PARTICIPANTS ON THE HODGKIN LYMPHOMA EXPANSION COHORT: Total bilirubin: =<1.5 × institutional upper limit of normal (ULN), or =< 3 x ULN for participants with Gilbert’s disease or with atazanavir- or indinavir-induced unconjugated hyperbilirubinemia without AST or ALT elevation, and must have a total bilirubin less than 3.0 mg/dL), within 2 weeks prior to enrollment
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) within 30 days of day 1 of study; NOTE: patients with elevated bilirubin secondary to Gilbert’s disease are eligible to participate in the study
Total bilirubin =< 1.5 x upper limit of normal (ULN) (except in patients with Gilbert‘s syndrome who must have total bilirubin =< 3.0 x ULN)
Bilirubin =< 1.5 x institutional upper limits of normal (ULN); if patient has documented Gilbert’s syndrome bilirubin must be < 3 x institutional ULN
Within 2 weeks prior to screening step registration and within 4 weeks prior to treatment step registration: Total bilirubin =< 1.5 X institutional upper limit of normal (ULN) (unless documented Gilbert’s syndrome, for which bilirubin =< 3 x institutional ULN is permitted)
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
Bilirubin =< 1.5 x ULN upper limit of normal (except in patients with documented Gilbert’s disease, who must have a total bilirubin =< 3.0 mg/dL), must be obtained within 8 weeks prior to screening for protocol therapy
Total bilirubin < 1.5 x institutional upper limit of normal (=< 3 mg/dL in case of Gilbert’s syndrome)
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
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 upper limit of normal (ULN) unless isolated hyperbilirubinemia attributed to Gilbert’s syndrome
Total bilirubin =< 1.5 x upper limit of normal (ULN), except for patients with known Gilbert’s syndrome
Total bilirubin =< 1.5 x upper limit of normal (ULN) except subjects with documented Gilbert’s syndrome (> 5 x ULN) or liver metastasis, who must have a baseline total bilirubin =< 3.0 mg/dL
Total bilirubin =< 1.5 x upper limit of normal (ULN); patients with Gilbert’s Syndrome must have bilirubin =< 3 x ULN (for treatment phase)
Measured within 28 days prior to registration: total bilirubin =< 1.5 x institutional upper limit of normal (ULN). In the case of known Gilbert’s syndrome, a higher serum total bilirubin (< 2 × ULN) is allowed.
Serum total bilirubin =< 1.5 x upper limit of normal (ULN) or =< 3 x ULN for patients with Gilbert’s disease
Bilirubin =< 1.5 x the upper limit of normal (ULN); for subjects with known Gilbert’s disease, bilirubin =< 3.0 mg/dL
Total Bilirubin ? 1.5 x upper limit of normal (ULN), or patients diagnosed with Gilberts syndrome, that have been reviewed and approved by the medical monitor.
Total bilirubin within normal institutional limits (unless patient has Gilbert’s syndrome in which total bilirubin should be =< 2 x upper limit of normal [ULN])
Total bilirubin < 1.5 X upper limit of normal unless known diagnosis of Gilbert’s disease
Total bilirubin =< 1.5 x upper limit of normal (ULN) except patients with documented Gilbert’s syndrome (=< 3 x ULN)
Total bilirubin within normal institutional limits (or < 2 X the upper limit of normal in those with Gilbert’s disease)
Total bilirubin =< 1.5 x institutional upper limit of normal, unless due to Gilbert’s syndrome
Total bilirubin =< 1.25 x institutional upper limit of normal (ULN), with the exception of < 2.9 mg/dL for patients with Gilbert’s disease
Total bilirubin =< 1.5 x upper limit of normal (ULN) (or =< 2.5 x ULN for subjects with asymptomatic Gilbert’s syndrome)
Total serum bilirubin =< 1.5 x upper limit of normal (ULN), unless due to Gilbert’s syndrome
Bilirubin =< 1.5 x the upper limit of normal (ULN) within 7 days before the first dose of cabozantinib. For subjects with known Gilbert’s disease, bilirubin =< 3.0 mg/dL
Serum bilirubin ? 1.5 × upper limit of normal (ULN) or ? 2 x ULN if patient is known to have Gilbert’s disease as the only underlying hepatic disorder
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 institutional upper limit of normal (ULN) (or 2.0 x ULN in patients with documented Gilbert’s syndrome)
Total bilirubin=< 1.5 x upper limit of normal (ULN) (if, however, the participant has Gilbert’s disease or unconjugated hyperbilirubinemia that is considered to be secondary to with atazanavir or indinavir therapy, then the total bilirubin must be =< 3 x ULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN), unless due to Gilbert’s syndrome or hemolysis, in which case =< 3.0 x ULN is allowed
Total bilirubin (except for Gilbert’s syndrome) =< 2.5 x upper limit of normal (ULN)
Total bilirubin ? 1.5 x institutional upper limit of normal (ULN) (or ? 2.5 x ULN with Gilbert’s disease) within 28 days prior to registration
Serum bilirubin < 1.5 x upper limit of normal (ULN) (except for patients with documented Gilbert’s disease)
Total bilirubin =< 1.5 x upper limit of normal (ULN) unless due to Gilbert’s disease; if total bilirubin is > 1.5 x ULN, a direct bilirubin should be performed and must be =< upper limit of normal (obtained =< 14 days prior to registration)
Total bilirubin =< 2 x upper limit of normal (ULN) (except in the case of subjects with documented Gilbert’s disease >= 3 x ULN)
Total bilirubin < 1.5 times upper limit of normal except for known conjugation diseases such as Gilbert’s; direct bilirubin is not an inclusion criteria
Total bilirubin level =< 1.5 x upper limit of normal (ULN) or in patients with Gilbert’s syndrome, a total bilirubin of =< 3.0
Total bilirubin =< upper limit of normal (ULN) (except in Gilbert’s syndrome)
TREATMENT WITH SJCAR19: Total bilirubin =< 3 times the upper limit of normal for age, except in subjects with Gilbert’s syndrome
Total bilirubin =< 1.5 x upper limit of normal (ULN) (unless Gilbert’s disease), =< 5 days prior to C1D1
Serum bilirubin >= 1.5 x upper limit of normal (ULN), patients with Gilbert’s syndrome and a total bilirubin of < 3 times ULN are permitted)
Total 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 upper limit of normal (ULN) (patients with Gilbert’s syndrome may have serum bilirubin ? 3 x ULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN), except patients with Gilbert’s syndrome in whom total bilirubin must be < 3.0 mg/dL, within 2 weeks of registration
Total bilirubin =< institutional upper limit of normal (except for patients with Gilberts' syndrome who must have normal direct bilirubin)
Serum bilirubin =< 2 x the upper limit of normal (ULN) (except for patients with Gilbert’s disease)
Obtained within 28 days prior to the first dose of cabozantinib: bilirubin =< 1.5 x the upper limit of normal (ULN). For subjects with known Gilbert’s disease, bilirubin =< 3.0 mg/dL.
Total bilirubin =< 1.5 x upper limit of normal (ULN), unless due to Gilbert’s disease obtained =< 14 days prior to registration
Total bilirubin > 3 x institutional upper limit of normal (ULN) (unless documented Gilbert’s syndrome)
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (or =< 2.0 x ULN in patients with documented Gilbert’s syndrome)
Total bilirubin below the upper limit of normal (ULN), excluding patients with Gilbert’s syndrome
Total bilirubin =< 2 X upper limit laboratory normal (ULN); subjects with non-clinically significant elevations of bilirubin due to Gilbert’s disease are not required to meet these criteria
Serum bilirubin =< 1.5 x institutional upper limit of normal (ULN) (except patients with Gilbert’s syndrome, who can have total bilirubin < 3 mg/DL)
Total bilirubin < 1.5 x upper limit of normal (ULN) \r\n* For patients with Gilbert’s syndrome total bilirubin < 3.0 x ULN
Total serum bilirubin =< 2 x upper limit of normal (ULN), unless due to Gilbert’s syndrome.
Total bilirubin =< upper limit of normal (ULN) unless elevation is thought to be due to Gilbert’s syndrome
Total bilirubin within normal institutional limits (patients with confirmed Gilbert’s syndrome with a total bilirubin =< 2.0 x upper limit of normal [ULN], may be included in this study)
Within 7 days before the first dose of study treatment: Bilirubin =< 1.5 x the upper limit of normal (ULN); for subjects with known Gilbert’s disease, bilirubin =< 3.0 mg/dL
Serum bilirubin > 1.5 times the upper limit of normal (ULN) (except patients with Gilbert’s syndrome: total bilirubin of > 3 x ULN) at the time of screening
Total serum bilirubin =< 2 x upper limit of normal (ULN), unless due to Gilbert’s syndrome.
Total bilirubin (except for Gilbert’s syndrome) =< 2.5 x upper limit of normal (ULN)
Serum bilirubin =< 1.5 x upper limit of normal (ULN) or =< 3 x ULN for patients with Gilbert’s disease
Total bilirubin =< 1.5 x upper limit of normal (ULN) unless elevation due to Gilbert’s syndrome obtained =< 7 days prior to registration
Total bilirubin =< 1.5 x upper limit of normal (ULN) (unless related to Gilbert’s or Meulengracht’s syndrome)
Total bilirubin =< 1.5 X upper limit of normal (ULN) (patients with diagnosed Gilbert’s syndrome will not be excluded if their direct bilirubin is within normal institutional limits)
Serum bilirubin =< 2 x the upper limit of normal (ULN) (except for patients with Gilbert’s disease)
Total bilirubin =< 1.5 x upper limit of normal (ULN), unless due to Gilbert’s disease obtained =< 14 days prior to registration
Serum bilirubin =< 1.5 x institutional upper limit of normal (ULN) unless diagnosed with Gilbert’s syndrome.
Total bilirubin =< 2.0 x institutional upper limit of normal ([ULN]; unless attributable to Gilbert’s disease or other causes of inherited indirect hyperbilirubinemia, at which point total bilirubin must be =< 4.0 x ULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (unless due to Gilbert’s disease or disease-related hemolysis, then =< 3.0 x ULN)
Total bilirubin =< 1.5 ULN (upper limit of normal), unless due to Gilbert’s syndrome
Bilirubin =< 1.5 x upper limit of normal (ULN) (obtained within 28 days prior to first study treatment)\r\n* Subjects with known Gilbert’s disease should have a serum bilirubin =< 3 x ULN
Within 14 days of registration: Bilirubin within normal institutional limits (or < 2 X the upper limit of normal (ULN) in those with Gilbert’s disease)
Total bilirubin < 1.5 x upper limit of normal (ULN) (except in patients diagnosed with Gilbert’s disease)
LYMPHODEPLETION: Bilirubin =< 1.5 x upper limit of normal (ULN) unless attributed to Gilbert’s syndrome, obtained within 72 hrs prior to procurement
Obtained =< 14 days prior to registration: Total bilirubin =< 1.5 x upper limit of normal (ULN) unless due to Gilbert’s syndrome
Bilirubin =< 1.5 x upper limit of normal (ULN) unless due to Gilbert’s syndrome
Total bilirubin =< 1.5 times upper limit of normal (ULN) at the screening visit unless an alternate nonmalignant etiology exists (e.g., Gilbert’s disease)
Total bilirubin =< 1.5 times upper limit of normal (ULN) at the screening visit unless an alternate nonmalignant etiology exists (eg, Gilbert’s disease)
Total bilirubin =< 1.5 times upper limit of normal (x ULN) (=< 3 x ULN if considered to be due to leukemic involvement or Gilbert’s syndrome)
Total bilirubin =< 1.5 x upper limit of normal (ULN) or =< 3 × ULN in the case of suspected/documented Gilbert’s syndrome
Total bilirubin =< 2 times the upper limit of normal (ULN) (or =< 3.0 x ULN if deemed to be elevated due to Gilbert’s disease or leukemia)
Total bilirubin =< 1.5 x upper normal limit if documented hepatic involvement with lymphoma, or =< 5 x upper normal limit if history of Gilbert’s disease
Bilirubin =< 2 x the upper limit of normal (except Gilbert’s syndrome)
Total bilirubin < 3.0 x the upper limit of normal (ULN) for age (patients who have been diagnosed with Gilbert’s disease are allowed to exceed this limit)
Total bilirubin =< 1.5 x upper limit of normal (ULN) except subjects with documented Gilbert’s syndrome (> 3 x ULN), who must have a baseline total bilirubin =< 3.0 mg/dL
PHASE I: Total bilirubin =< 1.5 x upper limit of normal (ULN) (unless Gilbert’s disease)
Total bilirubin =< 1.5 x upper limit of normal (< 3 x ULN if Gilbert’s disease)
Total bilirubin > 1.5 x upper limit of normal (ULN) (unless evidence of Gilbert’s disease)
Total serum bilirubin =< 1.5 x upper limit of normal (ULN) unless attributable to Gilbert’s syndrome
Total bilirubin =< 3 x institutional upper limit of normal, unless there is a known history of Gilbert’s disease
Total serum bilirubin =< 1.5 x upper limit of normal (ULN), OR in patients with Gilbert’s syndrome, a total bilirubin =< 3.0
Serum bilirubin < 1.5 x upper limit of normal (ULN) except in patients with Gilbert’s syndrome as defined by > 80% unconjugated bilirubin
Serum total bilirubin =< 1.5 x upper limit of normal (ULN) or =< 3 x ULN for patients with Gilbert’s disease
Total bilirubin =< 1.5 x the upper limit of the normal range (ULN) unless related to disease or patient known to have underlying Gilbert’s disease
Total bilirubin =< 2 x institutional upper limit of normal (ULN) (except for known Gilbert’s syndrome/familial non-hemolytic jaundice)
Bilirubin =< 1.5 x upper limit of normal (ULN); for subjects with Gilbert’s disease =< 3.0 mg/dL
Total bilirubin =< 2 x upper limit of normal (ULN) (unless related to lymphoma or Gilbert’s disease) OR =< 5 x ULN for subjects with documented or suspected Gilbert’s disease, or related to involvement of the liver by the lymphoma, obtained =< 7 days prior to registration
Total bilirubin =< 2 times upper limit of normal (x ULN) (3 x ULN if considered to be due to leukemia involvement or Gilbert’s syndrome)
Total bilirubin =< 2 times upper limit of normal (x ULN) (=< 3 x ULN if considered to be due to leukemic involvement or Gilbert’s syndrome)
Total bilirubin =< 1.5 x the upper limit of normal (ULN) unless considered due to Gilbert’s syndrome
Total bilirubin =< 1.5 X upper limit of normal OR in patients with Gilbert’s syndrome, a total bilirubin =< 3.0
Total bilirubin (Tbili) < 1.6 x upper limit of normal (ULN)\r\n* Except subjects with known Gilbert’s syndrome
Within 4 days prior to the first dose of cabozantinib: Bilirubin =< 1.5 x the upper limit of normal (ULN) (for subjects with known Gilbert’s disease, bilirubin =< 3.0 mg/dL)
Total bilirubin =< 1.5 x upper limit of normal (ULN), unless due to Gilbert’s syndrome (< 5 if liver involvement with primary tumor)
Total bilirubin < 2 times upper limit of normal (unless due to Gilbert’s syndrome), performed within 28 days prior to registration
Total bilirubin =< 1.5 x upper limit of normal (ULN) OR 3 x ULN for Gilbert’s disease
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (patients with Gilbert’s syndrome may have serum bilirubin > 1.5 × ULN)
Total bilirubin =< 1.5 X institutional upper limit of normal (except for patients with documented Gilbert’s disease)
Bilirubin =< 1.5 x the upper limit of normal (ULN); for subjects with known Gilbert’s disease, bilirubin =< 3.0 mg/dL
Bilirubin =< 2 x upper limit of normal (ULN) (unless documented Gilbert’s syndrome, for which bilirubin =< 3 x upper limit of normal [ULN] is permitted) obtained within 2 weeks prior to registration
RANDOMIZED PHASE II (ARMS K AND L): Bilirubin =< 2 x upper limit of normal (ULN) (unless documented Gilbert’s syndrome, for which Bilirubin =< 3 x upper limit of normal [ULN] is permitted); obtained within 2 weeks prior to registration
Total bilirubin =< 1.5 x upper limit of normal OR in patients with Gilbert’s syndrome, a total bilirubin =< 3.0
Total bilirubin =< 2 x upper limit laboratory normal (ULN); subjects with non-clinically significant elevations of bilirubin due to Gilbert’s disease are not required to meet these criteria
Total bilirubin =< 1.5 x local institutional upper limit of normal (ULN)\r\n* If elevated total bilirubin is due Gilbert’s disease or disease-related hemolysis then total bilirubin =< 3.0 x local institutional ULN
Within 4 weeks of preregistration: Total bilirubin =< upper normal institutional limits (except for patients with Gilbert’s disease who are eligible despite elevated serum bilirubin level)
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 =< 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)
Bilirubin =< 1.5 times (x) upper limit of normal (ULN) (except patients with Gilbert’s syndrome, who must have a total bilirubin less than 3.0 mg/dL)
Total bilirubin < 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)
Adequate hepatic function (>= 1.5 x upper limit of normal [ULN]; patient’s with Gilbert’s disease are not excluded)
Within 14 days prior to first dose of study drug treatment: Serum bilirubin =< 1.5 x the upper limit of normal (ULN); patients with known Gilbert’s disease may have a bilirubin =< 3.0 x ULN
RENAL COHORT: Laboratory values as follows within 4 days before the first dose of daratumumab: bilirubin ? 1.5 x upper limit of normal (ULN); for subjects with known Gilbert’s disease, bilirubin ? 3.0 mg/dL
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
Within 14 days prior to day 1 of protocol therapy unless otherwise stated: Total bilirubin =< 1.5 X upper limit of normal (ULN) OR if Gilbert’s syndrome =< 3.0 X ULN
Serum bilirubin =< 1.5 x institutional upper limit of normal (ULN) unless diagnosed with Gilbert’s syndrome.
Total bilirubin =< 2.5 X institutional upper limit of normal or =< 3 in subjects with Gilbert’s syndrome
Total bilirubin =< 1.5 × institutional upper limit of normal (ULN), unless known Gilbert’s syndrome has been diagnosed
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN; unless attributable to Gilbert’s disease or other causes of inherited indirect hyperbilirubinemia, at which point total bilirubin must be =< 2.5 x ULN)
Obtained =< 7 days prior to registration: Total bilirubin =< 1.5 times the upper limit of normal (ULN) except for unconjugated hyperbilirubinemia of Gilbert’s syndrome
Total bilirubin =< 1.5 x upper limit of normal (ULN); except in case of Gilbert’s disease
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 institutional upper limit of normal (ULN), (except for patients with known Gilbert’s syndrome who must have normal direct bilirubin)
Serum bilirubin greater than 3 times the upper limit of normal, unless attributed to Gilbert’s syndrome
Serum bilirubin =< 1.5 x institutional upper limit of normal (ULN) except subjects with known Gilbert’s syndrome
Total bilirubin =< 1.5 x the upper limit of normal (ULN); for subjects with known Gilbert’s disease, =< 3 mg/dl
Total bilirubin =< 1.5 x upper limit of normal (ULN) (unless Gilbert’s syndrome or disease infiltration of the liver is present)
Total bilirubin =< 1.5 x upper limit of normal (ULN) (except for patients with well-documented Gilbert’s syndrome) (obtained =< 14 days prior to registration)
Total bilirubin < upper limit of normal (ULN) or up to 2 x ULN if patient has clinically documented Gilbert’s syndrome (elevated unconjugated bilirubin from decreased UDP glucuronosyltransferase 1 family, polypeptide A1 [UGT1A1] activity)
Total bilirubin < 1.5 x institutional upper limit of normal with direct bilirubin within normal limits except for participants with Gilbert’s disease
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
Bilirubin =< 1.5 x institutional upper limit of normal (ULN) except subjects with known Gilbert’s syndrome, within 2 weeks of the first dose of study treatment
Serum bilirubin =< 1.5 x institutional upper limit of normal (ULN) except subjects with known Gilbert’s syndrome
Serum bilirubin =< 1.5 x upper limit of normal (ULN) (=< 3.0 if Gilbert’s syndrome)
Bilirubin (total) less than or equal to the upper limit of normal; an exception to this may be allowed for participants with Gilbert’s syndrome with prior approval by the protocol chair
Total bilirubin > 2 x upper limit of normal (ULN) (except in the case of subjects with documented Gilbert’s disease > 3 x ULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (or =< 2.5 x ULN with Gilbert’s disease)
Total bilirubin < 1.5 times the upper limit of normal (ULN) unless due to Gilbert’s disease or hemolysis
Total bilirubin =< 1.5 x upper limit of normal (ULN) (or =< 3.0 mg/dL if known Gilbert’s syndrome)
Total bilirubin =< 1.5 x upper limit of normal (ULN) (patients with Gilbert’s syndrome may have serum bilirubin > 1.5 ULN)
Total bilirubin =< 1.5 x institutional upper limit of normal; unless due to Gilbert’s syndrome
Total bilirubin =< 1.5 x upper limit of normal in the absence of Gilbert’s disease; for patients with Gilbert’s syndrome: direct bilirubin =< 1.5 x upper limit of normal
Total bilirubin =< 1.5 x upper limit of normal (ULN) (unless Gilbert’s syndrome or disease infiltration of the liver is present)
Total bilirubin =< 1.5X upper limit of normal (ULN) unless secondary to Gilbert’s disease
Total bilirubin within normal institutional limits or < 3 x the upper limit of normal in patients with Gilbert’s disease
Total bilirubin =< 2 times upper limit of normal (x ULN) (=< 3 x ULN if considered to be due to leukemic involvement or Gilbert’s syndrome)
Serum bilirubin less than or equal to 1.5 x upper limit of normal (ULN) (Participants with serum bilirubin abnormalities greater than this specified limit are eligible only if they have known Gilberts disease.)
Total serum bilirubin =< 1.5 x upper limit of normal (ULN) unless due to Gilbert’s disease
Total bilirubin < upper limit of normal (ULN) (except for Gilbert’s disease)
Total bilirubin =< 1.5 X institutional upper limit of normal; =< 3.0 upper limit of normal (ULN) accepted in subjects with Gilbert’s syndrome
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 =< 1.5 X the upper limit of normal (ULN) unless a known history of impaired bilirubin conjugation such as Gilbert’s, for whom the maximum will be 2.5 ULN
Total bilirubin =< 1.5 x upper limit of normal (ULN), except in cases of Gilbert’s disease
Total bilirubin =< 1.5 X upper limit of normal (ULN) obtained =< 7 days prior to randomization; patients with known Gilbert’s syndrome who have serum bilirubin =< 3 X ULN may enroll
Total bilirubin =< institutional upper limit of normal (ULN) (or =< 3 X ULN if Gilbert’s syndrome present or if bilirubin increase related to MF)
Total bilirubin =< 1.5 X upper limit of normal (ULN) unless history of Gilbert’s syndrome documented prior to first-line treatment of cancer and other liver function tests are within normal limits
Total bilirubin =< 1.5 x upper limit of normal (ULN) except subject with documented Gilbert’s syndrome (=< 5 x ULN) or liver metastasis, who must have a baseline total bilirubin =< 3.0 mg/dL
Total bilirubin =< 1.5 X upper limit of normal (ULN) (unless bilirubin rise due to Gilbert’s syndrome)
Total bilirubin =< 1.5 x upper limit of normal (ULN) (except in patients diagnosed with Gilbert’s disease) (within 7 days prior to registration)
Total bilirubin =< 1.5 x institutional upper limit of normal (patients with documented Gilbert’s disease are allowed total bilirubin up to 3 x upper limit of normal [ULN])
Total bilirubin =< 1.5 times the upper limit of normal (ULN) unless due to Gilbert’s disease or hemolysis
Total bilirubin =< 1.5 x upper limit of normal (ULN), unless due to Gilbert’s syndrome
Total bilirubin =< 1.5 times upper limit of normal unless due to Gilbert’s disease within 14 days before enrollment
Total bilirubin =< 2 x upper limit of normal (ULN), unless patient has a documented history of Gilbert’s disease, then direct bilirubin =< 1.0 mg/dL
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 < institutional upper limit of normal (patients with documented Gilbert’s disease are allowed total bilirubin up to 1.5 x upper limit of normal [ULN])
Total bilirubin =< 4 X institutional upper limit of normal unless 2nd to Gilbert’s disease
Serum bilirubin =< 2 x the upper limit of normal (ULN) (except for patients with a confirmed diagnosis of Gilbert’s disease)
Total bilirubin =< 1.5 x ULN (upper limit of normal), unless the patient meets the criteria for Gilbert’s syndrome; the upper limit value for bilirubin for subjects with Gilbert’s syndrome is less than 3 mg/dl\r\n* Note: A diagnosis of Gilbert’s disease will be made in the presence of (1) unconjugated hyperbilirubinemia noted on several occasions; (2) normal results from complete blood cell (CBC) count, reticulocyte count, and blood smear; (3) normal liver function test results; and (4) an absence of other disease processes that can explain the unconjugated hyperbilirubinemia
Total bilirubin =< 1.5 x upper limit of normal (ULN) (patients with diagnosed Gilbert’s syndrome will not be excluded if their direct bilirubin is within normal institutional limits)
Total bilirubin =< 1.5 X institutional upper limit of normal (ULN); in case of known Gilbert’s syndrome, < 2 x ULN is allowed
Total bilirubin =< 1.5 x upper limit of normal (ULN) unless due to Gilberts disease
PART B: Total bilirubin =< 1.5 x institutional upper limit of normal (ULN), unless due to Gilbert’s syndrome
Total bilirubin =< 1.5 x upper limit of normal (ULN) unless Gilbert’s syndrome or disease infiltration of the liver is present
Total bilirubin =< 1.5 × upper limit of normal (ULN) (or =< 2.5 x ULN for subjects with asymptomatic Gilbert’s syndrome)
Total bilirubin =< the institutional upper limit of normal (exception permitted in patients with Gilbert’s syndrome after discussion with study principal investigator [PI], on a case by case basis and if liver function tests are within normal limits)
Total bilirubin =< 1.5 x institutional upper limit of normal (unless elevated from documented Gilbert’s syndrome)
Total bilirubin =< 1.5 x upper limit of normal (ULN); if patient has Gilbert’s disease, then patient must have isolated hyperbilirubinemia (e.g. no other liver function test abnormality), with maximum bilirubin =< 2 X institutional ULN
Total bilirubin =< 1.5 times the upper limit of normal (ULN); for patients with known Gilbert’s disease, total bilirubin should be =< 3 mg/dL
Bilirubin =< 1.5 X the upper limit of normal (ULN); for participants with known Gilbert’s disease, bilirubin =< 3.0 mg/dL
Bilirubin =< 2 x the upper limit of normal (except Gilbert’s syndrome)
Total bilirubin < 1.5 X institutional upper limit of normal (patients with documented Gilbert’s disease are allowed total bilirubin up to 3 X upper limit of normal [ULN])
Bilirubin < to 2.0 x normal (except Gilbert’s Syndrome)
Total bilirubin =< upper limit of normal (ULN) (except for Gilbert’s disease)
Bilirubin =< 1.5 X upper limit of normal (ULN) or =< 3 X ULN for patients with Gilbert’s disease
Total bilirubin less than institutional upper limit of normal; NOTE: patients with a diagnosis or history of Gilberts will be eligible
Bilirubin* =< 2 x upper limit of normal\r\n* In the absence of Gilbert’s disease
Total bilirubin =< 1.5 x upper limit of normal (ULN) appropriate for age (except for patients with Gilbert’s syndrome, who must have a total bilirubin < 3 mg/dL) within 30 days prior to registration
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 serum bilirubin =< 1.5 X upper limit of normal (ULN) except for subjects with known Gilbert’s disease, who may enroll if the conjugated bilirubin is =< 1.5 ULN
Total bilirubin =< upper limit of normal (ULN) (excluding Gilbert’s disease)
Bilirubin =< upper limit of normal (ULN); for patients with Gilbert’s disease, =< 2.5 x ULN is allowed
Serum total bilirubin =< 1.5 x upper limit of normal (ULN) (unless known Gilbert’s disease)
Total bilirubin =< 1.5 x upper limit of normal (ULN) except in patients with Gilbert’s disease
Total bilirubin =< 2 times upper limit of normal (x ULN) (=< 3 x ULN if considered to be due to leukemic involvement or Gilbert’s syndrome)
Total bilirubin < 1.5 x upper limits of normal (ULN) except Gilbert’s syndrome where < 3 x ULN is allowed
Total serum bilirubin < 2 x upper limit of normal (unless due to hemolysis or Gilbert’s syndrome, then no upper limit)
Total bilirubin: within normal institutional limits; if, however, the participant has Gilbert’s disease or unconjugated hyperbilirubinemia which is felt to be secondary to with atazanavir or indinavir therapy, then the total bilirubin must be =< 3 x upper limit of normal [ULN])
Total bilirubin =< 1.5 × upper limit of normal (ULN) (unless Gilbert’s syndrome or disease infiltration of the liver is present)
Total bilirubin =< 1.5 x upper normal limit, or =< 5 x upper normal limit if documented hepatic involvement with lymphoma or history of Gilbert’s syndrome
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)\r\n* Patients with Gilbert’s disease: =< 3 x ULN
Total bilirubin =< 1.5 x upper limit of normal (ULN); for subjects with known Gilbert’s disease or similar syndrome with slow conjugation of bilirubin, total bilirubin =< 3.0 mg/dL
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
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
Serum total bilirubin =< 1.5 x upper limit of normal (ULN) (except for patients with documented Gilbert’s syndrome)
Serum bilirubin =< upper limit of normal (ULN) (except for subjects with Gilbert’s disease who are eligible despite elevated serum bilirubin level)
Total bilirubin =< 1.5 x upper limit of normal OR in patients with Gilbert’s syndrome, a total bilirubin =< 3.0
Serum bilirubin =< 1.5 x upper limit of normal (ULN) or =< 3 x ULN for patients with Gilbert’s disease
Total bilirubin =< 1.5 x the upper limit of normal (ULN), unless presence of Gilbert’s syndrome
Total bilirubin > institutional upper limit of normal (ULN), unless due to hemolysis or Gilbert’s disease
Total bilirubin > 2 x institutional upper limit of normal (ULN) (unless documented Gilbert’s syndrome)
Total bilirubin =< 1.5 X institutional upper limit of normal (unless associated with Gilbert’s syndrome)
Total/direct bilirubin < 1.5 X institutional upper limit of normal; patients with elevation of indirect (unconjugated) bilirubin alone, as in Gilbert’s syndrome, are eligible
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) unless bilirubin rise is due to Gilbert’s syndrome
Serum total bilirubin < 2.0 x upper limit normal (ULN) (or < 3.0 x ULN if deemed to be elevated due to leukemia or Gilbert’s syndrome)
Total bilirubin =< 2.5 x upper limit of normal (ULN) except if the elevation is due to Gilbert’s syndrome (allowable at =< 5 x ULN) or myelofibrosis (per principle investigator [PI] discretion)
Total bilirubin < 1.5 X institutional upper limit of normal (unless associated with Gilbert’s syndrome)
Total bilirubin =< 1.2 x upper limit of normal (ULN) unless due to Gilbert’s disease
Total bilirubin >= 1.5 x upper limit of normal (ULN) (unless documented Gilbert’s)
Unless felt due to underlying disease and approved by the overall PI: Total bilirubin =< 1.5 x institutional upper limit of normal (ULN); patients with Gilbert’s disease may have total bilirubin up to =< 3 x institutional ULN
Total bilirubin =< 1.5 X institutional upper limit of normal, unless there is a known history of Gilbert’s disease
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN); an exception to this may be allowed for participants with Gilbert’s syndrome with documented approval by the protocol chair
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) Note: Higher total bilirubin levels (=< 3 mg/dL) can be allowed if due to known benign liver condition, i.e. Gilbert’s
Within 28 days prior to signing consent: Total bilirubin > upper limit of normal (ULN) (unless the patient has documented Gilbert’s syndrome)
Total bilirubin =< 2 × institutional upper limit of normal (ULN) and/or history of Gilbert’s syndrome
Obtained within 28 days prior to registration: Bilirubin =< 1.5 x upper limit of normal (ULN) (subjects with known Gilbert’s disease should have a serum bilirubin =< 3 x ULN)
Bilirubin > 1.5 x upper limit of normal (ULN) unless with Gilberts syndrome or
Bilirubin = < 1.5 X upper limit of normal (ULN) except for patients (pts) with (w/) documented history of Gilbert’s disease, obtained within 14 days prior to PET scan
Bilirubin < 1.5 x upper limit of normal (ULN) (unless Gilbert’s is suspected)
Bilirubin > 2 x institutional upper limits of normal (ULN), with exception of patients with Gilberts disease
Bilirubin (total) =< 1.5 times upper limit normal (with exception of Gilberts syndrome)
Total bilirubin =< 1.5 x upper limit of normal (ULN); patients with Gilbert’s syndrome are excluded from this requirement