Bilirubin less than 1.5 mg/dL (except for patients with Gilbert’s Syndrome of indirect hyperbilirubinemia)
Serum total cholesterol level =< 300 mg/dL
Bilirubin =< 1.5 mg/dL (or =< 3.0 mg/dL if due to Gilbert's syndrome) within 28 days prior to registration
ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Bilirubin =< 1.5 x ULN (except in patients with documented Gilbert’s disease, who must have a total bilirubin =< 3.0 mg/dL)
Bilirubin =< 1.5 mg/dL (or =< 3.0 mg/dL if due to Gilbert's syndrome or if liver metastases are present)
Serum direct bilirubin < 2 mg/dl or serum total bilirubin =< 3; NOTE: the above stipulation for normal hepatic function does not apply if liver dysfunction is due to leukemia infiltration
Obtained =< 48 hours prior to registration: Serum direct bilirubin < 2 mg/dL or serum total bilirubin =< 3
Total bilirubin (=< 1.5 mg/dl) normal unless history of Gilbert’s syndrome
Direct bilirubin < 3.0 mg/dL
Direct bilirubin =< 2.0 mg/dL
Total bilirubin =< 2.0 mg/dl
Total bilirubin of ? 2.0 mg/dL (? 3.0 mg/dL for patients with known Gilbert's syndrome)
Bilirubin < 1.4 mg/dl
Bilirubin >1.5 mg/dL, except for Gilbert's Syndrome or hemolysis.
Total bilirubin =< 2.0 mg/dL; in patients with Gilbert’s syndrome, total bilirubin >= 2.0 is permitted
Bilirubin =< 1.5 mg/dL
Serum bilirubin ? 1.5 x ULN, except in subjects with Gilbert's Syndrome who must have a total bilirubin < 3 mg/dL
Total bilirubin =< 1.5 x ULN (except in patients with Gilbert’s syndrome who may have total bilirubin < 3.0 mg/dL)
Total bilirubin ? 2 mg/dL
Total bilirubin =< 1.5 mg/dL (=< 2.0 in patients with known Gilbert's syndrome)
Serum bilirubin <1.5 mg/dL (except subjects with Gilbert's syndrome who may have total bilirubin <3.0 mg/mL)
Total bilirubin <2.0 mg/dL unless elevated due to known Gilbert's syndrome.
Serum total bilirubin > 1.5 mg/dL or > 3 × ULN for patients with hereditary benign hyperbilirubinemia
Total bilirubin =< 1.5 mg/dL
Bilirubin =< 3.0 mg/dL (unless due to Gilbert’s syndrome or hemolysis)
Total cholesterol < 300 mg/dL
Serum direct bilirubin =< 2 mg/dL (unless history of Gilbert’s)
Total serum bilirubin =< 2.0 mg/dL
Total bilirubin < 2 mg/dL (unless due to acute lymphoblastic leukemia [ALL])
Total bilirubin < 2.0 mg/dl (unless attributable to Gilbert's disease)
Total bilirubin >= 1.5 mg/dL (> 26 mol/L, SI unit equivalent)
Bilirubin < 1.5 mg/dl
Total bilirubin =< 1.5 mg/dL (=< 2.0 in patients with known Gilberts syndrome)
Total bilirubin ? 1.5 mg/dL (upper limit of normal) except subject with documented Gilbert's syndrome (? 5 x ULN) or liver metastasis, who must have a baseline total bilirubin ? 3.0 mg/dL
Subjects must have hematologic and renal functions as specified: Absolute neutrophil count ? 1500/mm3, platelets ? 100,000/mm3, Hgb ? 9.0g/dL, creatinine ? 1.7mg/dL, total bilirubin ? 1.5mg/dL, blood urea nitrogen (BUN) within 2 times the upper limit of normal, transaminases ? 4 times above the upper limits of the institutional norm.
Total bilirubin ?1.5 mg/dL unless elevated due to known Gilbert's syndrome.
Obtained within 21 days prior to study registration: total bilirubin =< 2.0 g/dL
Have a total bilirubin level ?2.0 mg/dL (unless secondary to Gilbert syndrome, hemolysis, or leukemia)
Serum total bilirubin ? 2.0 mg/dL (34 ?mol/L). In the case of Gilbert's syndrome, or documented liver or pancreatic involvement by lymphoma, serum total bilirubin must be ? 5.0 mg/dL (86 ?mol/L).
Obtained within 14 days prior to C1D1: Total Bilirubin =< 1.5 x ULN, except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL
Total bilirubin =< 1.5 mg/dl, except in subjects with Gilbert’s syndrome
Bilirubin less than or equal to 1.5 x the upper limit of normal (except subjects with Gilbert syndrome, who can have total bilirubin < 3 mg/dl)
Obtained =< 21 days prior to registration: total bilirubin =< 2.0 mg/dL (if total is elevated check direct and if normal patient is eligible)
Total bilirubin =< 1.5 mg/dL or < 2 mg/dL if attributable to hepatic infiltration by neoplastic disease or Gilbert’s syndrome
Total bilirubin =< 1.5 mg/dL or < 2 mg/dL if attributable to hepatic infiltration by neoplastic disease
Total bilirubin =< 1.5 mg/dL (25.65 umol/L)
Total bilirubin =< 2.4 mg/dL unless related to Gilbert’s disease or patient’s lymphoma
Total serum bilirubin > 2 mg/dL
Bilirubin ?2 x ULN (except subjects with Gilbert's syndrome, who must have total bilirubin < 3.0 mg/dL (<52 µmol/L))
Bilirubin (total) within normal institutional limits (except subjects with Gilbert syndrome who must have total bilirubin < 3.0 mg/dL)
Total bilirubin =< 1.5 mg/dL
Total bilirubin ?1.5 mg/dL not related to hemolysis or Gilbert's disease
Total bilirubin (TBL) ? 2.5 mg/dL, except for participants with Gilbert's syndrome.
Total bilirubin =< 1.5 mg/dL (=< 2.0 in participants with known Gilbert’s syndrome)
Total bilirubin =< 2.0 mg/dL unless due to Gilbert’s syndrome, hemolysis, or ineffective hematopoiesis
Obtained =< 21 days prior to registration and confirmed prior to the first dose of study drug: Total bilirubin =< 1.5 mg/dL (if total is elevated check direct and if normal patient is eligible)
Bilirubin =< 2.0 mg/dl, unless due to Gilbert’s, hemolysis or leukemic infiltration
Total bilirubin ? 2.0 mg/dl
Bilirubin > 2.0 mg/dL
Total bilirubin =< 1.5 mg/dL
Direct bilirubin ? 1.5 mg/dL or total bilirubin ? 1.5 mg/dL
Direct bilirubin ? 3.0 mg/dL (50 mmol/L)
Total bilirubin =< 3 mg/dL
Serum total bilirubin > 1.5 mg/dL or > 3 × ULN for patients with hereditary benign hyperbilirubinemia
Serum bilirubin must be ? 2.0 mg/dl
Bilirubin =< 3.0 mg/dL (unless due to Gilbert’s syndrome or hemolysis) for patients receiving MAC, RIC or RIC-MMF and bilirubin =< 5.0 mg/dL for patients receiving IOC (unless due to Gilbert’s syndrome or hemolysis)
Total bilirubin =< 1.5 mg/dL
ARM 2 - A: Total bilirubin =< 2.0 mg/dL
Total bilirubin ? 1.5mg/dl,
Total bilirubin =< 2.0 mg/dl unless due to underlying conjugation disease such as Gilbert’s
Total bilirubin of ? 1.5 mg/dL or ? 2.0 mg/dL for subjects with liver metastasis.
Bilirubin =< 2.0 x ULN, (except patients with Gilbert’s syndrome, who must have a total bilirubin less than 3.0 mg/dL)
Total bilirubin less than or equal to 2 mg/dl, except in patients with Gilbert’s syndrome, who must have a total bilirubin less than or equal to 3 mg/dl
Serum bilirubin < 2 mg/dL
Total bilirubin < 1.5 mg/dL
Serum bilirubin values < 2.0 mg/dL
RETREATMENT WITH MODIFIED T-CELLS INCLUSION CRITERIA: Total bilirubin: =< 3 x ULN for age OR conjugated bilirubin =< 2 mg/dL
Total bilirubin =< to 1.5 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dl
Serum bilirubin levels =< 1.5 mg/dL
PART I: Total bilirubin =< 1.5 mg/dl
Serum bilirubin =< 1.5 mg/dL
Total bilirubin less than or equal to 1.5 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dl
Bilirubin =< 1.5 mg/dL
Total bilirubin less than or equal to 2 mg/dl, except in patients with Gilbert’s syndrome, who must have a total bilirubin less than or equal to 3 mg/dl
Total bilirubin =< 1.5 x ULN (except subjects with Gilbert syndrome, who must have total bilirubin < 3.0 mg/dL) within 14 days prior to first dose of protocol-indicated treatment.
Within 14 days of the first dose of study drug: Total bilirubin =< 1.5 x ULN (except patients with Gilbert syndrome who must have total bilirubin < 3.0 mg/dL)
Serum total bilirubin > 1.5 mg/dL or > 3 x ULN for patients with hereditary benign hyperbilirubinemia
Total bilirubin =< 2.0 mg/dL
Total bilirubin =< to 2.0 mg/dl, except in patients with Gilbert’s syndrome, who must have a total bilirubin =< 3.0 mg/dl.
Total bilirubin within normal institutional limits; for patients with Gilbert’s syndrome, total bilirubin =< 3.0 mg/dL.
Total bilirubin =< 2.0 mg/ml
Direct bilirubin < 2.0 mg/dL
ARM I&II: Total bilirubin =< 1.5 mg/dl
Patients must have a serum bilirubin =< 2.0 mg/dl
Bilirubin less than or equal to 2.0 mg/dL (unless considered tumor related)
Total bilirubin =< 2.0 mg/dl, except in patients with Gilbert’s Syndrome, who must have a total bilirubin < 3.0 mg/dl
Bilirubin < 2.0 mg/dL
Bilirubin ? 2.0 mg/ml
A bilirubin of less than or equal to 1.5 mg/dL, excluding patients with Gilbert's disease
Direct bilirubin must be < 2 mg/dL unless the elevation is known to be due to Gilbert syndrome within 3 days prior to enrollment.
Bilirubin > 1.15 mg/dL
Bilirubin =< 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL).
Bilirubin < 1.5 mg/dL (unless benign congenital hyperbilirubinemia).
Total bilirubin < 1.5 x institutional normal limits (subjects with known Gilbert syndrome are eligible with total bilirubin < 3.0 mg/dL).
Direct bilirubin > 2.0 mg/dL
Total bilirubin less than or equal to 2 mg/dl, except in patients with Gilbert’s syndrome, who must have a total bilirubin less than or equal to 3 mg/dl
Total Serum Bilirubin ? 1.5 x ULN (< 3.0 mg/dL if subject has Gilbert's syndrome)
COHORT 1: HORMONE RECEPTOR POSITIVE BREAST CANCER: Total bilirubin < 1.5 X ULN, unless known diagnosis of Gilbert’s syndrome, where bilirubin =< 5 mg/dL will be permitted; Gilbert’s syndrome will be defined as elevated unconjugated bilirubin, with conjugated (direct) bilirubin within the normal range and less than 20% of the total; total bilirubin will be permitted up to 5 mg/dL, if patients have historical readings consistent with the definition of Gilbert’s syndrome prior to entering study
COHORT 2: TRIPLE NEGATIVE BREAST CANCER: Total bilirubin < 1.5 X ULN, unless known diagnosis of Gilbert’s syndrome, where bilirubin =< 5 mg/dL will be permitted; Gilbert’s syndrome will be defined as elevated unconjugated bilirubin, with conjugated (direct) bilirubin within the normal range and less than 20% of the total; total bilirubin will be permitted up to 5 mg/dL, if patients have historical readings consistent with the definition of Gilbert’s syndrome prior to entering study
COHORT 3: ENDOMETRIAL CANCER: Total bilirubin < 1.5 X ULN, unless known diagnosis of Gilbert’s syndrome, where bilirubin =< 5 mg/dl will be permitted; Gilbert’s syndrome will be defined as elevated unconjugated bilirubin, with conjugated (direct) bilirubin within the normal range and less than 20% of the total; total bilirubin will be permitted up to 5 mg/dL, if patients have historical readings consistent with the definition of Gilbert’s syndrome prior to entering study
Obtained within 14 days prior to randomization/registration: total Bilirubin =< 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL)
Bilirubin < 1.5 mg/dL
Total bilirubin ? 1.5 mg/dl, except in subjects with Gilbert's syndrome.
Obtained within 28 days prior to registration: bilirubin < 2 mg/dl
Total bilirubin =< 1.5 x ULN (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)
Bilirubin less than or equal to 1.5 x the upper limit of normal (except subjects with Gilbert syndrome, who can have total bilirubin < 3 mg/dl)
Direct bilirubin =< 2.0 mg/dL in the absence of suspected Gilbert’s disease (if Gilbert’s disease is suspected, the total bilirubin must be =< 3.0 mg/dL)
Bilirubin less than or equal to 1.5 x the upper limit of normal (except subjects with Gilbert syndrome, who can have total bilirubin < 3 mg/dl)
Total bilirubin =< 1.5 mg/dL
Bilirubin =< 1.5 mg/dL (OR in patients with Gilbert’s syndrome, a total bilirubin =< 3.0) (within 16 days before starting therapy)
Total bilirubin =< 2.0 mg/dL, except in patients with Gilbert’s syndrome, who must have a total bilirubin =< 3.0 mg/dL
Total bilirubin =< 2 mg/dL; for subjects with known Gilbert’s disease, bilirubin =< 3.0 mg/dL
Total bilirubin =< 3.0 mg/dL
Total bilirubin ? 3.0 mg/dL
Within 14 days of the first dose of the study drugs: Total bilirubin =< 1.5 mg/dl.
Serum total bilirubin\t ? 2 mg/dl (biliary stent is allowed) within 10 days prior to “on study” status
Total bilirubin =< 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL) within 14 days of registration
Total bilirubin =< 2 mg/dL or direct bilirubin =< ULN for those with total bilirubin > 2 x ULN; subjects with Gilbert syndrome will be eligible if total bilirubin is < 3.0 mg/dL
Bilirubin =< 3.0 mg/dL (obtained within three days prior to study treatment)
Direct or conjugated bilirubin < 3 mg/dl
Total bilirubin > 3 mg/dl
Total bilirubin < 3.0 g/dl OR < 5.0 g/dl if Gilbert’s syndrome or disease infiltration of the liver is present
Total bilirubin =< 1.5 x ULN within 14 days of study registration (except subjects with Gilbert Syndrome who must have total bilirubin < 3.0 mg/dl).
Obtained within 21 days prior to randomization/registration: Total bilirubin =< 1.5 x ULN (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL).
Total bilirubin =< 1.5 mg/dl, except in subjects with Gilbert’s syndrome
Serum direct bilirubin =< 2 mg/dL (34 umol/L) within 21 days prior to initiation of therapy
Within 14 days of the first dose of study drug: Total bilirubin =< 1.5 mg/dl
REP ELIGIBILITY: Total bilirubin less than or equal to 2.0 mg/dL, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dL
CHEMOTHERAPY/CELL INFUSION ELIGIBILITY: Total bilirubin less than or equal to 2.0 mg/dL, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dL
Serum total bilirubin =< 3 mg/dL (performed within 14 days of treatment initiation)
Patients with bilirubin levels > 2 mg/dL
Total bilirubin within normal institutional limits except in patients with Gilbert’s syndrome who must have a total bilirubin < 3.0 mg/dL
Total bilirubin =< to 1.5 mg/dL, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dL
Total bilirubin < 2.0 mg/dL (? 3.0 mg/dL for patients with known Gilbert's syndrome)
Total bilirubin =< 1.5 mg/dL within 30 days of registration
Total bilirubin (except patients with Gilbert’s Syndrome, who are eligible for the study but exempt from the total bilirubin eligibility criterion) =< 2.0 mg/dl within 14 days prior to Step 2 registration and
Bilirubin =< 1.5 mg/dl
Total bilirubin (T bili) =< 1.5 mg/dL except for patients with Gilbert’s syndrome or hemolysis
Serum bilirubin =< 1.5 mg/dL
Total serum bilirubin =< 1.5 mg/dl
Bilirubin =< 2 mg/dL
Serum bilirubin =< 3.0 mg/dL.
Bilirubin =< 1.5 x ULN (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)
Total bilirubin =< 2.0 mg/dl
Total bilirubin =< 1.5 x ULN (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)
Total bilirubin (Bili T) =< 1.5 x ULN (although patients with Gilbert syndrome can have total bilirubin < 3.0 mg/dL), within 30 days before study registration
Obtained within 14 days prior to enrollment: bilirubin =< 1.5 mg/dL
Total bilirubin =< 1.5 mg/dl
Total bilirubin =< 1.5 x ULN (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL) within 14 days prior to first dose
(For both cohorts A and B): Total serum bilirubin =< 2.0 mg/dL
Serum total bilirubin =< 1.5 x ULN (subjects with Gilbert syndrome can have a total bilirubin < 3 mg/dL), performed within 14 days of protocol registration
Bilirubin =< 1.6 mg/dL (except patients with Gilbert’s syndrome, who must have a total bilirubin less than 3.0 mg/dL) obtained < 4 weeks prior to starting treatment
Direct bilirubin =< 2.0 mg/100 ml
Obtained within 14 days of randomization: Total bilirubin =< 1.5 x ULN (except subjects with Gilbert Syndrome who must have total bilirubin < 3.0 mg/dL)
Direct bilirubin =< 2.0 mg/dL
Total bilirubin < 2 mg/dl
Total bilirubin =< 2 mg/dL
Total bilirubin > 1.5 x ULN (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)
Total bilirubin =< 1.5 mg/dL, except in subjects with Gilbert’s Syndrome in whom total bilirubin must be =< 3.0 mg/dL
Total bilirubin less than or equal to 2.0 mg/dl
Total bilirubin =< 2.5 mg/dl within 30 days of enrollment to study
Total bilirubin =< 1.5 x ULN (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)
Bilirubin =< 1.5 mg/dL
Total bilirubin ? 1.5 mg/dl
Total bilirubin =< 2.0 mg/dL\r\n* If Gilbert's disease is suspected and total bilirubin > 2.0 mg/dL, direct bilirubin must be =< 2.0 mg/dL
Serum total bilirubin =< 1.5 X ULN OR except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL
Total bilirubin =< 1.5 mg/dl within 14 days prior to study entry
Within 14 days prior to planned start of treatment: Total serum bilirubin =< 2.2 mg/dL
Total bilirubin < 2.0 mg/dl-exception permitted in patients with Gilbert’s syndrome
Bilirubin < 2.5 mg/dL (unless due to Gilbert's disease)
Total bilirubin =< 1.5 x ULN (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)
Bilirubin =< 2.0 mg/dl
Total bilirubin < 1.5 X ULN, unless known diagnosis of Gilbert‘s syndrome, where bilirubin =< 5 mg/dl will be permitted; Gilbert’s syndrome will be defined as elevated unconjugated bilirubin, with conjugated (direct) bilirubin within the normal range and less than 20% of the total; total bilirubin will be permitted up to 5 mg/dl, if patients have historical readings consistent with the definition of Gilbert’s syndrome prior to entering study
Total bilirubin =< 1.5 mg/dl
Subjects with total bilirubin > 2.0 mg/dL at day 1 are not eligible for enrollment
Total bilirubin < 1.5 mg/dL (or =< 3.0 mg/dL in patients with Gilbert syndrome)
Total bilirubin =< 2.0 mg/dL unless due to known Gilbert’s disease obtained =< 14 days prior to registration\r\n* NOTE: If total bilirubin is > 2 mg/dL, a direct bilirubin should be performed and must be < 1.5 mg/dL for Gilbert’s to be diagnosed
A bilirubin of up to 2.0 mg/dL, excluding patients with Gilbert's disease
Bilirubin ? 2.0 x ULN, (except patients with Gilbert's Syndrome, who must have a total bilirubin less than 3.0 mg/dL)
EXCEPTIONS:\r\n* Total bilirubin >= 5 mg/dL in patients with Gilbert's syndrome as defined by > 80% unconjugated\r\n* Total bilirubin >= 7.5 with direct fraction > 0.7 if patient is receiving a protease inhibitor at the time of initial evaluation\r\n* Hepatic dysfunction attributed to lymphoma, KSHV-MCD, or KICS
Total Bilirubin =< 1.5 x ULN (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)
Serum bilirubin =< 2.0 mg/dl
Total bilirubin =< 2 mg/dL, except for patient's with Gilbert's syndrome
Bilirubin less than or equal to 2.0 mg/dL (unless considered tumor related)
Total bilirubin =< 1.5 mg/dL
Total bilirubin =< 1.5 mg/dL
PHASE II: Total bilirubin =< 1.5 mg/dL
Total bilirubin =< 1.5 mg/dL, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dL
Total bilirubin less than or equal to 2 mg/dL (> 2 mg/dL permitted if the patient has evidence of Gilbert’s disease based upon prior bilirubin elevation or genetic testing)
Total bilirubin =< 1.5 mg/dL x upper limit of normal (ULN) (except subjects with Gilbert syndrome who can have total bilirubin =< 3.0 mg/dL)
Total bilirubin =< to 1.5 mg/dL, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dL
Bilirubin =< 2 x ULN (except subjects with Gilbert’s syndrome, who must have total bilirubin < 3.0 mg/dL)
Bilirubin =< 1.5 mg/dL (excluding Gilbert’s syndrome)
Total bilirubin =< 1.5 mg/dL, unless hyperbilirubinemia is attributable solely to Gilbert’s syndrome
Total bilirubin < 2 mg/dl
Total bilirubin =< 2mg/dL, obtained within 14 days of first dose of drug
Total bilirubin =< to 1.5 mg/dl, except in patients with Gilbert’s Syndrome who must have a total bilirubin less than 3.0 mg/dl
Total bilirubin < 1.5 X institutional normal limits (subjects with known Gilbert syndrome are eligible with total bilirubin < 3.0 mg/dL)
Total bilirubin =< 3 mg/dL unless due to Gilbert’s syndrome, hemolysis, or ineffective hematopoiesis
Serum bilirubin >= 2 mg/dL
Direct bilirubin >= 2.0 mg/dL not related to hemolysis or Gilbert’s disease
Total bilirubin =< 1.5 mg/dL (25.65 umol/L)
Total bilirubin =< 1.5 mg/dL
Bilirubin > 3.0 mg/dL
Total bilirubin less than or equal to 2.0 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dl
Total bilirubin =< 1.5 x ULN, except subjects with Gilbert’s syndrome or liver metastases, who must have a baseline total bilirubin =< 3.0 mg/dL
Bilirubin < 1.5 mg/dL (except for Gilbert’s syndrome which will allow bilirubin =< 2.0 mg/dL)
Total bilirubin =< 2.0 mg/dL (unless previously diagnosed with Gilbert’s syndrome)
Total bilirubin =< 1.5 mg/dL (except Gilbert’s syndrome or known hemolysis or leukemic infiltration) obtained =< 7 days prior to registration
Total bilirubin =< 1.5 mg/dl
Total bilirubin =< 2 mg/dL (unless directly attributable to lymphoma)
Total bilirubin less than or equal to 2.0 mg/dl
Total bilirubin =< 1.5 upper limit of normal unless the patient is receiving a protease inhibitor known to be associated with increased bilirubin (e.g. atazanavir), in which case total bilirubin =< 7.5 mg/dL with direct fraction =< 0.7
Bilirubin less than or equal to 2.0 mg/dl
Bilirubin less than or equal to 1.5 mg/dl (unless due to Gilbert’s syndrome)
Obtained =< 14 days prior to registration: Total bilirubin =< 1.5 mg/dL or direct bilirubin =< 1.0 mg/dL for patients with Gilbert’s syndrome
Serum total bilirubin =< 1.5 mg/dL
Total bilirubin =< 1.5 x ULN except in patients with documented Gilbert’s syndrome or liver metastasis, who must have a baseline total bilirubin =< 3.0 mg/dl
Bilirubin < 2.0 mg/dl, unless subject has Gilbert’s syndrome (=< 3.0 mg/dL)
Total bilirubin =< to 1.5 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dl
Direct bilirubin < 1.5 mg/dl, unless due to Gilbert’s or secondary to hemolysis
Total bilirubin =< 1.5 x ULN; except subjects with Gilbert syndrome who can have total bilirubin < 3.0 mg/dL) obtained within 14 days of first treatment
Total bilirubin =< 1.5 x ULN (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL) obtained within 14 days prior to randomization/registration
Direct bilirubin =< 2.0 mg/dl
Total or direct bilirubin =< 1.5 mg/dL
Total bilirubin < 1.5 mg/dL.
Total bilirubin =< 2.0 mg/dl (except for patients in whom hyperbilirubinemia is attributed to Gilbert’s syndrome)
Total bilirubin =< 1.6 mg/dL
Bilirubin =< 1.5 x ULN (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)
Total bilirubin =< 1.5 mg/dL (25.65 mol/L)
Total bilirubin =< 1.5 X normal institutional limits (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)
Bilirubin =< 2.0 mg/dL
Total bilirubin < 3 mg/dL
Total bilirubin =< 2.0 mg/dL
Total bilirubin =< 3.0 mg/dl
Total bilirubin =< 2.0 mg/dL
Bilirubin < 1.5 mg/dL, with the exception of patients thought to have Gilbert’s syndrome, who may have a total bilirubin above 1.5 mg/dL
Bilirubin (total) < 2.0 ml/dl within 14 days of study entry
Total bilirubin =< 1.5 mg/dl, unless increase is due to hemolysis or congenital disorder
Bilirubin less than or equal to 3.0 mg/dL
Total serum bilirubin =< 2.0 mg/dL
Serum bilirubin =< 2.0 mg/dl
Total bilirubin =< 2.5 mg/dL
Serum bilirubin < 1.5 mg/dl
Total bilirubin > 3 mg/dL
Total bilirubin < 2.0 mg/dL
Bilirubin =< 1.5 mg/dL
Total bilirubin =< 5.0 mg/dL
Bilirubin >= 1.5 mg/dL
Total bilirubin =< 1.5 mg/dL
Serum total bilirubin less than 2.5 mg/dl; patients with elevations of serum total bilirubin up to 10 mg/dl may be considered for participation if such elevations are thought to be due to liver involvement by malignancy; however, in these latter patients, if the bilirubin (BR) level does not decrease to less than or equal to 2.5 mg/dl after induction chemotherapy, eligibility for the transplant (research) phase will be at the discretion of the PI
Has total bilirubin < 1.5 mg/dL, serum albumin > 3.0 gm/dL, AST and ALT < 1.5 ULN or < 3 x ULN for subjects with known hepatic metastases
Total bilirubin =< 1.5 mg/dL
Patients with Gilbert syndrome are excluded from the requirement of a normal bilirubin but they must have an indirect bilirubin of < 6 mg/dl, and a direct bilirubin of < 0.5 mg/dl in order to be eligible; (Gilbert syndrome is found in 3-10% of the general population and is characterized by mild, chronic hyperbilirubinemia in the absence of liver disease or overt hemolysis)
Total bilirubin =< 2.5 mg% (unless from Gilbert’s disease or disease-related)
Bilirubin less than or equal to 2 mg/dL
Total bilirubin < 1.5 mg/dl
Serum bilirubin < or =< 2.0 mg/dl
ELIGIBILITY CRITERIA FOR T-CELL PRODUCT INFUSION: Total bilirubin: =< 3 x ULN for age OR conjugated bilirubin =< 2 mg/dL
RETREATMENT WITH MODIFIED T CELLS: Total bilirubin: =< 3 x ULN for age OR conjugated bilirubin =< 2 mg/dL
Bilirubin =< 1.5 mg/dL
Total bilirubin =< 1.6 mg/dL prior to biopsy
Total bilirubin =< 3 mg/dL
Total bilirubin =< 1.5 x ULN (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)
Total bilirubin =< 1.5 mg/dL, unless increase is due to hemolysis or congenital disorder
PART 2: Total serum bilirubin must be < 3 mg/dL unless the elevation is thought to be due to Gilbert’s disease or hemolysis
Direct bilirubin < 1 mg/dl
Total bilirubin =< 2.0 mg/dL; (does NOT apply to patients with Gilbert’s syndrome)
Total bilirubin less or equal to 2 mg/dl
To commence second line irinotecan, bilirubin should be < 1 mg/dL; if between 1-2 mg/dL initial dose should be reduced by one dose level; if > 2 mg/dL, then irinotecan will not be used
Total bilirubin =< 1.5 mg/dl within 14 days of the first dose of study drug
Bilirubin < 1.5 mg/dL
Serum bilirubin > 1.2 mg/dl
Bilirubin less than or equal to 2.0 mg/dL (unless considered tumor related)
Within 2 weeks of enrollment: Bilirubin =< 2.0 mg/dl
Total bilirubin =< 2.0 mg/dl
Bilirubin =< 2.5 mg/dL
Total bilirubin >= 1.5 mg/dL and not related to hemolysis or Gilbert's disease; patients with total bilirubin >= 1.5 mg/dL to 3 mg/dL are eligible if at least 75% of the bilirubin is indirect
Serum bilirubin =< 3.0 mg/dL
Total bilirubin =< 2 mg/dL
Within 30 days of first vaccination: Total bilirubin =< 1.5 mg/dl
Total bilirubin =< to 1.5 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dl
Patients must have a serum bilirubin =< 2.0 mg/dl
Total bilirubin =< 2.0 mg/dL
Total bilirubin < 3.0 mg/dl (if total bilirubin is >= 3.0 patient is eligible if direct bilirubin is within normal limits)
Serum bilirubin must be ? 2.0 mg/dl
Total bilirubin =< 2.5 mg/dL
Bilirubin (Gilbert's Disease) =< 3.0 mg/dL
Total bilirubin ? 3.0 mg/dL
Bilirubin =< 2 mg/dL
Serum bilirubin > 3.0 mg/dL.
Total serum bilirubin > 1.5 mg/dl
Total bilirubin =< to 1.5 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dl
Total bilirubin =< 2.0 mg/dL (=< 3.0 mg/dL for patients with known Gilbert’s syndrome), unless these are thought to be due to AML
Total bilirubin =< 2 mg/dL
Serum bilirubin > 2.0 mg/dl (unless segmental infusion is planned)
Bilirubin =< 1.5 mg/dL
Total serum bilirubin =< 1.5 mg/dl (patients with total bilirubin > 1.5 mg/dL eligible only with Gilbert’s syndrome)
Direct bilirubin =< 2.0 mg/dl
Bilirubin < 2.0 mg/dL, unless subject has Gilbert’s Syndrome (=< 3.0 mg/dL)
Total serum bilirubin =< 2.0 mg/dL
Total bilirubin < 2 mg/dL
Serum bilirubin > 2.0 mg/dl that is not due to Gilbert’s syndrome or hemolysis
Serum direct bilirubin =< 2 mg/dL (34 umol/L)
Bilirubin =< 2.0 x ULN, (except patients with Gilbert’s Syndrome, who must have a total bilirubin less than 3.0 mg/dL)
Serum bilirubin =< 2.0 g/dL
Bilirubin =< 1.5 mg/dL
Total bilirubin =< 2.0 mg/dL
Total bilirubin =< to 1.5 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dl
Total serum bilirubin > 1.5 mg/dl
Total bilirubin less than or equal to 2.0 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dl (Turnstile II)
Total bilirubin < 2 mg/dL
Bilirubin equal or less than 1.5 mg/dl except for Gilbert’s disease
Total bilirubin =< 2 mg/dl
Total bilirubin =< 2 mg/dl
Total bilirubin =< 2 mg/dL
Relapsed/refractory MCL: Serum bilirubin < 1.5 mg/dl
Total or direct bilirubin =< 1.5 mg/dL (if not due to the leukemia itself or known Gilbert’s syndrome) (as documented by treating physician)
Bilirubin > 3.0 mg/dL
RECIPIENT: Serum conjugated bilirubin < 2.5 mg/dl
Total serum bilirubin > 2 mg/dL
Total bilirubin =< 2.0 mg/dl
Bilirubin =< 1.5 mg/dl (unless Gilbert's syndrome)
Bilirubin =< 2.0 mg/dl
Bilirubin =< 3.0 mg/dL
Direct bilirubin of =< 2 mg/dL
Total bilirubin of < 2 mg/dl unless due to hemolysis, leukemia organ infiltration, or Gilbert’s syndrome
Bilirubin level at/above 100 umol per liter (5.8 mg/dL)
Total bilirubin < 2.0 mg/dl, unless a diagnosis of Gilbert’s disease
Total bilirubin =< 1.5 mg/dL
Total bilirubin less than or equal to 2.0 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dl (Turnstile II)
Bilirubin < 2 mg/dL
Bilirubin =< 1.5 mg/dL (=< 3.0 mg/dL with liver metastasis)\r\n* Subjects with Gilbert's disease may have bilirubin up to 2.5 mg/dL (or 3.0 mg/dL with liver metastasis)
Bilirubin =< 1.5 x ULN, (except patients with Gilbert’s syndrome, who must have a total bilirubin less than 3.0 mg/dL)
Total bilirubin =< 2 mg/dL
Bilirubin =< 2 mg/dL
Total bilirubin > 2.0 mg/dl
Bilirubin =< 1.5 x upper limit of normal unless the patient is receiving protease inhibitor therapy (e.g. indinavir, ritonavir, nelfinavir, or atazanavir) known to be associated with increased bilirubin, in which case total bilirubin =< 7.5 mg/dL with direct fraction =< 0.7 mg/dL
Total bilirubin =< 1.5 mg/dl, except in patients with Gilbert’s syndrome, who must have a total bilirubin =< 3.0 mg/dl
Bilirubin < 1.5 mg/dL with the exception of patients thought to have Gilbert’s syndrome, who may have a total bilirubin above 1.5 mg/dL
Bilirubin =< 1.5 mg/dL
Have a total bilirubin level ?2.0 mg/dL (unless secondary to Gilbert syndrome, hemolysis, or leukemia)
Total bilirubin >= 2.0 mg/dl in the absence of a history of Gilbert's disease
Bilirubin < 1.5 mg/dl
Bilirubin =< 1.95 mg/dL
Total serum bilirubin > 1.5 mg/dl
Total bilirubin < 3 mg/dl
Bilirubin =< 3.0 mg/dL (unless due to Gilbert’s syndrome or hemolysis)
Serum total bilirubin < 2.5 mg/dl
Patients must have a serum bilirubin =< 2.0 mg/dl
Bilirubin =< 2.0 mg/dl, unless known Gilbert's syndrome
Serum total bilirubin > 2.5 mg/dl; if the abnormal liver function is attributable to liver involvement by malignancy, patients may be eligible with serum total bilirubin up to 5.0 mg/dl, provided the patient has no evidence of impending hepatic failure (encephalopathy or prothrombin time > 2 times the upper limit of normal)
Patients must have bilirubin =< 1.5 mg/dl
Total serum bilirubin > 1.5 mg/dl
Bilirubin =< 2.5 mg/dL
Total bilirubin =< 1.5 mg/dL or direct bilirubin =< 1.0 mg/dL for patients with Gilberts syndrome
Total bilirubin =< 2 mg/dL unless hemolysis or Gilbert’s disease
Bilirubin < 1.5 mg/dL
The total serum bilirubin =< 2.5 mg/dL
Laboratory test results within these ranges: Absolute neutrophil count ? 1.0 x 109/L, Platelet count ? 50 x 109/L, Serum creatinine ? 1.5 mg/dL, Total bilirubin ? 1.5 mg/dL, AST & ALT ? 2 x ULN
Serum bilirubin > 3.0 mg/dl\r\n* In some cases where there is an elevated bilirubin, and the tumor may be isolated from a vascular standpoint, treatment may proceed
Serum bilirubin > 3.0 mg/dl; * In some cases where there is an elevated bilirubin, and the tumor may be isolated from a vascular standpoint, treatment may proceed
Serum bilirubin less than or equal to 2.0 mg/dL unless considered due to involvement by tumor when an upper limit of 5.0 mg/dL is acceptable
Direct bilirubin >= 3.1 mg/dl
Bilirubin =< 2.0 mg/100 ml
Total bilirubin =< 2.0 mg/dl
Total bilirubin =< 2.0 mg/dl
Total bilirubin less than or equal to 2.0 mg/dl, except in patients with Gilbert's syndrome who must have a total bilirubin less than 3.0 mg/dl (Turnstile II - Chemotherapy/Cell Infusion - Inclusion Criteria)
Bilirubin < 2.0 mg/dl, or total bilirubin =< 4.5 mg/dl with direct fraction =< 0.3 mg/dl in patients for whom these abnormalities are felt to be due to protease inhibitor therapy
Bilirubin < 1.5 mg/dl
Total serum bilirubin concentration >3.0 mg/dL UNLESS attributed to GvHD
Bilirubin =< upper limit of normal (except in patients with documented Gilbert’s disease, who must have a total bilirubin =< 3.0 mg/dL)
Total bilirubin within normal institutional limits (patients with Gilbert's syndrome must have a total bilirubin < 3.0 mg/dL)
Total bilirubin >1.5 mg/dL
Total bilirubin ?1.5 mg/dL.
Total bilirubin ? 2 mg/dL (except in patients with Gilbert's Syndrome)
Total bilirubin ? 2 mg/dL (except in patients with Gilbert's Syndrome)
Total bilirubin ? 1.5 × (< 3 mg/dL for subjects with Gilbert's disease)
Serum total bilirubin <2.0 mg/dL (34 µmol/L)
Total bilirubin ?2mg/dl
Total bilirubin =< 2.2 mg/dL
Total bilirubin must be less than 2 mg/dl (unless due to CLL involvement of liver or a known history of Gilbert’s disease)
Serum bilirubin < 1.5 mg/dl performed within 60 days of enrollment
Total bilirubin =< 1.5 mg/dL, except in subjects with Gilbert’s syndrome in whom total bilirubin must be =< 3.0 mg/dL
Total bilirubin =< 1.5 mg/dL, except in subjects with Gilbert’s syndrome in whom total bilirubin must be =< 3.0 mg/dL.
BLADDER: Clinical laboratory values at screening: bilirubin ? 1.5 x the ULN; for subjects with known Gilbert’s disease, bilirubin ? 3.0 mg/dL
Within 7 days before the first dose of cabozantinib: Bilirubin =< 1.5 x the upper limit of nomal (ULN); for subjects with known Gilbert’s disease, bilirubin =< 3.0 mg/dL
Total bilirubin =< to 2.0 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dl
Total bilirubin </= 1.5 x ULN except in patients with documented Gilbert’s syndrome or liver metastasis, who must have a baseline total bilirubin 3.0 mg/dl within 3 weeks prior to initial treatment
Total serum bilirubin > 1.5 x ULN (patients with Gilbert’s disease may be included if their total bilirubin is =< 3.0 mg/dL).
ENROLLMENT: Adequate liver function, defined as: total bilirubin =< 2 mg/dl
Total serum bilirubin must be < 3mg/dL unless the elevation is thought to be due to Gilbert’s disease or hemolysis
Obtained within 28 days prior to registration: Bilirubin =< 1.5 mg/dL
Serum bilirubin < 1.5 mg/dl unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin.
Bilirubin < 2mg/dL
Serum total bilirubin < 1.5 mg/dL
Bilirubin (total) =< 1.7 mg/dL
Bilirubin =< 2.0 mg/dL
Total bilirubin =< 2.0 mg/dL
Total bilirubin ?1.5 × ULN or total bilirubin of ?2 mg/dL, whichever is higher.
Direct bilirubin < 1.4 mg/dL (23.9 micromoles/L); Note: a total bilirubin of < 1.4 mg/dL (23.9 micromoles/L) is acceptable to meet this requirement
Serum bilirubin values < 2 mg/dL
Total bilirubin =< grade 1\r\n* Note: If total bilirubin is 2 to 3 mg/dL, but direct bilirubin is normal, then the patient will be considered eligible
Bilirubin =< grade 1\r\n* If bilirubin is 2-3 mg/dL, but direct bilirubin is normal then patient will be considered eligible
Total bilirubin < 2.0 mg/dl
Total bilirubin =< 1.5 x ULN (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)
Bilirubin less than or equal to 1.5 x the upper limit of normal (except subjects with Gilbert syndrome, who can have total bilirubin < 3 mg/dl)
Obtained within 30 days prior to registration: Bilirubin 1.5 =< (ULN)\r\n* Except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL
Serum total bilirubin < 2 mg/dl (except if known Gilbert syndrome AND normal transaminases)
Total bilirubin =< 2 mg/dl (biliary stent is allowed)
Total bilirubin =< 1.5 mg/dL
Total bilirubin > 2 mg/dL (in the absence of Gilbert’s disease)
Total bilirubin < 2.0mg/dL unless due to Gilbert’s disease
Total bilirubin ? 2.0 mg/dL not related to hemolysis or Gilbert's disease.
Total bilirubin =< 1.5 mg/dL or direct bilirubin =< 0.4 mg/dL
Serum bilirubin greater than 1.5 mg/dl
Direct bilirubin < 1.4 mg/dL (23.9 micromoles/L); note: a total bilirubin of < 1.4 mg/dL (23.9 micromoles/L) is acceptable to meet this requirement
Total bilirubin =< 2.0 mg/dL
Serum bilirubin > 3.0 mg/dl
Bilirubin =< 2.0 mg/dL
Bilirubin =< 2.0 mg/dl
Within 14 days of registration: Total bilirubin =< 2.0 mg/dL
Total bilirubin within =< 1.5 normal institutional limits (patients with Gilbert’s syndrome with total bilirubin up to 2.5 mg/dL is allowed)
Serum bilirubin < 1.5 mg/dl
Bilirubin =< 2.0 mg/dL within 2 weeks before baseline
Total bilirubin =< 2mg/dL.
Serum bilirubin =< 1.5 x ULN, (except patients with Gilbert’s syndrome, who must have a total bilirubin less than 3.0 mg/dL)
Total bilirubin < 2.0 mg/dl
Serum bilirubin >= 6 mg/dl
Bilirubin =< 1.5 mg/dl
Total bilirubin < 4.5 mg/dl with direct fraction =< 0.3 mg/dl in patients for whom these abnormalities are felt to be due to protease inhibitor therapy
Total bilirubin =< 2 mg/dl unless high indirect bilirubin is due to a congenital disorder
Pretreatment serum bilirubin =< 2.5 x ULN or total bilirubin < 4.5 mg/dl with direct fraction =< 0.3 mg/dl in patients for whom these abnormalities are felt to be due to protease inhibitor therapy
Direct bilirubin =< 2mg/dL
Serum bilirubin < 2 mg/dL
Bilirubin =< 2 mg/dl, within 14 days prior to registration
Total bilirubin less than or equal to 2.0 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dl
Bilirubin =< 1.6 mg/dL (except patients with Gilbert’s syndrome, who must have a total bilirubin less than 3.0 mg/dL)
Total bilirubin: =< 2.0 mg/dL
Total bilirubin =< 2.0 mg/dl
Total bilirubin >= 1.5 mg/dL (> 26 mol/L, International System of Units [SI] unit equivalent)
Total bilirubin =< 2 mg/dL (=< 3 mg/dL in case of Gilbert's syndrome)
Direct bilirubin =< 1 mg/dL
Patients must have a serum bilirubin =< 2.0 mg/dl
Total bilirubin < 2.0 mg/dL
Bilirubin =< 1.5 mg/dl, in patients with Gilbert's syndrome, a total bilirubin =< 3.0 mg/dL
Total bilirubin =< to 2.0 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dl
Direct bilirubin > 1.5 mg/dL
Total bilirubin =< 2.5 mg% (unless from Gilbert’s disease or disease-related)
Total bilirubin less than or equal to 2.0 mg/dL, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dL
Bilirubin < 1.5 mg/dL
Total bilirubin less than or equal to 2.0 mg/dL, except in patients with Gilbert's syndrome who must have a total bilirubin less than 3.0 mg/dL
Total bilirubin less than or equal to 2.0 mg/dL, except in patients with Gilbert's syndrome who must have a total bilirubin less than 3.0mg/dL
Total bilirubin =< 4.0 mg/dl
Total bilirubin =< 1.5 mg/dL
Bilirubin =< 1.5 mg/dl
Bilirubin =< 2.0 mg/dL
Bilirubin < 2.0 mg/dL
Bilirubin < 2.0 mg/dL
Serum total bilirubin < 2 mg/dl; patients with Gilbert syndrome are excluded from the requirement of a normal bilirubin
Total bilirubin < 1.5 mg/dL
Total bilirubin =< 2.0 mg/dl
Bilirubin =< 2 x ULN (except subjects with Gilbert syndrome who must have total bilirubin < 3.0 mg/dL)
Bilirubin =< 2 x ULN (except subjects with Gilbert’s syndrome, who must have total bilirubin < 3.0 mg/dL)
Total bilirubin =< 1.5 mg/dL
Serum bilirubin =< 3.0 mg/dl for Group A
Serum bilirubin =< 2.0 mg/dl for Group B or C (unless segmental infusion can be performed, then serum bilirubin =< 3.0 mg/dl allowed)
Total bilirubin must be =< 1.5 mg/dL except in patients with Gilbert’s syndrome (as defined by > 80% unconjugated bilirubin) it must be < 5 mg/dl
Bilirubin < 1.5 mg/dL, with the exception of patients thought to have Gilbert's syndrome, who may have a total bilirubin above 1.5 mg/dL
Bilirubin =< 1.5 mg/dL
No history of severe prior or ongoing chronic liver disease; total bilirubin =< 2.0 mg/dl
Total bilirubin =< 2.2 mg/dL
Total bilirubin >= 1.5 mg/ml
Poor liver function defined as bilirubin >= 2 mg/dl (not due to hemolysis, Gilbert’s or primary malignancy) or
Total bilirubin =< 5 mg/dL
Bilirubin =< 1.5 mg/dL
Bilirubin =< 1.5 mg/dL within four weeks prior to randomization
Total bilirubin =< 2.0 mg/dL
Serum bilirubin =< 1.5 mg/dL; patients with Gilbert's disease: serum bilirubin < 5 mg/dL
Total bilirubin =< 1.5 mg/dL (25.65 umol/L) (except patients with Gilbert's disease)
Bilirubin < 2.0 mg/dL;
Total bilirubin =< 2.0mg/dL
Bilirubin ? 1.5 mg/dl
Bilirubin ? 1.5 mg/dl
Bilirubin less than 1.5 mg/dL; (except in patients with Gilbert's syndrome, who must have a total bilirubin less than 3.0 mg/dL)
Serum total bilirubin > 1.5 × ULN or > 3.0 mg/dL for subjects with documented Gilbert's syndrome
Bilirubin < 2.0 mg/dL.
Total bilirubin less than or equal to 2 mg/dL
Serum bilirubin > 2.0 mg/dl (except in the case of Gilbert syndrome or ongoing hemolytic anemia)
Serum bilirubin =< 2.0 x ULN (except patients with Gilbert’s syndrome, who must have a total bilirubin less than 3.0 mg/dL)
Bilirubin > 2 mg/dl (total) except > 5 mg/dl in patients with Gilbert’s syndrome as defined by > 80% unconjugated
Total bilirubin =< 1.5 mg/dl
Within 56 days prior to randomization: Serum total bilirubin < 3.0 mg/dL
Serum bilirubin < 2.0 mg/dL unless Gilberts disease
Total bilirubin =< 2 mg/dL
Total bilirubin =< 1.5 mg/dL
Total bilirubin ? 2.0 mg/dL not related to Gilbert's disease or hemolysis.
Total bilirubin =< 3.0 mg/dl
Bilirubin ? 2.5 mg/dL
Total bilirubin =< 2.0 mg/dL
Total bilirubin =< 1.5 mg/dl
Bilirubin =< 2 x ULN (except subjects with Gilbert’s syndrome, who must have total bilirubin < 3.0 mg/dL)
Bilirubin within normal limits (except subjects with Gilbert's syndrome, who must have a total bilirubin < 3.0 mg/dL)
Total bilirubin ?1.5 mg/dL
Bilirubin =< 1.5 x ULN (except for patients with Gilbert’s syndrome, who must have a total bilirubin =< 3 mg/dL)
Bilirubin =< 1.5 x ULN; for patients with Gilbert's syndrome, bilirubin =< 3.0 mg/dL is acceptable
Serum bilirubin =< 2.0 mg/dl
Total bilirubin < 2.0 mg/dL
Total bilirubin (except patients with Gilbert’s syndrome, who are eligible for the study but exempt from the total bilirubin eligibility criterion) =< 2.0 mg/dl
Serum total bilirubin =< 2.0 mg/dL
Bilirubin < 2.0 mg/dl, unless subject has Gilbert’s syndrome (=< 3.0 mg/dL)
Total bilirubin ? 3 x ULN, (except patients with Gilbert's Syndrome, who must have a total bilirubin less than 3.0 mg/dL)
Total bilirubin less than or equal to 2.0 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dl
Have plasma total cholesterol < 300 mg/dL
Have plasma total cholesterol > 300 mg/dL
Total bilirubin =< 2.5 mg/dl (unless the patient has a history of Gilbert’s syndrome)
Total bilirubin =< 1.5 x ULN (except subjects with Gilbert Syndrome who must have total bilirubin < 3.0 mg/dL)
Total bilirubin =< 1.5 mg/dL
Bilirubin < 1.5 mg/dL
Total bilirubin > 2.0 mg/dl, except in patients with Gilbert's syndrome whose total bilirubin must not exceed 3.0 mg/dl) deemed by investigator to be irreversible
Total bilirubin > 2.0 mg/dl, except in patients with Gilbert's syndrome whose total bilirubin must not exceed 3.0 mg/dl)
Total bilirubin =< 1.5 mg/dL (< 3 mg/dL for patients with Gilbert’s syndrome)
Bilirubin less than or equal to 3.0 mg/dL
Patients must have a serum bilirubin =< 1.5 mg/dl
Total serum bilirubin =< 1.5 × the ULN; for subjects with known Gilbert’s disease or similar syndrome with slow conjugation of bilirubin, total bilirubin =< 3.0 mg/dL
Total bilirubin =< 2 mg/dL
Patients must have adequate organ and marrow function defined as: absolute neutrophil count (ANC) >/= 1,000/mL, platelets >/=75,000/mL; creatinine clearance >/= 35 ml/min; total bilirubin </= 2 X ULN (exceptions may apply to benign non-malignant indirect hyperbilirubinemia such as Gilbert syndrome); ALT (SGPT) and or AST (SGOT) </= 5 X ULN Exception for patients with liver metastasis: total bilirubin </= 3 x ULN; ALT (SGPT) </= 8 X ULN; Fasting lipid profile: cholesterol </= 350 mg/dL; triglycerides </= 400 mg/dL Corrected calcium >/= 8.4 mg/dL; phosphorus >/= 2.5 mg/dL for denosumab
Bilirubin =< 3.0 mg/dl, unless considered due to tumor
If the patient is to be treated with cisplatin, the serum bilirubin of =< 2.0 mg%
Total bilirubin =< 1.5 x ULN (< 3 mg/dL for subjects with Gilbert's disease)
Total bilirubin =< 2.0 mg/dL, unless due to Gilbert’s disease
Total Serum Bilirubin ? 1.5 x ULN (< 3.0 mg/dL if subject has Gilbert's syndrome)
Total bilirubin ? 1.5 × ULN (except in patients with Gilbert Syndrome who can have total bilirubin < 3.0 mg/dL).
Total bilirubin < 2.0 mg/ dl
Serum bilirubin ? 1.5 x ULN, except in patients with Gilbert's Syndrome who must have a total bilirubin < 3 mg/dL
Total serum bilirubin =< 2.0 mg/dL
Bilirubin < 2.0 mg/dl
Bilirubin =< 3.0 mg/dL (unless due to Gilbert’s syndrome or hemolysis)
Advanced bilirubin levels > 3 mg/dl
Bilirubin less than or equal to 2.0 mg/dl
Total bilirubin =< 1.5 mg/dL (if total is elevated check direct and if normal patient is eligible), obtained =< 21 days prior to registration and confirmed prior to the first dose of study drug
Total bilirubin =< 1.5 mg/dl
Bilirubin =< 1.5 mg/dL
Total bilirubin =< 1.5 mg/dl
Bilirubin =< 1.5 mg/dL (OR in patients with Gilbert’s syndrome, a total bilirubin =< 3.0) (within 16 days before starting therapy)
Total bilirubin =< 2.0. mg/dL or < 2.5 mg/dL if attributable to hepatic infiltration by neoplastic disease or Gilbert’s syndrome
Serum bilirubin < 1.5 mg/dL
In the case of Gilberts syndrome, or documented liver or pancreatic involvement by lymphoma, the requirement for total bilirubin is =< 5.0 mg/dL
Bilirubin =< 2 mg/dL, unless due to chronic GVHD
Total bilirubin =< 2 mg/dl unless high indirect bilirubin is due to a congenital disorder
Total bilirubin =< 1.5 mg/dL or < 2 mg/dL if attributable to hepatic infiltration by neoplastic disease
Serum bilirubin: ? 1.2 mg/dL
Total bilirubin =< ULN (except subjects with Gilbert syndrome who must have total bilirubin < 3.0 mg/dl)
Bilirubin =< 1.5 mg/dl (unless Gilbert's syndrome)
Serum bilirubin < 1.5 mg/dl
Total bilirubin =< 1.5 x ULN; for participants with Gilbert’s disease =< 3.0 mg/dL
Total bilirubin =< 2.0 mg/dL
Total bilirubin < 2.0 mg/dl-exception permitted in patients with Gilbert’s syndrome
Serum total bilirubin < 2 x ULN (except patients with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)
Total bilirubin =< 2.0 mg/dl-exception permitted in participants with Gilbert’s syndrome
Total serum bilirubin =< 2 mg/dL
Obtained =< 21 days prior to registration: Total bilirubin =< 2.0 mg/dL (if total is elevated check direct and if normal patient is eligible)
Bilirubin =< 2.0 mg/dl within 21 days prior to study registration unless patient has Gilbert’s syndrome
Serum bilirubin < 1.5 mg/dl
Total bilirubin =< 1.5 mg/dl
Direct bilirubin < 2.0 mg/dl
Bilirubin =< 1.5 mg/dl
Bilirubin =< 3.0 mg/dL
Bilirubin =< 1.5 mg/dL (or =< 3.0 mg/dL if due to Gilbert's syndrome)
Total bilirubin within normal limits, 0–1 mg/dL
Total bilirubin =< 1.5 mg/dL (exception: patients with documented Gilbert’s syndrome are allowed to participate despite elevated bilirubin)
Bilirubin < 1.5 mg/dl (OR in patients with Gilbert’s syndrome, a total bilirubin =< 3.0 mg/dL)
Total bilirubin =< 1.5 mg/dL (except Gilbert’s syndrome or known hemolysis or leukemic infiltration)
Bilirubin =< 2.5 x ULN (except for patients with Gilbert’s syndrome, who must have a total bilirubin =< 3 mg/dL)
Bilirubin =< 2.0 x ULN, (except patients with Gilbert's syndrome, who must have a total bilirubin less than 3.0 mg/dL)
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
Serum direct bilirubin < 2 mg/dL (34 Omol/L) within 30 days prior to cycle 1 day 1
Total bilirubin < 2.0 mg/dL
Total bilirubin =< 1.5 mg/dL
Total bilirubin =< 5.0 mg/dL
Bilirubin =< 1.5 mg/dL
Total bilirubin < 2.0 mg/dL unless due to Gilbert’s disease, hemolysis or leukemia
Bilirubin < 2.0 mg/dL
COHORT A: Bilirubin =< 1.5 x ULN (except patients with Gilbert's syndrome, who must have a total bilirubin less than 3.0 mg/dL)
COHORT B: Bilirubin =< 1.5 x ULN (except patients with Gilbert's syndrome, who must have a total bilirubin less than 3.0 mg/dL)
Serum total bilirubin =< 2.5 mg/dL; Note, patients with Gilbert’s syndrome may have elevated bilirubin at baseline prior to diagnosis with AML or MDS; patients with Gilbert’s syndrome are included if their total bilirubin is =< 2 times their baseline total bilirubin
Serum total bilirubin > 2.5 mg/dL; Note, patients with Gilbert’s syndrome may have elevated bilirubin at baseline prior to diagnosis with AML or MDS; patients with Gilbert’s syndrome are excluded if their total bilirubin is > 2 times their baseline total bilirubin
Serum total bilirubin > 2.0 mg/dL
Total bilirubin < 1.5 mg/dl
Bilirubin =< 1.8 mg/dL within 4 weeks of enrollment
Within 30 days prior to initiation of protocol treatment: Bilirubin =< 1.5 mg/dL\r\n* Subjects with documented Gilbert’s disease may have bilirubin up to 2.5 mg/dL
Bilirubin =< 1.5 mg/dl
Alanine aminotransferase ? 5 × ULN and total bilirubin < 2.0 mg/dL (or < 3.0 mg/dL for subjects with Gilbert's syndrome or leukemic infiltration of the liver)
Bilirubin =< 2 mg/dl within 30 days prior to registration
Total bilirubin > 2.0 mg/dL (or > 3.0 mg/dL in participants with documented Gilbert syndrome)
Total bilirubin =< 1.5 x ULN, except subjects with Gilbert’s syndrome who can have total bilirubin =< 3.0 mg/dL
Total bilirubin =< 1.5 mg/dL
Total bilirubin =< 3.0 mg/dL
Serum direct bilirubin < 2 mg/dL (34 Omol/L) within 7 days of time of consent
Total bilirubin =< 1.5 mg/dl
Total bilirubin =< 2.0 mg/dl, except in cases of Gilbert’s disease
Total bilirubin =< 2.5 mg/dl
Total bilirubin =< 1.5 mg/dl
Bilirubin =< 1.5 mg/dL (OR in patients with Gilbert's syndrome, a total bilirubin =< 3.0) (within 16 days before starting therapy)
Total bilirubin within normal institutional limits; for patients with Gilbert's syndrome, total bilirubin =< 3.0 mg/dL
Total bilirubin =< 1.2 mg/dL; for patients with Gilbert syndrome, the direct bilirubin should be within the institutional normal range
Total bilirubin =< 3.0 mg/dL
Total bilirubin =< 3.0 mg/dL and no evidence of bile obstruction
Bilirubin < 2.0 mg/100 ml
Total bilirubin =< 3 mg/dL
Total bilirubin =< 2 mg/dl; patients with biliary obstruction can join if bilirubin corrects to required limit after adequate biliary drainage
Serum bilirubin level of less than 1.5 mg/dl
Total bilirubin < 2 X ULN (except for subjects with documented Gilbert’s syndrome who can have total bilirubin < 3.0 mg/dl)
Total or direct bilirubin =< 1.5 mg/dL
Total bilirubin =< 1.5 mg/dL
Total bilirubin =< 1.5 mg/dl
Total bilirubin =< 2.0 mg/dl
Total bilirubin =< 1.5 mg/dL
Total bilirubin =< 1.5 mg/dL
Total bilirubin < 2.0 mg/dl
Total bilirubin =< 1.5 mg/dL
Total bilirubin =< 2.0 mg/dL
Total bilirubin =< 3.0 mg/dL (or direct bilirubin < 1 mg/dL)
Total bilirubin =< 2.0 mg/dL
Serum bilirubin < 1.5 mg/dl
Total bilirubin =< 1.5 mg/dL
Total bilirubin =< 1.5 mg/dL
Total serum bilirubin < 1.5 mg/dL
Serum total bilirubin < 2.0 mg/dL, patients with Gilbert's Syndrome should contact the medical monitor
Total serum bilirubin must be < 3 mg/dL unless the elevation is thought to be due to Gilbert's disease or hemolysis
Total bilirubin > 3 mg/dL
Total bilirubin =< 1.5 mg/dL (unless benign congenital elevated bilirubin)
Direct bilirubin less than or equal to 3.0 mg/dL
Total serum bilirubin =< 1.5 mg/dL
Bilirubin =< 1.5 ULN, (except patients with Gilbert’s syndrome, who must have a total bilirubin less than 3.0 mg/dL)
Bilirubin =< 2.0 mg/dL
Total bilirubin =< 2.0 mg/dL (unless MCL related or attributable to Gilbert’s disease)
Bilirubin of < 3 mg/dl
Total bilirubin =< 3 mg/dL
Total bilirubin < 1.5 mg/dL
Bilirubin =< 3.0 x ULN, (except patients with Gilbert’s syndrome, who must have a total bilirubin less than 3.0 mg/dL)
Serum bilirubin < 2 mg/dL (unless due to Gilbert's syndrome)
total bilirubin > 2.0 mg/dl (34 µmol/L) except in cases of Gilberts Syndrome and documented liver or pancreatic involvement by lymphoma
Bilirubin < 3.0 mg/dl
Bilirubin =< 2.0 x ULN, (except patients with Gilbert’s syndrome, who must have a total bilirubin less than 3.0 mg/dL)
Total bilirubin <1.6 mg/ml
Total Bilirubin >1.5x ULN (except subjects with Gilbert syndrome, total bilirubin <3.0 mg/dL)
Total bilirubin =< to 1.5 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dl
Bilirubin: ~ 2.0 x ULN (except for subjects with Gilbert’s syndrome, who must have a total bilirubin of less than 3.0 mg/dL)
Bilirubin =< 1.5 mg/dL
Total bilirubin >= 1.5 mg/dL and not related to hemolysis or Gilbert's disease; patients with total bilirubin >= 1.5 mg/dL to 3 mg/dL are eligible if at least 75% of the bilirubin is indirect
Total bilirubin =< 2 mg/dl (biliary stent is allowed)
Bilirubin =< 2.0 mg/100 ml
Bilirubin < 2.0 mg/dl (unless attributed to Gilbert's disease)
Bilirubin =< 2.0 mg/dL
Serum bilirubin =< 1.5 mg/dL
Elevation of bilirubin to > 3 mg/dl
Total bilirubin =< 1.5 mg/dl, within 14 days of registration
Bilirubin < 2.0 mg/dL
Total bilirubin =< 2.0 mg/dl
Bilirubin less than or equal to 3.0 mg/dL (unless considered tumor related)
Serum bilirubin =< 2.0 mg/dl, within 4 weeks prior to first immunization
Total bilirubin < 2.5 mg/dL (unless documented Gilbert’s syndrome)
Total bilirubin =< 3 mg/dL
Total bilirubin less than or equal to 2.0 mg per dL
Total bilirubin < 1.5 mg/dl
Total bilirubin of =< 1.5 mg/dl
Total bilirubin < 2 mg/dL
Total bilirubin =< 1.5 mg/dl unless felt secondary to Gilbert's disease
Total bilirubin =< 1.5 mg/dL
Total bilirubin =< 1.5 mg/dL
Total bilirubin =< 1.5 x ULN (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)
=< 10 days prior to enrollment/randomization: Total bilirubin =< 1.5 mg/dl
Within 8 weeks of randomization: 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 bilirubin ?1.5 x ULN, except in patients with Gilbert's Syndrome who must have a total bilirubin <3 mg/dL (51.3 ?mol/L)
Total bilirubin <1.5 x ULN, except for patients with Gilbert's disease who are eligible if total bilirubin ? 3mg/dL.
Bilirubin < 1.5x ULN (except for patients with Gilbert's disease, for whom the upper acceptable limit of serum bilirubin is 3mg/dL)
Adequate hepatic and renal function laboratory values within 14 days prior to registration: Total bilirubin =< 1.5 mg/dL except for patients with a history of elevated total bilirubin, such as in Gilbert's
Bilirubin =< 2.0 mg/dL
Bilirubin =< 2.0 mg/dL
Bilirubin =< 2.0 mg/dL
Bilirubin =< 2 mg/dL
Total bilirubin =< 3.0 mg/dL
Bilirubin =< 2.0 mg/dL
PRIOR TO POST-TRANSPLANT IMMUNOTHERAPY: Bilirubin =< 2.0 mg/dL
Bilirubin < 2.0 mg/100 ml
Total bilirubin < 2.0 mg/dl except < 5 mg/dL in patients with Gilbert’s (as defined as > 80% unconjugated hyperbilirubinemia without other known cause); unless impairment due to organ involvement by lymphoma
Serum bilirubin > 2 mg/dl (unless due to Gilbert’s syndrome)
Total bilirubin =< 2 X ULN, except for patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dl (part 1 & 2)
Total bilirubin less than or equal to 1.5 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dl
Bilirubin =< 1.5 X upper limit of normal (ULN) unless the patient is receiving protease inhibitor therapy (i.e. indinavir, ritonavir, nelfinavir, and atazanavir) known to be associated with increased bilirubin: in this case total bilirubin =< 7.5 mg/dl and the direct fraction is =< 0.7 mg/dl
Total bilirubin =< 2.0 mg/dL obtained =< 14 days prior to registration (if total is elevated check direct and if normal patient is eligible)
Serum direct bilirubin < 1.5 mg/dL (unless Gilbert's syndrome)
Serum bilirubin =< 2.0 mg/dl
Serum total bilirubin >2.0 mg/dL (with the exception of Gilbert's Syndrome)
Direct bilirubin > 0.5mg/dL
Serum total bilirubin less than 2.5 mg/dl; patients with elevations of serum total bilirubin up to 10 mg/dl may be considered for participation if such elevations are thought to be due to liver involvement by malignancy; however, in these latter patients, if these values do not decrease to less than or equal to 2.5 times the upper limit of normal during induction chemotherapy, such patients will not be eligible for the transplant phase of the protocol, and will thus be taken off study
Patient has total bilirubin > 2.5 mg/dL.
Bilirubin < 1.5 mg/dl
Bilirubin =< 1.5 mg/dl (total) except < 5 mg/dl in patients with Gilbert’s syndrome as defined by > 80% unconjugated
Bilirubin levels greater than 3 mg/dl
Total bilirubin =< 1.5 mg/dl
Direct bilirubin =< 1.4 mg/dL (if total bilirubin > 1.4 mg/dL)
Serum total bilirubin of at least 3 mg/dL
Serum direct bilirubin < 1.5 mg/dL (unless Gilbert's syndrome)
Total bilirubin =< 1.2 mg/dL (except patients with Gilbert’s syndrome)
Bilirubin =< 1.5 mg/dl
Total bilirubin =< 3 x ULN (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)
Total bilirubin < 1.5 mg/dL or UNL
Total bilirubin =< 2 mg/dL
Bilirubin < 3 mg/dl unless due to disease
Serum direct bilirubin less than 1 mg/dl (unless due to Gilbert’s syndrome or hemolysis)
Bilirubin > 3.0 mg/dl
Bilirubin: =< 2.0 x ULN (except for subjects with Gilbert’s syndrome, who must have a total bilirubin of less than 3.0 mg/dL)
Serum bilirubin levels =< 1.5 mg/dL except for patients with Gilbert’s syndrome
Total bilirubin < 2.5 mg/dl
Bilirubin for Gilbert’s =< 3.0 mg/dl
Total bilirubin =< to 2.0 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dl
Total serum bilirubin > 2.0 mg/dl
Total bilirubin =< to 1.5 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dl
Serum bilirubin < 1.5 mg/dl
Bilirubin less than or equal to 1.5 mg/dL; even if organ function abnormalities are considered due to tumor, the upper limit for bilirubin is less than or equal to 2.0 mg/dL (unless due to hemolysis or Gilbert’s disease, i.e. mainly indirect bilirubin)
Serum total bilirubin < 2 mg/dl; patients with Gilbert syndrome are excluded from the requirement of a normal bilirubin
Bilirubin < 1.5 mg/dl except for Gilbert’s disease
Total bilirubin ?1.5 mg/dL
Total bilirubin < 2.0 mg/dL
Total bilirubin =< 2.0 mg/dL
Total bilirubin =< 2.5 mg/dL
Total bilirubin =< 2.0 mg/dl
Total bilirubin =< 1.5 mg/dl
Bilirubin less than or equal to 3 mg/dL within 24 hours of enrollment
Bilirubin < 1.5 mg/dl
No impairment of hepatic function (serum bilirubin level of less than 1.2 mg/dl)
Serum total bilirubin =< 2.0 mg/dL
Bilirubin <1.5 mg/dL or direct bilirubin <1.0 mg/dL
Total bilirubin less than or equal to 1.5 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dl
Total bilirubin =< 3 mg/dl
Total bilirubin =< 2 mg/dL
Bilirubin =< 1.5 mg/dL
Total bilirubin >2.5 mg/dL
Total bilirubin <1.5 mg/dl, except in subjects with Gilbert's syndrome
Total bilirubin ?2 mg/dL
Bilirubin =< 1.5 ULN, (except patients with Gilbert’s syndrome, who must have a total bilirubin less than 3.0 mg/dL)
Total bilirubin ?3.0 mg/dL
Direct bilirubin less than or equal to 3.0 mg/dL
total bilirubin of ? 2.0 mg/dl (? 3.0 mg/dl for patients with known Gilbert's syndrome)
Patient must have adequate hepatic function documented by a total bilirubin of ? 2.0 mg/dl (? 3.0 mg/dl for patients with known Gilbert's syndrome) and ALT and AST ? 3 times the ULN for the reference lab.
Total bilirubin =< 2.5 mg/dL
Serum total bilirubin > 1.5 mg/dL or > 3 × ULN for patients with hereditary benign hyperbilirubinemia
Total bilirubin =< 1.5 mg/dL (unless there is a known history of Gilbert's syndrome)
Total bilirubin < 2.0 mg/dL, except when the patient is known to have Gilbert’s syndrome, the total bilirubin can be =< 3.0 mg/dL
Total bilirubin =< to 1.5 mg/dL, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dL
Total bilirubin =< 1.5 mg/dL
Direct bilirubin equal to or less than 2.0 mg/dL
Total bilirubin =< 2.5 mg/dl
Serum bilirubin levels =< 1.5 mg/dL except for patients with Gilbert’s syndrome
Does the subject have an ALT < 3 times the upper limit of the laboratory reference range and total bilirubin < 1.5 mg/dL?
Total bilirubin of ? 1.5 mg/dL or ? 2.0 mg/dL for subjects with liver metastasis
Total bilirubin < 1.5 mg/dl
Total bilirubin =< 2.0 mg/dL
Total bilirubin =< 2.0 mg/dL (excluding Gilbert’s syndrome), unless due to lymphoma
Abnormal liver function tests: Serum aspartate transaminase (AST/SGOT) or alanine transaminase ( ALT/SGPT) 2 x upper limit of normal (ULN). Serum bilirubin. Total bilirubin > 2.0 mg/dL (34 µmol/L), conjugated bilirubin > 0.8 mg/dL.
Total bilirubin < 4.0 mg/dl
Total bilirubin =< 2.5 mg/dL
Serum direct bilirubin =< 2 mg/dL (34 umol/L) within 14 days prior to randomization
Total bilirubin =< 2.0 mg/dL unless due to Gilbert’s syndrome, hemolysis, or ineffective hematopoiesis
Total bilirubin ?3.0 mg/dL
Must have total serum bilirubin ? 3 mg/dl
Bilirubin ?1.5 mg/dL
Bilirubin less than 1.5 mg/dL; (except in patients with Gilbert's syndrome, who must have a total bilirubin less than 3.0 mg/dL)
Total bilirubin < 1.5 mg/dl
Serum bilirubin =< 1.5 mg/dL; except for patients with Gilbert's disease: serum bilirubin < 5 mg/dL
Total bilirubin =< 1.5 mg/dl
Bilirubin =< 1.6 mg/dL
Total bilirubin =< to 1.5 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dl
Total bilirubin less than or equal to 2 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3 mg/dl
Conjugated bilirubin </= 1.5 mg/dL (or total bilirubin </= 2.5 mg/dL)
Bilirubin =< 1.5 mg/dL
Bilirubin =< 1.50 mg/dL
Total bilirubin < 1.5 mg/dl
Total bilirubin < 3.0 mg/dl
Bilirubin =< 3.0 mg/dL (unless due to Gilbert’s syndrome or hemolysis)
Bilirubin =< 3.0 x ULN (except patients with Gilbert's syndrome, who must have a total bilirubin less than 3.0 mg/dL)
Serum total bilirubin > 2.0 mg/dL
Total bilirubin =< 3 mg/dl
Total bilirubin =< 2.0 mg/dl
Total bilirubin < 2.0 mg/dL or < 1.50 x ULN for the institution whichever is higher
Bilirubin > 2.0 mg/dL (26 umol/L)
ALT < 3 times ULN and bilirubin < 1.5 mg/dL
Serum bilirubin levels =< 1.5 mg/dL
Bilirubin =< 1.5 mg/dl (unless Gilbert's syndrome)
Total bilirubin < 1.5 X ULN mg/dl
Serum direct bilirubin =< 2.0 mg/dl
Total bilirubin =< 1.5 mg/dl
Total Bilirubin > 2 mg/dL
Total bilirubin < 2 × upper limit of normal, direct bilirubin < 2.0 mg/dL.
Serum bilirubin < 2.0 mg/dL
Serum bilirubin < 3 mg/dl
Patients must have a serum bilirubin equal to or =< 2.0 mg/dl (isolated hyperbilirubinemia related to Gilbert's disease allowed)
Total serum bilirubin ? 2.0 mg/dL
Total bilirubin =< 1.5 x ULN; (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)
Total bilirubin < 2 mg/dL
Serum bilirubin > 25 umol/L (1.5 mg/dL)
Total bilirubin less than or equal to 2.0 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dl
Total bilirubin =< 1.5 mg/dL
Total bilirubin =< to 1.5 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dl
Total bilirubin =< 2.5 mg/dl
Total bilirubin =< to 1.5 mg/dl, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dl
Total serum bilirubin > 2 mg/dL
Bilirubin =< 2.0 x ULN, (except patients with Gilbert’s syndrome, who must have a total bilirubin less than 3.0 mg/dL)
Bilirubin > 1.6 mg/dL
Total bilirubin =< 1.5 mg/dL unless due to Gilbert’s disease
Patients with bilirubin between 1.5-3.0 mg/dL due to lymphoma may be entered and doses adjusted
Bilirubin =< 2.0 mg/dL
Total bilirubin =< 1.5 mg/dL
Total bilirubin ? 1.5 x ULN (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)
Total serum bilirubin =< 1.5 mg/dL
Total bilirubin =< 1.5 mg/dL X ULN unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin
Bilirubin =< 3.0 mg/dL (unless due to Gilbert’s syndrome or hemolysis)
Serum direct bilirubin >= 1 mg/dl (except Gilbert's syndrome or hemolysis)
Bilirubin level >= 3.7 mg/dL.
Serum bilirubin =< 1.0 mg/dL
Total bilirubin < 2.5 mg/dL unless the increase in bilirubin is attributable to Gilbert‘s syndrome
Bilirubin =< 2.5 mg/dL, except for patients with Gilbert’s syndrome or hemolysis
Total bilirubin =< 1.5 mg/dL
Bilirubin ? 2.0 mg/dl; AST and ALT < 5.0 times the ULN
Bilirubin =< 1.5 x ULN (except subjects with Gilbert’s syndrome who must have total bilirubin =< 3.0 mg/dL), obtained within 14 days of the first dose of study drug
Total serum bilirubin =< 1.5 mg/dl (patients with total bilirubin > 1.5 mg/dL eligible only with Gilbert’s syndrome)
Total bilirubin =< 1.5 mg/dL
Total bilirubin < 2.0 mg/dl-exception permitted in participants with Gilbert’s syndrome
Total bilirubin =< 1.5 mg/dL
A total bilirubin of less than 2.5 mg/dL, unless these values are due to underlying hematologic malignancy
Total bilirubin equal to or less than 2 mg/dl
Total bilirubin =< 3.0 mg/dL (bilirubin =< 1.5 x ULN)
Serum bilirubin ? 1.5 times the upper limits of normal. Subjects with a history of Gilbert's syndrome may be enrolled if the total bilirubin is < 3 mg/dL with an indirect bilirubin of > 1.5 mg/dL
Total bilirubin < 2.0 mg/dl, unless hepatic dysfunction is a manifestation of cGVHD; for patients in whom a diagnosis of hemolysis or Gilbert’s is made, the total bilirubin is allowed to be elevated
A bilirubin of up to 2.0 mg/dL, excluding patients with Gilbert’s disease
Serum bilirubin =< 2.0 mg/dL within 28 days prior to registration
Total bilirubin =< 3.0 mg/dL
Total bilirubin < 2.0 mg/dl
Total bilirubin =< 1.5 mg/dl within 90 days of enrollment
Total cholesterol =< 200 mg/dl
Total bilirubin =< 2.0 mg/dl
Total bilirubin ?1.5 mg/dL
Iron (Fe) phosphatase =< 5 x upper limit of normal and total bilirubin =< 2.5 mg/dL except for patients with Gilbert’s syndrome or hemolysis
Bilirubin =< 1.5 mg/dL (or =< 3.0 mg/dL for patients with Gilbert’s syndrome)
Serum bilirubin must be ? 2.0 mg/dl
Total bilirubin =< 2.5 mg/dl (unless the patient has a history of Gilbert’s syndrome)
Serum bilirubin must be ? 2.0 mg/dl
Total serum bilirubin =< 2.0 mg/dL
Bilirubin =< 1.5 mg/dl
Total bilirubin < 1.5 mg/dl
T. bilirubin < 2 mg/dl (Patients with Gilbert Syndrome total bilirubin <3xULN and direct bilirubin ? 35%)
Total bilirubin > 2.0 mg/dL
Total bilirubin =< 2.0 mg/dl
Total bilirubin >= 2 x the upper limits of normal or > 3.0 mg/dl in patients with Gilbert’s syndrome
Have plasma total cholesterol < 200 mg/dL
Subjects must have a serum direct bilirubin < 2.0 mg/dL unless related to Gilbert’s syndrome of hemolysis; if the total bilirubin =< 2.0, direct bilirubin does not need to be drawn
Bilirubin > 1.4 mg/dl
Total bilirubin ? 1.5 mg/dL
Total bilirubin =< 2.0 mg/dL
Bilirubin < 2.0 mg/dL
Bilirubin < 2.0 mg/ dL
Serum total bilirubin ? 2.5 mg/dL (43 ?mol/L), except for subjects with Gilbert's syndrome.
Total serum bilirubin < 2.0 mg/dL, within 2 weeks prior to study start
Total bilirubin =< 2 mg/dL
Total bilirubin < 1.5 mg/dL
Serum bilirubin =< 2.0 mg/dl
Total Bilirubin <4.0 mg/dl
Bilirubin > 1.6 mg/dL
Serum bilirubin =< 1.5 mg/dL
Total bilirubin =< 1.5 x ULN mg/dL
Bilirubin > 1.5 mg/dL
Total bilirubin =< 2.0 mg/dL (except patients with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)