bilirubin =< 2 x upper limit of normal (ULN)
Total Bilirubin ? 1.5 x upper limit of normal
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin > 1.5 x the upper limit of reference range (ULRR)
Total bilirubin < 2 x the institutional upper limit of normal
Within 14 days prior to registration: Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)
Serum total bilirubin =< 1.5 x upper limit of normal (ULN)
Patient has > 1.5 x upper limit of normal (ULN) total bilirubin unless history of Gilbert's syndrome
Bilirubin < 1.5 x upper limit of normal (ULN)
Total bilirubin superior to 2 x ULN (Upper Limit of Normal).
Total bilirubin less than or equal to 1.5 X the upper limit of normal (ULN) except for unconjugated hyperbilirubinemia of Gilbert's syndrome
Serum bilirubin =< 1.5 x institutional upper limit of normal (IULN)
Total bilirubin ? 3 times upper limit of normal (ULN) for age
Serum bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin =< 1.5X upper limit of normal (ULN) unless secondary to Gilbert’s disease
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)
Total bilirubin < 3 X upper limited of normal (ULN) for age
Direct bilirubin equal to or less than 1.5 x upper limit of normal (ULN)
Total bilirubin =< 2 times upper limit of normal (x ULN) (=< 3 x ULN if considered to be due to leukemic involvement or Gilbert’s syndrome)
Serum bilirubin less than or equal to 1.5 x upper limit of normal (ULN) (Participants with serum bilirubin abnormalities greater than this specified limit are eligible only if they have known Gilberts disease.)
Total bilirubin >1.5 x upper limit of normal (ULN).
Total bilirubin =< 1.25 times upper limit of normal
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin =< 1.5 X upper limit of normal (ULN)
Total serum bilirubin =< 1.5 x upper limit of normal (ULN) unless due to Gilbert’s disease
Total bilirubin less than 1.5 x upper limit of normal (ULN)
Total bilirubin > institutional upper limit of normal or
Bilirubin <= 1.5 times the upper limit of normal (ULN).
Bilirubin < or equal to 1.5 x upper limit of normal (ULN)
Total bilirubin =< 1.5 times the upper limit of normal
Bilirubin =< 2.0 x the institutional normal upper limit unless secondary to bile duct obstruction by tumor
Total bilirubin: =< 1.5 X institutional upper limit of normal
Total bilirubin =< 1.5 x institutional upper limit of normal
Serum bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin =< 1.5 x the upper limit of the normal range (ULN)
Total bilirubin < upper limit of normal (ULN) (except for Gilbert’s disease)
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) except for patients with bilirubin elevation due to Gilbert's disease who will be allowed to participate
Total bilirubin =< 2 x UIHC upper limit of normal
Total bilirubin less than 2-fold upper limit of normal (ULN)
Total bilirubin =< 1.5 X institutional upper limit of normal; =< 3.0 upper limit of normal (ULN) accepted in subjects with Gilbert’s syndrome
Bilirubin < 3 x upper limit of normal (ULN)
Total bilirubin =< 1.5 x institutional upper limit of normal
Total bilirubin =< 2 x upper limit of normal (ULN) or, if total elevated, direct bilirubin =< 2 x upper limit of normal (ULN) obtained within 4 weeks prior to registration
Total bilirubin =< 2 x upper limit of normal (ULN) or, if total elevated, direct bilirubin =< 2 x upper limit of normal (ULN)
Bilirubin < 2 x the upper limit of normal
Bilirubin 1.5 times or less than the upper limit of normal
Bilirubin =< 1.5 x upper limit of normal
Bilirubin < 1.5 X ULN (the upper limit of normal) (subjects with confirmed Gilbert disease as the cause of their elevated bilirubin are to be permitted)
Total bilirubin < 1.5 x upper limit of normal (ULN) for age
Bilirubin (sum of conjugated + unconjugated) =< 1.5 times institutional upper limit of normal (ULN) for age
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin ? 1.5 x upper limit of normal (ULN) with the following exception:
Total bilirubin =< 1.5 x upper limit of normal (ULN); patients with known history of Gilbert syndrome and total bilirubin < 2 x ULN and normal aspartate aminotransferase (AST)/alanine aminotransferase (ALT) are eligible, obtained =< 7 days prior to registration
Within 14 days of enrollment: Bilirubin =< 1.5 the upper limit of normal (ULN) for the institution\r\n* For patients with known Gilbert's disease: bilirubin =< 3 x ULN
Total bilirubin =< 1.5 x upper limit of normal (ULN) or =< 3 x ULN if documented hepatic involvement with lymphoma, or =< 5 x ULN if history of Gilbert's syndrome
Direct bilirubin =< 1.5 x institutional upper limit of normal (IULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN), or direct bilirubin =< ULN in patients with Gilbert’s syndrome
Total bilirubin =< 1.5 x upper limit of normal, or, for patients who have undergone biliary stenting, total bilirubin of =< 2 or two down trending values
Total bilirubin =< 1.5 X the upper limit of normal (ULN) unless a known history of impaired bilirubin conjugation such as Gilbert’s, for whom the maximum will be 2.5 ULN
Total bilirubin =< 1.5 x upper limit of normal (ULN), except in cases of Gilbert’s disease
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (however, patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled)
Total bilirubin =< 3 x institutional upper limit of normal
Total bilirubin =< 1.5 X upper limit of normal (ULN) obtained =< 7 days prior to randomization; patients with known Gilbert’s syndrome who have serum bilirubin =< 3 X ULN may enroll
Total bilirubin =< institutional upper limit of normal (ULN) (or =< 3 X ULN if Gilbert’s syndrome present or if bilirubin increase related to MF)
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin =< 2.5 times upper limit of normal; AND
Total bilirubin =< 1.5 x institutional upper limit of normal, within 14 days of study registration
Total bilirubin =< 1.5 x upper limit of normal (ULN, unless due to Gilbert syndrome, in which case it should be =< 3.0 x ULN)
Total bilirubin < 2 X institutional upper limit of normal (ULN) unless predominantly indirect and therefore likely due to hemolysis or Gilbert’s syndrome
Serum bilirubin =< 1.5 x institutional upper limit of normal (ULN); (unless Gilbert's syndrome, without concurrent clinically significant liver disease), obtained within 14 days prior to first treatment
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)
Total bilirubin =< 1.5 X institutional upper limit of normal
Total bilirubin > 3 times the upper limit of normal
Total bilirubin =< 1.5 X upper limit of normal (ULN) unless history of Gilbert’s syndrome documented prior to first-line treatment of cancer and other liver function tests are within normal limits
Total bilirubin =< 1.25 x upper limit normal (ULN)
Bilirubin < 1.5 x the upper limit of normal (ULN)
Total bilirubin less than 3 x institutional upper limit of normal (ULN)
Serum bilirubin =< institutional upper limit of normal (IULN)
Total 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/dL
Total bilirubin =< 1.5 X upper limit of normal (ULN) (unless bilirubin rise due to Gilbert’s syndrome)
Total bilirubin =< 1.5 x upper normal limit, or =< 3 x upper normal limit if documented hepatic involvement with lymphoma, or =< 5 x upper normal limit if history of Gilbert’s disease
Total bilirubin =< 1.5 x upper limit of normal (ULN) (except in patients diagnosed with Gilbert’s disease) (within 7 days prior to registration)
Total bilirubin =< 2 x upper limit of normal (ULN) or if total bilirubin is > 2 x ULN, the direct bilirubin must be normal
Bilirubin < 1.5 x upper limit of normal (unless Gilbert's syndrome)
Within 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: patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled
Total bilirubin =< 1.5 x the upper limit of the normal range (ULN)
Obtained within 14 weeks prior to registration on study: bilirubin < 1.5 x upper limit of normal (ULN)
Total bilirubin within 1.5 times the institutional upper limit of normal (ULN)
Serum total bilirubin =< 1.5 x upper limit of normal (ULN)
Serum bilirubin =< 1.5 x upper limit of normal (ULN); for patients with Gilbert’s disease, serum bilirubin up to =< 3 x ULN is allowed provided normal direct bilirubin
Total bilirubin =< 1.5 x upper limit of normal (ULN) for age
Serum total bilirubin: =< 1.5 x upper limit of normal (ULN) obtained within 14 days prior to registration
Total bilirubin =< 1.5 x institutional upper limit of normal (patients with documented Gilbert’s disease are allowed total bilirubin up to 3 x upper limit of normal [ULN])
Total bilirubin =< 1.5 X upper limit of normal (ULN)
Total bilirubin =< 1.5 times upper limit of institutional normal (ULN) for age obtained =< 7 days prior to registration
Total bilirubin =< 2.5 x the upper limit of normal
Serum total bilirubin less than or equal to 1.5 x upper limit of normal (ULN)
Total bilirubin =< 2 X institutional upper limit of normal
Total bilirubin =< 1.5 times institutional upper limit of normal (ULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN); if patient has known Gilbert’s syndrome, direct bilirubin =< 2.0 x ULN obtained =< 14 days prior to registration
Bilirubin < 1.5 times the upper limit of normal (ULN)
Total bilirubin =< 1.5 times the upper limit of normal (ULN) unless due to Gilbert’s disease or hemolysis
Total bilirubin =< 1.5 x the upper limit of the normal range (ULN)
Serum bilirubin =< 1.5x institutional upper limit of normal (ULN)
Bilirubin > 1.5 x institutional upper limit of normal (ULN), within 21 days of initiation of protocol therapy
Total bilirubin =< 1.5 x upper limit of normal (ULN) (obtained =< 7 days prior to randomization)
Bilirubin =< 1.5 times upper limit of normal
Total bilirubin level =< 2.0 x institutional upper limit of normal (ULN)
Total serum bilirubin =< 2.0 x institutional upper limit of normal (IULN)
Major Inclusion Criteria:\n\n          1. Signed written informed consent must be obtained and documented according to the\n             International Conference on Harmonisation (ICH) and be in accordance with local\n             regulatory requirements\n\n          2. A histologically confirmed hematologic malignancy that is advanced, relapsed, or\n             refractory to standard, currently available anti-cancer treatment options\n\n          3. ? 18 years of age\n\n          4. Eastern Cooperative Oncology Group (ECOG) performance status of ? 1 at dose escalation\n             phase and of ? 2 at dose expansion phase\n\n          5. Male or female patients of child-producing potential must agree to use contraception\n             or avoidance of pregnancy measures during the study and for 30 days after their last\n             dose\n\n          6. Females of childbearing potential must have a negative serum pregnancy test\n\n          7. Aspartate transaminase (AST) ? 2.5 x upper limit of normal (ULN) and alanine\n             transaminase (ALT) ? 2.5 × upper limit of normal (ULN). Patients whose disease\n             involves the liver and who have laboratory values of AST ? 3.5 ULN, AST ? 3.5 ULN, and\n             albumin ? 35g/L may be enrolled if agreed upon by the Principal Investigator and\n             Medical Monitor for the Sponsor\n\n          8. Total bilirubin < 1.5 x ULN, except for cases in which elevation of total bilirubin is\n             due to elevated levels of unconjugated bilirubin consistent with a diagnosis of\n             Gilbert's Syndrome\n\n          9. Life expectancy ? 3 months
Total bilirubin =< 1.5 X institutional upper limit of normal
Total bilirubin =< 1.5 x the institutional upper limit of normal (ULN)
Bilirubin =< 1.5 times upper limit of normal
Total bilirubin =< 2.0 x institutional upper limit of normal (IULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)
Total bilirubin below institutional upper limit of normal
Total bilirubin =< 1.5 x institutional upper limit of normal for age
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)
Bilirubin =< 1.5 x upper limit of normal (ULN), except for patients with documented history of Gilbert’s disease who may have direct bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin within ULN (upper limit of normal)
Serum bilirubin =< upper limit of normal; or total bilirubin =< 2.0 x the ULN with direct bilirubin within the normal range in patients with well documented Gilbert syndrome
Total serum bilirubin =< institutional upper limit of normal (ULN) obtained =<14 days prior to randomization
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Serum bilirubin =< 1.5 times upper-limit of normal (ULN)
Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age and
Total bilirubin =< 1.5 X institutional upper limit of normal\r\n* Note: patients with hyperbilirubinemia clinically consistent with an inherited disorder of bilirubin metabolism (e.g., Gilbert syndrome) will be eligible at the discretion of the treating physician and/or the principal investigator
Total 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)
Total bilirubin =< 1.5 times the upper limit of normal (ULN) unless due to Gilbert’s disease or hemolysis, then =< 3.0 times ULN
Total bilirubin =< 1.5 x upper limit of normal (ULN), unless due to Gilbert’s syndrome
Total bilirubin =< upper limit of normal (ULN) except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL
Total bilirubin =< 2 x upper limit of normal
Total bilirubin < 3 x upper limit of normal (ULN)
Total bilirubin > 3 times the upper limit of normal
Total bilirubin =< 1.5 upper limit of normal (ULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin < 2 times the upper limit of normal (ULN) (except patients with Gilbert’s syndrome who must have a total bilirubin of < 3 times ULN)
Total bilirubin ? 1.5 * the upper limit of the normal range (ULN).
Bilirubin < 2 times the upper limit of normal (ULN) (except patients with Gilbert’s syndrome who must have a total bilirubin of < 3 times ULN)
Total bilirubin < 1.5 times the upper limit of normal (x ULN) for the institution
Direct bilirubin ? 1.5 x upper limit of normal (ULN)
Total bilirubin =< 1.5 upper limit of normal within 30 days prior to registration
Total bilirubin =< 1.5 times upper limit of normal unless due to Gilbert’s disease within 14 days before enrollment
Total bilirubin level <= 1.5 x the upper limit of normal (ULN), unless the patient has known Gilbert's disease
Total serum bilirubin =< institutional upper limit of normal
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)
Total bilirubin < 1.5 times institutional upper normal limit (unless due to disease involvement of liver, hemolysis or a known history of Gilbert’s disease)
Within 14 days of registration: Total bilirubin < institutional upper limit of normal
Bilirubin =< 1.5 x upper limit of normal (ULN)
Bilirubin < 2 times the upper limit of normal (ULN) (except patients with Gilbert’s syndrome who must have a total bilirubin of < 3 times ULN)
Total bilirubin =< 1.5 × the institutional upper limit of the normal range (IULN)
Total bilirubin less than or equal to 1.5 x upper limit of normal (ULN) for age
Total bilirubin =< 2 x upper limit of normal (ULN), unless patient has a documented history of Gilbert’s disease, then direct bilirubin =< 1.0 mg/dL
Total bilirubin less than or equal to the upper limit of normal
Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age, and
Serum total bilirubin ?1.5 × upper limit of normal (ULN), unless considered due to Gilbert's disease or disease involvement following approval by the Medical Monitor;
AT THE TIME OF INFUSION: Bilirubin ? 3 x upper limit of normal
Total bilirubin normal;
Serum total bilirubin =< 2 times the upper limit of normal
Total bilirubin =< 1.5 times ULN (upper limit of normal)
Total bilirubin > 2.5 times the upper limit of normal
Total bilirubin =< upper limit of normal
Patient has total bilirubin > 2 x ULN (upper limit of normal)
Total bilirubin =< institutional upper limit of normal (ULN)
Total bilirubin must be within the limit of normal
Total bilirubin < institutional upper limit of normal (patients with documented Gilbert’s disease are allowed total bilirubin up to 1.5 x upper limit of normal [ULN])
Total bilirubin =< 4 X institutional upper limit of normal unless 2nd to Gilbert’s disease
At least 4 weeks (28 days) prior to registration: Serum bilirubin =< 1.5 x upper limit of normal (ULN)
Hepatic: Serum total bilirubin ?2.5 x upper limit of normal (ULN), ALT (SGPT) and AST (SGOT) ?2.5 x ULN.
Total bilirubin < 2 x institutional upper limit
Bilirubin ? 1.5 x upper limit of normal (ULN); does not apply to patients with Gilbert's syndrome
Serum bilirubin =< 2 x the upper limit of normal (ULN) (except for patients with a confirmed diagnosis of Gilbert’s disease)
Total bilirubin =< 1.5 x upper limit of normal (ULN)
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)
Total bilirubin =< 1.5x the upper limit of normal
Total bilirubin ? 1.5 X upper limit of normal (ULN)
Serum bilirubin =< 1.8 X upper limit of normal
Total bilirubin =< 1.5 x ULN (upper limit of normal), unless the patient meets the criteria for Gilbert’s syndrome; the upper limit value for bilirubin for subjects with Gilbert’s syndrome is less than 3 mg/dl\r\n* Note: A diagnosis of Gilbert’s disease will be made in the presence of (1) unconjugated hyperbilirubinemia noted on several occasions; (2) normal results from complete blood cell (CBC) count, reticulocyte count, and blood smear; (3) normal liver function test results; and (4) an absence of other disease processes that can explain the unconjugated hyperbilirubinemia
Bilirubin > 1.5 x institutional upper limit of normal (ULN); patients with benign hyperbilirubinemia (e.g., Gilbert’s syndrome) are eligible
Total bilirubin =< 1.5 × institutional upper limit of normal
Total bilirubin =< x 1.5 upper limit of institutional normal
Total bilirubin =< 1.5 x upper normal limit (UNL)
Total bilirubin =< 1.5 x upper limit of normal (ULN) (patients with diagnosed Gilbert’s syndrome will not be excluded if their direct bilirubin is within normal institutional limits)
Total bilirubin =< 1.5 X institutional upper limit of normal
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN).
Bilirubin < 1.5 x upper limit of normal (ULN) except for unconjugated hyperbilirubinemia or Gilbert's syndrome
Total bilirubin within 2 x upper limit of normal
Adequate hepatic function, with bilirubin < 1.5 x the upper limit of normal (ULN)
Obtained within 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
Total bilirubin level =< 1.5 x the upper limit of normal (ULN) range
Bilirubin < 1.5 x the upper limit of normal (ULN)
Total bilirubin =< 1.5 X institutional upper limit of normal (ULN); in case of known Gilbert’s syndrome, < 2 x ULN is allowed
Total bilirubin =< 1.5 x upper limit of normal (ULN) unless due to Gilberts disease
PART B: Total bilirubin =< 1.5 x institutional upper limit of normal (ULN), unless due to Gilbert’s syndrome
Direct bilirubin within upper limit of normal (ULN)
Serum bilirubin < 1.5 x upper limit of normal (ULN) (except for patients with documented Gilbert's disease)
Total bilirubin < 2 x institutional upper limit of normal
Total bilirubin < 1.5 x upper limit of normal (ULN) for age
Serum total bilirubin ?1.5 × upper limit of normal (ULN), unless considered due to Gilbert's disease, a gene mutation in UGT1A1, or leukemic organ involvement, following approval by the Medical Monitor;
Total bilirubin =< 2.0 x institutional upper limit of normal
Total bilirubin =< 2 x institutional upper limit of normal (ULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) (or =< 2.5 x ULN for patients with Gilbert’s syndrome)
Total bilirubin =< the upper limit of normal (ULN)
Serum total bilirubin =< 1.5 x upper limit normal (ULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN) unless Gilbert’s syndrome or disease infiltration of the liver is present
Total bilirubin =< 1.5 × upper limit of normal (ULN) (or =< 2.5 x ULN for subjects with asymptomatic Gilbert’s syndrome)
Normal serum bilirubin
Bilirubin less than or equal 1.5 x upper limit of normal (ULN) except for unconjugated hyperbilirubinemia or Gilbert's syndrome
Serum total bilirubin =< 1.5 x upper limit of normal (ULN)
Serum bilirubin =< 1.5 x upper limit of normal (ULN) unless attributable to Gilbert's syndrome
Total bilirubin\r\n* If cirrhosis present: part of Child Pugh requirement\r\n* If no cirrhosis: bilirubin (bili) should be =< 2 x upper limit of normal (ULN)
Serum total and direct bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin > 5 x upper limit of normal
Total bilirubin =< 1.5 X institutional upper limit of normal (ULN)
Bilirubin =< 1.5 times (x) the institutional upper limit of normal (ULN)
Total bilirubin =< institutional upper limit of normal (ULN) or =< 1.5 X institutional ULN (if the patient has liver metastases)
Total bilirubin =< 1.5 x upper limit of normal if no biliary stenting has been done; OR 2.0 x upper limit of normal if patient is status post (s/p) biliary stenting; OR two downtrending values
Total bilirubin =< upper limit of normal (ULN)
Bilirubin < 1.5 times the upper limit of normal (ULN)
Serum bilirubin =< 1.5 x upper limit of normal (ULN)
Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age
Serum total bilirubin > 1.5 x upper limit of normal (ULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN); 3 x ULN if due to hepatic involvement
Total bilirubin ? 1.5 × upper limit of normal (ULN) (? 2 x ULN for subjects with cholangiocarcinoma)
Total bilirubin =< 2 x upper limit of normal (ULN) (exceptions may apply to benign non-malignant indirect hyperbilirubinemia such as Gilbert syndrome)
Obtained =< 7 days prior to registration: Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (unless elevated from documented Gilbert’s syndrome)
Total bilirubin =< 1.5 x upper limit of normal
Total bilirubin =< 1.5 X institutional upper limit of normal (unless due to Gilbert's disease)
Total bilirubin > 3 x upper limit of normal (ULN).
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin =< 1. 5 times the institutional upper limit of normal
Total bilirubin =< 1.5 times the upper limit of normal (ULN)
Total bilirubin =< institutional upper level of normal (ULN)
Direct bilirubin =< 1.5 upper limit of normal (ULN) age unless elevation thought to be due or hepatic infiltration by the hematologic malignancy
Serum bilirubin >= 1.5 x upper limit of normal (ULN) or for patients with Gilbert's disease, >= 3 mg/dL at the screening visit
Total bilirubin < 1.5 x upper normal institutional limit
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Total serum bilirubin =< the upper limit of normal (ULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) or =< 3.0 x institutional ULN if the patient has Gilbert's syndrome
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin > 1.5 times upper normal limit (unless due to chronic GVHD)
Total bilirubin =< 1.5 x upper limit of normal (ULN) for age
Total bilirubin =< institutional upper limit of normal (ULN)
Bilirubin > 1.5 upper limit of normal (ULN) when it is clearly not related to GVHD
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN); if patient has Gilbert’s disease, then patient must have isolated hyperbilirubinemia (e.g. no other liver function test abnormality), with maximum bilirubin =< 2 X institutional ULN
Total serum bilirubin < institutional upper limit of normal (ULN)
Total bilirubin < 2.0 times the institutional upper limit of normal (ULN)
Total bilirubin < 1.5 x upper limit of normal
Total bilirubin less than or equal to 2 x upper limit of normal (ULN) (exceptions may apply to benign non-malignant indirect hyperbilirubinemia such as Gilbert syndrome)
Total bilirubin =< 1.5 times the upper limit of normal (ULN); for patients with known Gilbert’s disease, total bilirubin should be =< 3 mg/dL
Total bilirubin =< 1.5 x upper limit of normal
Within one week of study entry: Total bilirubin =< 1.5 x upper limit of normal, OR, for patients who have undergone biliary stenting, total bilirubin =< 2.0 OR two downtrending values
Bilirubin =< 1.5 the upper limit of normal (ULN) for the institution
Bilirubin =< 1.5 X the upper limit of normal (ULN); for participants with known Gilbert’s disease, bilirubin =< 3.0 mg/dL
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN); =< 3 x institutional ULN if the patient has Gilbert's syndrome
Total bilirubin less than 2 x upper limit of normal
Total bilirubin =< 3.0 x upper limit of normal (ULN)
Bilirubin =< 2 x the upper limit of normal (except Gilbert’s syndrome)
Total bilirubin ? 1.5 x the upper limit of the normal range (ULN).
Total bilirubin < 1.5 X institutional upper limit of normal (patients with documented Gilbert’s disease are allowed total bilirubin up to 3 X upper limit of normal [ULN])
Total bilirubin =< 2 X upper limit of normal (ULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN) for age
Serum bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin =< 2 x ULN (upper limit of normal)
Total bilirubin =< 1.5 x the upper limit of normal
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN) obtained =< 14 days prior to randomization
Bilirubin < 2 X upper limit of normal (ULN)
Direct bilirubin =< 1.5 X institutional upper limit of normal (ULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)
Bilirubin =< 1.5 x institutional upper limit normal
Within 14 days after subjects signed the treatment consent: Total bilirubin < upper limit of normal (ULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin =< 1.5 x upper limit of normal if no biliary stenting was done
Total bilirubin =< 2.5 x normal prior to biopsy
Within 14 days prior to registration: Bilirubin =< 1.5 x upper limit of normal range
Total bilirubin =< upper limit of normal (ULN)
Serum bilirubin =< 1.5 x upper limit of normal (ULN) unless deemed elevated secondary to lymphoma involvement of the liver or known Gilbert's syndrome
Total bilirubin < 1.5 upper limit of normal (ULN)
Total bilirubin =< upper limit of normal (ULN) (except for Gilbert’s disease)
Total bilirubin =< 1.5 x the upper limit of the normal range (ULN) (obtained =< 14 days prior to registration)
Total bilirubin =< 1.5 x upper limit of normal (ULN) for age
Total bilirubin =< 2 times upper limit of normal
Bilirubin =< 1.5 X upper limit of normal (ULN) or =< 3 X ULN for patients with Gilbert’s disease
Total bilirubin =< 2.5 X institutional upper limit of normal
Total bilirubin less than institutional upper limit of normal; NOTE: patients with a diagnosis or history of Gilberts will be eligible
Bilirubin =< 1.5 x the upper limit of normal (ULN)
ARMs A, C, D: Total bilirubin within normal range (or =< 1.5 X upper limit of normal [ULN] if liver metastases are present); or total bilirubin =< 3.0 x ULN with direct bilirubin within normal range in patients with Gilbert syndrome
Bilirubin < 2 times the upper limit of normal
Adequate liver function, as evidenced by total serum bilirubin =< 1.5 times the upper limit of normal (patients with Gilbert’s disease are eligible, provided intermittent indirect hyperbilirubinemia)
Total bilirubin within =< 1.5 x institutional upper limit of normal
Serum bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN) or if total bilirubin is > 1.5 x ULN the direct bilirubin must be normal
Bilirubin within the institutional upper limit of normal (ULN)
Total bilirubin =< 1.5 x the upper limit of normal (ULN) for age
Total bilirubin =< 1.5 times the upper limit of normal within two weeks prior to enrollment
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin =< 1.5 x upper limit of normal
Bilirubin* =< 2 x upper limit of normal\r\n* In the absence of Gilbert’s disease
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (however, patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled)
Total 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 registration
Serum bilirubin =< 1.5 x institutional upper limit of normal (ULN) (=< 3 x institutional ULN in patients with Gilbert's syndrome)
Total bilirubin ? 2 × upper limit of normal (ULN) or < 3 x ULN for patients with Gilbert-Meulengracht Syndrome
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)
Total bilirubin > 1.5 × upper limit of normal (ULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN) (obtained within 14 days prior to the first study treatment [course 1, day 1]) with the following exception:\r\n* Patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled
Total serum bilirubin =< 1.5 X upper limit of normal (ULN) except for subjects with known Gilbert’s disease, who may enroll if the conjugated bilirubin is =< 1.5 ULN
Total bilirubin < the upper limit of normal (ULN)
Serum bilirubin =< 1.5 x institutional upper limit of normal (ULN); (unless Gilbert's syndrome, for which bilirubin =< 3 x institutional upper limit of normal [ULN], without concurrent clinically significant liver disease), obtained within 14 days prior to first treatment
Bilirubin < 1.5 x the upper limit of normal (ULN)
Bilirubin =< 2 x upper limit of normal (ULN)
Serum bilirubin < 1.5 x the upper limit of normal (ULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin =< upper limit of normal (ULN) (excluding Gilbert’s disease)
Total bilirubin =< 1.5 x laboratory upper limit of normal
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Bilirubin =< 2 x upper limit of normal (ULN)
Total bilirubin < 1.5 x institutional upper limit of normal
Total bilirubin 1.5 x upper limit of normal (ULN)
Total bilirubin < 1.5 X institutional upper limit of normal
Total bilirubin < 2.0 times the institutional Upper Limit of Normal (ULN)
Serum bilirubin < 1.5 x normal
Bilirubin less than 6 times the upper limit of normal
DONOR: Bilirubin =< 2.5 x upper limit of normal (ULN)
Patients with bilirubin =< 2 x upper limit of normal
Serum Bilirubin must be ? 3 x Upper Limit of Normal (ULN) if this elevation is solely due to ASM/MCL, otherwise serum bilirubin must be
Serum bilirubin =< 1.5 x upper limit of normal (ULN)
Total and direct bilirubin < 1.5 times upper limit of laboratory normal
Bilirubin < 1.5 x upper limit of normal (ULN)
Bilirubin < 2 times the upper limit of normal
Bilirubin =< 1.5 x normal
Serum bilirubin =< 2 x the institutional upper limit of normal (ULN)
Total bilirubin =< 1.5 x upper limit of normal
Bilirubin =< upper limit of normal (ULN); for patients with Gilbert’s disease, =< 2.5 x ULN is allowed
Total bilirubin =< 1.5 institutional upper limit of normal (IULN)
Total bilirubin < 1.5 x upper limit of normal (ULN)
Total bilirubin ?2 × upper limit of normal (ULN)
Total bilirubin =< 1.5 x upper limit of normal, unless known Gilbert's syndrome
Bilirubin less than or equal to 1.5 x upper limit of normal, CTCAE v 4.0 grade 1
Total bilirubin =< 1.5 x upper limit of normal (ULN) unless elevation is deemed due to leukemia infiltration; in these patients, dose modification may be required based on standard guidelines
Total bilirubin < 1.5 times upper limit of normal (ULN), except patients with Gilbert's syndrome who must have total bilirubin of < 3 times ULN
Serum total bilirubin =< 1.5 x upper limit of normal (ULN) (unless known Gilbert’s disease)
Total bilirubin ?2 times the upper limit of normal (× ULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN) except in patients with Gilbert’s disease
Bilirubin =< 2.0 times normal
Total bilirubin =< 1.5 x the upper limit of the normal (ULN) range
Total bilirubin > upper limit of normal
Total bilirubin =< 2 times upper limit of normal (x ULN) (=< 3 x ULN if considered to be due to leukemic involvement or Gilbert’s syndrome)
Total bilirubin =< 3 times the upper limit of normal unless hepatic dysfunction is related to liver involvement with disease
Total bilirubin =< 1.5 × upper limit of normal (ULN) for the laboratory unless resulting from hemolysis
Total bilirubin ? 1.5 times the upper limit of normal (ULN)
Total bilirubin =< within upper limit of normal (ULN)
Total bilirubin =< 1.5 x the upper limit of the normal range (ULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin =< 1.5 times the upper limit of normal (ULN)
Total bilirubin =< 1.5 X upper limit of normal
Bilirubin =< 1.5 x upper limit of normal (ULN)
Hepatic: Total conjugated bilirubin ? 1.25 x upper limit of normal (ULN); aspartate transaminase (AST) and alanine transaminase (ALT) < 3 x upper limit of normal (ULN) or < 5 x ULN in the setting of liver metastases
Total bilirubin =< 2 x institutional upper limit of normal (ULN)
Direct bilirubin =< 2.0 x upper limit of normal (ULN) (unless considered due to leukemia involvement)
Serum total bilirubin ? 2.0 mg/dL (34.2 ?mol/L); or > 3.0 × upper limit of normal (ULN) for subjects with hereditary benign hyperbilirubinemia
Total bilirubin =< 1.5 times the upper limit of normal (ULN)
Hepatic: Total bilirubin < upper limit of the normal range (ULN); aspartate transaminase (AST) and alanine transaminase (ALT) ? 3 x ULN
Total serum bilirubin < 2 x upper limit of normal (unless due to hemolysis or Gilbert’s syndrome, then no upper limit)
Total bilirubin > 2 x upper limit of normal
Total bilirubin =< 1.5 x institutional upper limit of normal
Bilirubin =< 1.5 x upper limit of normal
Total bilirubin =< 1.5 x laboratory upper limit of normal
Total bilirubin =< 1.5 x the upper limit of the normal range (ULN)
Serum total bilirubin =< 1.5 x upper limit of normal (ULN)
Total 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 normal
Total bilirubin: within normal institutional limits; if, however, the participant has Gilbert’s disease or unconjugated hyperbilirubinemia which is felt to be secondary to with atazanavir or indinavir therapy, then the total bilirubin must be =< 3 x upper limit of normal [ULN])
Total bilirubin =< 1.5 × upper limit of normal (ULN) (unless Gilbert’s syndrome or disease infiltration of the liver is present)
Total bilirubin =< 1.5 X upper limit of normal (ULN)
Total bilirubin =< 1.5 times upper limit of normal (ULN) institutional limits (unless Gilbert's disease)
Total bilirubin < 1.5 times upper limit of normal (ULN) institutional limits (unless Gilbert's disease)
Total bilirubin ? 1.25 x upper limit of the normal range (ULN); aspartate transaminase (AST) and alanine transaminase (ALT) ? 3 x ULN
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
Total bilirubin =< 1.5 x institutional upper limit of normal
Total bilirubin: < 1.5 x upper limit of institutional normal for age
Total bilirubin =< 1.5 x the upper limit of the normal range (ULN)
Total bilirubin =< 1.5 x the upper limit of the normal range (ULN)
Inadequate hepatic function (Total bilirubin > 1.5 times the institutional upper limit of normal (ULN) (except known Gilbert's syndrome); Alanine transaminase (ALT) or aspartate transaminase (AST) > 2.5 times the institutional ULN. ALT or AST up to 3 times the institutional ULN permitted if total bilirubin is normal
Bilirubin >= 3 x upper limit of normal
Total bilirubin =< 3 X upper limit of normal (ULN)
Total bilirubin </=1.5 times the upper limit of normal (ULN)
Bilirubin =< 1.5 times the upper limit of normal (ULN) for the institution
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
Total bilirubin < 2.0 x upper limit of normal (ULN)
Total bilirubin =< 1.5 x institutional upper limit of normal
Adequate hepatic function (total bilirubin ? 1.5x ULN (upper limit of normal) for the institution; AST [aspartate transaminase] and ALT [alanine transaminase] ? 3x ULN, or ? 5x ULN if due to liver involvement by tumor).
Total bilirubin =< 1.5 x upper normal limit, or =< 5 x upper normal limit if documented hepatic involvement with lymphoma or history of Gilbert’s syndrome
Total bilirubin < 1.5 x upper limit of normal (ULN)
Total 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).
Total bilirubin =< 1.5 times the institutional upper limit of normal
Total bilirubin =< upper limit of normal (ULN)
Total bilirubin =< 1.5 x the institutional upper-normal limit (IUNL)
Total bilirubin < 1.5 x upper limit of normal
Total bilirubin =< 1.5 x the upper limit of normal (ULN); for subjects with known Gilbert's disease, bilirubin =< 3.0 mg/dL
Patients must have adequate hepatic function with a total bilirubin =< 1.5 times upper limit normal (ULN) within one week prior to treatment
Total bilirubin =< upper limit of normal
MESOTHELIOMA COHORTS (COHORTS 1 AND 2 ONLY): Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)
LUNG ADENOCARCINOMA COHORT (COHORT 3 ONLY): Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)
PANCREATIC CANCER COHORT (COHORT 4 ONLY): Total bilirubin =< 2 x institutional upper limit of normal (ULN)
Bilirubin =< 1.5 times the upper limit of normal (x ULN) for the institution or =< 3 mg/dl in a subject with Gilbert syndrome
Total bilirubin > 2 times upper normal limit (unless due to tumor involvement of liver or a known history of Gilbert’s disease)
Total bilirubin < 1.5 x institutional upper limit of normal; for patients with Gilbert’s syndrome or levels of indirect bilirubin above the upper limit of normal, direct bilirubin will be used for eligibility and should be < 1.5 x institutional upper limit of normal
SELUMETINIB ARM: Serum bilirubin > 1.5 x upper limit of normal (ULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN) or if total bilirubin is > 1.5 x ULN, the direct bilirubin must be normal
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Bilirubin < 1.5 x upper limit of normal (ULN)
RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Total bilirubin =< 1.5 times institutional upper limit of normal (ULN)
NON-PROGRESSED DIPG (STRATUM 2): Total bilirubin =< 1.5 times institutional upper limit of normal (ULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)\r\n* Patients with Gilbert’s disease: =< 3 x ULN
Total bilirubin within 2 x upper limit of normal
Total bilirubin =< 1.5 x upper limit of normal (ULN) except for patients with known Gilbert syndrome
Total bilirubin =< institutional upper limit of normal
Within 14 days prior to first study treatment: Total bilirubin =< 1.5 x the upper limit of normal (ULN)
Total bilirubin <=1.5*upper limit of normal (ULN).
Total bilirubin =< 1.5 X institutional upper limit of normal
Total bilirubin < 3 x the upper limit of normal (ULN), +/- 7 days from date of ICF signing
Total 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/dL
Bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin =< 1.5 x laboratory upper limit of normal
Bilirubin =< institutional upper limit of normal (ULN)
Total Bilirubin < 2 X upper limit of normal (ULN)
Bilirubin < 5 x upper limit of normal
Total bilirubin: within normal institutional limit
Bilirubin =< 2 x institutional upper limit of normal
Total bilirubin < 2.0 x upper limit of normal (ULN)
Bilirubin > upper limit of normal (ULN)
Direct bilirubin =< 1.5 x the upper limit of normal (ULN); for subjects with known Gilbert’s disease, direct bilirubin =< 3.0 mg/dL
Total bilirubin =< 1.5 x institutional upper normal limit (UNL) or =< 3 x institutional UNL if known Gilbert’s syndrome
Total bilirubin =< 1.5 x upper limit of normal (ULN) for age
Total bilirubin =< 1.5 x institutional upper limit of normal
Total bilirubin less than or equal to 1.5 x upper limit of normal (ULN)
Total bilirubin =< 5 x upper limit of normal AND decreasing at least two time points if patient is s/p biliary stenting
Total bilirubin =< 1.5 x upper limit of normal if no biliary stenting was done
Total bilirubin =< 1.5 institutional upper limit of normal (IULN)
Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age
Total bilirubin =< 2.0 x upper limit of normal
Total bilirubin =< 1.5 X institutional upper limit of normal (ULN)
Bilirubin =< to 2.0 x normal
Total bilirubin =< 1.5 x institutional upper limit of normal
Conjugated bilirubin less than twice the upper limit of normal
Serum bilirubin less than 3 X upper limit of normal
Total bilirubin =< 1.5 x upper limit of normal, and
Normal total serum bilirubin
Total bilirubin =< 1.5 times the upper normal limit (UNL), except patients with Gilbert’s syndrome in whom total bilirubin must be < 3.0 mg/dL
Total bilirubin =< 1.5 times upper limit normal (ULN) other than cases of Gilbert disease
Serum total bilirubin =< 1.5 x upper limit of normal (ULN) (except for patients with documented Gilbert’s syndrome)
Total bilirubin of =< 2 upper limit of normal (ULN)
Serum bilirubin =< upper limit of normal (ULN) (except for subjects with Gilbert’s disease who are eligible despite elevated serum bilirubin level)
Total bilirubin ? upper limit of normal (ULN);
Total bilirubin < 2 times the upper limit of normal (ULN) (except patients with Gilbert’s syndrome who must have a total bilirubin of < 3 times ULN)
Bilirubin < 1.5 times the upper limit of normal
Total bilirubin </=1.5 times the upper limit of normal (ULN)
Total bilirubin =< 1.5 X institutional upper limit of normal
Inadequate liver function as indicated by total bilirubin >= 1.5 times the upper limit of normal
Total bilirubin =< 1.5 X institutional upper limit of normal
Total bilirubin =< 2.0 x institutional upper limit of normal (IULN)
Total bilirubin =< 1.5 x institutional upper limit of normal
Bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin > 1.5×ULN (upper limit of normal).
Bilirubin =< 3 times the upper limit of normal for age
Participants with normal hepatic function: Total bilirubin and alanine aminotransferase (ALT) must be ? upper limit of the normal range (ULN).
Bilirubin =< 3 times the upper limit of normal for age
Total bilirubin =< 1.5 x upper limit of normal OR in patients with Gilbert’s syndrome, a total bilirubin =< 3.0
Bilirubin > 1.5 times the upper limit of the normal range (ULN).
Serum bilirubin =< 2 X institutional upper limit of normal (IULN)
Bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin <=upper limit of normal (ULN)
Serum total bilirubin =< 1.5 x ULN (upper limit of normal)
Total bilirubin =< 1.5 x institutional upper limit of normal
Bilirubin (sum of conjugate + unconjugated) =< 1.5 x upper limit of normal (ULN) for age
Total bilirubin =< 1.5 x upper limit of normal (ULN) for age
Serum bilirubin =< 1.5 x upper limit of normal (ULN) or =< 3 x ULN for patients with Gilbert’s disease
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin =< 1.5 x the upper limit of normal (ULN)
Total serum bilirubin no more than 1.5 x upper limit of normal (ULN)
Total bilirubin =< 3 x institutional upper limit of normal
Serum bilirubin =< 2 x upper limit of normal
Total bilirubin =< 1.5 x institutional upper limit of normal; Note: patients with hyperbilirubinemia clinically consistent with an inherited disorder of bilirubin metabolism (e.g., Gilbert syndrome) will be eligible at the discretion of the treating physician and/or the principal investigator
Serum bilirubin <=1.5 x upper limit of normal (ULN)
Total 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.
Bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin =< 2.0 x institutional upper limit of normal (IULN)
Total bilirubin =< upper limit of normal (ULN)
Total bilirubin =< upper limit of normal (ULN)
Bilirubin =< 1.5 x upper limit normal
Total bilirubin =< 1.5 x the upper limit of normal (ULN), unless presence of Gilbert’s syndrome
Total bilirubin =< 2 X upper limit of normal (ULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) obtained =< 7 days prior to registration
Total bilirubin > institutional upper limit of normal (ULN), unless due to hemolysis or Gilbert’s disease
Total bilirubin < 1.5 x institutional upper limit of normal
Bilirubin =< 1.5 x the upper limit of normal (ULN)
Bilirubin: ? 1.5 × the upper normal limit of institution's normal range.
Bilirubin =< 1.5 X upper limit of normal (ULN)
Total bilirubin =< institution upper limit of normal
serum bilirubin ?1.5 X ULN (Upper Limit of Normal)
Total bilirubin ? 2 x Upper Limit of Normal (ULN)
Total bilirubin less than 1.5 times upper limit of normal (ULN), or less than 3 times ULN at study entry in a patient with documented Gilbert’s disease
Serum total bilirubin ? 1.5 x upper limit of normal (ULN).
Total bilirubin > 2 x institutional upper limit of normal (ULN) (unless documented Gilbert’s syndrome)
Total bilirubin =< 2.0 x institutional upper limit of normal
> 1.5 x upper limit of normal (ULN) total bilirubin
Total bilirubin =< 2.0 x institutional upper limit of normal (IULN)
Total bilirubin =< 1.5 times institutional upper limit of normal (ULN)
Serum bilirubin within normal range (or total bilirubin =< 3.0 x upper limit of normal [ULN] with direct bilirubin within normal range in patients with well documented Gilbert syndrome)
Total bilirubin =< 1.5 X institutional upper limit of normal (unless associated with Gilbert’s syndrome)
Serum total bilirubin =< 1.5 x upper limit of normal (ULN)
Bilirubin =< 1.5 x normal
Bilirubin ? 1.5 X upper limit of normal
Total bilirubin =< institutional upper limit of normal (ULN)
Total bilirubin =< 2.5 X institutional upper limit of normal (ULN)
Total bilirubin =< 1.5 x institutional upper limit of normal; note: patients with hyperbilirubinemia clinically consistent with an inherited disorder of bilirubin metabolism (e.g., Gilbert syndrome) will be eligible at the discretion of the treating physician and/or the principal investigator
Total bilirubin 1.5 x normal for age, AND
Total bilirubin ? 3 times the upper limit of normal (ULN)
Total bilirubin =< 2 x upper limit of normal (ULN)
Cohort A: Total bilirubin less than 1.5 x upper limit of normal (ULN) (unless known Gilbert's disease)
Total bilirubin =< 1.5 x the upper limit of normal (ULN)
Total bilirubin =< institutional upper limit of normal
Total bilirubin =< 1.5 times upper limit of normal (ULN)
Bilirubin =< 1.5 x the upper limit of normal (ULN); for subjects with known Gilbert's disease, bilirubin =< 3.0 mg/dL
Bilirubin within 1.5 x the upper limit of normal for age, with the exception of those with Gilbert syndrome
Total bilirubin =< 1.5 X institutional upper limit of normal
Total bilirubin =< 1.5 times the upper limit of normal for age
Bilirubin =< 1.5 upper limit of normal (ULN)
Total bilirubin =< 1.5 X institutional upper limit of normal (ULN)
Serum total bilirubin =< 1.5 x upper limit of normal (ULN)
Bilirubin < 1.5 times upper limit of normal (ULN)
Total/direct bilirubin < 1.5 X institutional upper limit of normal; patients with elevation of indirect (unconjugated) bilirubin alone, as in Gilbert’s syndrome, are eligible
Total bilirubin =< 1.5 times upper limit of normal (ULN) for age
Bilirubin =< 3.0 x upper limit of normal (ULN)
Total bilirubin ?1.5 × upper limit of normal (ULN)
Bilirubin < 1.5 times upper limit of normal
Donor must have adequate hepatic function as defined by a total bilirubin <3x upper limit of normal.
Total bilirubin <1.5 x upper limit of normal (ULN), unless considered due to Gilbert's syndrome
Total bilirubin within 1.5 x of the upper limit of normal (ULN) institutional limits, patients with elevation of unconjugated bilirubin alone, as in Gilbert's disease, are eligible
Total bilirubin =< 2 x upper limit of normal (ULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN), or if total bilirubin is > 1.5 ULN, the direct bilirubin must be normal
Bilirubin less than or equal to 1.5 times the upper limit of normal (ULN) except for unconjugated hyperbilirubinemia of Gilbert's syndrome.
Serum bilirubin must be within the upper limit of normal (ULN)
Total bilirubin > 1.5 x upper limit of normal.
Total bilirubin >= 1.5 times upper limit of normal (ULN)
Total bilirubin less than 2.5 X institutional upper limit of normal (ULN)
Total bilirubin within 1.5 x institutional upper limit of normal
Total bilirubin < 1.5 X institutional upper limit of normal
Total bilirubin =< upper limit of normal
Total bilirubin =< 1.5 x upper limit of normal (ULN) for age
Serum bilirubin < 1.5 times the Upper Limit of Nor-mal (ULN).
Bilirubin =< the institutional upper limit of normal
Total bilirubin =< upper limit of normal (ULN)
Serum bilirubin =< 1.5 x upper limit of normal (ULN)
Bilirubin =< 1.5 x institutional upper limit of normal (IULN)
Total bilirubin =< 2 x upper limit of normal (ULN) for age
Serum bilirubin < 1.5 times the Upper Limit of Nor-mal (ULN).
Bilirubin < 1.5 times upper limit of normal (ULN) for age
Total bilirubin =< 1.5 x normal
Total bilirubin =< 1.5 x upper limit of normal (ULN)\r\n* Except in case of Gilbert disease
Total bilirubin less than upper limit of normal (ULN) (within four weeks prior to the study)
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) OR direct bilirubin =< IULN for patients with total bilirubin > 1.5 x IULN
Total bilirubin =< 1.5 x upper limit of normal (ULN) unless due to Gilbert’s syndrome or of non-hepatic origin
Total bilirubin < 2 times the upper limit of normal
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) unless bilirubin rise is due to Gilbert’s syndrome
Total bilirubin =< 2 x institutional upper limit of normal (ULN)
Total bilirubin < 1.5 x upper limit of normal (ULN), If patient has known Gilbert’s syndrome, direct bilirubin < 2.0 x ULN
Serum total bilirubin < 2.0 x upper limit normal (ULN) (or < 3.0 x ULN if deemed to be elevated due to leukemia or Gilbert’s syndrome)
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin =< 2.5 x upper limit of normal (ULN) except if the elevation is due to Gilbert’s syndrome (allowable at =< 5 x ULN) or myelofibrosis (per principle investigator [PI] discretion)
Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin (TBL) < 1.5 × upper limit of normal (ULN; except for subjects with documented Gilbert's syndrome)
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin =< 1.5 times upper limit of normal
Total bilirubin < 2 times the upper limit of normal (ULN) (except patients with Gilbert’s syndrome who must have a total bilirubin of < 3 times ULN)
Serum bilirubin =< 1.5 x upper limit of normal (ULN); for patients with Gilbert’s disease, serum bilirubin up to =< 3 x ULN is allowed provided normal direct bilirubin
Serum bilirubin < 2 x upper limit of normal
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)
Serum total bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin < 1.5 X institutional upper limit of normal (unless associated with Gilbert’s syndrome)
Total bilirubin =< 1.2 x upper limit of normal (ULN) unless due to Gilbert’s disease
Serum bilirubin < 3.0 x institutional upper limit of normal (IULN)
Bilirubin =< 1.5 upper limit of normal (ULN)
Total bilirubin =< 1.2 institutional upper limit of normal (ULN)
Total bilirubin >= 1.5 x upper limit of normal (ULN) (unless documented Gilbert’s)
Total bilirubin < 2.5 x institutional upper limit of normal
Direct bilirubin 5 x upper limit of normal (based on institutional standards)
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Unless felt due to underlying disease and approved by the overall PI: Total bilirubin =< 1.5 x institutional upper limit of normal (ULN); patients with Gilbert’s disease may have total bilirubin up to =< 3 x institutional ULN
Total bilirubin ? 2.5 times upper limit of normal (ULN);
Direct bilirubin =< 1.5 x institutional upper limit of normal (IULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (=< 1.5 x institutional upper limit of normal [ULN] in patients with well documented Gilbert’s syndrome)
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) except patients with documented Gilbert’s syndrome within 28 days prior to registration
Bilirubin ?1.5 × upper limit of normal (ULN) except for unconjugated hyperbilirubinemia or Gilbert's syndrome;
Total bilirubin =< 1.5 x upper limit of normal for age
Serum total bilirubin ? 1.5 x upper limit of normal (ULN) within 14 days prior to registration
Serum bilirubin count < 1.5 x normal
Total bilirubin =< 1.5 X institutional upper limit of normal, unless there is a known history of Gilbert’s disease
Serum bilirubin count < 1.5 x upper limit normal (ULN)
Total bilirubin =< 1.5 times upper limit of normal (ULN) OR direct bilirubin normal (per institute standards)
Bilirubin =< 1.5 times the upper limit of normal
Obtained within 14 days prior to initiation of treatment: Serum bilirubin < 1.5 times the upper limit of normal (ULN)
Serum bilirubin =< 1.5 x upper limit of normal (ULN)
Serum bilirubin < 1.5 times upper limit of normal
Total serum bilirubin < 2 times upper limit of normal
Total bilirubin =< institutional upper limit of normal
Total bilirubin =< 1.5 x upper limit of normal (ULN) for age
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)
Total (T.) bilirubin > 2 x upper limit of normal or alanine aminotransferase (ALT) > 4 x upper limit of normal or unresolved veno-occlusive disease
Bilirubin less than or equal to 1.5 x upper limit of the normal range (ULN)
Total bilirubin ? 1.5 x upper-normal limit (ULN)
Total bilirubin within the upper limit of normal based on institutional values
Bilirubin less than 1.5 x normal limit (NL)
Total bilirubin ? 1.5xULN (upper limit of normal)
Total bilirubin < 1.5 x upper limit of normal for age, and
Serum bilirubin </= 3 times upper limit of normal (x ULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Total serum bilirubin (TBL) ?1.5 × upper limit of normal (ULN);
Total bilirubin < 1.5 x upper limit of normal (ULN) (unless known Gilbert syndrome)
Total bilirubin =< 1.0 upper limit of normal (ULN)
Total bilirubin =< 1.5 institutional upper limit of normal
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN); an exception to this may be allowed for participants with Gilbert’s syndrome with documented approval by the protocol chair
Total bilirubin ?1.5 times upper limit of normal value (ULN), aspartate transaminase (AST) and alanine transaminase (ALT) ?5 × ULN.
Serum bilirubin =< 1.5 times the upper limit of normal; or total bilirubin =< 3 times the upper limit of normal with direct bilirubin within the normal range in patients with well documented Gilbert syndrome
Total bilirubin < 2 x the institutional upper limit of normal (ULN)
Total bilirubin greater than 2 times upper limit of normal
Total bilirubin must be < 2.0 times the upper limit of the institutional normal range; test results must be no more than 3 months old
Total bilirubin must be < 1.5 times the upper limit of normal
Baseline direct bilirubin lower than three times the upper limit of normal
Total bilirubin =< 2.0 x institutional upper limit of normal (IULN)
Minocycline trial only: screening results for total bilirubin must be < 2 times the upper limit of normal
Patient has > 1.5 x upper limit of normal (ULN) total bilirubin
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)
Patient with total bilirubin three times the upper limit of normal
Total bilirubin =< 1.5 x upper limit of normal (ULN) (except for Gilbert's syndrome)
Bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin must be < 1.5 times the upper limit of normal, as evidenced in laboratory values =< 3 months old
Bilirubin\t< 1.5 x normal
Bilirubin =< 1.5 x upper limit of normal (ULN)
Bilirubin =< 2 x upper limit normal
Total bilirubin > upper limit of normal (ULN)
Bilirubin < 5 x upper limit of normal
Bilirubin < 1.5 x upper limit of normal (ULN)
Liver function: total bilirubin < 2x the upper limit of normal (unless elevated bilirubin is attributed to Gilbert's Syndrome) and alanine aminotransferase (ALT) / aspartate aminotransferase (AST) < 2.5x the upper limit of normal.
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)
Total bilirubin =< 2 x institutional upper limit of normal (ULN)
Total bilirubin =< 3 x institutional upper limit of normal (ULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)
Total bilirubin =< 3.0 x institutional upper limit of normal (ULN)
Total 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’s
Total bilirubin =< 3 x institutional upper limit of normal (ULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin =< 2 x institutional upper limit of normal (ULN)
Bilirubin =< 1.5 x upper limit of normal (unless elevated bilirubin is due to Gilbert’s syndrome or of non-hepatic origin)
Bilirubin =< 3 x upper limit of normal
Total bilirubin < 1.5 x the upper limit of normal; patients who have been diagnosed with Gilbert's disease are allowed to exceed the defined bilirubin value of 1.5 x the upper limit of normal
Total bilirubin =< 1.5 x upper limit of normal range (ULN)
Total bilirubin =< 3 x upper limit of normal (ULN)
Bilirubin < 1.5 times upper limit of normal
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)
Within 28 days prior to signing consent: Total bilirubin > upper limit of normal (ULN) (unless the patient has documented Gilbert’s syndrome)
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin < 1.5 x upper limit of normal (ULN)
Direct bilirubin > 2 x upper limit of normal (ULN)
Serum total bilirubin =< 2 x upper limit of normal value (ULN)
Bilirubin =< 1.5 times the upper limit of normal (ULN)
Required prior to infusion of ATLCAR.CD30 cells: Bilirubin =< 1.5 times the upper limit of normal (ULN)
Bilirubin > 1.5 × upper limit of normal (CTCAE grade 2)
Total bilirubin =< 2 x institutional upper limit of normal (ULN)
Total bilirubin =< 1.5 × institutional upper limit of normal (ULN)
Total bilirubin < 1.5 x upper limit of normal (ULN)
Total bilirubin =< 1.5 x upper limit of institutional normal
Total bilirubin level =< 1.5 times upper limit of normal (ULN)
Total bilirubin =< 2 × institutional upper limit of normal (ULN) and/or history of Gilbert’s syndrome
Total bilirubin =< 1.5 x institutional upper limit of normal
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Within 30 days of eligibility confirmation: Total bilirubin =< 1.5 X institutional upper limit of normal
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)
Measured within 28 days prior to administration of study treatment: Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)
Bilirubin =< 3 x normal
Serum bilirubin =< 1.5 x institutional upper limit of normal (ULN) (=< 3 x institutional ULN in patients with Gilbert's syndrome)
Obtained within 28 days prior to registration: Bilirubin =< 1.5 x upper limit of normal (ULN) (subjects with known Gilbert’s disease should have a serum bilirubin =< 3 x ULN)
Total bilirubin < 1.5 × upper limit of normal (ULN); does not apply to patients with Gilbert's syndrome
Bilirubin > 1.5 x upper limit of normal (ULN) unless with Gilberts syndrome or
Total bilirubin within 1.5 times the institution’s upper limit of normal (ULN)
Total bilirubin < 1.5 x the upper limit of normal; patients who have been diagnosed with Gilbert’s disease are allowed to exceed the defined bilirubin value of 1.5 x the upper limit of normal
Liver function: total bilirubin < 1.5 x the upper limit of normal and alanine aminotransferase (ALT)/aspartate aminotransferase (AST) < 2.5x the upper normal limit. Patients who have been diagnosed with Gilbert's Disease are allowed to exceed the defined bilirubin value of 1.5x the upper limit of normal.
Total bilirubin =< 1.5 × institutional upper limit of normal (ULN)
Bilirubin =< upper limit of institutional normal
Total bilirubin less than the upper limit of normal
Individuals with bilirubin > 2.5 x normal upper limit any time during the previous 2 months
Bilirubin = < 1.5 X upper limit of normal (ULN) except for patients (pts) with (w/) documented history of Gilbert’s disease, obtained within 14 days prior to PET scan
Total bilirubin =< 1.5 x the upper limit of normal (ULN)
SUB-STUDY I: Total bilirubin > 3 times the upper limit of normal
SUB-STUDY II: Total bilirubin > 3 times the upper limit of normal
SUB-STUDY III: Total bilirubin > 3 times the upper limit of normal
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)
Total bilirubin > 2 times the upper limit of normal
Total bilirubin > 2 times the upper limit of normal
Total bilirubin within 1.5 x institutional level of normal or direct bilirubin =< upper limit of normal (ULN) for patient with total bilirubin levels > 1.5 ULN)
Total bilirubin <1.5x the upper limit of normal unless considered due to Gilbert's syndrome in which case, <3x the upper limit of normal
Bilirubin < 1.5 x upper limit of normal (ULN) (unless Gilbert’s is suspected)
Bilirubin > 1.5 x (upper limit of normal [ULN]) obtained < 2 weeks prior to study enrollment
Total serum bilirubin > 1.5 times upper limit of normal; increased serum bilirubin due to Gilbert's syndrome is permitted
Total bilirubin > 3 times the upper limit of normal
Bilirubin > 1.5 x upper limit of normal (ULN)
Bilirubin > 1.5 x institutional upper limit of normal (ULN)
Bilirubin (total) less than 4.0 times below or above the upper or lower limit range
Bilirubin > 1.5 x upper limit of normal (ULN)
Total bilirubin > 1.5 x upper limit of normal (ULN)
Total bilirubin =< 1.5 X institutional upper limit of normal
Total bilirubin =< 1.5 X institutional upper limit of normal
Total bilirubin less than 4.0 times below or above the upper or lower limit range
Bilirubin (total) =< 1.5 times upper limit normal (with exception of Gilberts syndrome)
Bilirubin > 1.5 x institutional upper limit of normal (ULN)
Total bilirubin =< 1.5 x upper limit of normal for age (ULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN) (unless known Gilbert's syndrome)
Total bilirubin =< 2 x institutional upper limit of normal (ULN); if total bilirubin is > 2 x ULN, the direct bilirubin must be normal
Total bilirubin =< 1.5 x institutional upper limit of normal (within 14 days of study registration)
Total bilirubin =< 1.5 x the institutional upper limit of normal (IULN) for age
Total bilirubin =< 1.5x upper limit of normal (ULN) (or if =< 4 gm/dL and direct bilirubin is within normal limits [WNL])
Total bilirubin > 2 times the upper limit of normal
Total bilirubin below upper limit of normal
Direct bilirubin ? 1.5 x upper limit of normal (ULN)
Total Bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin =< 1.5 x the upper limit of the normal range (ULN)
Bilirubin <4.0 mg/dl, SGOT ? 1.5 times the upper limit of normal
Total bilirubin < 2 X institutional upper limit of normal (ULN)
Total bilirubin =< 1.5 x the upper limit of the normal range (ULN)
Total bilirubin level =< 1 x the upper limit of normal (ULN) range
Bilirubin =< 1.5 x normal
Total bilirubin < 1.5 x upper limit of normal
Total bilirubin within the normal range at the screening visit
Total bilirubin =< 1.25 x the institutional upper limit of normal (ULN)
Total bilirubin =< 1.5 X upper limit of normal (ULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN); patients with Gilbert’s syndrome are excluded from this requirement
bilirubin <2x upper limit of normal for age
Cohort 2 (mild): Bilirubin > 1-1.5 × upper limit of the normal range (ULN) or aspartate aminotransferase (AST) > ULN, but bilirubin ? ULN
Serum bilirubin ? 1.5 x ULN (upper limit of normal).
Total bilirubin must be <=1.5*the upper limit of normal (ULN).
Total bilirubin ?1.5 times the upper limit of normal (ULN)
Total bilirubin ? 1.5 times the upper limit of normal (ULN). For intrahepatic cholangiocarcinoma (IHCC) patients only, total bilirubin ? 2.5 times ULN is acceptable
Total bilirubin =< 1.5 X institutional upper limit of normal
Bilirubin ?1.5 × upper limit of normal (ULN) except for unconjugated hyperbilirubinemia or Gilbert's syndrome.
Total bilirubin =< 1.5 x upper limit of normal (ULN)
total bilirubin ? 1.5 X institutional upper normal limit (UNL),
Total bilirubin =< 1.5 times upper limit of normal (unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin)