Bilirubin =< 1.5 x upper limit of normal (ULN)
Direct bilirubin =< 3 x upper limit of normal (ULN) for age, and
Bilirubin =< 1.5 upper limit of normal (ULN)
Bilirubin less than or equal to 1.5 x upper limit of normal (ULN) (CTCAE grade 1)
Bilirubin =< 1.5 upper limit of normal (ULN)
Direct bilirubin < 2.0 x upper limit of normal (ULN)
Bilirubin =< 1.5 x upper limit of normal (ULN)
Serum bilirubin =< 1.5 x upper limit of normal (ULN)
Serum bilirubin < 1.5 x the upper limit of normal (ULN) or < 5 x the ULN if secondary to liver metastasis
Serum bilirubin < 2 x upper limit of normal (ULN)
Bilirubin =< 1.5 x upper limit of normal (ULN), within 14 days prior to registration
Serum bilirubin =< 2 x upper limit of normal (ULN)
Serum bilirubin =< 1.5 x upper limit of normal (ULN)
Bilirubin < 1.5 x upper limit of normal (ULN)
Serum bilirubin > 1.5 x upper limit of normal (ULN)
Serum bilirubin =< 2.0 × the upper limit of normal (ULN).
Serum bilirubin < 2 x upper limit of normal.
Within 28 days prior to registration: Bilirubin =< 1.5 x upper limit of normal (ULN)
Bilirubin < 1.5 X upper limit of normal (ULN)
Bilirubin < 1.5 x upper limit of normal (ULN)
Serum bilirubin =< 1.5 x upper limit of normal (ULN).
Bilirubin < 2 x 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)
Bilirubin =< 1.5 x upper limit of normal (ULN)
Serum bilirubin =< 1.5 x upper limit of normal (ULN)
Serum bilirubin =< 1.5 x institutional upper limit of normal (ULN)
Within 14 days prior to registration: Bilirubin =< 1.5 x the upper limit of normal (ULN)
Bilirubin > upper limit of normal (ULN)
Serum bilirubin =< 1.5 x upper limit of normal (ULN)
Bilirubin =< 2 x upper limit of normal (ULN)
Serum bilirubin =< 1.5 x institutional upper limit of normal (ULN)
Bilirubin < 2 x upper limit of normal (ULN) and
Bilirubin < 1.5 x the upper limit of normal (ULN)
Serum bilirubin < 2 x upper limit of normal
Serum bilirubin > upper limit of normal (ULN)
Serum bilirubin =< 1.5 x institutional upper limit of normal (ULN)
Serum bilirubin =< 1.5 x upper limit of normal (ULN) (institutional upper limit of normal)
Bilirubin < 2.5 x upper limit of normal (ULN)
Bilirubin =< 3 x upper limit of normal (ULN)
Bilirubin =< 1.5 x upper limit of normal (ULN)
Serum bilirubin =< 1.5 x institutional upper limit of normal (ULN)
Bilirubin > upper limit of normal (ULN)
Serum bilirubin =< 1.5 x upper limit of normal (ULN)
Serum bilirubin ? 1.5 x institutional upper limit of normal (ULN)
Serum bilirubin =< 1.5 x upper limit of normal
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).
Serum bilirubin =< 2 x upper limit of normal (ULN)
Bilirubin =<1.5 x upper limit of normal (ULN)
TREATMENT: Bilirubin < 3 × upper limit of normal (ULN)
Serum bilirubin =< 2 x upper limit of normal (ULN)
Serum bilirubin =< 1.5 x upper limit of normal (ULN)
Bilirubin =< 1.5 x upper limit of normal (ULN)
Serum bilirubin =< 1.5 x upper limit of normal (ULN)
Serum bilirubin of =< 1.5 × upper limit of normal
Serum direct bilirubin =< 2.0 x ULN (upper limit of normal)
Serum bilirubin < 2x upper limit of normal (ULN)
Bilirubin =< 3 x upper limit of normal (ULN)
Bilirubin < 1.5 x upper limit of normal (ULN)
Serum bilirubin =< 2 x upper limit of normal
Hepatic (bilirubin < 2 x upper limit of normal [ULN]) or
Serum bilirubin =< 1.5 x upper limit of normal (ULN)
Serum bilirubin =< 2 x the institutional upper limit of normal (ULN)
Hepatic-bilirubin > 2 X upper limit of normal (ULN)
Direct bilirubin ? 2x upper limit of normal (ULN)
Bilirubin and creatinine less than 2 × upper limit of normal (ULN) for the institution
Bilirubin ? 1.0 x upper limit of normal (ULN)
Serum bilirubin =< 2.5 x institutional upper limit of normal (ULN)
Direct bilirubin =< 1.5 x upper limit of normal (ULN) for age, and
Bilirubin < 3 x upper limit of normal (ULN)
Direct bilirubin < 1.5 x upper limit of normal (ULN) for age and institution
Bilirubin < 1.5 x upper limit of normal (ULN)
Bilirubin =< 2 x upper limit of normal (ULN)
Bilirubin =< 1.5 x upper limit of normal (ULN)
Serum bilirubin =< 1.5 x upper limit of normal (ULN)
Bilirubin < 1.5 x upper limit of normal (ULN)
Bilirubin less than 1.5 x upper limit of normal (ULN)
Serum bilirubin >= 1.5 x upper limit of normal (ULN)
Serum bilirubin =< 1.5x upper limit of normal
Serum bilirubin up to 1.2 x upper limit of normal
Serum bilirubin < 1.5x upper limit of normal
Serum bilirubin < 1.5 x institutional upper limit of normal (ULN)
Bilirubin < 1.5 x upper limit of normal (ULN)
Serum bilirubin =< 1.5 x upper limit of normal (ULN)
Direct bilirubin equal to or less than 1.5 x upper limit of normal (ULN)
Bilirubin < or equal to 1.5 x upper limit of normal (ULN)
Serum bilirubin =< 1.5 x upper limit of normal (ULN)
Bilirubin < 3 x upper limit of normal (ULN)
Bilirubin < 1.5 x the upper limit of normal (ULN)
Serum bilirubin =< 1.5x institutional upper limit of normal (ULN)
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)
Direct bilirubin ? 1.5 x upper limit of normal (ULN)
Bilirubin =< 1.5 x upper limit of normal (ULN)
At least 4 weeks (28 days) prior to registration: Serum bilirubin =< 1.5 x upper limit of normal (ULN)
Serum bilirubin =< 1.8 X upper limit of normal
Adequate hepatic function, with bilirubin < 1.5 x the upper limit of normal (ULN)
Bilirubin < 1.5 x the upper limit of normal (ULN)
Direct bilirubin within upper limit of normal (ULN)
Serum bilirubin =< 1.5 x upper limit of normal (ULN)
Bilirubin > 1.5 upper limit of normal (ULN) when it is clearly not related to GVHD
Bilirubin =< 1.5 the upper limit of normal (ULN) for the institution
Serum bilirubin =< 1.5 x upper limit of normal (ULN)
Bilirubin < 2 X upper limit of normal (ULN)
Bilirubin =< 1.5 x the upper limit of normal (ULN)
Serum bilirubin =< 1.5 x upper limit of normal (ULN)
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)
Bilirubin =< 2 x upper limit of normal (ULN)
DONOR: Bilirubin =< 2.5 x upper limit of normal (ULN)
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)
Bilirubin < 1.5 x upper limit of normal (ULN)
Serum bilirubin =< 2 x the institutional upper limit of normal (ULN)
Bilirubin =< 1.5 x upper limit of normal (ULN)
SELUMETINIB ARM: Serum bilirubin > 1.5 x upper limit of normal (ULN)
Bilirubin < 1.5 x upper limit of normal (ULN)
Bilirubin =< 1.5 x upper limit of normal (ULN)
Bilirubin > upper limit of normal (ULN)
Serum bilirubin less than 3 X upper limit of normal
Bilirubin =< 1.5 x upper limit of normal (ULN)
Bilirubin =< 1.5 x upper limit of normal (ULN)
Serum bilirubin =< 2 x upper limit of normal
Serum bilirubin <=1.5 x upper limit of normal (ULN)
Bilirubin =< 1.5 x upper limit of normal (ULN)
Bilirubin =< 1.5 x the upper limit of normal (ULN)
Bilirubin =< 1.5 X upper limit of normal (ULN)
serum bilirubin ?1.5 X ULN (Upper Limit of Normal)
Bilirubin =< 1.5 upper limit of normal (ULN)
Bilirubin =< 3.0 x upper limit of normal (ULN)
Serum bilirubin must be within the upper limit of normal (ULN)
Serum bilirubin =< 1.5 x upper limit of normal (ULN)
Serum bilirubin < 2 x upper limit of normal
Bilirubin =< 1.5 upper limit of normal (ULN)
Serum bilirubin count < 1.5 x upper limit normal (ULN)
Serum bilirubin =< 1.5 x upper limit of normal (ULN)
Bilirubin less than or equal to 1.5 x upper limit of the normal range (ULN)
Bilirubin =< 1.5 x upper limit of normal (ULN)
Bilirubin =< 1.5 x upper limit of normal (ULN)
Bilirubin < 1.5 x upper limit of normal (ULN)
Direct bilirubin > 2 x upper limit of normal (ULN)
Bilirubin > 1.5 x (upper limit of normal [ULN]) obtained < 2 weeks prior to study enrollment
Bilirubin > 1.5 x upper limit of normal (ULN)
Bilirubin > 1.5 x upper limit of normal (ULN)
Direct bilirubin ? 1.5 x upper limit of normal (ULN)
Serum bilirubin ? 1.5 x ULN (upper limit of normal).
Within 2 weeks prior to registration: Total bilirubin =< 1.5 x ULN
Total bilirubin =< 1.5 x ULN within 14 days prior to registration.
Total bilirubin =< 1.5 X ULN (may not have abnormalities in both bilirubin and transaminases)
Total bilirubin >1.5 x ULN
Total bilirubin ? 1.5 × ULN
Total bilirubin =< 1.5 x ULN
Total bilirubin > 1.5 x ULN
Serum total bilirubin ? 1.5 × ULN (On fractionation ? 90% of total bilirubin should be unconjugated. Total bilirubin must be <4 X ULN for patients with Gilbert's syndrome).
Total bilirubin =< 1.5 × ULN
Total bilirubin =< 1.5 x ULN
Total bilirubin =< 1.5 x ULN
Total bilirubin is no higher than the ULN;
Bilirubin (total) >1.5x ULN
Total bilirubin ?1.5 ULN
Total bilirubin > 1.5 x ULN
Total bilirubin < institutional ULN within 14 days of enrollment to trial
Total bilirubin ? 1.5 x institutional ULN. If total bilirubin is > ULN and < 1.5 x ULN, it must be non-rising for at least 7 days.
Total bilirubin ?1.5 x ULN
Total bilirubin =< 1.5 x institutional ULN
Total bilirubin ?1.5 × institutional ULN
Total bilirubin ? 1.5 ULN
Total bilirubin ?1.5× ULN
Total bilirubin =< 1.5 x institutional ULN
Total bilirubin ? 1.5 x ULN
Total bilirubin =< 1.5 X ULN
Total bilirubin =< 2.0 x ULN
Total bilirubin =< 1.5 X ULN (unless there is lymphoma in the liver)
PART II: Total bilirubin =< 1.5 x ULN
Total bilirubin < 1.5 X ULN
Within 7 days of enrollment and with 24 h of starting lymphodepleting chemotherapy: Total bilirubin =< 1.5 X ULN.
Total bilirubin =< 1.5 X institutional ULN
Total Bilirubin =< 1.5 x ULN
Total bilirubin =< 1.5 x ULN
Total bilirubin =< 1.5 x ULN
Total bilirubin =< 1.5 x ULN
A total bilirubin =< 1.5 ULN
Total bilirubin ? 1.5x institutional ULN
Total bilirubin <1.5 x ULN
Total bilirubin =< 1.5 X ULN.
Total bilirubin =< ULN
Total bilirubin =< 2.5 x ULN prior to biopsy
Total bilirubin ? 1.5 x the upper limit of normal (ULN), unless suspected to have Gilbert's disease. For newly diagnosed AML patients < 75 years of age, total bilirubin ? 3 x ULN; for ? 75 years of age, total bilirubin ? 1.5 x ULN.
Total bilirubin ? 1.5 x ULN
Total bilirubin < 1.5 x ULN
Total bilirubin =< 1.5 x ULN.
Total bilirubin =< ULN for the laboratory
Total bilirubin less than or equal to 1.5 x ULN
Total bilirubin =< 1.5 x ULN
Total bilirubin =< 1.5 x ULN
Total bilirubin =< 1.5 x ULN
Total bilirubin =< 1.5 X ULN
Total bilirubin ? 2 × ULN
Total bilirubin =< 1.5 X ULN
Total bilirubin =< 1.5 × ULN and < 2 mg/dl\r\n* Note: patients who have a total bilirubin level > 1.5 × ULN will be allowed if their indirect bilirubin level is =< 1.5 × ULN
Total bilirubin =< 1.5 x ULN
Total bilirubin >= 2 x ULN
Within 14 days prior to registration: Total bilirubin =< 1.5 x ULN
Total bilirubin ? 1.5 ULN
Total bilirubin concentration < 1.5 x the ULN
Total bilirubin =< 1.5 X ULN
Total bilirubin < 1.5 x ULN
Total bilirubin =< 2.5 x the institutional ULN
ARM A COHORT 1: Total bilirubin =< 1.5 x ULN
Total bilirubin ? 1.5 x ULN or
Total bilirubin =< 1.5 x the institutional ULN
Total bilirubin < 1.5 x ULN
Total bilirubin =< 1.5 x ULN
For Part A participants: total bilirubin concentration =< 2 x the institutional ULN for age
For Part B participants: total bilirubin concentration =< 1.5 x the institutional ULN for age
Total bilirubin < 1.5 x ULN for age
Total bilirubin =< 1.5 x ULN
Total bilirubin =< 1.5 x ULN
Total bilirubin =< 1.5 x ULN
Total bilirubin =< 1.5 x ULN
Total bilirubin =< 1.5 x ULN
Total bilirubin =< ULN
Total bilirubin > 1.5×ULN
Total bilirubin =< 1.5 x ULN
Total bilirubin < 2.5 x the institutional ULN
Total bilirubin =< 2.5 x the institutional ULN, measured prior to conditioning chemotherapy
Total bilirubin:\r\n* If no known liver metastases: total bilirubin < 1.5 x institutional upper limit of normal (ULN)\r\n* If known liver metastases, then: total bilirubin < 2.5 x ULN
Total bilirubin =< 2.0 x ULN for age
total bilirubin ? 1.5 × ULN,
Total bilirubin < 2.0 x ULN
Total bilirubin =< 1.5 x the institutional ULN
Total bilirubin =< 1.5 x ULN
Total bilirubin ?1.5 x ULN
Total bilirubin <1.5 x ULN
Total bilirubin < 1.5 x ULN
Total bilirubin =< 1.5 x ULN
Total bilirubin ? 1.5 x of institutional ULN within 14 days prior to registration
Total bilirubin =< 1.5 x ULN =< 14 days prior to registration
Total bilirubin =< 1.5 x ULN
Total bilirubin < 3 x ULN for age
Total bilirubin < 3 x ULN
Total bilirubin =< 1.5 x ULN
Total bilirubin =< 1.5 x ULN
Baseline total bilirubin > 1.5 x ULN
Total bilirubin =< 1.5 x ULN
Total bilirubin =< 2.0 x ULN; in the setting of metastatic disease to the liver, total bilirubin =< 2.5 x ULN; if a patient is known or suspected to have Gilbert’s disease, total bilirubin up to =< 2.5 x ULN is allowed
Total bilirubin <1.5 x ULN
Total bilirubin =< 1.5 ULN (CTCAE grade 1)
Total bilirubin =< 1.5 x ULN
Total bilirubin ? 1.5 x ULN.
Total bilirubin ? 1.5 x ULN.
Total bilirubin =< 1.5 X ULN
Total bilirubin ? 1.5 × ULN. Patients with liver lesions who do not have hepatocellular carcinoma and who have a total bilirubin ? 2.0 x ULN may be eligible if agreed upon by the investigator and medical monitor for the sponsor.
Total bilirubin ? 3.0 x ULN
Patients must have a total bilirubin level ? 1.5 x ULN (? 2 x ULN if it is non-rising for a period of 10 days prior to initiation of therapy).
Total bilirubin =< 2.5 x the institutional ULN
Total bilirubin ? 1.5 × ULN.
Total bilirubin <=1.5*ULN;
Total bilirubin =< 1.5 x ULN
Total bilirubin ? 1.5 × ULN. Patients with liver lesions who do not have hepatocellular carcinoma and who have a total bilirubin < 2.0 x ULN may be eligible if agreed upon by the investigator and medical monitor for the sponsor.
Total bilirubin =< 1.5 x ULN
Total bilirubin =< 1.5 x ULN for the lab
Total bilirubin =< 1.5 x institution’s ULN
Total bilirubin =< 1.5 x ULN for age AND
Total Bilirubin ? 2.0 X ULN
Total bilirubin =< 1.5 x institution's ULN
Total bilirubin ? 1.5 x ULN
Total bilirubin ? 1.5X ULN
Total Bilirubin =< 1.5 x ULN
Total bilirubin =< 1.5 x ULN
Total bilirubin ? 1.5 x ULN
Total bilirubin (TBL) > 2 x ULN
Total bilirubin =< 1.5 x institutional ULN
Total bilirubin ? 1.5 × ULN
Total bilirubin =< 1.5 x institutional ULN
Total bilirubin > 1.0 x ULN
Total bilirubin ?1.5 x ULN
Total bilirubin =< 2.0; exception for patients with liver metastasis: total bilirubin =< 3 x ULN
Total bilirubin =< 1.5 institutional ULN
Total bilirubin level ?1.5 × ULN.
Total bilirubin ? 1.5 x ULN
Total bilirubin > 2 x ULN
Total bilirubin ? 1.5 × ULN
Total bilirubin =< 2.0 x ULN
Total bilirubin =< 1.5 x institutional ULN
Total bilirubin < 1.5 x ULN; concomitant elevations in bilirubin above 1.0 x ULN are not permitted
Total bilirubin =< 1.5 x ULN
Total bilirubin < or equal to 1.5 × ULN
Total bilirubin ? 1.5 × ULN.
Total bilirubin >= 3 x ULN
Total bilirubin =< 1.5 x ULN
Total bilirubin =< 1.5 x ULN
Total bilirubin =< 2 x ULN
Total bilirubin ? 2.0 × ULN
Total bilirubin =< 1.5 x institution's ULN
Total bilirubin concentration < 1.5 x the institutional ULN
Total bilirubin < 3 x ULN
Total bilirubin =< ULN
Total bilirubin >3 x ULN.
Total bilirubin ? 1.5 ULN
Total bilirubin =< 2 x ULN
Total bilirubin =< 1.5 x ULN
Total bilirubin =< 1.5 X ULN
Total bilirubin =< 1.5 X institutional ULN
Total bilirubin =< 1.5 x ULN
Total bilirubin =< 1.5 x ULN
Total bilirubin less than or equal to 1.5 x ULN
Exception for patients with liver metastasis: total bilirubin =< 3 x ULN
Total bilirubin =< 2.0; exception for patients with liver metastasis: total bilirubin =< 3 x ULN
Total bilirubin =< 1.5 x ULN
Total bilirubin ? 2 x ULN
Total bilirubin =< 1.5 x ULN
Total bilirubin =< 1.5 x ULN
Total bilirubin =< 1.5 x ULN
Total bilirubin > 1.5 x ULN at screening
Total bilirubin all < 2.5 x the institutional ULN
Total bilirubin concentration < 3 X the institutional ULN
Patient has > 1.5 x ULN total bilirubin
Total bilirubin =< ULN
Total bilirubin < 2 x ULN
Total bilirubin ? 1.5 x ULN
Total bilirubin ? 1.5 x ULN
Total bilirubin must be =< 1.5 x ULN
Total bilirubin > 1.5 x ULN
Total Bilirubin < 1.5 x ULN
Total bilirubin ?1.5 x ULN
Patient's total bilirubin must be ? 1.5 x ULN.
Total bilirubin =< 1.5 x ULN
Total bilirubin ? 1.5 x ULN
Total bilirubin ? 1.5x institutional ULN
Total bilirubin >1.0 x ULN.
Total bilirubin =< ULN
Total bilirubin =< 2.0 x ULN
Total bilirubin =< ULN
Total bilirubin >= 1.5 × the ULN for the institution
Total bilirubin (TBili) <1.5 x ULN
Total bilirubin =< 1.5 x ULN
Total bilirubin ?1.5 x ULN
Total bilirubin =< 1.5 x ULN
Total bilirubin =< 1.5 x ULN
Total bilirubin =< 1.5 x ULN for age
Total bilirubin =< 1.5 x ULN
Total bilirubin > 2x ULN
Total bilirubin =< 1.5 X ULN
Total bilirubin =< 2.0 x ULN
Total bilirubin =< 1.5 x ULN
Total bilirubin =< 1.5 x ULN for age
Total bilirubin =< 1.5 x ULN
Total bilirubin =< 1.5 x ULN.
Total bilirubin > 1.5 x ULN
Total bilirubin < 3 x ULN
Total bilirubin >= 1.5 x ULN 14 days prior to study enrollment
Total bilirubin =< 10 x ULN
Total bilirubin =< 1.5 x ULN
Total bilirubin ? 1.5 ULN of institution's range
Total bilirubin (bili) =< 1.5 x ULN or
Total bilirubin > 1.5 x ULN
Total bilirubin =< 2 x institutional ULN
Total bilirubin =< 1.5 x institutional ULN
Total bilirubin < 1.5 x ULN
Total bilirubin £ 1.5 × ULN
Total bilirubin < 1.5 x ULN for age
Total bilirubin within 2 x ULN
Total bilirubin < 5 X institutional ULN
Total bilirubin less than or equal to 1.5 x ULN
Total bilirubin < 3 x ULN
Bilirubin (total) > 1.5 x ULN
Total bilirubin < 1.5 X ULN
Total bilirubin =< 1.5 x ULN
Total bilirubin ?1.5×ULN.
Total bilirubin ? 1.5 x ULN.
Total bilirubin ? 1.5 x ULN
Creatinine =< 1.5 x upper limit of normal (ULN) or
Creatinine =< 1.5 x upper limit of normal (ULN)
Within 14 days prior to registration: Creatinine =< 1.5 x institutional upper limit of normal (ULN)
Creatinine =< 1.5 x upper limit of normal (ULN) documented within 28 days prior to step 1 registration
Creatinine =< 1.5 x upper limit of normal
Serum creatinine ? 2 × upper limit of normal (ULN) OR
Patients with a creatinine =< 2 x upper limit of normal for age
Serum creatinine =< 1.5 x institutional upper limit of normal (ULN) OR
Creatinine =< 1.5 x upper limit of normal
Serum creatinine ? 1.5 × upper limit of normal (ULN)
Serum creatinine =< 1.5 x upper limit of normal (ULN) OR
Creatinine > 1.5 × upper limit of normal (ULN).
Creatinine =< 1.5 X the institutional upper limit of normal (ULN)
Creatinine =< 1.5 x upper limit of normal
Creatinine =< 1.5 x upper limit of normal range
TREATMENT: Creatinine =< 2 x upper limit of normal for age
Serum creatinine ?1.5 × upper limit of normal (ULN);
Serum creatinine =< 1.5 x upper limit of normal (ULN)
Obtained =< 2 weeks prior to registration: Serum creatinine =< 1.5 x upper limit of normal (ULN)
Serum creatinine =< 2 x the upper limit of normal (ULN)
Serum creatinine: =< 1.5 x upper limit of normal (ULN) within 8 weeks of pre-registration
INCLUSION - INFUSION: Patients with a creatinine ? 2 x upper limit of normal for age
Serum creatinine < 2 x upper normal limit
Serum creatinine < 1.5x institution upper limit of normal
Serum Creatinine =< 1.5 x upper limit of normal (ULN)
Serum Creatinine ?1.5 × institutional upper limit of normal (ULN)
Serum creatinine =< 1.5 x upper limit of normal (ULN)
Creatinine ? 1.5 x upper limit of normal (ULN) or Creatinine clearance ? 50% of lower limit of normal (LLN)
serum creatinine < upper limit of normal (ULN);
Creatinine > 1.5 × upper limit of normal (ULN)
Creatinine =< 1.5 x institutional upper limit of normal (ULN)
Serum creatinine ? 2X upper limit of normal
Creatinine ?1.5 x the upper limit of normal
Serum creatinine ? 2 x upper limit of normal
Serum creatinine ? 1.5 x upper limit or normal
ELIGIBILITY CRITERIA AT TIME OF TREATMENT: Patients with a creatinine ? 2 x upper limit of normal for age
Patients with a creatinine ? 2x upper limit of normal for age
Creatinine =< 2.0 x upper limit of normal (ULN)
Serum creatinine =< 1.5 X upper limit of normal (ULN)
INCLUSION - TREATMENT: Serum creatinine ? 2x upper limit of normal
Serum creatinine =< 1.5 x upper limit of normal (ULN)
Serum creatinine =< 1.5 x upper limit of normal (ULN) for reference lab
Creatinine ? 1.5 x upper limit of normal
Creatinine < 1.5 x upper limit of normal (or ULN)
Within 14 days of randomization: Creatinine =< 1.5 x the institutional upper limit of normal (ULN)
Creatinine =< 1.5 x the upper limit of normal (ULN)
Serum creatinine =< 1.5 x upper limit of normal (ULN)
Serum creatinine ? 2 x the upper limit of normal (ULN)
Creatinine =< 1.5 X upper limit of normal (ULN)
Creatinine =< 1.5 x institutional upper limit of normal (ULN), within 2 weeks of registration
Serum creatinine =< 1.5 x upper limit of normal (ULN) OR
Serum creatinine level less than or equal to 1.5 x institutional upper limit normal (ULN) (CTCAE v4.03 grade 1)
Within 14 days prior to registration: Creatinine =< 1.5 x upper limit of normal (ULN)
Serum creatinine =< 1.5 x upper limit of normal (ULN) or >= 60 mL/minute for subjects with creatinine levels > 1.5 x the institutional ULN
Serum creatinine < 2 × upper limit of normal (ULN)
Creatinine =< 1.5 x institutional upper limit of normal (ULN)
Creatinine =< 1.5 x institutional upper limit of normal (ULN), within 2 weeks of registration (except where specified otherwise)
Within 4 weeks prior to the registration: creatinine =< 2 X the upper limit of normal
Creatinine =< 2 x upper limit of normal (ULN)
Creatinine =< 1.5 X upper limit of normal (ULN).
Serum creatinine < 2.0 x upper limit of normal
Serum creatinine ? 1.5 x institution’s ULN (upper limit of normal)
Serum creatinine =< 1.5 x ULN (upper limit of normal)
Creatinine levels < 1.5 x upper limit of normal (ULN).
Creatinine =< 1.5 upper limit of normal (ULN)
Serum creatinine =< 1.5 x institution upper limit of normal (ULN)
Serum creatinine =< 1.5 x institution upper limit of normal (ULN)
Creatinine =< 1.5 X upper limit of normal (ULN)
Serum creatinine < 1.5 x upper limit of normal (ULN)
Serum creatinine of < 3.0 x ULN (upper limit of normal)
Serum creatinine =< 2.0 X upper limit of normal (ULN)
Creatinine within 1.5 x upper limit of normal OR
Completed within 10 days of SBRT treatment initiation: Serum creatinine =< 1.5 X upper limit of normal (ULN) OR
Serum creatinine =< 1.5 X upper limit of normal (ULN) OR
Serum creatinine =< 1.5 X institutional upper limit of normal (ULN)
Serum creatinine < 1.5 x age-adjusted upper limit of normal (ULN)
Serum creatinine of =< 1.5 x the upper limit of normal
Creatinine =< 1.5 x upper limit of normal OR
PHASE I: Creatinine < 1.5 x the institutional upper limit of normal (ULN)
Creatinine =< 1.5 x upper limit of normal (ULN)
Creatinine =< 2.0 x upper limit of normal (ULN)
Serum creatinine less than or equal to 2 x upper limit of normal (ULN)
Renal impairment as evidenced by serum creatinine >1.5 × upper limit of normal (ULN)
Serum creatinine =< 2 x upper limit of normal (ULN)
Creatinine =< 1.5 x upper limit of normal (ULN)
Serum creatinine ?1.5 × upper limit of normal (ULN) for institution
Creatinine ? 1.5 x upper limit of normal (ULN) or Creatinine clearance ? 50%
Serum creatinine concentration < 3 x the upper limit of normal (ULN) based on the age of the patient
Serum creatinine ? 1.5 x upper limit of normal (ULN) or
Serum creatinine =< 1.5 x upper limit of normal
AT THE TIME OF INFUSION: Serum creatinine ? 2x upper limit of normal for age
Creatinine less than or equal to 1.5 x institutional upper limit of normal (ULN), CTCAE version 4 grade 1
Creatinine levels < 1.5 x upper limit of normal (ULN)
Creatinine =< 1.5 x upper limit of institutional normal (ULN)
Creatinine =< 1.5 x upper limit of normal (ULN)
Serum creatinine =< 1.2 x the upper limit of normal (ULN) prior to biopsy
TREATMENT: Patients with a creatinine ? 2 x upper limit of normal for age
Creatinine (Cr) =< 1.5 X upper limit of normal (ULN)
Creatinine =< 2.0 x upper limit of normal (ULN)
Creatinine less than or equal to 1.5 x institutional upper limit of normal (ULN)
plasma creatinine ? 1.5 x upper limit of normal (ULN) for the institution
Serum creatinine =< 1.5 x upper limit of normal (ULN)
Serum creatinine of =< 1.5 × upper limit of normal
Serum creatinine =< 1.5 x upper limit of normal (ULN)
Creatinine < 1.5 X upper limit of normal (ULN) or
Serum creatinine =< 1.5 x upper limit of normal (ULN)
Creatinine =< 2.0 x upper limit of normal (ULN)
Serum creatinine =< 1.5 x upper limit of normal (ULN)
Creatinine =< 1.5 X institutional upper limit of normal (ULN)
Serum creatinine < 3 x upper limit of normal for age
Creatinine =< 2 x upper limit of normal
Creatinine less than 1.5 x upper limit of normal
Patients must have normal organ function as defined below:\r\n* Serum creatinine < 2.0 x institutional upper limit of normal (ULN)\r\n* International normalized ratio (INR) < 1.5 x institutional ULN
Creatinine less or equal to 3 x upper limit of normal (ULN)
Creatinine =< 2 x upper limit of normal for age
Creatinine =< 3 X upper limit of normal (ULN)
Creatinine =< 2 X upper limit of normal (ULN)
Creatinine =< 2.0 mg/dL for patients over 18 years or =< 2.5 x institutional upper limit of normal (ULN) for age, measured prior to conditioning chemotherapy
Serum creatinine =< 1.5 x upper limit of normal (ULN)
Creatinine clearance >= 50 mg/dl OR serum creatinine =< 1.5 x upper limit of normal (ULN)
Serum creatinine =< 1.5 x upper limit of normal (ULN)
Serum creatinine =< 2 x upper limit of normal
Serum creatinine < 1.5 x upper limit of normal
serum CA-125 level ?2x upper limit of normal (ULN) (in screening)
Serum creatinine ? 1.5 x upper limit of normal (ULN)
Renal function: creatinine ? 1.5 x institutional upper limit of normal (ULN);
Within 14 days prior to registration: Serum creatinine =< 1.5 x upper limit of normal (ULN)
Serum creatinine ? 1.5x upper limit of normal
Serum creatinine ? 1.5 X upper limit of normal (ULN)
Serum creatinine =< 1.5 x upper limit of normal (ULN)
Creatinine greater than or equal to 1.5 x upper limit of normal (ULN)
Serum creatinine =< 1.5 x upper limit of normal (ULN)
Serum creatinine < 3 x upper limit of normal (ULN)
Creatinine =< 1.5 x upper limit of normal (ULN) or
Creatinine =< 1.5 x upper limit of normal (ULN)
Serum creatinine =< 1.5 x upper limit of normal (ULN)
Serum creatinine =< 1.5 x upper limit of normal (ULN) OR
Serum creatinine =< 1.5 x upper limit of normal and/or creatinine clearance > 50% lower limit of normal
Creatinine =< 1.5 x upper limit of normal (ULN)
Creatinine =< 1.5 x upper limit of normal (ULN)
Serum creatinine =< 1.5 x upper limit of normal
Creatinine =< 1.5x upper limit of normal
Serum creatinine =< 2 x upper limit of normal
Serum creatinine =< 1.5 x upper limit of normal
Serum creatinine > 1.5 x upper limit of normal
Serum creatinine =< 1.5 x upper limit of normal
Serum creatinine >= 1.5 x upper limit of normal
Serum creatinine < 2 x the upper limit of normal
Creatinine (non-isotope dilution mass spectrometry [IDMS]) =< 1.5 x institutional upper limit normal (ULN), CTCAE grade 1
Creatinine =< 1.5 x upper limit of normal (ULN)
Serum creatinine =< 1.5 x upper limit of normal (ULN)
A serum creatinine of ?1.5 x Upper Limit of Normal ULN OR
Serum creatinine < 1.5 X upper limit of normal (ULN) (institutional)
Serum creatinine =< 1.5 x upper limit of normal (ULN)
Creatinine less than or equal to 1.5 x institutional upper limit of normal (ULN)
Creatinine =< 2.0 x upper limit of normal (ULN)
Creatinine =< 1.5 x upper limit of normal
Serum creatinine =< 1.5 x upper limit of normal (ULN) OR
Serum creatinine < 2.5 x the upper limit of normal (ULN)
Creatinine =< 1.5 x upper limit of normal (ULN) within 14 days prior to study registration
Serum creatinine =< 2.0 mg/dL for patients over 18 years or =< 2.5 x institutional upper limit of normal (ULN) for age
Serum creatinine ? 1.5 X upper limit of normal
Creatinine =< 3 x upper limit of normal (ULN)
Creatinine =< 1.5 x institutional/laboratory upper limit of normal (ULN)
Serum creatinine ?1.5 X upper limit of normal (ULN)
Serum creatinine =< 1.5 x upper limit of normal (ULN)
Serum creatinine =< 1.5 x upper limit of normal (ULN)
Creatinine =< 1.5 x upper limit of normal
Serum creatinine < 1.5 X ULN (the upper limit of normal)
Prior to cyclophosphamide and T cell infusions: creatinine >= 3.0 x upper limit of normal (ULN)
Creatinine < 2 x institution upper limit of normal OR
Serum creatinine =< 1.5 X upper limit of normal (ULN) (within 14 days of treatment initiation) OR
Serum creatinine =< 1.5 x upper limit of normal (ULN), should be performed within 28 days of treatment initiation, unless otherwise indicated OR
Creatinine =< 2.5 x upper limit of normal (ULN)
Creatinine (Cr) < 1.5 upper limit of normal (ULN)
Serum creatinine =< 2.0 x upper limit of normal (ULN)
Creatinine > 1.5 x the upper limit of normal
Serum creatinine =< 1.5 x upper limit of normal (ULN)
Creatinine =< 1.5 x upper limit of normal (ULN)
Creatinine =< 1.5 x upper limit of normal (ULN); institutional norms are acceptable
Creatinine =< 1.5 x upper limit of normal (ULN)
Creatinine =< 2.5 x upper limit of normal (ULN)
Creatinine =< 2.0 x upper limit of normal (ULN)
Creatinine =< 2 x upper limit of normal (ULN)
AT THE TIME OF INFUSION: Creatinine ? 2 x upper limit of normal for age
Creatinine =< 1.5 x upper limit of normal (ULN)
Creatinine < 2 x upper limit of normal (ULN)
Creatinine >= 3.0 x upper limit of normal (ULN)
COHORT A: Creatinine =< 2.0 x upper limit of normal (ULN)
Serum creatinine =< 2.5 x upper limit of normal
Serum creatinine =< 1.5 x upper limit of normal (ULN)
Serum creatinine =< 1.5 x the upper limit of normal
Serum creatinine </=2x upper limit of normal
Serum creatinine =< 1.5 x upper limit of normal (ULN)
Creatinine =< 1.5 x upper limit of normal (ULN)
Serum creatinine > 2 x upper limit of normal
Creatinine =< 1.5 x upper limit of normal (institutional ULN)
Serum creatinine =< 3 x upper limit of normal (ULN)
Creatinine =< 1.5 x upper limit of normal (ULN)
Serum creatinine < 2.0 x upper limit of normal (ULN)
Creatinine =< 1.5 x upper limit of normal
Serum Creatinine =< 1.5 X the upper limit of normal (ULN)
Creatinine =< 2 x upper limit of normal (ULN)
Serum creatinine of =< 1.5 X the upper limit of normal
Serum creatinine =< 1.5 x upper limit of normal (ULN)
Creatinine =< 1.5 x institutional upper limit of normal (ULN), CTCAE grade 1
Creatinine =< 3.0 x upper limit of normal (ULN)
Within 14 days prior to registration: Creatinine =< 1.5 x upper limit of normal range
Creatinine =< 2.0 x upper limit of normal (ULN)
Creatinine: ~ 2 x upper limit or normal (ULN)
Creatinine =< 1.5 x upper limit of normal (ULN)
Creatinine < 1.5 x upper limit of normal (ULN)
Serum creatinine =< 1.5 x upper limit of normal (ULN)
Serum creatinine within 1.5 x upper limit of normal (CTCAE 4.0 grade 1 abnormality is acceptable)
Creatinine =< 2.5 x upper limit of normal (ULN)
Serum creatinine =< 1.5 x upper limit of normal (ULN)
Creatinine =< 2 x upper limit of normal (ULN)
Serum creatinine =< 1.5 x institution upper limit of normal (ULN)
Creatinine =< 2 X upper limit of normal (ULN)
Creatinine =< 1.5 x upper limit of normal (ULN) for children and =< 2.0 x ULN for adults
Serum creatinine =< 1.5 x upper limit of normal (ULN)
Serum creatinine =< 1.5 x institutional upper limit of normal (ULN), obtained within 14 days prior to first treatment
Creatinine =< 3 x upper limit of normal (ULN)
Creatinine =< 1.5 x upper limit of normal for the laboratory
Creatinine =< 2 x upper limit of normal for age
Serum creatinine concentration < 3 X the institutional upper limit of normal (ULN)
Serum creatinine =< 2 x upper limit of normal (ULN)
Creatinine less than or equal to 1.5 x upper limit of normal, CTCAE v 4.0 grade 1
Creatinine =< 1.6 x the upper limit of normal (ULN)
Creatinine less than or equal to 1.5 x institutional upper limit normal (ULN), CTCAE v4.0 grade 1
Creatinine: =< 2.0 x upper limit of normal (ULN)
Serum creatinine >= 2 x upper limit of normal
Serum creatinine =< 1.5 x the upper limit of normal (ULN)
Serum creatinine less than or equal to 1.5 x institutional upper limit normal (ULN)
Serum creatinine >= 2 x upper limit of normal
Serum creatinine (Cr) ? 1.5 x upper limit of normal (ULN).
Serum creatinine =< 1.5 x upper limit of normal or
serum creatinine of ? 1.5x upper limit of normal (ULN) for the reference lab.
Serum creatinine =< 1.5 x institution’s ULN (upper limit of normal), or
Creatinine < 1.5 x upper limit of normal (ULN)
Creatinine < 1.5 x upper limit of normal (ULN)
Creatinine < 2 x upper limit of normal (ULN)
Serum creatinine < 1.5 × the upper limit of normal (ULN).
Serum creatinine =< 1.5 x upper limit of normal (ULN)
Creatinine (Cr) =< 1.5 x upper limit normal
Serum chromogranin A level >5 x upper limit of normal and/or serum neuron specific enolase (NSE) >2x upper limit of normal
Creatinine < 1.5 X Upper Limit of the Normal (ULN)
Serum creatinine =< 1.5 x upper limit of normal (ULN)
Serum creatinine < 1.5 upper limit of normal (ULN)
Creatinine =< 1.5 x upper limit of normal (ULN), within 14 days prior to initiation of study drug
Creatinine needs to be less than or equal to 1.3 x upper limit of normal (ULN)
Creatinine =< 2.0 mg/dL (< 2 x upper limit of normal [ULN])
Serum creatinine =< 1.5 x upper limit of normal (ULN) for age
Creatinine =< 3.0 x upper limit of normal (ULN)
Creatinine =< 1.5 x institutional upper limit of normal (ULN), CTCAE grade 1
Serum creatinine of =< 1.5 X the upper limit of normal
Creatinine > 1.5 X upper limit of normal.
Creatinine =< 3 x upper limit of normal (ULN)
Renal: serum creatinine less than 2x upper limit of normal for age (as per local laboratory)
Serum creatinine =< 1.5 x upper limit of normal (ULN) OR
Creatinine =< 2.0 x upper limit of normal (ULN)
Creatinine =< 1.5 x upper limit of normal (ULN)
Creatinine < 1.5 x institutional upper limit of normal (ULN)
Performed within 10 days of treatment initiation: Creatinine =< 1.5 x upper limit normal (ULN) OR
Serum creatinine =< upper limit of normal (ULN)
Subjects who have a serum creatinine > 2 x upper limit of normal (ULN)
Serum creatinine =< 2.5 x upper limit of normal (ULN) (within 7 days)
Creatinine < 1.5 x upper limit of normal (ULN) OR
Creatinine =< 1.5 x upper limit of normal (ULN)
Creatinine =< 2 x upper limit of normal (ULN)
Creatinine =< 1.5 x the upper limit of normal (ULN)
Serum creatinine < institutional upper limit of normal (ULN)
Serum creatinine =< 2 x upper limit normal
Creatinine < 3.0 x upper limit of normal (ULN)
Creatinine =< institutional upper limit of normal (ULN)
Normal renal function as determined by a serum creatinine < upper limit of normal
Serum creatinine > 2.5 x ULN (upper limit of normal)
Serum creatinine ? 1.5 x upper limit of normal (ULN) for age
Na within 2 x upper limit of normal (ULN)
Serum creatinine less than or equal to 1.5 x institutional upper limit normal (ULN)
SUB-STUDY I: Serum creatinine > 2 time the upper limit of normal
SUB-STUDY II: Serum creatinine > 2 time the upper limit of normal
Creatinine > 2 x upper limit of normal
Serum creatinine =< 1.5 x upper limit of normal (ULN)
Serum creatinine =< 2 x upper limit of normal (ULN)
Serum creatinine > 1.5 x upper limit of normal (ULN)
Serum creatinine =< 1.5 x upper limit of normal (ULN)
Have a serum creatinine above 1.5 upper limit of normal (ULN) (collected within the past 4 weeks); ULN is per institutional definition
Serum creatinine ? 1.5 x upper limit of normal (ULN).
Serum lipase =< 1.5 x institutional upper limit of normal
Serum lipase =< 1.5 x institutional upper limit of normal
Serum lipase =< upper limit of normal
Lipase =< 1.5 x upper limit of normal (ULN)
Serum lipase =< upper limit of normal
Lipase < 2 x the upper limit of normal
Lipase < 1.5 x the upper limit of normal (except for participants with adenocarcinoma of the pancreas)
Serum lipase < 3 X institutional upper limit of normal
Lipase < 1.5 x upper limit of normal
Serum lipase > normal limits for the institution
Lipase < 1.5 x the upper limit of normal
Lipase =< 2 × upper limits of normal
Serum lipase =< upper limit of normal (IULN)
Total bilirubin < 1.5 x upper limit of normal
Total bilirubin =< 1.5 x the upper limit of normal
Total bilirubin =< 1.5 x the upper limit of normal
Total bilirubin =< 1.5 x institution's upper limit of normal
Total bilirubin less than or equal to the institution's upper limit of normal
Total bilirubin =< 1.5 x upper limit of normal
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
Total bilirubin < 2 x upper normal limit
Total bilirubin =< 1.5 X MSKCC upper limit of normal
Total bili ? 1.5 x upper limit or normal
Serum creatinine, total bilirubin, ALT/SGPT </= 2.0 x upper limit of normal
Total bilirubin =< 2.0 x upper limit of normal within 14 days of treatment initiation
Total bilirubin =< 1.5 X institution upper limit of normal
Total bilirubin =< 1.5 x institution’s upper limit of normal
Total bilirubin < 1.5 x upper limit of normal
Total bilirubin ? 2.0 x institution’s upper limit of normal
Total bilirubin within 2 x upper limit of normal
Total bilirubin =< 1.5 x upper limit of normal
Total bilirubin =< 1.5 x the upper limit of normal
Total bilirubin >= 2 x the upper limit of normal
Total bilirubin less than 2 x upper limit of normal
Total bilirubin =< 1.5 x upper limit of normal
Total bilirubin < 1.5 x upper limit normal
Total bilirubin ? 2.0 x the upper limit normal
Serum total bilirubin > 1.5 x upper limit of normal
Total bilirubin =< 1.5 x upper limit of normal
Total bilirubin =< 1.5 x upper limit of normal for age
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
Total bilirubin =< 2 x UIHC upper limit of normal
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 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 =< 2.5 x the upper limit of normal
Total bilirubin =< 2 x upper limit of normal
Total bilirubin =< 1.5 upper limit of normal within 30 days prior to registration
Total bilirubin less than or equal to the upper limit of normal
Total bilirubin =< upper limit of normal
Total bilirubin must be within the limit of normal
Total bilirubin =< 1.5x the upper limit of normal
Total bilirubin within 2 x upper limit of normal
Total bilirubin > 5 x upper limit of normal
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 =< 1.5 x upper limit of normal
Total bilirubin < 1.5 x upper limit of normal
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
Total bilirubin less than 2 x upper limit of normal
Total bilirubin =< 1.5 x the upper limit of normal
Total bilirubin =< 5 x upper limit of normal if patient is s/p biliary stenting AND decreasing at least two time points after stenting
Total bilirubin =< 1.5 x upper limit of normal if no biliary stenting was done
Total bilirubin =< 1.5 x upper limit of normal
Total bilirubin =< 1.5 x laboratory upper limit of normal
Total bilirubin =< 1.5 x upper limit of normal
Total bilirubin > upper limit of normal
Total bilirubin =< 1.5 X upper limit of normal
Total bilirubin > 2 x upper limit of normal
Total bilirubin =< 1.5 x laboratory upper limit of normal
Total bilirubin < 1.5 x upper limit of normal
Total bilirubin =< upper limit of normal
Total bilirubin within 2 x upper limit of normal
Total bilirubin =< 1.5 x laboratory upper limit of normal
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 =< 2.0 x upper limit of normal
Total bilirubin =< 1.5 x upper limit of normal, and
Total bilirubin =< institution 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.
Total bilirubin =< upper limit of normal
Total bilirubin < 2 × upper limit of normal, direct bilirubin < 2.0 mg/dL.
Total bilirubin =< 1.5 x upper limit of normal for age
Total bilirubin ? 1.5xULN (upper limit of normal)
Total bilirubin < 1.5 x upper limit of normal for age, and
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 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 less than the upper limit of normal
Total bilirubin below upper limit of normal
Total bilirubin < 1.5 x upper limit of normal
Bilirubin > 2.0
Serum bilirubin < 1.8
Serum bilirubin =< 1.8
Serum bilirubin =< 1.8
Serum bilirubin =< 1.8
Serum bilirubin =< 1.8
Serum bilirubin =< 1.8
Serum bilirubin =< 2.0
Bilirubin less than or equal to 3.0
Bilirubin < 2.0
Bilirubin =< 1.2
Normal serum bilirubin
Bilirubin < 1.5
Bilirubin > 1.5
Serum bilirubin < 1.5 x normal
Bilirubin =< 2.0
Bilirubin =< 1.5
Direct bilirubin less than 3.0, indirect bilirubin less than 4.0
Bilirubin > 2.0
Serum bilirubin count < 1.5 x normal
Serum bilirubin =< 2.0
Bilirubin > 2
Bilirubin > 10.0
Bilirubin < 2.5
Bilirubin =< 1.5 x normal
Patients with bilirubin =< 2 x upper limit of normal
INCLUSION CRITERIA FOR SECOND-LINE THERAPY: Bilirubin =< 1.5 X the upper limit of normal
INCLUSION CRITERIA FOR THIRD-LINE THERAPY: Bilirubin =< 1.5 X the upper limit of normal
Bilirubin =< 1.5 x laboratory normal
Bilirubin =< 1.5 x upper limit of normal range
TREATMENT: Bilirubin =< 2 x upper limit of normal
Patients with bilirubin =< 3 x normal
Bilirubin < 1.5 mg/dL, ALT < 3 x upper limit of normal
Patients with bilirubin ? 2 x upper limit of normal
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).
INCLUSION - INFUSION: Patients with bilirubin ? 3 x upper limit of normal
Bilirubin > 1.5 x the upper limit of normal
Bilirubin ? 2X upper limit of normal
Bilirubin ? 2 x upper limit of normal
ELIGIBILITY CRITERIA AT TIME OF TREATMENT: Patients with bilirubin ? 3 x upper limit of normal
Patients with bilirubin ? 2x upper limit of normal
Bilirubin ? 1.5 x upper limit of normal
Total bilirubin < 1.5 x upper limit of reference range (< 3 x upper limit of reference range in patients with Gilbert's disease)
Baseline serum troponin above the upper limit of normal
Patients with 5-­hydroxyindoleacetic acid (HIAA) levels above or below the upper limit of normal range (normal: 0 to 15 mg/24 hours) and those with unknown values at baseline are allowed to participate
Bilirubin < 1.5 x upper limit of normal
Bilirubin level above the normal reference range
Serum conjugated (direct) bilirubin < 2 x upper limit of normal for age as per local laboratory
Cardiac troponin value above the Upper Limit of Normal (ULN);
Total bilirubin ? 1.5 X the upper normal limit of institution's normal range
PT and PTT must be ? 1.5 X upper normal limit of institution's normal range
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
Must have had an elevated serum CA125 level twice the upper limit of normal (per reference lab normal range) measured within 4 weeks of enrollment.
Bilirubin =< to 2.0 x normal.
Within 4 weeks prior to the registration: bilirubin =< 1.5 X upper limit of normal
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
Serum bilirubin < 1.5 x upper limit of normal values
Total bilirubin =< 1.5 x upper limit of reference range ( < 3 x upper limit of reference range in patients with Gilbert’s disease)
Documented bilirubin and hepatic transaminases of =< 2.5 x upper limit of normal (ULN)
AT THE TIME OF INFUSION: Bilirubin ? 3 x normal
TREATMENT: Patients with bilirubin ? 2 x upper limit of normal
PART 2: Transaminases must be < 3 x the upper limit of normal
Patients must have bilirubin < 1.5 x normal
Serum bilirubin =< twice the upper limit of normal
Transaminases > 5x upper limit of normal for age
Conjugated (direct) bilirubin less than 2 x upper limit of normal
Bilirubin =< 1.5 x the upper limit of normal
Bilirubin =< 2x upper limit of normal
Bilirubin less than or equal to 2 x upper limit of normal
Bilirubin =< 3 x upper limit of normal
Bilirubin =< 1.5 fold the upper limit of normal
Bilirubin =< 2.5 X the upper normal limit of institution's normal range
Bilirubin =< 1.5 x normal
Direct bilirubin > 3x upper limit of normal
Bilirubin =< 3 x upper limit of normal
Bilirubin < 5 x upper limit of normal
Bilirubin < 5 x normal
Liver: transaminases < 5 x upper limit of normal and bilirubin < 3 x upper limit of normal
Bilirubin < 1.5 x upper limit of normal
Bilirubin level above the normal reference range
Bilirubin =< to 2.0 x normal
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)
Transaminases must be < 3 x the upper limit of normal per reference values of treating institution
Non-fasting bilirubin =< 1.5 X the upper normal limit of institution's normal range
Bilirubin =< 1.5 x upper limit of normal
Patients must have serum direct bilirubin =< 2.0 mg/dl and transaminases =< 3x institution upper limit of normal
Transaminases < 2.5 x upper limit of normal
Non-fasting direct bilirubin =< 1.5 × the upper normal limit of institution's normal range
Transaminases < 5.0 x upper limit of normal (ULN)
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)
Bilirubin < 1.5 x ULN of the institutional normal reference range
Bilirubin =< 2 x upper limit of normal value
Transaminases < 2.5 x upper limit of normal (up to 5 x upper limit of normal [ULN] in patients with liver metastases)
Bilirubin =< 3 x upper limit of normal
Bilirubin =< 1.5 X laboratory normal
Bilirubin* within normal range
Transaminases < 3x upper limit of normal
Total bilirubin > 1.5 x the upper limit of reference range (ULRR)
Serum bilirubin < 2 x upper limit of normal, or considered not clinically significant by the study doctor or designee
Bilirubin < 2 x the upper limit of normal
Bilirubin =< 1.5 x upper limit of normal
AT THE TIME OF INFUSION: Bilirubin ? 3 x upper limit of normal
Transaminases must be < 3 x the upper limit of normal per reference values of referring institution
Patients who test positive for hepatitis C antibody (Ab) are eligible provided all of the following criteria are met: 1) total bilirubin =< 2 x upper limit of normal; 2) AND aspartate aminotransferase (AST) =< 3 x upper limit of normal; AND 3) liver biopsy (pathology) demonstrates =< grade 2 fibrosis and no cirrhosis
Non-fasting direct bilirubin =< 1.5 × the upper normal limit of institution's normal range; for subjects with liver metastases, non-fasting direct 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; the combination of 5-FU and oxaliplatin is known to be safe to be administered in patients with such abnormal liver function tests
Within 14 days prior to registration: Bilirubin =< 1.5 x upper limit of normal range
Transaminases =< 5 x the upper limit of normal for age appropriate indices
Patients with bilirubin =< 2 x upper limit of normal
Bilirubin =< 1.5 x normal
Bilirubin less than or equal to 1.5 x upper limit of normal, CTCAE v 4.0 grade 1
Bilirubin =< 1.5 x upper limit of normal
Sodium >= 130 mg/dl and =< upper limit of normal
Bilirubin >= 3 x upper limit of normal
Bilirubin < 5 x upper limit of normal
Non-fasting bilirubin =< 1.5 X the upper normal limit of institution's normal range; non-fasting 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
Bilirubin =< to 2.0 x normal
Conjugated bilirubin less than twice the upper limit of normal
Bilirubin =< 1.5 x upper limit normal
Bilirubin: ? 1.5 × the upper normal limit of institution's normal range.
Bilirubin < 2.0 mg/mL x upper limit of normal; this requirement reflects the excretion of CPX-351 by the liver
Bilirubin =< 1.5 x normal
Bilirubin ? 1.5 X upper limit of normal
Direct bilirubin 5 x upper limit of normal (based on institutional standards)
Bilirubin less than 1.5 x normal limit (NL)
Bilirubin > 5 x upper limit of normal if documented in the last month and not lowered to < 5 x normal prior to study enrollment; extra blood work will not be drawn unless the patient already has the lab abnormalities documented and need to be corrected
Serum bilirubin > 1.5 x the upper limit of reference range (ULRR)
Bilirubin\t< 1.5 x normal
Bilirubin =< 2 x upper limit normal
Bilirubin < 5 x upper limit of normal
Bilirubin =< 3 x upper limit of normal
Bilirubin > 1.5 × upper limit of normal (CTCAE grade 2)
Bilirubin =< 3 x normal
Serum bilirubin > 1.5 x the upper limit of reference range (ULRR)
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.
Individuals with bilirubin > 2.5 x normal upper limit any time during the previous 2 months
Adequate bone marrow reserves (neutrophil count >1.5 x109 /l and platelet count >100 x109/l), adequate renal function (serum creatinine ? 1.5 x upper limit of normal) and hepatic function (ALAT, ASAT ? 2.5 x upper limit of normal, alkaline phosphatase ? 2.5 x upper limit of normal and total bilirubin ? 2.0 x upper limit of normal).
Bilirubin =< 1.5 x normal
bilirubin <2x upper limit of normal for age
AST/ALT =< 3 x upper limit of normal (ULN)
AST =< 8 x upper limit of normal (ULN)
INCLUSION CRITERIA FOR SECOND-LINE THERAPY: For patients with known hepatic metastases, AST and ALT =< 5 X the upper normal limit of institution's normal range
INCLUSION CRITERIA FOR THIRD-LINE THERAPY: AST and ALT =< 3 X the upper normal limit of institution's normal range
INCLUSION CRITERIA FOR THIRD-LINE THERAPY: For patients with known hepatic metastases, AST and ALT =< 5 X the upper normal limit of institution's normal range
AST and ALT ? upper limit of normal
Hepatic: direct bilirubin ? 3 x upper limit of normal, or AST/ALT ? 5 x upper limit of normal
AST ? 5 x upper limit of normal
AST and ALT ? 5 x the upper limit of normal
AST and ALT ? 3.0 X the upper normal limit of institution's normal range
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x the upper normal limit of institution's normal range, at the time of enrollment; for subjects with liver metastases, AST and ALT =< 5 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
ALT < 2 x upper limit of normal
DONOR: ALT < 2 x upper limit of normal
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3.0 x the upper normal limit of institution's normal range; for subjects with liver metastases, AST and ALT < 5 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
AST and ALT =< 2 x institutional upper limit of normal
AST or ALT >= 3 x ULN (upper limit of normal)
ADDITIONAL CRITERIA FOR STUDY CONTINUATION: AST and ALT =< 2 X upper level of normal
AST and ALT <5x upper limit of normal
Patients who test positive for hepatitis C (HepC) antibodies (Ab) are eligible provided all of the following criteria are met: bilirubin =< 2 x upper limit of normal; ALT/AST =< 3 x upper limit of normal; and clinical evaluation to rule out cirrhosis
RANDOMIZED PHASE II (ARMS K AND L): AST/ALT =< 2.5 x upper limit of normal (ULN), obtained within 2 weeks prior to registration
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) must be =< 3 X normal\r\n* If AST and ALT are > 3 < 5 x upper limit of normal (ULN), patient may be eligible if:\r\n** Liver biopsy performed within 60 days of hematopoietic cell transplantation (HCT) excludes active cirrhosis grade greater than 2/4 and bridging fibrosis\r\n** No clinically evident ascites\r\n** Patient with hepatitis B or C are excluded if AST or ALT > 3 x upper limit (UL)
AST & ALT ? 5 x the upper limit normal
AST, ALT, and total bilirubin ? 3x upper limit of normal;
DONORS: ALT < 2 x upper limit of normal
Subjects must have normal organ and marrow function as defined below:\n\n               1. Absolute neutrophil count ? 1500/cmm\n\n               2. Platelets ? 100,000/cmm\n\n               3. Total bilirubinwithin normal limits of the institution\n\n               4. AST/ALT ? 2.5 X institutional upper limit of normal (ULN) or ? 5 X institutional\n                  upper limit of normal (ULN) in the presence of liver metastases\n\n               5. Creatinine ? 1.5 X institutional upper limit of normal (ULN)
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3.0 × the upper normal limit of institution's normal range; for subjects with liver metastases, AST and ALT < 5 × the upper normal limit of institution's normal range AS LONG AS THERE IS NO persistent nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, or eosinophilia
DONOR: ALT < 2 x upper limit of normal
AST and ALT > 2 x upper limit of normal
AST and ALT >= 2 x upper limit of normal
AST/ALT =< 3 X upper limit of normal (ULN)
AST or ALT ? 3 x the institutional upper limit of normal
ALT and AST< 5 X upper limit of normal
AST/ALT > 3 x upper limit of normal
AST/ALT ? 3X ULN (upper limit of normal)
AST/ALT =< 2 x upper limit of normal (ULN)
AST =< 5 x upper limit of normal
Serum AST and ALT ? 2.5 x Institutional upper limit of normal (ULN)
DONOR: ALT < 2 x upper limit of normal
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3.0 × the upper normal limit of institution's normal range; for subjects with liver metastases, AST and ALT < 5 × 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; the combination of 5-FU and oxaliplatin is known to be safe to be administered in patients with such abnormal liver function tests
AST =< 2 x upper limit of normal
AST or ALT > 2 x upper limit of normal
AST/ALT ? 5 X upper limit of normal
DONOR: ALT < 2 x upper limit of normal
AST and ALT ?3 x upper limit of normal
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3.0 X the upper normal limit of institution's normal range; for subjects with liver metastases, AST and ALT < 5 X the upper normal limit of institution's normal range AS LONG AS THERE IS NO persistent nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, or eosinophilia
Hepatic function: AST and ALT ? 2.5 × the upper normal limit of institution's normal range. For subjects with liver metastases, AST and ALT ? 5 × the upper normal limit of institution's normal range;
AST and ALT </= 3x the upper limit of normal
ALT < 2.5 X institutional upper limit of normal
ALT and AST > 2.5 X upper limit of normal
AST/ALT =< 2.5 x upper limit of normal (ULN)
AST and ALT <10x upper limit of normal
AST, ALT ? 2.5 x upper limit of normal