Must be obtained within 14 days prior to registration for protocol therapy: Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Must have total bilirubin ? 1.5 × institutional ULN [? 2.0 x ULN in presence of liver metastases] within 14 days prior to randomization.
Direct bilirubin ? 1.5 × ULN (may be assumed if total bilirubin is below ULN)
Total bilirubin ? 1.5 x ULN (unless has Gilbert's syndrome)
Within 14 days of treatment initiation: Serum total bilirubin =< upper limit of normal (ULN) OR direct bilirubin =< ULN for patients with total bilirubin levels > ULN; (except patients with Gilbert’s syndrome, who must have a total bilirubin less than 3.0 mg/dL)
Total serum bilirubin =< 1.5 x ULN
Within 6 weeks prior to randomization: Total bilirubin must be =< upper limit of normal (ULN) for the laboratory (lab) unless the patient has a bilirubin elevation > ULN to 1.5 x ULN due to Gilbert’s disease or similar syndrome involving slow conjugation of bilirubin
Total bilirubin =< 1.5 x upper limit of normal (ULN) in absence of Gilbert disease (total bilirubin =< 3 x ULN with Gilbert); also, if hyperbilirubinemia is clearly attributed to liver metastases total bilirubin =< 3 x ULN is permitted
Re-registration: total bilirubin =< 1.5 x ULN in absence of Gilbert disease (total bilirubin =< 3 x ULN with Gilbert); if hyperbilirubinemia is clearly attributed to liver metastases, total bilirubin =< 3 x ULN is permitted
Total bilirubin =< 1.5 x ULN except subjects with normal direct bilirubin or those with known Gilbert’s syndrome, obtained within 4 weeks prior to randomization
Within 2 weeks prior to registration: Total bilirubin =< 1.5 x ULN
Patients must have total bilirubin =< 1.5 x IULN
Patients must have total bilirubin =< 2.5 x IULN
Total bilirubin =< ULN (institutional upper limit of normal) except elevated total bilirubin < 1.5 x ULN due to Gilbert’s disease or similar syndrome involving slow conjugation of bilirubin, measured within 28 days prior to randomization
If total bilirubin is > upper limit of normal (ULN) (NOTE: in subjects with Gilbert’s syndrome, if total bilirubin is \r\n> ULN, measure direct and indirect bilirubin and if direct bilirubin is within normal range, subject may be eligible) or
Within 14 days prior to registration: Total Bilirubin =< 1.5 x ULN (patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled)
Direct or total bilirubin < 1.5 x ULN (unless related to Gilbert’s or Meulengracht’s syndrome); the values must be obtained within 48 hours prior to randomization
Obtained within 28 days prior randomization: total bilirubin must be =< 1.5 x ULN (upper limit of normal) for the lab unless the patient has a bilirubin elevation > 1.5 x ULN to 3 x ULN due to Gilbert’s disease or similar syndrome involving slow conjugation of bilirubin; and
Total bilirubin =< 1.5 x ULN (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 x ULN), within 4 weeks of randomization
Total bilirubin =< 1.5 x ULN within 14 days prior to registration.
Bilirubin =< 1.5 x ULN
Serum total bilirubin =< 1.5 x upper limit of normal (ULN) (Note: in subjects with Gilbert’s syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is =< 1.5 x ULN, subject is eligible) within 90 days prior to Step 1 registration
Total serum bilirubin ? ULN; or total bilirubin ? 3.0 × ULN with direct bilirubin within normal range in patients with documented Gilbert's Syndrome.
Total bilirubin (T. bili) =< 1.3
Obtained within 14 days prior to treatment start: Total serum bilirubin =< 1.5 x ULN; or total bilirubin (TBILI) =< 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert’s syndrome
Within 10 days of treatment initiation: Bilirubin =< 1.5 X IULN\r\n* Bilirubin > 1.5 x ULN is allowed in subjects with conjugated bilirubin disorder or Gilbert's syndrome
Within 21 days of treatment initiation:\r\nSerum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Total bilirubin =< 1.5 x ULN; except subjects with known Gilbert’s syndrome
Total bilirubin equal to or less than 1.5 times the ULN
Total bilirubin =< 1.5 X ULN (may not have abnormalities in both bilirubin and transaminases)
Bilirubin ? 1.5 × ULN unless evidence of Gilbert's disease in which case < 3 x ULN
Total bilirubin ? 1.5 × ULN (except in patients with Gilbert Syndrome who can have total bilirubin < 3.0 mg/dL). Direct bilirubin ? ULN for patients with total bilirubin levels >1.5 × ULN.
Bilirubin < 1.5 × ULN except in patients with Gilbert's disease Renal Function
Total serum bilirubin ? 1.5 X ULN
Total bilirubin > 1.5 times ULN (patients with confirmed Gilbert's syndrome may be included in the study)
Bilirubin =< 1.5 x ULN OR direct bilirubin of =< ULN for subjects with total bilirubin levels of > 1.5 x ULN obtained within 14 days prior to registration
Within 14 days of treatment initiation: Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN (up to 14 days before treatment initiation)
Total bilirubin =< 3.0 x ULN; if patient has known Gilbert’s syndrome direct bilirubin =< 1.5 x ULN
Total bilirubin =< 1.5 x ULN OR, for subjected with total bilirubin levels > 1.5 x ULN, a direct bilirubin =< ULN must be met within 28 days of C1D1
Bilirubin =< 2 x ULN
Within 14 days of treatment initiation:\r\nSerum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Within 10 days of treatment initiation: Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin ? 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 ULN to 3 x ULN due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin; and
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 10 days of treatment initiation
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Total bilirubin >1.5 x ULN
Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 14 days of treatment initiation
Total bilirubin ? 1.5 × ULN
COHORT 1: Serum total bilirubin =< 1.5 X ULN unless considered due to leukemic organ involvement, Gilbert’s or hemolysis, OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN within 14 days of treatment initiation
COHORT 2: Serum total bilirubin =< 1.5 X ULN unless considered due to leukemic organ involvement, Gilbert’s or hemolysis, OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN within 14 days of treatment initiation
Total bilirubin ?2.0
Bilirubin =< 1.5 x ULN (unless documented Gilbert's disease), within 14 days of registration
Total bilirubin =< 1.5 x ULN
Total bilirubin > 1.5 x ULN
SAFETY RUN-IN: Within 10 days of registration: Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
RANDOMIZED PHASE II CLINICAL TRIAL: Within 10 days of registration: Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 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 x upper limit of normal (ULN); or total bilirubin =< 3.0 x ULN or direct bilirubin =< 1.5 x ULN in patients with well-documented Gilbert’s syndrome
Within 30 days prior to enrollment: Total bilirubin equal to or less than 1.5 times the ULN
Total serum bilirubin =< 1.5 X ULN (except participants with Gilbert’s syndrome, who can have a total bilirubin [bili] < 5 X ULN), performed within 14 days of treatment initiation
Bilirubin ? 2.5 × ULN (? 4 × ULN for subjects with Gilbert's disease);
Serum total bilirubin =< 1.5 x ULN OR
Direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Total bilirubin and direct bilirubin =< ULN
Patients with hyperbilirubinemia clinically consistent with an inherited disorder of bilirubin metabolism (e.g., Gilbert syndrome) will be eligible at the discretion of the principal investigator if total bilirubin is =< 1.5 X ULN
Total bilirubin =< 1.5 × ULN
Serum bilirubin ? institutional 1.5 times upper limit of normal (ULN) (OR for patients with documented Gilbert syndrome, total bilirubin ? 3.0 times ULN with direct bilirubin ? ULN)
Total bilirubin less than or equal to 1.5 X ULN except for unconjugated hyperbilirubinemia of Gilbert's syndrome
Total bilirubin =< 2.0 x upper limit of normal (ULN) or direct bilirubin =< 1.5 x ULN in patients with well-documented Gilbert’s syndrome
Total bilirubin < ULN; or total bilirubin =< 3.0 x ULN or direct bilirubin =< 1.5 x ULN in patients with well-documented Gilbert’s syndrome
Total bilirubin =< 1.5 x ULN; or =< 2 x ULN (if upon judgment of the treating physician, it is believed to be due to EMH related to MF)
Total serum bilirubin ?1.5 times ULN
Serum bilirubin levels ?2 x ULN
Total bilirubin =< 1.5 x ULN
Total bilirubin =< 1.5 x ULN
Total bilirubin is no higher than the ULN;
Serum bilirubin =< 1.5 x institutional ULN
Serum bilirubin > 1.5 × ULN; bilirubin up to 3 x ULN is permitted in individuals with documented liver involvement by lymphoma or if due to known Gilbert syndrome or other organ system that may place the patient at undue risk to undergo treatment
Serum bilirubin < 1.5 x the ULN for the reference lab;
Total bilirubin =< 1.5 x the IULN
Bilirubin (total) >1.5x ULN
Total bilirubin ? 1 X ULN (subjects with Gilbert’s disease can have bilirubin of up to 1.5 X ULN)
Total bilirubin ?1.5 ULN
Serum total bilirubin =< 1.5 x upper limit of normal (ULN). In the case of known Gilbert’s syndrome, a higher serum total bilirubin (< 2 x ULN) is allowed.
Total bilirubin ? 1.5 x ULN or direct bilirubin ? ULN for subjects with total bilirubin > 1.5 x ULN
Within 10 (except as noted) days of planned treatment initiation: Serum bilirubin =< 1.5 x institutional ULN OR direct bilirubin =< ULN for patients with total bilirubin levels > 1.5 x ULN
Total bilirubin =< 1.5 x ULN OR direct bilirubin =< 1 x ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for patients with total bilirubin levels > 1.5 ULN.
total bilirubin must be ? ULN for the lab unless the patient has a bilirubin elevation > ULN to 1.5 x ULN due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin; and
Total serum bilirubin less than ULN.
Serum bilirubin =< 2 x ULN
Total bilirubin > 1.5 x ULN
Total bilirubin ? 1.5 × institutional ULN (total bilirubin of ? 3 x institutional ULN in subjects with documented Gilbert's syndrome).
Total serum bilirubin =< 1.5 x ULN unless the patient has documented Gilbert syndrome
Total bilirubin < ULN; or total bilirubin =< 3.0 x ULN or direct bilirubin =< 1.5 x ULN in patients with well-documented Gilbert’s syndrome
Obtained =< 2 weeks prior to registration: Total bilirubin =< 1.5 x ULN
Obtained within 28 days prior to registration: Bilirubin < 2.0 X ULN
Total bilirubin =< upper limit of normal performed within 30 days prior to the date of registration (ULN, Note: In subjects with Gilbert’s syndrome, if total bilirubin is > ULN, measure direct and indirect bilirubin and if direct bilirubin is =< ULN, subject may be eligible)
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 10 days of treatment initiation
Within 14 days of treatment registration: Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Total serum bilirubin > 1.5 times ULN
Obtained within 14 days prior to registration: Total bilirubin =< 1.5 ULN (unless documented Gilbert's disease)
Total bilirubin < ULN; or total bilirubin =< 3.0 x ULN or direct bilirubin =< 1.5 x ULN in patients with well-documented Gilbert’s syndrome
Total bilirubin < institutional ULN within 14 days of enrollment to trial
total bilirubin ? 1.5 × upper limit of normal (ULN) OR direct bilirubin ? ULN for subjects with total bilirubin levels > 1.5 x ULN (except subject with Gilbert's Syndrome, who can have total bilirubin < 3.0 mg/dl)
Bilirubin =< 1.5 times ULN before starting therapy
Total serum bilirubin ?1.5 x ULN. In subjects with Gilbert's syndrome, if total bilirubin is >1.5 × ULN, measure direct and indirect bilirubin and if direct bilirubin is ?1.5 × ULN, subject may be eligible)
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 (in case of known Gilbert’s syndrome, < 2 x ULN is allowed) within 8 weeks of pre-registration
Hepatic status: Serum total bilirubin ? 1 x upper limit of normal (ULN; in the case of known Gilbert's syndrome, a higher serum total bilirubin [< 1.5 x ULN] is allowed), aspartate aminotransferase and alanine aminotransferase ? 1.5 x ULN, and alkaline phosphatase ? 1.5 x ULN;
Bilirubin =< 1.5 x ULN (unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin); bilirubin =< 3 x ULN is permissible if due to disease
Bilirubin =< 2.5 x ULN (=< 4 x ULN for subjects with Gilbert’s disease)
Total bilirubin ?1.5 x ULN
Total serum bilirubin ? 1.5 × upper limit of normal for the study site (ULN) (in patients with known Gilbert Syndrome, total bilirubin ? 3 × ULN, with direct bilirubin ? 1.5 × ULN)
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 14 days of treatment initiation
Total bilirubin =< 1.5 x institutional ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN within 14 days of treatment initiation
Total bilirubin =< 1.5 x the upper limits of normal (ULN), except for subjects with Gilbert Syndrome who can have bilirubin < 3
Bilirubin =< 1.5 x ULN (unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin)
Serum bilirubin =< 1.5 x ULN
Serum total bilirubin =< 1.5 X ULN unless due to Gilbert’s disease, hemolysis or leukemic infiltration OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 14 days of D1 of treatment under LCCC1522
Total bilirubin =< 1.5 x upper limit of normal (ULN), except for patients with Gilbert’s syndrome, who may only be included if total bilirubin =< 3.0 x ULN or direct bilirubin =< 1.5 x ULN, at the screening visit
Total bilirubin >1.5 times ULN
Total bilirubin ?1.5 × institutional ULN
Bilirubin =< 1.5 x ULN
Serum total bilirubin =< 1.5 upper limit of normal (ULN) or, direct bilirubin =< ULN for participants with total bilirubin levels > 1.5 ULN (performed within 14 days of treatment initiation)
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN (performed within 28 days of treatment initiation)
Total bilirubin ? 1.5 ULN
Bilirubin ?1.5 × institutional ULN.
Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =<1.5 X institutional ULN OR direct bilirubin =< institutional ULN for subjects with total bilirubin levels > 1.5 institutional ULN, performed within 28 days of study registration
Total serum bilirubin =< 1.5 x upper limit of normal (ULN) (< 3 x ULN in patients with documented/suspected Gilbert’s disease with concomitant direct bilirubin =< 1.5 x ULN)
Total bilirubin ? 1.5 × ULN or direct bilirubin ? ULN.
Serum bilirubin =< 1.0 x ULN
Total bilirubin ? 2
Serum bilirubin < 2 x ULN
Total bilirubin ?1.5× ULN
Total bilirubin =< 1.5 x institutional ULN
Total bilirubin ? 1.5 x ULN
OBTAINED =< 7 DAYS PRIOR TO REGISTRATION: Total bilirubin =< ULN
Total bilirubin =< 1.5 X 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 =< ULN =< 28 days prior to registration
Serum total bilirubin =< 1.5 x IULN OR direct bilirubin =< IULN for patients with total bilirubin > 1.5 x IULN
Bilirubin < 1.5 x ULN (unless bilirubin rise is due to Gilbert’s syndrome [as defined by > 80% unconjugated hyperbilirubinemia] or of non-hepatic origin)
Total bilirubin =< 2.0 x ULN
Bilirubin up to 2.5 x ULN.
Total bilirubin =< 1.5 X ULN (unless there is lymphoma in the liver)
Total bilirubin ?1.5 times the upper limit of normal (ULN) (in patients with known Gilbert Syndrome, a total bilirubin ?3.0 x ULN, with direct bilirubin ?1.5 x ULN)
Total bilirubin =< 2.0 x institutional ULN, unless documented Gilbert’s syndrome
Bilirubin > 2.0
PART II: Total bilirubin =< 1.5 x ULN
Hepatic: Total bilirubin =< upper limit of normal (ULN) for age, or if total bilirubin is > ULN, direct bilirubin is =< 1.4 mg/dL
Serum total bilirubin =< 2 x ULN (except for patients with Gilbert’s Syndrome)
Bilirubin =< 1.5 x ULN
Bilirubin =< 2 unless consistent with Gilbert’s (total/direct > 5)
Bilirubin =< 1.5 x ULN
Performed within 10 business days of treatment initiation with the exception of beta- HCG (72 hours), if applicable: Serum total bilirubin =< 1.5 X ULN or direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN.
Within 14 days of randomization: Bilirubin =< ULN (unless documented Gilbert's disease)
At time of registration and within 4 weeks prior to initiating on-protocol treatment: Total bilirubin =< 1.5 x ULN, OR direct bilirubin =< ULN for participants with total bilirubin levels >1.5 x ULN
Hepatic: < 2 x ULN total serum bilirubin, unless there is congenital benign hyperbilirubinemia.
Total bilirubin < 1.5 X ULN
Bilirubin ?1.5x the upper limit of normal (ULN). For subjects with documented Gilbert's disease, bilirubin ?3.0 mg/dL. For subjects with documented liver metastases, bilirubin ? 2.5x ULN.
Total bilirubin =< 1.5 x ULN (unless Gilbert’s syndrome or disease infiltration of the liver is present, who may be included if total bilirubin =< 3.0 x ULN or direct bilirubin =< 1.5 x ULN)
Within 10 days prior to the start of study treatment: Total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for participants with total bilirubin levels > 1.5 x ULN
Total bilirubin ? 1.5 x ULN OR in subjects with Gilbert’s syndrome, a total bilirubin ? 3.0 x ULN
Total bilirubin ?1.5 times the ULN (or ?3 x ULN, if patient has Gilbert syndrome)
Serum bilirubin =< 1.5 x ULN
Total bilirubin < 1.5 x ULN (or =< 3 x ULN for patients with documented Gilbert syndrome)
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 28 days of treatment initiation
Performed within 10 days of treatment initiation: Serum total bilirubin ? 1.2 X ULN OR in case of Gilbert’s disease an elevated total bilirubin is allowed if direct bilirubin is ? 40% of total
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, should be performed within 10 days of treatment initiation
Within 7 days of enrollment and with 24 h of starting lymphodepleting chemotherapy: Total bilirubin =< 1.5 X ULN.
Total bilirubin ? 2 X upper limits of normal (ULN) (except in the case of subjects with documented Gilbert’s disease > 3 x ULN)
Total bilirubin =<1.5 x ULN (excepting Gilbert’s syndrome)
Total serum bilirubin =< 1.5 x ULN
Within 28 days prior to treatment start: Total bilirubin =< 1.5 x upper limit of normal (ULN) (Note: In subjects with Gilbert’s syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is =< 1.5 x ULN, subject may be eligible)
STRATUM A: Total bilirubin =< ULN or if > ULN then direct bilirubin =< 1.5 x ULN
STRATUM B: Total bilirubin =< ULN; or if > ULN then direct bilirubin =< 1.5 x ULN
STRATUM C: Total bilirubin =< ULN; or if > ULN then direct bilirubin =< 1.5 x ULN
Bilirubin =< 1.5 x ULN, (Patients with documented Gilbert’s syndrome and conjugated bilirubin within the normal range may be allowed into the study; in this event, it will be documented that the patient was eligible based on\r\nconjugated bilirubin levels)
Serum total bilirubin =< 1.5 x institutional ULN (except subjects with Gilbert’s syndrome, who must have normal direct bilirubin)
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 10 days of treatment
Bilirubin =< 1.5 x ULN OR in subjects with Gilbert’s syndrome, a total bilirubin =< 3.0 x ULN
Serum total bilirubin ? 1.5 X ULN OR direct bilirubin ? ULN for subjects with total bilirubin levels > 1.5 ULN within 21 days of treatment initiation
Bilirubin =< 3 X ULN or < 5 X ULN in the presence of liver metastases
Serum bilirubin ?1.5 × ULN (Grade ? 1).
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN within 21 days of treatment initiation
Total serum bilirubin ? 1.5 x ULN (in subjects with known Gilbert Syndrome, a total bilirubin ? 3.0 x ULN, with direct bilirubin ? 1.5 x ULN)
Performed within 10 days of treatment initiation: serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum bilirubin < 1.5 x upper limit of normal (ULN); Note: In subjects with Gilbert’s syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is =< 1.5 x ULN, subject may be eligible
Obtained within 21 days prior to cycle 1, day 1: serum bilirubin =< 1.5 x ULN
Serum total bilirubin =< 1.5 times upper limit of normal (ULN) OR direct bilirubin =< ULN for subjects with total bilirubin >= 1.5 x ULN
Should be performed within 30 days of treatment initiation: serum total bilirubin ? 1.5 X ULN OR direct bilirubin ? ULN for subjects with total bilirubin levels > 1.5 ULN
Total bilirubin =< 1.5 X institutional ULN
Within 28 days of cycle 1 day 1: Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN (performed within 10 days of treatment initiation)
Within 5 days prior to the start of study treatment: Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN.
bilirubin <= 1.5 x ULN* * Unless considered to be due to leukemic organ involvement i. Subjects who are < 75 years of age may have a bilirubin of <= 3.0 x ULN
Total bilirubin < 2.5 ULN. Subjects with a known history of Gilberts Disease and an isolated elevation of indirect bilirubin are eligible.
Total bilirubin =< 1.5 x ULN (patients with Gilbert’s syndrome may have serum bilirubin > 1.5 x ULN)
Total bilirubin ? 2x the institutional ULN with the exception of patients with Gilbert syndrome; patients with Gilbert syndrome may be included if their total bilirubin is ? 3.0x ULN and direct bilirubin is ? 2x ULN
Total bilirubin =< 1.5 x ULN\r\n* Except in the case of Gilbert disease, in which case total bilirubin must be =< 3 x ULN
Total serum bilirubin ? 1.5 x ULN, (except for patients with known Gilbert's Syndrome ? 3 x ULN is permitted)
Bilirubin =< 1.5 x ULN
Total bilirubin > ULN (NOTE: in subjects with Gilbert’s syndrome, if total bilirubin is > ULN, measure direct and indirect bilirubin and if direct bilirubin is within normal range, subject may be eligible) or
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Total bilirubin ? ULN (except in patients who have Gilbert’s syndrome or patients with recently placed stents for biliary obstruction when bilirubin should be < 1.5 X ULN) obtained ? 14 days prior to randomization
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin ? ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 14 days of treatment initiation
ALT > 5x ULN, AST > 5x ULN, or total bilirubin > 3 mg/dL [SI: > 51 ?mol/L] within 7 days prior to Day 1
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 28 days of treatment initiation
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum bilirubin =< 1.0 x ULN
Total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 x ULN
Serum total bilirubin =< 1.5 x ULN
Serum bilirubin < 1.8
Within 4 weeks before enrollment: Total bilirubin =< 2.5 x ULN; except if the elevation is due to Gilbert's syndrome
Serum bilirubin ? 1.5 x institutional ULN (in subjects with Gilbert’s syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin and patient is eligible if direct bilirubin ? 1.5 x ULN)
To be performed within 14 days of treatment initiation: serum total bilirubin ? 1.5 x ULN OR direct bilirubin ? ULN for subjects with total bilirubin levels > 1.5 ULN
Bilirubin =< 1.5 x ULN.
Obtained =< 14 days prior to registration: Total bilirubin =< 1.5 x upper limit of normal (ULN) (in patients with well-documented Gilbert’s syndrome and the total bilirubin is grade 1, then direct bilirubin value must be =< 1.0 mg/dL)
Within 10 days of treatment initiation: Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN.
Within 10 days of treatment initiation: Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Total serum bilirubin < 1.5 x ULN, unless the patient has documented Gilbert syndrome
Within 14 days of treatment initiation: Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 10 days of treatment initiation
Performed within 10 days of treatment initiation: Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN.
Within 7 days of registration: Total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 x ULN
Obtained =< 14 days prior to registration: Serum total bilirubin =< 1.5 X upper limit of normal (ULN) or direct bilirubin =< (ULN) for subjects with total bilirubin levels > 1.5 ULN
Within 10 days prior to on-study date: Serum total bilirubin ? 1.5 X ULN OR
Direct (conjugated) bilirubin ?2 x ULN
Within 28 days prior to enrollment: Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin >= 1.5 ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for patients with total bilirubin levels > 1.5 ULN
Total bilirubin =< 1.5 x ULN (except if the patient has Gilbert’s syndrome who can have total bilirubin =< 2 x ULN) must be met during screening (within 21 days) and also prior to study drug administration on cycle 1 day 1
Within 10 days of treatment initiation: Serum total bilirubin =< 1.5 X ULN
Total bilirubin ? 1.5 × upper limit of normal (ULN) OR direct bilirubin ? ULN for subjects with total bilirubin levels > 1.5 x ULN
Within 14 days prior to registration: Bilirubin =< 1.5 x ULN; for patients with Gilbert's syndrome, bilirubin =< 3 x ULN is acceptable
Within 10 days of treatment initiation: Serum total bilirubin ? 1.5 X ULN OR direct bilirubin ? ULN for subjects with total bilirubin levels > 1.5 ULN
Total Bilirubin =< 1.5 x ULN
Total serum bilirubin =< 1.5 x ULN (=< 3 x ULN or direct bilirubin =< 1.5 x ULN if known Gilbert’s syndrome)
Serum total bilirubin ? 1.5 X ULN OR direct bilirubin ? ULN for subjects with total bilirubin levels > 1.5 ULN
Total bilirubin < 1.5 X institutional upper limit of normal OR direct bilirubin =< ULN for patients with total bilirubin > 1.5 ULN
Total bilirubin =< 1.5 x ULN
Serum total bilirubin =< 1.5 x ULN or direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 x ULN
Serum bilirubin =< 1.0 x ULN
Total bilirubin =<1.5 X institutional ULN (or =< 3 X institutional ULN for patients with documented Gilberts syndrome) (unless dysfunction is secondary to lymphoma involvement)
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN (performed within 10 days of treatment initiation)
Total bilirubin =< 1.5 x ULN (In the expansion cohort, subjects with Gilbert’s syndrome [hereditary indirect hyperbilirubinemia] who must have a total bilirubin of =< 3 x ULN).
Performed within 10 days of treatment initiation: Serum total bilirubin =< 1.5 X ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 X upper limit of normal (ULN) OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 10 days of treatment initiation
Serum bilirubin > 1.5 x ULN; patients with known Gilbert’s disease who have a serum bilirubin level =< 3 x ULN may be enrolled
Obtained =< 14 days prior to registration: Total bilirubin =< 1.5 x the upper limit of the normal range (ULN) or if total bilirubin is > 1.5 x ULN, the direct bilirubin must be =< 2.0 mg/dL
Bilirubin =< 1.5 x ULN (unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin)
Obtained =< 28 days prior to registration: Total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for patients with total bilirubin levels > 1.5 x ULN
Performed within 7 days of treatment initiation: Total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Performed within 14 days of treatment initiation: Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin >= 1.5 ULN
Total bilirubin ?1.5 times the ULN, or direct bilirubin <ULN for patients with total bilirubin levels >1.5xULN;
Total serum bilirubin ? 1.5 times the ULN
Bilirubin =< 1.5 x ULN (unless documented Gilbert's disease) within 14 days of cycle 1 day 1
Total bilirubin =< 1.5 x ULN
Total serum bilirubin =< 1.5 ULN
Serum bilirubin =< 1.5 x ULN
Total bilirubin =< 1.5 x ULN
Total bilirubin ? 1.5 x ULN (AST, ALT, and total bilirubin ? 3 × ULN in subjects with documented Gilbert’s syndrome or hyperbilirubinemia clearly attributed to lymphoma involvement of the liver)
Bilirubin =< 1.5 x ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Total bilirubin ?1.5 × ULN except for unconjugated hyperbilirubinemia or Gilbert's syndrome
ALT, AST > 2.5 ULN or total bilirubin > 1.5 ULN (not attributable to Gilbert’s)
Serum total bilirubin =< 1.5 x ULN or =< 3 x ULN if patient has Gilberts disease OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 14 days of treatment initiation
Serum total bilirubin =< 1.5 x ULN, performed within 10 days of treatment initiation OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN; for subjects with Gilbert’s disease =< 3 mg/dL
Patients must have adequate organ and bone marrow function within 14 days prior to registration, as defined by: total bilirubin total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (except patients with Gilbert syndrome or liver metastasis, who can have total bilirubin =< 3.0 x ULN)
Serum bilirubin < 1.5 x ULN
Subjects with Gilbert’s syndrome, confirmed by genotyping or Invader UGTIA1 molecular assay prior to study entry, must have total bilirubin < 3.0 times ULN
A total bilirubin =< 1.5 ULN
Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Total bilirubin > or = 1.5 x ULN, unless due to Gilbert’s disease.
Total bilirubin =< 1.5 x ULN obtained =< 14 days prior to registration
bilirubin ? 1.5 x ULN;
Performed within 10 days of treatment initiation: Serum total bilirubin =< 2.0 x ULN (unless considered due to Gilbert’s disease or leukemia disease) or direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Total serum bilirubin =< 1.5 x ULN unless the patient has documented Gilbert syndrome. If organ function abnormalities are considered due to tumor, total serum bilirubin must be =< 2 x ULN
Serum total bilirubin >= 1.5 x ULN OR direct bilirubin >= ULN for patients with total bilirubin levels > 1.5 x ULN
Bilirubin =< 5 x ULN
Bilirubin =< 1.5 x ULN
Hepatic impairment, defined as total bilirubin > 1.5 x institutional ULN (patients with benign hyperbilirubinemia [e.g., Gilbert’s syndrome] are eligible) or
Total serum bilirubin =< 1.5 x ULN
Serum total bilirubin =< 1.5 x upper limit of normal (ULN) OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Total bilirubin =< 1.5 x upper limit of normal (ULN), except for patients with Gilbert’s syndrome who may be included if total bilirubin =< 3.0 x ULN or direct bilirubin =< 1.5 x ULN
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) OR direct bilirubin =< ULN with total bilirubin > 1.5 x ULN
Within 28 days prior to registration for protocol therapy: Serum total bilirubin => 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Total bilirubin ? 1.5x institutional ULN
Total bilirubin <1.5 x ULN
Performed within 10 days of treatment initiation: Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Bilirubin =< 1.5 ULN (for patients with liver metastasis up to =< 5 times of ULN is allowed)
Determined within 3 weeks of treatment initiation: Serum bilirubin =< 1.5 x upper limit of normal (ULN) OR direct bilirubin =< ULN for a subject with total bilirubin level > 1.5 x ULN
bilirubin ? 1.5 × ULN* ° Subjects who are < 75 years of age may have bilirubin of ? 3.0 × ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN; unless due to Gilbert’s disease or hemolysis
Total bilirubin =< 1.5 X ULN.
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN within 14 days of treatment initiation
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Total bilirubin =< ULN
Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Bilirubin =< 1.5 x ULN (unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin)
Serum total bilirubin =< 1.5 x ULN
Total bilirubin =< 2.5 x ULN prior to biopsy
Total bilirubin < 2.0
Serum bilirubin =< 1.8
Bilirubin =< 1.5 x ULN
Within 10 days of treatment initiation: Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Total bilirubin: =< 1.5 X ULN (isolated bilirubin > 1.5 X ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%)
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\r\n* Direct bilirubin =< ULN for patients with total bilirubin levels > 1.5 x ULN
Total bilirubin =< 1.5 X upper limit of normal (ULN); if total bilirubin > 1.5 X ULN then direct bilirubin =< ULN (obtained =< 14 days prior to registration)
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.
Direct bilirubin ? 2.0 × the upper limit of laboratory normal (ULN). (NOTE: direct bilirubin will only be determined if total bilirubin is ? 2.0 × ULN)
Within 14 days of treatment initiation: Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Total bilirubin </=2 times the ULN
Serum total bilirubin =< 1.5 X institutional ULN OR direct bilirubin =< institutional ULN for subjects with total bilirubin levels > 1.5 institutional ULN, performed within 14 days of registration
Total bilirubin ? 1.5 x ULN
Total bilirubin =< 1.5 x ULN; (in patients with well documented Gilbert’s syndrome, total bilirubin =< 3 x ULN with direct bilirubin within normal range)
Total bilirubin < 1.5 x ULN
Obtained =< 14 days prior to registration: Direct bilirubin =< 1.5 x ULN
Total bilirubin < institutional upper limit of normal (ULN), except for subjects with documented Gilbert’s syndrome, for which =< 3.0 x ULN or direct bilirubin =< 1.5 x ULN
Total bilirubin =< 1.5 X upper limit of normal (ULN) (or total bilirubin =< 3.0 X ULN with direct bilirubin =< 1.5 X ULN in patients with well-documented Gilbert’s syndrome) obtained =< 14 days prior to registration
Performed within 10 days of treatment initiation: Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Liver function: ALT and AST ? 2.5 × ULN; Total bilirubin ? 1.5 × ULN (or ? 3 times ULN for subjects with documented Gilbert's syndrome or for whom indirect bilirubin concentrations suggest an extra-hepatic source of elevation)
Total bilirubin ?1.5 x ULN (does not include patients with Gilbert's Disease)
Bilirubin > 2 x ULN
Total bilirubin < 2 x upper limits of normal (ULN) except Gilbert syndrome where < 3 x ULN is allowed
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 X ULN
Direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 2.0 X ULN (performed within 28 days of registration)
Serum total bilirubin =< 1.5 x ULN or direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 x ULN performed within 10 days of treatment initiation
Total bilirubin =< 1.5 x ULN; subjects with Gilbert’s syndrome should have direct bilirubin within normal institutional limits
Total bilirubin level ? 1.5 x ULN, except for patients with known Gilbert's syndrome (confirmed by the UGT1A1 polymorphism analysis), who are excluded if total bilirubin>3.0 x ULN or direct bilirubin > 1.5 x ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Total bilirubin =< 1.5 x ULN.
Total bilirubin =< 1.5 x ULN (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL) or =< 2 x ULN if lenalidomide is being prescribed; should be obtained within 21 days prior to enrollment
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum bilirubin =< 1.5 x institutional ULN
Serum total bilirubin =< 1.5 X ULN or direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN (within 10-15 days of treatment initiation)
Total bilirubin =< ULN for the laboratory
Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for patients with total bilirubin levels > 1.5 ULN
Total serum bilirubin =< 1.5 x ULN; for patients with well documented Gilbert’s syndrome, total bilirubin =< 3 x ULN with direct bilirubin within normal range
Total bilirubin >1.5 times ULN, except for patients with Gilbert's syndrome who are excluded if total bilirubin >3.0 x ULN or direct bilirubin >1.5 x ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN within 16 days of treatment initiation
Serum total bilirubin =< 1.5 × upper limit of normal (ULN) (Note: In subjects with Gilbert’s syndrome, if total bilirubin is > 1.5 × ULN, measure direct and indirect bilirubin and if direct bilirubin is =< 1.5 × ULN, subject may be eligible)
Total serum bilirubin =< 1.5 x ULN; or total bilirubin =< 3 x ULN with direct bilirubin within normal range in patients with well documented Gilbert’s syndrome
Bilirubin =< 1.5 x ULN (unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin, in which case the total bilirubin should be < 3 x ULN)
Total bilirubin less than or equal to 1.5 x ULN
Total serum bilirubin < ULN; or total bilirubin ? 3.0 × ULN with direct bilirubin within normal range in patients with well-documented Gilbert's Syndrome
Total bilirubin =< 2 mg/dL, or direct bilirubin =< ULN for those with total bilirubin > 2 x ULN performed within 7 days of treatment initiation
Total bilirubin =< 1.5 x ULN
Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, during screening and on cycle 1, day 1
Total bilirubin ?1.5 times ULN; and
Serum bilirubin < 1.5 x ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN within 14 days of treatment initiation
Serum total bilirubin =< ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > ULN (performed within 10 days of treatment initiation)
Obtained within 14 days prior to registration; total bilirubin ? ULN
Total bilirubin > 1.5 x ULN (Patients with a history of Gilbert's syndrome may participate if total bilirubin is less than or equal to 1.5 x ULN and the AST/ALT and alkaline phosphatase meet the protocol-specified levels for eligibility)
Bilirubin =< 1.5 x ULN (unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin)
Total bilirubin > 5
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Total bilirubin =< 1.5 x ULN
Bilirubin =< 1.5 x ULN; for subjects with documented/suspected Gilbert’s disease, bilirubin =< 3 x ULN
Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Total bilirubin =< 1.5 x ULN
Within 10 days of treatment initiation: Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Total bilirubin =< 1.5 X ULN
Obtained =< 14 days prior to randomization: Total bilirubin =< upper limit of normal (ULN)\r\n* NOTE: If total bilirubin is out of range then direct bilirubin must be =< ULN
Serum total bilirubin: =< 1.5 X ULN OR direct bilirubin =< ULN for participants with total bilirubin levels > 1.5 ULN
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >= 2.5 x ULN; Note: in subjects with Gilbert’s syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is =< 1.5 x ULN, subject may be eligible
Total serum bilirubin =< 2.0 x ULN (except if Gilbert’s disease)
Bilirubin =< 1.0 x ULN (exceptions for Gilbert’s syndrome)
Completed within 10 days of SBRT treatment initiation: Serum total bilirubin =< 1.5 X ULN OR
Completed within 10 days of SBRT treatment initiation: Direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Total serum bilirubin =< 1.5 x upper limit of normal (ULN) OR direct bilirubin =< ULN if total bilirubin levels > 1.5 x ULN
Total bilirubin is less than or equal to ULN, except the case in which the elevated total bilirubin is not a sign of liver disease, such as the Gilbert Syndrome, in which case a total bilirubin less than or equal to 2 x ULN is acceptable
Total bilirubin ? 2 × ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 x ULN or direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN within 14 days of treatment initiation
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN within 14 days prior to registration
Serum bilirubin < 3 x ULN
Within 14 days prior to registration: Total bilirubin =< 1.5 x ULN (except in patients with Gilbert’s disease)
Bilirubin > 1.5 x upper limit of normal (ULN), except for patients with known Gilbert syndrome who are excluded if total bilirubin > 3.0 x ULN or direct bilirubin > 1.5 x ULN
Total bilirubin ?1.5 times ULN; and
PART 2 GROUP 1 INCLUSION CRITERIA: Total serum bilirubin (sum of conjugated + unconjugated) =< 1.5x upper limit of normal (ULN), except for subjects with Gilbert’s Syndrome who may be included if total bilirubin is =< 3.0 x ULN and direct bilirubin is =< 1.5 x ULN
PART 2 GROUP 2A INCLUSION CRITERIA: Total serum bilirubin (sum of conjugated + unconjugated) =< 1.5x ULN, except for subjects with Gilbert’s Syndrome who may be included if total bilirubin is =< 3.0 x ULN and direct bilirubin is =< 1.5 x ULN
PART 2 GROUP 3 INCLUSION CRITERIA: Total serum bilirubin (sum of conjugated + unconjugated) =< 1.5x ULN, except for subjects with Gilbert’s Syndrome who may be included if total bilirubin is =< 3.0 x ULN and direct bilirubin is =< 1.5 x ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Total bilirubin =< 2 x ULN (except patients with documented Gilbert’s syndrome)
Total serum bilirubin levels < 1.5 x ULN (note: in subjects with Gilbert’s syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is =< 1.5 x ULN, subject may be eligible)
PHASE II SCLC: Total bilirubin =< 1.5 x ULN (unless Gilbert’s disease)
UROTHELIAL CARCINOMA EXPANSION COHORT: Total bilirubin =< 1.5 x ULN (=< 3 x ULN for subjects with Gilbert’s disease)
mCRPC EXPANSION COHORT: Total bilirubin =< 1.5 x ULN (=< 3 x ULN for subjects with Gilbert’s disease)
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 10 days of treatment initiation
Total bilirubin ? 1 x ULN (unless elevated due to Gilbert's syndrome or extrahepatic source as denoted by increased indirect bilirubin fraction. Subjects with ?1 x ULN will be tested for direct bilirubin fraction so that the indirect fraction can be calculated).
Total bilirubin =< 1.5 X ULN
Total bilirubin =< 1.5 x ULN, except for patients with Gilbert’s syndrome who may be included if total bilirubin =< 3.0 x ULN and direct bilirubin =< 1.5 x ULN
Total bilirubin =< 1.5 x upper limit of normal (ULN) or =< 3 x ULN for patients with Gilbert’s disease (in patients [pts] with elevated total bilirubin due to increased indirect bilirubin, pts with direct bilirubin =< 1.5 x ULN are eligible)
Bilirubin =< 1.5 x ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Total bilirubin =< 1.5 x upper limit of normal (ULN), except for patients with Gilbert’s syndrome or documented hepatic involvement with lymphoma who may be included if bilirubin =< 3.0 x ULN or direct bilirubin =< 1.5 x ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum bilirubin =< 1.5 x ULN
Serum total bilirubin =< 1.5 x upper limit of normal (ULN) (note: in subjects with Gilbert’s syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is =< 1.5 x ULN, subject may be eligible)
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Bilirubin =< 1.5 x ULN
Serum total bilirubin =< 1.5 X ULN or direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 X ULN (except for subjects with Gilbert Syndrome, who may have total bilirubin < 3.0 mg/dl) or direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 X ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 X ULN
Patient must meet the following laboratory values at the screening visit: Absolute Neutrophil Count ?1.5 x 109/L. Platelets ?75 x 109/L. Hemoglobin (Hgb) ?9 g/dL. Serum creatinine <1.5 mg/dL. Total bilirubin ?1.5 x upper limit of normal (ULN) (isolated bilirubin >1.5x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%). Aspartate transaminase (AST) ? 3.0 x ULN, except for patients with liver metastasis, who may only be included if AST ?5.0 x ULN. Alanine transaminase (ALT) ? 3.0 x ULN, except for patients with liver metastasis or tumor infiltration, who may only be included if ALT ?5.0 x ULN. Prothrombin time (PT)/International normalized ratio (INR) and Partial thromboplastin time (PTT) ?1.5xULN. Note: patients receiving therapeutic anticoagulation agents prior screening are permitted. Albumin 2.5 g/dL.
Performed 28 days prior to study registration up to the first dose of study drug: serum total bilirubin =< 1.5 X ULN (except for subjects with Gilbert syndrome, who may have total bilirubin < 3.0 mg/dl) or direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 x ULN
Total serum bilirubin ? 1.5 x ULN (? 3.0 x ULN if Gilbert’s disease)
Within 10 days of treatment initiation: Serum total bilirubin =< 1.5 X ULN (=< 3 X ULN if Gilbert’s syndrome) OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 10 days of treatment initiation
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN (within 28 days of treatment initiation)
Total bilirubin above 2.5 ULN in the absence of hemolysis or diagnosis of Gilbert’s syndrome
Performed within 14 days (+3 working days) of treatment initiation: Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Total bilirubin > 2 X upper limit of normal (ULN) , or direct bilirubin > 2.0 mg/dL (except patients with Gilbert’s syndrome, then total bilirubin greater than 2 X ULN allowed in the absence of other hepatic signs or symptoms)
Total serum bilirubin ? 1.5 x ULN
Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Bilirubin =< 1.5 x ULN
Total bilirubin =< 1.5 x ULN; subjects with Gilbert’s syndrome should have direct bilirubin within normal institutional limits
bilirubin ? 1.5 x ULN
Total bilirubin < 2.0 mg/dl with the exception of patients with Gilbert syndrome; patients with Gilbert syndrome may be included if their total bilirubin is >= 3.0 x upper limit of normal (ULN) and direct bilirubin =< 1.5 x ULN
Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 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
Performed within 14 days of treatment initiation: Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Total bilirubin > 1.5 x ULN, except for patients with Gilbert's syndrome who are excluded if total bilirubin > 3.0 x ULN or direct bilirubin > 1.5 x ULN.
Total bilirubin < ULN; or total bilirubin =< 3.0 x ULN or direct bilirubin =< 1.5 x ULN in patients with well documented Gilbert’s syndrome
Total bilirubin levels =< 1.5 x ULN
Total bilirubin =< 1.5 x ULN
Bilirubin =< 2 x ULN
CAPMATINIB INCLUSION CRITERIA: Total bilirubin =< 1.5 x upper limit of normal (ULN); patients with Gilbert’s syndrome may be included if total bilirubin =< 3 x ULN or direct bilirubin =< 1.5 x ULN
CERITINIB INCLUSION CRITERIA: Total bilirubin =< 1.5 x upper limit of normal (ULN); patients with Gilbert’s syndrome may be included if total bilirubin =< 3 x ULN and direct bilirubin =< 1.5 x ULN
REGORAFENIB INCLUSION CRITERIA: Total bilirubin =< 1.5 x upper limit of normal (ULN); patients with Gilbert’s syndrome may be included if total bilirubin =< 3 x ULN or direct bilirubin =< 1.5 x ULN
ENTRECTINIB INCLUSION CRITERIA: Total bilirubin =< 1.5 x upper limit of normal (ULN); patients with Gilbert’s syndrome may be included if total bilirubin =< 3 x ULN or direct bilirubin =< 1.5 x ULN
Demonstrate adequate organ function as defined: Absolute neutrophil count (ANC) ?1,500 /mcL Platelets ?100,000 / mcL Hemoglobin ?9 g/dL or ?5.6 mmol/L without transfusion or EPO dependency (within 7 days of assessment) Serum creatinine OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ?1.5 X upper limit of normal (ULN) OR ?60 mL/min for subject with creatinine levels > 1.5 X institutional ULN Serum total bilirubin ? 1.5 X ULN OR Direct bilirubin ? ULN for subjects with total bilirubin levels > 1.5 ULN AST (SGOT) and ALT (SGPT) ? 2.5 X ULN OR ? 5 X ULN for subjects with liver metastases Albumin >2.5 mg/dL
Total bilirubin >= 2 x ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Bilirubin =< 1.5 x ULN unless known to have Gilbert’s syndrome or elevated bilirubin resulting from hemolysis
PHASE I: Bilirubin < 1.5 x ULN
Serum bilirubin =< 1.8
Within 14 days prior to registration: Total bilirubin =< 1.5 x ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum bilirubin =< 1.5 x ULN
Adequate hepatic function with total bilirubin and ALT < 1.5X the upper limit of normal (ULN), except in patients with Gilbert's Syndrome must have a total bilirubin < 3X ULN and ALT < 3X ULN. In cases of known liver metastases, ALT ? 5X ULN is acceptable (total bilirubin must be < 1.5X ULN).
Serum bilirubin =< 2.0 x ULN
Serum bilirubin less than or equal to 1.5 x ULN
Total bilirubin > 2 x institutional ULN (except for known Gilbert’s syndrome/familial non-hemolytic jaundice)
Bilirubin =< 1.5 x ULN
Total bilirubin =< 1.5 x upper limit of normal (ULN), except for patients with Gilbert’s syndrome who may be included if total bilirubin =< 3.0 x ULN or direct bilirubin =< 1.5 x ULN
Total bilirubin ? 1.5 x ULN for age, direct bilirubin ? ULN for age
Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Within 3 months of registration: Bilirubin =< 1.5 x upper limit of normal (ULN); in subjects with Gilbert’s syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin; if direct bilirubin is =< 1.5 x ULN, subject may be eligible
Conjugated bilirubin <1.5 x ULN
Total serum bilirubin ?1.5 × ULN, unless due to Gilbert's syndrome
Total bilirubin ? 1.5 ULN
Total bilirubin concentration < 1.5 x the ULN
Patients with abnormal hepatic function will be eligible and will be grouped according to criteria summarized below:\r\n* Group A: Normal hepatic function\r\n** Bilirubin =< ULN\r\n** Aspartate aminotransferase (AST) =< ULN\r\n* Group B: Mild hepatic dysfunction\r\n** B1: bilirubin =< ULN and AST > ULN\r\n** B2: ULN < bilirubin =< 1.5 x ULN and any AST\r\n* Group C: Moderate hepatic dysfunction\r\n** 1.5 x ULN < bilirubin =< 3 x ULN and any AST\r\n* Group D: Severe hepatic dysfunction\r\n** 3 x ULN < bilirubin =< 10 x ULN and any AST; hepatic function tests should be repeated within 24 hours prior to starting initial therapy and may result in patients’ group assignment being altered if different to registration test results
Serum total bilirubin =< 1.5 X ULN (patients who do not meet this criteria must have a direct\r\nbilirubin =< 1.5 X ULN)
Total bilirubin =< 1.5 X ULN
Total bilirubin < 1.5 x ULN
Serum total bilirubin =< 1.5 X ULN OR
Direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Total bilirubin =< 2.5 x the institutional ULN
ARM A COHORT 1: Total bilirubin =< 1.5 x ULN
ARM B COHORT 3: Total bilirubin =< 1.5 x IULN
ARM C COHORT 4: Total bilirubin =< 2 X IULN
Direct bilirubin > 2 x ULN
Total bilirubin =< 1.5 x ULN unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin
PHASE II COLORECTAL CANCER COHORT 6 (MEDI+C ONLY):\r\nTotal bilirubin =< 1.5 X ULN; for subjects with documented/suspected Gilbert’s disease, bilirubin =< 3 X ULN
Total bilirubin < 3 x IULN
Serum bilirubin =< 2 x ULN
Total bilirubin ? 1.5 x ULN or
Direct bilirubin ? ULN for subjects with total bilirubin levels > 1.5 x ULN
Total bilirubin =< 1.5 x ULN for the laboratory\r\n* Exception: if a patient has documented Gilbert’s syndrome and a total bilirubin is > 1.5 x ULN, the total bilirubin requirement may be waived provided the direct bilirubin is within normal limits (WNL) for the laboratory
Total serum bilirubin =< 1.5 x ULN (in patients with known Gilbert syndrome, a total bilirubin =< 3.0 x ULN, with direct bilirubin =< 1.5 x ULN)
Total bilirubin < 1.5 times ULN unless due to Gilbert's disease
ADDITIONAL CRITERIA FOR STUDY CONTINUATION: Total bilirubin =< 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin =< 2.0 x ULN)
Total bilirubin =< 1.5 x the institutional ULN
Performed within 28 days prior to study registration up to the first dose of study drug: Serum total bilirubin =< 1.5 X ULN or direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Total bilirubin < 2.5 x upper limit of normal (ULN); direct bilirubin < 2 x ULN for Gilbert's syndrome;
Total bilirubin < 1.5 x ULN
Total bilirubin =< 1.5 x ULN
Serum total bilirubin =< 1.5 X ULN or direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 10 days of treatment initiation
Total serum bilirubin =< 1.5 x ULN (=< 3 x ULN for Gilbert’s syndrome)
Serum bilirubin =< 1.0 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
Bilirubin =< 1.5 x ULN
Total bilirubin < 1.5 x ULN for age
Bilirubin =< 2 x ULN (must be within 7 days of MLA)
Total bilirubin =< 1.5 x ULN
Serum total bilirubin =< 1.5 x ULN
Performed within 10 days of treatment initiation; serum total bilirubin ? 1.5 X ULN or direct bilirubin ? ULN for subjects with total bilirubin levels > 1.5 ULN
Must be met within 28 days of C1D1: Total bilirubin =< 1.5 x upper limit of normal (ULN) (unless evidence of Gilbert’s syndrome, in which case, direct bilirubin must be =< 1.0 x ULN)
EXCLUSION CRITERIA FOR ENROLLMENT: Total bilirubin > 3 times the ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Total bilirubin =< 1.5 x ULN
AST/ALT =<3 X ULN; -Bilirubin =<1.5 X ULN, unless resulting from hemolysis
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Total bilirubin =< 1.5 x IULN
Total bilirubin < 2 x upper limits of normal (ULN) except Gilbert’ syndrome where < 3 x ULN is allowed
Total bilirubin =< 1.5 x upper limit of normal (ULN), except for patients with Gilbert’s syndrome who may be included if total bilirubin =< 3.0 x ULN or direct bilirubin =< 1.5 x ULN
Bilirubin > 1.5 x ULN
Total bilirubin =< 1.5 x ULN (isolated bilirubin > 1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%)
Total bilirubin =< 1.5 x ULN
Bilirubin =< 1.5 x ULN or =< 3 x ULN for subjects with documented/suspected Gilbert’s disease
Total bilirubin =< 3
Total bilirubin =< 1.5 x ULN unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin
Laboratory values: Screening serum creatinine >1.5×upper limit of normal (ULN), alanine aminotransferase (ALT) >3×ULN or >5×ULN if liver metastases are present, total bilirubin >2×ULN, absolute neutrophil count (ANC) <1,500/mm3, platelet concentration <100,000/mm3, hemoglobin <9 g/dL, albumin <2 gm/dL.
Bilirubin =< 1.5 x ULN
Total bilirubin =< 1.5 x IULN
bilirubin ? 1.5 x ULN
Total bilirubin =< 1.5 x ULN
Total bilirubin =< 1.5 x ULN
Total bilirubin =< 3.0
Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for patients with total bilirubin level 1.5 ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum bilirubin < 1.5 times ULN
Bilirubin =< 1.5 X ULN
Total bilirubin > 1.5 x ULN (or > 3 x ULN for patients with documented Gilbert syndrome)
Total bilirubin >= 1.5 x ULN (subjects with Gilbert's syndrome can have bilirubin of up to 1.5 x ULN), OR
Total bilirubin =< ULN
Total bilirubin =< 1.5 x ULN (patient with diagnosed Gilbert’s syndrome and normal direct bilirubin will be allowed)
Total bilirubin > 1.5×ULN
total bilirubin 1.5 times greater than the ULN, except if related to ALL/LBL,
Serum bilirubin =< 1.5 x ULN
Total bilirubin =< 1.5 x ULN for the laboratory (total bilirubin criteria may be waived if a patient has documented Gilbert’s disease)
Total bilirubin =< 3.0
Serum bilirubin =< 1.8
Serum bilirubin < ULN (exception of Gilbert disease)
Creatinine and total bilirubin ? 1.5 times ULN
Total bilirubin =< 2 x ULN (except patients with documented Gilbert's syndrome)
Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for patients with total bilirubin levels > 1.5 x ULN
Bilirubin =< 1.5 times ULN
Total bilirubin less than or equal to 1.5
Total bilirubin less than or equal to 3.0
Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for patients with total bilirubin levels > 1.5 x ULN
Total bilirubin =< 3.0
Total bilirubin =< 1.5 x ULN
Exception for patients with liver metastasis: total bilirubin =< 3 x ULN; ALT (SGPT) =< 8 X ULN
Total bilirubin < 2.5 x the institutional ULN
Bilirubin < 2 times ULN (performed within 14 days prior to registration)
Total bilirubin =< 2.5 x the institutional ULN, measured prior to conditioning chemotherapy
Serum total bilirubin =< 1.5 x institutional ULN (Note: In subjects with Gilbert’s syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is =< 1.5 x ULN, subject may be eligible)
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 serum bilirubin >2.5 × upper limit of normal (ULN; except for subjects with Gilbert's Syndrome for whom direct bilirubin is <2.5 × ULN), or liver cirrhosis, or chronic liver disease Child-Pugh Class B or C.
Total bilirubin > 1.5 x ULN, except for patients with Gilbert's syndrome who are excluded if total bilirubin > 3.0 x ULN or direct bilirubin > 1.5 x ULN
Bilirubin =< 1.5 x institutional ULN (unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin)
Bilirubin =< 1.5 x ULN
Serum bilirubin =< 1.8
Serum bilirubin =< 1.8
Bilirubin =< 2 unless consistent with Gilbert’s (total/direct > 5)
Serum bilirubin =< 2.0
Total bilirubin =< 2.0 x ULN for age
Hepatic Parameters: Total Bilirubin </= ULN; Alkaline Phosphatase </= 2 x ULN; AST and ALT </= 2 x ULN If the patient has a history of Gilbert's Syndrome, check direct and indirect bilirubin. If in the judgment of the attending medical oncologist it is safe to treat the patient, the patient will be considered eligible for this criteria.
Adequate liver function defined as total bilirubin or direct bilirubin equal to or less than 1.5 x ULN; alanine aminotransferase (ALT or SGPT) equal to or less than 2.5 x ULN (5 x ULN if tumor has affected the liver)
Bilirubin < 2.0
Total serum bilirubin?1.5 x ULN, (except for patients with known Gilbert's Syndrome?3 x ULN is permitted)
Serum total bilirubin ? 1.5 X ULN OR direct bilirubin ? ULN for subjects with total bilirubin levels > 1.5 ULN
Total bilirubin < 3 x ULN (except if confirmed history of Gilbert's disease)
Total bilirubin ?1.5 x the upper limit of the normal range (ULN) (except for Gilbert syndrome: direct bilirubin ?2 x ULN).
Total bilirubin =< 2 x upper limit of normal (ULN) (if > 2 x ULN direct bilirubin is required and should be =< 1.5 x ULN), obtained =< 14 days prior to registration
Serum total bilirubin ? 1.5 x ULN OR o Direct bilirubin ? ULN for subjects with total bilirubin >1.5 x ULN
total bilirubin ? 1.5 × ULN,
Total bilirubin (<=) 2* ULN or direct bilirubin level (<=) 2.0* ULN
Serum total bilirubin =< 1.2 X ULN OR in case of Gilbert’s disease an elevated total bilirubin is allowed if direct bilirubin is =< 40% of total, should be performed within 10 days of treatment initiation
bilirubin < 1.5 ULN, excluding Gilbert's syndrome
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Total bilirubin < 2.0 x ULN
Total bilirubin =< upper limit of normal (ULN) except in patients with Gilbert’s syndrome; patients with Gilbert’s syndrome may enroll if direct bilirubin =< 1.5 x ULN (repeat if more than 3 days before the first dose)
Alanine transaminase ALT >3x upper limit of normal (ULN) AND bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
Serum total bilirubin =< 1.5 X upper limit of normal (ULN) or direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Total bilirubin > 2 mg/dL, except for patients with Gilbert's syndrome who are excluded if total bilirubin > 3.0 x ULN or direct bilirubin > 1.5 x ULN
Bilirubin level < 1.5 x ULN
Total serum bilirubin ? 1.5 × ULN.
Total bilirubin > ULN (except in patients diagnosed with Gilbert's disease).
Bilirubin > 1.5 times ULN
Total Bilirubin ? 1.0 x ULN (unless elevated secondary to benign conditions such as Gilbert's disease)
Total bilirubin =< 1.5 x the institutional ULN
Serum bilirubin within normal range (or =< 1.5 x ULN if liver metastases are present; or total bilirubin =< 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert Syndrome)
Bilirubin < 1.5 x ULN; transaminases < 3 x ULN
Total bilirubin <1.5 times ULN
Total bilirubin =< 1.5 x ULN
Total bilirubin ?1.5 x ULN
Within 14 days prior to registration: Total serum bilirubin level =< 1.5 x ULN; direct bilirubin =< ULN for subjects with total bilirubin > 1.5 x ULN (patients with isolated indirect bilirubin elevations and a history of Gilbert’s syndrome are eligible)
Serum bilirubin within normal limits (WNL) or =< 1.5 x ULN in patients with liver metastases; or total bilirubin =< 3.0 x ULN with direct bilirubin WNL in patients with well documented Gilbert’s syndrome
Within 14 days prior to randomization: Total bilirubin must be =< 1.5 x upper limit of normal (ULN) for the lab or direct bilirubin =< ULN for patients with bilirubin levels > 1.5 x ULN
Total bilirubin <1.5 x ULN
Serum total bilirubin =< 1.5
Total bilirubin < 1.5 x ULN
Total bilirubin ? 1.5 x ULN (excepting Gilbert’s syndrome)
Serum total bilirubin ? 1.5 X ULN OR direct bilirubin ? ULN for subjects with total bilirubin levels > 1.5 ULN
Within 14 days of first dose of study drug: Bilirubin =< 1.5 x ULN (< 2 x ULN if hyperbilirubinemia is due to Gilbert’s syndrome)
Total bilirubin < 1.5 X upper limit of normal (ULN) (in women with prior documented bilirubin elevations consistent with Gilbert’s syndrome, total bilirubin up to 3 X ULN will be allowed)
Serum bilirubin ? 1.5 x ULN, with the exception of patients with known Gilbert disease: serum bilirubin level ? 3 x ULN
Adequate hepatic function, defined as serum aspartate transaminase (AST) and alanine transaminase (ALT) < 2.5 x upper limit of normal (ULN), and total bilirubin ? 1.5 x ULN except Gilbert's Syndrome where a direct bilirubin ? 1.5 ULN will be used.
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Bilirubin =< 1.5 X ULN
Total bilirubin =< 1.5 x ULN
REGISTRATION TO TREATMENT (STEP 1): Serum total bilirubin =< 1.5 X ULN OR direct bilirubin \r\n=< ULN for subjects with total bilirubin levels > 1.5 X ULN, within 14 days prior to first dose of pembrolizumab
REGISTRATION TO TREATMENT (STEP 2): Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 X ULN, within 14 days prior to first dose of pembrolizumab
Bilirubin must be =< 1.5 x ULN, except participants with Gilbert’s syndrome where bilirubin must be =< 2.0 x ULN
Within 14 days of study drug(s) initiation: Serum bilirubin within normal limits (WNL) or =< 1.5 x ULN in patients with liver metastases; or total bilirubin =< 3.0 x ULN with direct bilirubin WNL in patients with well documented Gilbert’s syndrome.
Serum total bilirubin ? 1.5 x ULN
For high risk and very high risk CLL-IPI (Arms A and B) only; obtained ? 30 days prior to randomization: Total bilirubin ? 1.5 x upper limit of normal (ULN) (or total bilirubin ? 3.0 x ULN with direct bilirubin ? 1.5 x ULN in patients with well-documented Gilbert’s syndrome)
Total bilirubin ? 1.5 x of institutional ULN within 14 days prior to registration
Total serum bilirubin ? 1.5 x ULN; in subjects with known or suspected Gilbert’s syndrome, if total bilirubin is > 1.5 x ULN, direct bilirubin is ? 1.5 x ULN
Bilirubin =< ULN, if total bilirubin is > ULN, measure direct/indirect bilirubin to evaluate for Gilbert’s Syndrome (if direct bilirubin is within normal range, subject may be eligible)
Total bilirubin ? 1.5 ULN OR direct bilirubin ? ULN if total bilirubin > 1.5 x ULN
Total bilirubin =< institutional upper limit of normal (ULN) (unless due to known Gilbert’s syndrome or compensated hemolysis directly attributable to CLL); patients with Gilbert’s syndrome may enroll if direct bilirubin =< 1.5 x ULN of the direct bilirubin; elevated indirect bilirubin due to post-transfusion hemolysis is allowed
Serum total bilirubin ? 1.5 X ULN within 7 days of treatment initiation\r\n* Direct bilirubin ? ULN for subjects with total bilirubin levels > 1.5 ULN within 7 days of treatment initiation
Total bilirubin =< 1.5 x ULN =< 14 days prior to registration
All screening labs should be performed within 14 days (+3 working days) of treatment initiation: serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN;
Serum total bilirubin ? 1.5 X ULN OR direct bilirubin ? ULN for patients with total bilirubin levels > 1.5 ULN
Within 10 days of treatment initiation: total bilirubin =< 1.5 x ULN (3 X ULN if a exists a history of Gilbert syndrome) or direct bilirubin >= ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 28 days of treatment initiation
Total bilirubin < institutional upper limit of normal (ULN), except for subjects with documented Gilbert’s syndrome, for which =< 3.0 x ULN or direct bilirubin =< 1.5 x ULN
Bilirubin less than or equal to 1.5 x ULN (unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin)
Conjugated bilirubin =< 2 x ULN
Within 10 days of treatment initiation: Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Total bilirubin =< 1.5 x ULN
Total bilirubin =< 2 x ULN or =< 3 x ULN if Gilbert's disease).
At cycle 1 day 1 pre-dosing: Total bilirubin level >= 1.5 x ULN, (except for Gilbert syndrome: direct bilirubin >= 1.5 x ULN)
Total serum bilirubin =< 1.5 x ULN
Total bilirubin =< 1.5 x ULN; if liver metastases or metabolic disorder such as Gilbert’s syndrome, then =< 2.5 x ULN
Total bilirubin =< 1.5 X upper limit of normal (ULN) or if total bilirubin is > 1.5 X ULN, the direct bilirubin =< ULN
Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Total serum bilirubin =< 1.5 x ULN
Total bilirubin > 1.5 × ULN; > 3 × ULN with direct bilirubin > 1.5 × ULN in presence of Gilbert's disease.
Within 14 days prior to registration: Serum bilirubin =< 1.5 x institution’s ULN
Serum total bilirubin =< 1.5 x upper limit of normal (ULN) OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 x ULN obtained =< 28 days prior to registration
Total serum bilirubin >2.5 ULN (except for subjects with Gilbert's Syndrome for whom direct bilirubin is <2.5×ULN), or liver cirrhosis or chronic liver disease Child-Pugh Class B or C.
Within 28 days of study registration: Bilirubin =< 1.5 times the upper institutional limits of normal (ULN); patients with a history of Gilbert's syndrome may be enrolled if the total bilirubin is < 3 mg/dL with a predominance of indirect bilirubin; if the total bilirubin is > 1.5 x the institutional ULN, direct and indirect bilirubin will be measured and if direct bilirubin is =< 1.5 x the institutional ULN, the patient will be eligible to participate
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Total serum bilirubin =< 1.5 x ULN\r\n* NOTE: if total bilirubin is 2-3 mg/dL, but direct bilirubin is normal, then the patient will be considered eligible
Patients must have a total serum bilirubin =< 1.5 x ULN (grade =< 1) and a serum creatinine =< grade 1
Total bilirubin < 1.5 x institutional upper limit of normal (ULN) (< 2.0 x ULN for subjects with documented Gilbert’s syndrome or < 3.0 x ULN for subjects for whom the indirect bilirubin level suggests an extrahepatic source of elevation)
Total bilirubin must be =< ULN (upper limit of normal) for the lab unless the patient has a bilirubin elevation > ULN to 1.5 x ULN due to Gilbert’s disease or similar syndrome involving slow conjugation of bilirubin within 28 days before randomization
Total bilirubin =< 1.5 x ULN except subjects with normal direct bilirubin or those with known Gilbert’s syndrome
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN (performed within 10 days of treatment initiation)
Total bilirubin =< 1.5 x ULN for the laboratory; Note: Patients with known Gilbert’s syndrome are not eligible for this study
Serum total bilirubin: =< 1.5 X ULN OR
Direct bilirubin: =< ULN for patients with total bilirubin levels > 1.5 ULN
Total bilirubin =< 1.5 x ULN unless if evidence of indirect hyperbilirubinemia due to for example Gilbert’s syndrome
ARM A: obtained =< 14 days prior to registration: \r\n* Total bilirubin =< 1.5 x ULN
ARM B: obtained =< 14 days prior to registration: \r\n* Total bilirubin =< 1.5 x ULN
Total bilirubin =< 1.5 x ULN (patients with Gilbert’s syndrome may have serum bilirubin > 1.5 ULN)
Total bilirubin\r\n* If no known liver metastases:\r\n** Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (except subjects with Gilbert syndrome, who may have total bilirubin < 3.0 mg/dl)\r\n* If known metastasis:\r\n** Total bilirubin =< 5 ULN
Total bilirubin < 3 x ULN for age
Total serum bilirubin of =< 1.5 x institutional ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Bilirubin =< 1.5 x ULN (=< 3 x ULN for patients with Gilbert syndrome)
Total serum bilirubin =< 1.5 x ULN (in patients with known Gilbert syndrome, a total bilirubin =< 3.0 x ULN, with direct bilirubin =< 1.5 x ULN)
Total bilirubin =< 1.5 x ULN unless Gilbert’s syndrome of disease infiltration of the liver is present
Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 10 days of treatment initiation
Total bilirubin (TBil) and direct bilirubin (DBil) =< ULN with an exception of patients with confirmed Gilbert’s syndrome; for patients with confirmed Gilbert’s syndrome, the TBil should be =< 1.5 x ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 X upper limit of normal (ULN) or direct bilirubin =< ULN for patients with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 x institutional ULN (=< 3 x institutional ULN for Gilbert’s syndrome) OR direct bilirubin =< institutional ULN for subjects with total bilirubin levels > 1.5 institutional 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 =< 1.5 x ULN (=< 0.45 mg/dL)
Bilirubin =< 2.5 x ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN; patients with Gilbert’s syndrome must have a total bilirubin < 3.0 mg/dL
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for participants with total bilirubin levels > 1.5 x ULN, specimens must be collected within 10 days prior to the start of study treatment
Within 30 days prior to treatment initiation: Serum total bilirubin =< 1.5 X institutional ULN OR direct bilirubin =< institutional ULN for subjects with total bilirubin levels > 1.5 institutional ULN
Total bilirubin =< upper limit of normal (ULN) (except for patients with Gilbert’s syndrome who may only be included if the total bilirubin is =< 3.0 x institutional ULN or direct bilirubin =< 1.5 x ULN)
Pretreatment serum bilirubin =< 2.5 x institutional ULN or
Total bilirubin < 3 x ULN
Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Total bilirubin < 1.5 X ULN; patients with Gilbert's disease are exempt from this criteria
Total bilirubin =< ULN; or total bilirubin =< 3.0 x ULN or direct bilirubin in patients with well-documented Gilbert’s syndrome
Total bilirubin =< upper limit of normal (ULN) for age, or if total bilirubin is > ULN, direct bilirubin is =< 1.4 mg/dL, and
Total bilirubin =< ULN; or total bilirubin =< 3.0 x ULN with direct bilirubin =< 1.5 ULN n patients with well documented Gilbert’s syndrome
Total bilirubin =< 1.5 x ULN for the laboratory (total bilirubin criteria may be waived if a subject has documented Gilbert’s syndrome)
Bilirubin =<1.5 x ULN
Bilirubin =< 1.5 x ULN
Total bilirubin =< 1.5 x IULN
Bilirubin =< 1.5 x ULN
Bilirubin =< 1.5 ULN
Serum bilirubin =< 1.5 x ULN
Total bilirubin =< 1.5 x ULN
Total bilirubin must be =< upper limit of normal (ULN) for the lab unless the patient has a bilirubin elevation > ULN to 1.5 x ULN due to Gilbert’s disease or similar syndrome involving slow conjugation of bilirubin
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (isolated bilirubin > 1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%)
Bilirubin =< 1.5 x ULN
Total bilirubin =< 1.5 x ULN
Bilirubin =< 1.5 x ULN
Serum bilirubin < 2 x ULN for patients with liver metastases and =< 1.5 x ULN for patients without liver metastases, (except patients with Gilbert's syndrome, who must have a total bilirubin < 3.0 mg/dL)
Total bilirubin ? 2 times ULN            \r\n* Patients with documented diagnosis of Gilbert syndrome resulting in elevated total bilirubin levels will be eligible, provided all other eligibility criteria are met\r\n* Patients with a total bilirubin of 2-3 mg/dL and direct (conjugated) bilirubin in the normal range will be eligible, provided all other eligibility criteria are met
Total bilirubin =< 1.5 x IULN
Serum bilirubin =< 1.5 x ULN in patients with known Gilbert syndrome, total bilirubin =< 3 x ULN, with direct bilirubin =< 1.5 x ULN
Total serum bilirubin < 2.5 x ULN
Baseline total bilirubin > 1.5 x ULN
Bilirubin =< 2 x ULN
Total bilirubin =< 1.5 x ULN
Total bilirubin < 1.5
Total bilirubin < 1.5 x IULN
Serum 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 serum bilirubin ?1.5×ULN.
Total bilirubin =< 1.5 x ULN
Total serum bilirubin ? 1.5 x ULN (CTCAE Grade ? 1);
Total serum bilirubin ?2.0 x ULN unless the subject has documented Gilbert syndrome;
Total serum bilirubin ? 1.5 x ULN unless the patient has documented Gilbert syndrome and AST and ALT ? 2.5 x ULN.
Bilirubin less than or equal to 1.5 x ULN
Subjects who have BOTH bilirubin greater than ULN and AST/ALT greater than 1.0 x ULN are not eligible
Total bilirubin ? 1.5 x ULN.
Total bilirubin ? 1.5 x ULN.
Bilirubin ? 2.0 mg/dl with the exception of patients with Gilbert-Meulengracht syndrome; patients with Gilbert-Meulengracht syndrome may be included if their total bilirubin is ? 3.0 x ULN and direct bilirubin ? 1.5 x ULN
Hepatic: alanine aminotransferase (ALT), and aspartate aminotransferase (AST) > 2.5 x ULN, total serum bilirubin > 1.5 x ULN (patients with Gilbert's Disease may be included if their total bilirubin is ?3.0 mg/dL)
Serum total bilirubin ? 1.5 x ULN (except in subjects with Gilbert's who may have serum bilirubin < 3.0 x ULN),
Bilirubin ?1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin, such as hemolysis)
Total bilirubin < 1.5 X upper limit of normal (ULN); or < 3 x institutional ULN for Gilbert’s syndrome or HIV protease inhibitors; or < 5 x ULN and direct bilirubin < 0.7 mg/dL for patients on atazanavir containing HIV regimen
Total serum bilirubin <=1.5 * ULN
Total bilirubin =< 1.0 X ULN (institutional); for patients with Gilbert syndrome, the direct bilirubin should be within the institutional normal range
Total bilirubin =< 1.5 X ULN
Bilirubin =< 1.2
Total bilirubin: serum bilirubin within normal limits (WNL) or =< 1.5 x ULN in patients with liver metastases; or total bilirubin =< 3.0 x ULN with direct bilirubin WNL in patients with documented Gilbert’s syndrome
Total bilirubin within 1.5 x ULN, except those with Gilberts syndrome for whom this must be <3 x ULN
Bilirubin =< 1.5 x ULN obtained within 28 days prior to registration
Total serum bilirubin ? 2.0 × ULN (unless the subject has documented Gilbert Syndrome)
Hepatic: alanine aminotransferase (ALT), and aspartate aminotransferase (AST) > 2.5 x ULN, total serum bilirubin > 1.5 x ULN (patients with Gilbert's Disease may be included if their total bilirubin is ? 3.0 mg/dL).
Bilirubin =< 1.5 x ULN
Conjugated bilirubin <1.5 × ULN
Total bilirubin =< 1 x upper limit of normal (ULN); or total bilirubin =< 3.0 x ULN with direct bilirubin =< 1.5 x ULN in patients with well-documented Gilbert’s syndrome, obtained =< 21 days prior to registration
MF PATIENTS: Direct bilirubin =< 1.5 x ULN
Bilirubin < ULN
Total bilirubin less =< to 1 times ULN
Bilirubin =< 1.5 x ULN
Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Hepatic function: Conjugated bilirubin <1.5 × ULN and ALT and AST <3 × ULN
Total Bilirubin: ?1.5xULN OR Direct bilirubin ?ULN for subjects with total bilirubin levels >1.5xULN
Adequate liver function as assessed by total bilirubin ? 1.5x upper limit of normal (ULN), and alanine transaminase (ALT) and aspartate transaminase (AST) ? 2.5x ULN (? 5.0x ULN in the case of liver metastases). Patients with known Gilbert's syndrome may be enrolled with total bilirubin ? 3.0 mg/dL.
Total serum/plasma bilirubin ?1.5 times ULN.
Serum total bilirubin ?1.5 x ULN (unless subject had documented Gilbert's Syndrome)
Total bilirubin ? 2.0 X ULN, or ? 3.0 X ULN (for patients with Gilbert's Syndrome)
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.
Patients with Gilbert syndrome and bilirubin < 2 x ULN and normal AST/ALT
total serum bilirubin ?2.5 × ULN or ?5 × ULN in cases of Glibert's Syndrome or liver involvement by lymphoma
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).
Direct bilirubin ? 1.5 x ULN; or ? 2x ULN (if upon judgment of the treating physician, it is believed to be due to EMH related to MF);
Total bilirubin =< 2.5 x the institutional ULN
Total bilirubin < 1.5 x ULN unless the patient has Gilbert’s syndrome, in which case total (T) bilirubin < 2.5 x ULN required
Serum bilirubin 1.5 x ULN, obtained within 14 days prior to initiation of study treatment
Total bilirubin ? 1.5 × ULN.
Total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Bilirubin < 1.5 x ULN unless bilirubin is due to Gilbert’s syndrome, documented liver involvement with lymphoma, or of non-hepatic origin, in which case bilirubin should not exceed 3 g/dL
Total bilirubin <=1.5*ULN;
Total bilirubin =< 1.5 x ULN
Bilirubin ? 1.5 × ULN except for cases of documented or suspected Gilbert's disease, in which bilirubin must be ? 5 × ULN
Total bilirubin <upper limit of normal (ULN) except in participants with Gilbert's syndrome. Participants with Gilbert's syndrome may enroll if direct bilirubin <=1.5*ULN of the direct bilirubin.
Serum total bilirubin =< 1.5 x ULN
Serum bilirubin WNL or ?1.5 x the ULN in patients with liver metastases; or total bilirubin ?3.0 x ULN with direct bilirubin WNL in patients with well documented Gilbert's Syndrome.
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.
Bilirubin ?1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin, such as hemolysis)
Serum total bilirubin > 1.5 x ULN
Total bilirubin =< 1.5 x ULN (unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin); if considered related to ASM/MCL =< 3 x ULN
Serum total bilirubin ? 1.5 X ULN
Within 14 days of study start: Serum total bilirubin =< 1.5 x ULN
Direct bilirubin (bili) < 3 x ULN
Serum total bilirubin =< 1.5 X ULN or direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum bilirubin =< 1.5 x ULN or =< 3.0 x ULN for patients with Gilbert syndrome or documented hepatic involvement
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Bilirubin =< 1.5 x ULN; for subjects with liver metastases =< 3 x ULN is allowed
Bilirubin less than or equal to 1.5 x ULN
Total bilirubin =< 1.5 x ULN
Total bilirubin =< 1.5 x IULN
Total bilirubin < 1.5 x ULN (except for subjects with documented Gilbert's syndrome)
Total bilirubin =< 2 x ULN (except patients with documented Gilbert’s syndrome)
Total bilirubin =< 1.5 x ULN for the lab
Total bilirubin =< 1.5 x institution’s ULN
Direct bilirubin ? 2.0 x ULN
Serum bilirubin =< 2 x ULN
Serum direct bilirubin =< 1.5 x ULN; if considered related to ASM/MCL =< 3 x ULN
Total bilirubin < 1.5 times ULN
Total bilirubin =< 1.5 x ULN for age AND
Bilirubin =< 1.5 x ULN
Absolute neutrophil count ? 1,000/µL; platelets ? 75,000/µL; creatinine ? 1.5x upper limit of normal (ULN); total bilirubin ? 1.5x ULN; AST/ALT ? 2.5x ULN. For subjects with documented liver metastases, the AST/ALT may be ? 5x ULN.
Total Bilirubin ? 2.0 X ULN
Total bilirubin =< 1.5 x institution's ULN
Total bilirubin =< 2 x ULN (except patients with documented Gilbert's syndrome)
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) (< 2.0 x ULN for subjects with documented Gilbert’s syndrome or < 3.0 x ULN for subjects for whom the indirect bilirubin level suggests an extrahepatic source of elevation)
Serum total bilirubin =< 1.5 x upper limit of normal (ULN) OR direct bilirubin =< ULN if total bilirubin levels > 1.5 x ULN (within 14 days prior to day 1 of protocol therapy)
Bilirubin ?1.5 × institutional ULN;
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN (performed within 10 days of treatment initiation)
Serum total bilirubin ? 1.5 x Institutional ULN
Total bilirubin =< IULN; or total bilirubin =< 3.0 x IULN or direct bilirubin =< 1.5 ULN in patients with well documented Gilbert’s syndrome
Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 10 days of treatment initiation
Total bilirubin ? 1.5 x ULN
Total bilirubin > 1.5 x ULN, except for patients with Gilbert's syndrome who are excluded if total bilirubin > 3.0 x ULN or direct bilirubin > 1.5 x ULN
Total serum bilirubin within ULN
Bilirubin =< 1.5 x ULN OR in subjects with Gilbert’s syndrome, a total bilirubin =< 3.0 x ULN
Total bilirubin ? 1.5X ULN
Total-value bilirubin (TBil) and direct bilirubin (DBil) =< ULN with an exception of patients with confirmed Gilbert’s syndrome; for patients with confirmed Gilbert’s syndrome, the TBil should be =< 1.5 x ULN
Total bilirubin <1.5 x the institutional ULN, unless the subject has documented unconjugated bilirubin disorder such as Gilbert's syndrome.
Prior to cyclophosphamide and T cell infusions: bilirubin >=3 x ULN
Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Total bilirubin < ULN; or total bilirubin =< 3.0 x ULN or direct bilirubin =< 1.5 x ULN in patients with well-documented Gilbert’s syndrome.
Within 14 days prior to registration: total bilirubin =< 1.5 x institutional ULN (except participants with Gilbert syndrome, who can have total bilirubin =< 3.0 x institutional ULN with direct bilirubin that is within institutional ULN)
Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for participants with total bilirubin levels > 1.5 ULN (within 14 days of treatment initiation)
Total Bilirubin =< 1.5 x ULN
Within 72 h of initiating study treatment: Bilirubin =< 1.5 x upper limit of normal (ULN) or direct bilirubin =< ULN for subject with total bilirubin > 1.5 x ULN
Total serum bilirubin =< ULN (or =< 1.5 x ULN if documented hepatic involvement; or total bilirubin =< 3 x ULN with direct bilirubin =< 1.5 ULN in patients with documented Gilbert’s syndrome)
Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, should be performed within 28 days of treatment initiation, unless otherwise indicated
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Obtained =< 7 days prior to registration:\r\nTotal bilirubin =< 1.5 x ULN (does not apply to patients with isolated hyperbilirubinemia [e.g., Gilbert’s disease], in that case direct bilirubin should be =< 2 x ULN)
Absolute neutrophil count (ANC) >=1.5 X 10^9/liter (L), Hemoglobin >=9 grams (g)/deciliter (dL) (subjects that required transfusion or growth factor need to demonstrate stable hemoglobin for 7 days of 9 g/dL), Platelets >=100 X 10^9/L, prothrombin time (PT)/ international normalized ratio (INR) and partial thromboplastin time (PTT) - <=1.5 X upper limit of normal (ULN); Hepatic - Albumin >=2.5 g/dL, Total bilirubin <=1.5 X ULN (isolated bilirubin >1.5 X ULN is acceptable if bilirubin is fractionated and direct bilirubin <35% or subject has a diagnosis of Gilbert's syndrome), Alanine aminotransferase (ALT) <=2.5 x ULN OR <5 x ULN is acceptable for subjects with documented liver metastases/tumor infiltration; Renal - Creatinine <=1.5 X ULN OR Creatinine clearance [either directly measured or calculated by Cockcroft-Gault formula] >=40 milliliter (mL)/minute (min); Cardiac - Ejection fraction >=50% by echocardiogram or multigated acquisition scan (MUGA), Troponin (T) <=ULN, Potassium >=Lower limit of normal (LLN) and <=ULN, Magnesium >=LLN
Serum bilirubin =< 2.5 x ULN
Total bilirubin =< 1.5 x ULN
Total serum bilirubin =< 1.5 x ULN
Serum bilirubin =< 1.5 x ULN
Total bilirubin ? 1.5 x ULN
Bilirubin < 1.5 x ULN unless bilirubin is due to Gilbert’s syndrome, documented liver involvement with lymphoma, or of non-hepatic origin, in which case bilirubin should not exceed 3 g/dL
Total bilirubin (TBL) > 2 x ULN
Hepatic total bilirubin =< 1.5 X ULN (isolated bilirubin > 1.5 X ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%)
Within 4 weeks of administration of study therapy: Serum total bilirubin =< 1.5 x ULN or direct bilirubin =< ULN for patients with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 28 days of treatment initiation
Adequate liver function: Alanine transaminase (ALT) < 2 x Upper Limit of Normal (ULN) and bilirubin < 1.5 x ULN, (or if bilirubin is between 1.5-2 x ULN, they must have a normal conjugated bilirubin). If liver metastases are present ALT must be < 5 x ULN
Bilirubin levels >= 1.5 institutional ULN
Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 x ULN
Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Total bilirubin =< 1.5 x ULN (excepting Gilbert's syndrome)
Bilirubin > 2.5 x ULN
Bilirubin ?1.5 x ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Total bilirubin =< 1.5mg/dL (in patients with known Gilbert’s syndrome direct bilirubin =< 1.5 x upper limit of normal [ULN] will be used as organ function criteria, instead of total bilirubin)
Total bilirubin =< 1.5 x institutional ULN
Total bilirubin ? 1.5 × ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 x ULN
total bilirubin ? 1.5 × upper limit of normal (ULN) OR direct bilirubin ? ULN for subjects with total bilirubin levels > 1.5 x ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 14 days prior to registration
Within 14 days of treatment initiation: Serum total bilirubin =< 1.5 X institutional ULN OR direct bilirubin =< institutional ULN for subjects with total bilirubin levels > 1.5 institutional ULN
Serum total bilirubin ? 1.5 x ULN
Performed within 28 days of radiation therapy: Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Bilirubin less than or equal to 1.5 ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 28 days of treatment initiation
The following criteria for evidence of adequate hepatic function performed within 4 weeks prior to study entry must be met: total bilirubin must be less than or equal to upper limit of normal (ULN) for the lab unless the patient has a bilirubin elevation greater than ULN to 1.5 x ULN due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin; and alkaline phosphatase must be must be less than or equal to 1.5 x ULN for the lab; and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) must be less than or equal to 1.5 x ULN for the lab.
bilirubin less than or equal to 1.5 × ULN for all subjects age 75 and older* Subjects who are less than 75 years of age must have a bilirubin of less than 3.0 × ULN * Unless considered due to leukemic organ involvement. Note: Subjects with Gilbert's Syndrome may have a bilirubin greater than 1.5 × ULN per discussion between the investigator and AbbVie medical monitor.
Serum total bilirubin =< 1.5 x ULN (direct bilirubin =< ULN if total bilirubin [bili] > 1.5 x ULN)
Bilirubin =< 1.5 x ULN
Bilirubin =< 1.5 ULN
Bilirubin =< 1.5 x ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin >= 1.5 ULN
Total bilirubin =< 1.5 x institutional ULN
Serum total bilirubin =< 1.5 x upper limit of normal (ULN) OR direct bilirubin =< ULN for patients with total bilirubin levels > 1.5 x ULN (labs should be performed within 14 days of treatment initiation)
Bilirubin < 1.5 times ULN, unless bilirubin elevation is related to Gilbert’s syndrome for which bilirubin must be < 4 times ULN
Serum bilirubin within normal range (or =< 1.5 x ULN if liver metastases are present; or total bilirubin =< 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert syndrome)
Total bilirubin > 1.0 x ULN
Serum bilirubin =< 1.5 x ULN (except patients with Gilbert’s syndrome who must have a total bilirubin of < 3 times ULN)
Total serum bilirubin =< 1.5 x ULN; patients with Gilbert’s syndrome with baseline serum bilirubin exceeding this limit are allowed to participate
Direct bilirubin > 1.5 x ULN unless due to hemolysis or Gilbert’s syndrome
Total bilirubin ?1.5 x ULN
Direct bilirubin ? 2.0 x ULN
Bilirubin < 2.0 x ULN, unless subject has Gilbert’s disease
Total bilirubin =< 2.0; exception for patients with liver metastasis: total bilirubin =< 3 x ULN
Total serum bilirubin ?1.5 x ULN (<3.0 x ULN for participants with Gilbert syndrome)
Serum bilirubin =< 1.5 times the upper institutional limits of normal (ULN); patients with a history of Gilbert's syndrome may be enrolled if the total bilirubin is < 3 mg/dL with a predominance of indirect bilirubin
Total serum bilirubin =< 2.0 x ULN
Total serum bilirubin =< 1.5 x ULN
Total bilirubin =< 2.5 x upper limit of normal (ULN) unless due to Gilbert's disease; for those with a total bilirubin > 2.5 x ULN, a direct bilirubin should be performed and must be < 1.5 mg/dL for Gilbert's to be diagnosed; if value is higher due to hepatic involvement by CLL, patient is eligible
Bilirubin >= 3 x ULN
Total bilirubin =< 1.5 institutional ULN
Total bilirubin level ?1.5 × ULN.
Bilirubin must not be more than 1.5 x ULN (does not apply to patients with Gilbert’s disease)
Total bilirubin >= 1.5 times ULN
Total bilirubin ? 1.5 x ULN
Total bilirubin within normal ranges unless associated with hepatobiliary metastases or Gilbert syndrome, then total bilirubin ? 2 x ULN
Total bilirubin > 2 x ULN
Total bilirubin ? 1.5 × ULN
Total bilirubin levels < 1.5 X ULN
Total bilirubin within normal institutional limits (isolated bilirubin > 1.5 × institutional ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%)
Total bilirubin =< 1.5 x ULN (tested within 14 days prior to registration)
Total bilirubin ? 1.5 × institutional ULN except in the presence of Gilbert Syndrome
Total serum bilirubin ? 1.5 x institutional ULN
Total bilirubin =< upper limit of normal (ULN) except in patients with Gilbert's syndrome; patients with Gilbert's syndrome may enroll if direct bilirubin =< 1.5 x ULN of the direct bilirubin
Bilirubin < 1.5 x ULN 9unless bilirubin rise is due to Gilbert's syndrome or of nonhepatic origin)
Total bilirubin =< 2.0 x ULN
Bilirubin =< 1.5 x ULN
Total bilirubin =< 1.5 x institutional ULN
Serum 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 =< ULN (patient’s with Gilbert’s syndrome are eligible, even if total bilirubin is > ULN)
Bilirubin < 2 x ULN (or < 5 x ULN if liver is involved)
Total bilirubin =< 1.5 times ULN*
Total bilirubin =< grade 3
Bilirubin =< 1.5 x ULN
Serum bilirubin =< 1.5 x ULN
Bilirubin =< 2 x ULN (must be within 7 days of MLA)
Serum bilirubin =< 2.5 x ULN
Bilirubin =< 1.5 x ULN
Bilirubin =< 3 x ULN
Bilirubin >= 3 x ULN (unless Gilbert’s syndrome)
Total bilirubin =< 1.5 x ULN
Serum bilirubin =< 1.5 x ULN and
Bilirubin < 1.5 x ULN
Serum bilirubin within normal range (or =< 1.8 x ULN if liver metastases are present; or total bilirubin =< 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert syndrome)
Obtained =< 7 days prior to registration: Total bilirubin =< 1.5 x ULN (does not apply to patients with isolated hyperbilirubinemia [e.g., Gilbert’s disease], in that case direct bilirubin should be =< 2 x ULN)
Obtained within 2 weeks from study entry: Total bilirubin =< 1.5 x upper limit of normal (ULN) (patients with known Gilbert syndrome, a total bilirubin =< 3.0 x ULN, with direct bilirubin =< 1.5 x ULN)
Bilirubin =< 1.5 x ULN
Serum 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 =< 1.5 x ULN (patients with elevated bilirubin due to Gilbert's disease will not be excluded)
Total bilirubin =< 2 x ULN
Total bilirubin =< 1.5 x IULN
Total bilirubin ? 2.0 × ULN
Adequate liver function, defined as bilirubin ?1.5x ULN, ALT ?3.0x ULN, and AST ?3.0x ULN
Total bilirubin =< 1.5 x institution's ULN
Total bilirubin concentration < 1.5 x the institutional ULN
< 2.0 total serum bilirubin (unless secondary to hemolysis)
Total bilirubin < 3 x ULN
Serum bilirubin =< 1.5 X ULN
Total bilirubin < 2.0
Total bilirubin =< ULN
Bilirubin =< 5 x ULN
Total bilirubin >3 x ULN.
Total bilirubin ? 1.5 ULN
Total bilirubin =< 2 x ULN
Total bilirubin =< 1.5 X ULN; patients with increased bilirubin due to Gilberts disease will not be excluded, if increased bilirubin is the only protocol exclusion criteria met
Serum bilirubin levels =< 1.5 times the ULN range for the laboratory
Total bilirubin =<1.5 x ULN unless increase is due to Gilbert’s disease or similar syndrome involving slow conjugation of bilirubin
Serum bilirubin =< 1.5 x ULN
The patient has serum total bilirubin < 2 g/dL (unless the patient has a diagnosis of Gilbert's disease), SGOT (ALT) <3.5×ULN, and SGPT (AST) <3.5×ULN
Total bilirubin =< 1.5 x ULN
Bilirubin no greater than 1.5 times ULN
Total bilirubin =< 1.5 X ULN (except in patients with Gilbert's)
Serum bilirubin =< 1.5 x ULN
Subjects who have both bilirubin > ULN and AST/ALT > ULN
Serum bilirubin =< 1.5 x ULN
Total bilirubin =< 1.5 X ULN
Bilirubin < 2 times ULN
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ?3 × the upper limit of normal (ULN) and total bilirubin ?1.5 × ULN. If the total bilirubin is elevated between 1.5 x and 3 x ULN, patients with a direct bilirubin ? 1.5 X ULN are eligible during the Phase II portion.
Total bilirubin =< 1.5 X institutional ULN
Total bilirubin < 1.5 x ULN\r\n* Does not apply to patients with isolated hyperbilirubinemia (e.g., Gilbert's disease) grade < 3
Total serum bilirubin =< 2.0 x ULN
Total bilirubin =< 1.5 x ULN
Bilirubin < 1.5
Bilirubin > 1.5
Total bilirubin =< 1.5 x ULN
Bilirubin =< 1.5 x ULN
ARM B: Total bilirubin =< 1.5 X ULN (in patients with known Gilbert syndrome a total bilirubin =< 3.0 x ULN with direct bilirubin =< 1.5 X ULN)
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
Bilirubin =< 1.5 times ULN (if total bilirubin elevated, but direct is within normal limits [WNL], patient is eligible)
Total bilirubin =< 2.5 times ULN
Serum total bilirubin =< 1.5 x ULN or direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 x ULN
Serum bilirubin < 1.5 x ULN
Total bilirubin =< 1.5 x upper limit of normal (ULN); in patients with known Gilbert's syndrome direct bilirubin =< 1.5 x ULN will be used as organ function criteria, instead of total bilirubin
Total bilirubin =< 2.0; exception for patients with liver metastasis: total bilirubin =< 3 x ULN
Total bilirubin =< 2.0
Total bilirubin should be < 1.5 times ULN
Serum bilirubin <2x ULN
Bilirubin < 2.5 ULN
Serum total bilirubin < 1.5 x ULN
Total bilirubin =< 1.5 x ULN
Serum total bilirubin =< 2.0
Total bilirubin ? 2 x ULN
Total serum bilirubin =< 1.5 x ULN (=< 3 x ULN with direct bilirubin within normal range in patients with documented hepatic involvement, well documented Gilbert's syndrome)
Adequate hepatic function, defined as total bilirubin ?1.5 × upper limit of normal (ULN); AST ?2.5 × ULN; and ALT ?2.5 × ULN. For subjects with documented metastatic disease to the liver, AST and ALT: ?5 × ULN.
Adequate hepatic function, defined as total bilirubin ?1.5 × ULN; AST ?2.5 × ULN; and ALT ?2.5 × ULN.
Total bilirubin =< 1.5 x ULN
Total bilirubin ? 1.5 × upper limit of normal (ULN) OR direct bilirubin ? ULN for subjects with total bilirubin levels > 1.5 x ULN
Bilirubin > 1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin)
Serum total bilirubin =< 1.5 x ULN (1.5 mg/dL or 25.65 umol/L) OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN; except patients with Gilbert's disease (=< 3 x ULN)
Total bilirubin =< 1.5 x ULN
Total bilirubin =< 3.0
Serum total bilirubin =< 1.5 X ULN
Serum total bilirubin =< 1.5 x ULN
Total bilirubin =< 1.5 x ULN
Bilirubin ? 1.5 × ULN except for subjects with documented Gilbert's disease, ? 2.5 × ULN;
Total bilirubin > 1.5 x ULN at screening
Total bilirubin =< 1.5 x ULN (< 3.0 x ULN in the presence of Gilbert’s disease)
Total bilirubin all < 2.5 x the institutional ULN
Total bilirubin concentration < 3 X the institutional ULN
Total bilirubin =< 1.5
Bilirubin =< 2.0
Total bilirubin ?1.5 x ULN (except for subjects with documented Gilbert's syndrome)
Serum total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (isolated total bilirubin > 1.5 institutional ULN is acceptable if bilirubin is fractionated and direct bilirubin is < 35%)
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Total serum bilirubin ? 2.0 × ULN (unless the subject has documented Gilbert Syndrome)
Total bilirubin ? 1.5× ULN (or ? 3× ULN, with direct bilirubin ?1.5 × ULN, in patients with known Gilbert syndrome).
Serum total bilirubin =< 1.5 X ULN or direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Total bilirubin =< 1.5 x ULN unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin
Total bilirubin =< 1.5 x ULN unless the patient has documented Gilbert syndrome
If organ function abnormalities are considered due to leukemic infiltration, total bilirubin must be =< 2 x ULN
Total bilirubin =< 2
Total serum bilirubin < 1.5 x ULN, unless there is congenital benign hyperbilirubinemia
Bilirubin =< 1.5
Total bilirubin values <1.5 x ULN unless the bilirubin is principally unconjugated (in the context of hemolysis) or there is documented Gilbert's disease.
Direct bilirubin less than 3.0, indirect bilirubin less than 4.0
Patient has > 1.5 x ULN total bilirubin
Total bilirubin ? 1.5x ULN for age. If the total bilirubin is elevated, patient will still be eligible if the conjugated (direct) serum bilirubin ? ULN for age.
Bilirubin =< 1.5 times ULN
Total bilirubin < 1.5 × ULN (except for subjects with documented Gilbert's syndrome)
Total bilirubin =< 1.5 x ULN unless bilirubin rise is considered to be the result of leukemic involvement by the PI
Total bilirubin must be 1.5 ULN with the following exception: Patients with known Gilbert disease who have serum bilirubin level 3 ULN may be enrolled.
Total serum bilirubin =< 1.5 x ULN
Adequate hepatic function (total bilirubin ? 1.5×ULN for the institution; aspartate transaminase and alanine transaminase ? 2.5×ULN, or ? 5×ULN if due to liver involvement by tumor; albumin ? 3 g/dL)
Total bilirubin =< ULN
Bilirubin =< 1.5 x ULN, except in cases of patients with Gilbert’s disease, where =< 4 x ULN will be allowed
Adequate hepatic function (total bilirubin ? 1.5x ULN; AST and ALT ? 3x ULN).
Bilirubin ?1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin).
Serum bilirubin within normal range (or =< 1.5 x ULN if liver metastases are present; or total bilirubin =< 3.0 x ULN with direct bilirubin within normal range in patients with well-documented Gilbert Syndrome)
Total bilirubin < 1.5 x upper limits of normal (ULN) except Gilbert’s syndrome where < 3 x ULN is allowed
Total bilirubin < 2 x ULN
Total bilirubin ? 1.5 x ULN
Total bilirubin ? 1.5 x ULN
For patients with Gilbert's syndrome total bilirubin > 2.5 x ULN
Total bilirubin =< 1.5 times ULN and stable X 1 month
Total bilirubin must be =< 1.5 x ULN
Total bilirubin =< 2.0 x ULN, unless elevated bilirubin is attributable to Gilbert’s syndrome or to HIV medications (e.g., indinavir, tenofovir, atazanavir)
Serum bilirubin < 1.5 x ULN
Total bilirubin ?1.5 x ULN, unless secondary to Gilbert's disease
Serum bilirubin =< 2 times ULN
Serum bilirubin =< ULN
Total bilirubin > 1.5 x ULN
Serum total bilirubin =< 1.5 x ULN OR total bilirubin =< 4.0 ULN with direct bilirubin =< 1.5 x ULN in patients with well documented Gilbert syndrome
Total Bilirubin < 1.5 x ULN
Total serum bilirubin ? 1.5 x ULN
Total bilirubin ?1.5 x ULN
Total bilirubin < 1.5 x ULN (except subjects with Gilbert syndrome who can have total bilirubin < 3.0 mg/deciliter) should be obtained with 28 days prior to randomization
Bilirubin =< 1.5 x upper limit of normal (ULN) (CTCAE v4.03 grade 1; in patients with known Gilbert syndrome, a total bilirubin =< 3.0 x ULN, with direct bilirubin =< 1.5 x ULN)
Total bilirubin >1.5x ULN (unless due to Gilbert's Syndrome)
Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN within 7 days of treatment initiation
Serum total bilirubin < 1.5 x ULN
Serum bilirubin < 1.5 x ULN unless due to Gilbert's syndrome. o Serum bilirubin ? 1.0 x ULN unless due to Gilbert's syndrome, Treatment Arm B only (CC-122 in combination with ibrutinib)
Total bilirubin must be =< the upper limit of normal (ULN) for the lab unless the patient has a grade 1 bilirubin elevation (> ULN to 1.5 x ULN) resulting from Gilbert’s disease or similar syndrome due to slow conjugation of bilirubin; and
Serum bilirubin =< 1.5 x ULN (unless secondary to Gilbert's disease)
Direct bilirubin ? 2.0 x ULN
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 < 1.5 mg/dL for Gilbert’s to be diagnosed
Bilirubin ? 1.5 x the ULN
ALT and AST ? 2.5 upper limit normal (ULN), or < 5 x ULN if liver metastases are present; serum total bilirubin ? ULN or 1.5 x ULN if liver metastases are present or total 3 x ULN with direct bilirubin ? ULN in patients with well documented Gilbert Syndrome.
Bilirubin =< 1.5 ULN (subjects with documented diagnosis of Gilbert’s syndrome are eligible provided total bilirubin < 3.0 x ULN)
Total bilirubin >ULN: Subjects with Gilbert's syndrome are allowed if total bilirubin is <3.0 mg/dL and direct bilirubin is ?ULN,
Total bilirubin =< upper limit of normal (ULN) for age, or if total bilirubin is > ULN, direct bilirubin is =< 1.5 mg/dL
Total serum bilirubin ? ULN unless due to Gilbert's Syndrome;
Serum total bilirubin ? 1.5 x the ULN.
Total bilirubin =< upper limit of normal (ULN) for age, or if total bilirubin is > ULN, direct bilirubin is =< 1.4 mg/dl and
Adequate hepatic function: AST and ALT <2.5 x ULN, Total and Direct Bilirubin <1.5 x ULN. However, in the presence of liver metastases, AST and ALT must be <5 x ULN
Patient's total bilirubin must be ? 1.5 x ULN.
Total bilirubin =< 1.5 x ULN
Total serum bilirubin =< 2.0 x ULN
Bilirubin =< 1.5 x ULN
Serum total bilirubin =< 1.5 x ULN
Serum bilirubin =< 1.5 x ULN (patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled)
Bilirubin =< 2 x ULN
Bilirubin ? 1.5 × ULN except for cases of documented or suspected Gilbert's disease, in which bilirubin must be ? 5 × ULN
Total bilirubin < 3 x ULN, exception is elevated indirect bilirubin attributed to Gilbert’s syndrome or hemolysis
Total bilirubin ? 1.5 x ULN
Total bilirubin ? 1.5x institutional ULN
Serum bilirubin 1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin)
Bilirubin ?1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin)
Total bilirubin >1.0 x ULN.
Total bilirubin ? 1.5 × ULN except in cases of Gilbert's disease and liver metastases.
Serum total bilirubin >1.5 x ULN
Total bilirubin ? 1.5 X ULN. Patients with elevated bilirubin known to be due to Gilbert's disease may be enrolled after approval from the medical monitor, and
Serum total bilirubin ? 1.5 x ULN and AST/SGOT and ALT/SGPT ? 2.5 x ULN or ? 5 x ULN if liver metastases are present.
Performed within 10 days of treatment initiation: Serum total bilirubin =< 1.5 x upper limit of normal (ULN) OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Total bilirubin =< ULN
Participants with moderate hepatic impairment: total bilirubin must be > 1.5 to 3 x ULN with any ALT level.
Participants with severe hepatic impairment: total bilirubin must be > 3 x ULN with any ALT level.
Total bilirubin ? 1.5 × institutional ULN [? 2.0 x ULN in presence of liver metastases] within 14 days prior to randomization.
Total bilirubin =< 2.0 x ULN
Total bilirubin < 1.5 x ULN for age or normal conjugated bilirubin
Bilirubin =< 1.5 x ULN
Bilirubin < 1.5 × ULN.
Laboratory values: Screening serum creatinine >1.5 x upper limit of normal (ULN), alanine aminotransferase (ALT) >3×ULN or >5×ULN if liver metastases are present, total bilirubin >2×ULN, absolute neutrophil count (ANC) <1,500/mm3, platelet concentration <100,000/mm3, hemoglobin <9g/dL.
Total bilirubin =< ULN
Hepatic: total bilirubin ? 1.5 X ULN, ALT and AST ? ULN;
Bilirubin ? 1.5 × ULN except for cases of documented or suspected Gilbert's disease, in which bilirubin must be ? 5 × ULN
Total serum bilirubin < 1.5x institutional ULN
Total bilirubin ? 1.5 × ULN except subjects with documented Gilbert's syndrome (> 3 × ULN) or liver metastasis, who must have a baseline total bilirubin ? 3.0 mg/
Serum bilirubin =< 1.5 x ULN
Bilirubin and total bilirubin levels =< 1.5 x ULN
Serum Bilirubin ? ULN, AST and ALT ? ULN
Total bilirubin >= 1.5 × the ULN for the institution
Serum bilirubin < 1.5 x ULN
Have adequate baseline organ function defined by the following criteria: Total bilirubin <=1.5 x upper limit of normal (ULN) except for Gilbert's syndrome, or other conditions that are not indicative of inadequate liver function (i.e. elevation of indirect bilirubin (haemolytic) in the absence of alanine aminotransferase [ALT] abnormality). ALT <=3 x ULN. Serum Creatinine <=2.5 x ULN.
Total bilirubin (TBili) <1.5 x ULN
Serum bilirubin < 2 x ULN
Total bilirubin =< 1.5 × upper limit of normal (ULN), except in patients with previously documented Gilbert’s syndrome, in which case the direct bilirubin should be less than or equal to the ULN
Total bilirubin =< 1.5 x ULN
Total bilirubin ? ULN, SGOT (AST) and SGPT (ALT)< 1.5 x ULN. AST and/or ALT may be up to 5X ULN if with known liver metastases provided bilirubin is normal.
Total bilirubin > 1.5× the ULN for the institution, unless considered due to Gilbert's Syndrome
Total bilirubin =< 1.5 mg/dL; in patients with known Gilbert’s syndrome, direct bilirubin =< 1.5 x upper limit of normal (ULN) will be used as organ function criteria, instead of total bilirubin
Bilirubin ? 1.5 x ULN
Total bilirubin ?2.0 times the ULN for the institution, unless considered due to Gilbert's syndrome;
Total bilirubin ?1.5 x ULN
Serum bilirubin =< 1.5 x ULN
Total bilirubin ? 1.5 × ULN OR direct bilirubin ? 1 × ULN
Total bilirubin ? 1.5 × ULN except in patients with Gilbert's syndrome. Patients with Gilbert's syndrome may enroll if direct bilirubin ? 1.5 × ULN of the direct bilirubin.
Total bilirubin ?2 x ULN (?5 x ULN if considered due to Gilbert's syndrome or hemolysis)
Total bilirubin =< 2 X ULN unless related to antiretroviral use (e.g., atazanavir and indinavir), then the direct bilirubin must be =< 2 X ULN
Serum bilirubin =< 1.5 x ULN
Bilirubin ? 1.5 x ULN
Total bilirubin < 2.0
Bilirubin > 2.0
Bilirubin levels < 1.5 x ULN
Total bilirubin =< 1.5 x ULN
Total bilirubin < 1.5 x ULN (< 3.0 x ULN for subjects with documented Gilbert's Disease or for whom the indirect bilirubin level suggests an extrahepatic source of elevation);
Total bilirubin =< 1.5 x ULN
Serum bilirubin =< 1.5 x ULN
Patient has > 1.5 x ULN total bilirubin, unless history of Gilbert's syndrome
Adequate hepatic function as evidenced by the following serum chemistry values: total bilirubin, ULN. If total bilirubin is greater than (>) ULN, measure indirect bilirubin to evaluate for Gilbert's syndrome (if direct bilirubin is within normal range, participant may be eligible) ALP 2.5 x ULN; Trabectedin: if the ALP is >2.5 x ULN, then an ALP liver fraction or 5-nucleotidase must be obtained and ULN, AST and ALT 2.5 ULN
Documentation of inclusion criteria adequate organ function as evidenced by the following peripheral blood counts or serum chemistry values: hemoglobin 9 gram per deciliters (g/dL), absolute neutrophil count (ANC) 1,500/L, platelet count 100,000/L, serum creatinine 1.5*the upper limit of normal (ULN), creatine phosphokinase (CPK) 2.5*ULN and adequate hepatic function as evidenced by the following serum chemistry values: total bilirubin, ULN. If total bilirubin is greater than (>) ULN, measure indirect bilirubin to evaluate for Gilbert's syndrome (if direct bilirubin is within normal range, participant may be eligible) ALP <= 2.5*ULN; Trabectedin: if the ALP is >2.5*ULN, then an ALP liver fraction or 5-nucleotidase must be obtained and ULN, AST and ALT 2.5 ULN will be reviewed by the Sponsor before enrollment in the OEP may occur
Total bilirubin =< 1.5 x ULN for age
Total bilirubin =< 1.5 x ULN
Total bilirubin ?1.5 X ULN unless considered due to Gilbert's syndrome
Total bilirubin ?1.5X ULN, unless considered due to Gilbert's syndrome
Total bilirubin ?2X ULN, unless considered due to Gilbert's syndrome
Total bilirubin ?2X ULN, unless considered due to Gilbert's syndrome
Adequate laboratory values. a) Hemoglobin >/=10 gm/dL. b) White blood cell count (WBC) >/= 3000/µL. c) Absolute neutrophil count (ANC) >/= 1500/µL. d) Platelet count >/=100,000/µL. e) PT </= 1.5 x upper limit of normal (ULN). f) Activated partial thromboplastin time (aPTT) </= 1.5 x ULN. g) AST </=1.5 x ULN. h) ALT </= 1.5 x ULN. i) Total bilirubin </= 1.5 x ULN. j) Creatinine </=1.5 x ULN.
Bilirubin less than or equal to 1.5 x ULN
Total bilirubin > 2x ULN
Total bilirubin =< 1.5 X ULN
Bilirubin < 5 ULN
Bilirubin < 1.5 ULN
Bilirubin < 1.5 x ULN
Bilirubin < 1.5 times ULN
Total bilirubin =< 2.0
Total bilirubin < 1.5 times ULN
Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Bilirubin < 1.5 x ULN
Bilirubin > 1.5 x upper limit normal (ULN), except for patients with known Gilbert syndrome who are excluded if total bilirubin > 3.0 x ULN or direct bilirubin > 1.5 x ULN
Total bilirubin =< 2.0 x ULN
Total bilirubin < 1.5 times ULN
Bilirubin less than or equal to 1.5 x ULN
Total bilirubin =< 1.5 x ULN, except for patients with Gilbert’s syndrome who may be included if total bilirubin =< 3.0 x ULN OR direct bilirubin =< 1.5 x ULN
Total serum bilirubin < 1.5 x ULN
Total bilirubin =< 1.5 x upper limit of normal (ULN) or if total bilirubin is > 1.5 x ULN, the direct bilirubin =< ULN
Total bilirubin =< 2 x ULN, or < 5 ULN if Gilbert’s disease
Serum total bilirubin =< ULN or 1.5 x ULN if liver metastases are present or total 3 x ULN with direct bilirubin =< ULN in patients with well documented Gilbert syndrome
Total bilirubin =< 1.5 x ULN
Total bilirubin =< 1.5 x ULN for age
Total bilirubin =< 1.5 x ULN
Bilirubin > 1.5 X ULN
Bilirubin =< 1.5 x ULN
Total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Total serum bilirubin <1.5 × ULN and
Performed within 10 days of treatment initiation: Total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for patients with total bilirubin levels > 1.5 x ULN
Serum total bilirubin =< 1.5 x upper limit of normal (ULN) (except in subjects with Gilbert’s syndrome who have a total bilirubin > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is =< 1.5 x ULN, subject may be eligible)
Serum total bilirubin =< 2 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 2 ULN (performed within 10 days of treatment initiation)
Serum bilirubin =< 2.0 x ULN with the following exception: patients with known Gilbert’s disease should have a serum bilirubin =< 3 x ULN (obtained within 28 days prior to the first study treatment)
Total bilirubin =< 1.5 x ULN.
Total bilirubin > 1.5 x ULN
Serum bilirubin =< 2.0
Total bilirubin >= 2 x IULN
Bilirubin > 1 x ULN for the laboratory
Total bilirubin < 3 x ULN
Total bilirubin >= 1.5 x ULN 14 days prior to study enrollment
Bilirubin > 2
Bilirubin > 10.0
Total bilirubin =< 10 x ULN
Total bilirubin =< 1.5 x ULN
Bilirubin =< 1.5 x ULN (unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin)
Bilirubin =< 2.0 x ULN (unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin)
Total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Total bilirubin >1.5 × ULN; >3 × ULN with direct bilirubin, >1.5 × ULN in the presence of Gilbert's Disease
Total bilirubin =< 2, unless due to Gilbert’s disease
Total bilirubin =< 2 x ULN (in the expansion cohort, patients with Gilbert’s syndrome [hereditary indirect hyperbilirubinemia] who must have a total bilirubin of =< 3 x ULN)
Serum total bilirubin ? 2.0 x ULN
Serum bilirubin < institutional ULN (in patients with Gilbert’s disease, direct bilirubin < institutional ULN)
Serum total bilirubin =< 3
Total bilirubin level greater than 3 times the ULN
Total bilirubin ? 1.5 ULN of institution's range
Bilirubin < 2 x ULN
Bilirubin < 2.5
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 =< 2.0, within 30 days prior to enrollment
Total bilirubin =< 2 x institutional ULN obtained =< 45 days prior to randomization
Serum bilirubin ? 1.5 x ULN.
Total bilirubin < 1.5 x ULN
Total bilirubin £ 1.5 × ULN
Direct serum bilirubin ? 1.5 x ULN
Total bilirubin < 1.5 x ULN for age
Total bilirubin < ULN; or total bilirubin =< 3.0 x ULN or direct bilirubin =< 1.5 x ULN in patients with well- documented Gilbert’s syndrome
Serum bilirubin =< institution ULN (except for subjects with Gilbert’s Disease who are eligible despite elevated serum bilirubin level)
Total bilirubin >1.8, creatinine >2, hemoglobin <10, platelets <50,000, WBC <2,000)
Total bilirubin >1.5, creatinine >2, hemoglobin <10, platelets <50,000, WBC <2,000
Total bilirubin within 2 x ULN
Total bilirubin < 5 X institutional ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 10 days of treatment initiation
- Total bilirubin < 1.5 x ULN (< 3 x ULN in patients with known/suspected Gilbert's disease)
Total bilirubin less than or equal to 1.5 x ULN
Serum total bilirubin =< 1.5 x ULN, obtained within 14 days prior to C11-AMT PET scan
Total bilirubin < 3 x ULN
Bilirubin < 1.5 x ULN (unless Gilbert’s is suspected in which case total bilirubin < 3 x ULN)
Total bilirubin < 3.0
Bilirubin < 1.5 x ULN
Total bilirubin =< 1.5 X ULN (evaluated within 28 days of randomization); concomitant elevations in bilirubin and aspartate amino transferase (AST)/alanine aminotransferase (ALT) above 1.0 x ULN are not permitted
Bilirubin (total) > 1.5 x ULN
Total serum bilirubin =< 1.5 x ULN (if documented Gilberts syndrome =< 3 x ULN) obtained =< 14 days prior to registration
Total bilirubin ?1.5 x ULN, except in subjects with documented Gilbert's Syndrome, who must have a total bilirubin ?3 x ULN
Total bilirubin < 1.5 x ULN (if thought to be > 1.5 x ULN due to Gilbert’s disease or the patient’s AML, must discuss with the principal investigator [PI])
Total serum bilirubin < 1.5 x ULN or total bilirubin =< 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert’s syndrome or hemolysis or who required regular blood transfusions
Total bilirubin < 1.5 X ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, obtained =< 30 days prior to registration
Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 10 days of treatment initiation
Total bilirubin =< 1.5 x ULN
Total serum bilirubin =< 1.5 x ULN
Serum bilirubin =< 4.0 x ULN or LLN (except for patients with Gilbert’s disease)
Bilirubin > 1.5 x ULN
- Total bilirubin < 1.5 x ULN (< 3 x ULN in patients with known/suspected Gilbert's disease)
Hepatic lab values: Bilirubin>1.5 ULN; AST/ALT >2.5 ULN; Albumin < 2 g/dL; GGT > 2.5 ULN if Alkaline Phostphatase >2.5 ULN
Bilirubin > 1.5 x ULN
Bilirubin > 1.5 x ULN
Total bilirubin ?1.5×ULN.
Serum bilirubin =< 1.5 x institutional ULN
Bilirubin < 2 times ULN, performed within 28 days prior to registration
Greater than 3 x the ULN for total bilirubin (except for known cases of Gilbert’s syndrome, where the levels of conjugated bilirubin must be less than 3 x the ULN)
Total bilirubin ? 1.5 x ULN.
Total bilirubin >1.5 x ULN (unless Gilbert's syndrome or extrahepatic source as denoted by increased indirect bilirubin fraction)
Cohort 1 (normal hepatic function): Bilirubin ? ULN; AST ? ULN
Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Total bilirubin ? 1.5 x ULN
Serum total bilirubin =< 1.5 X upper limit of normal (ULN) (=< 3 X ULN if Gilbert’s syndrome) OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Total serum/plasma bilirubin ?1.5 times ULN.
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 10 days of protocol enrollment
Serum total bilirubin =< 1.5 X upper limit of normal (ULN) (=< 3 X ULN if Gilbert’s syndrome) OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN