Bilirubin =< 1.5 x ULN (CTCAE v 3.0 grade 1)
Bilirubin =< 1.5 x ULN
Patients with abnormal liver function will be eligible and will be grouped according to the criteria below* Group A (normal hepatic function)** Bilirubin =< upper limit of normal (ULN) and aspartate aminotransferase (AST) =< ULN* Group B (mild hepatic dysfunction)** B1: bilirubin =< ULN and AST > ULN** B2: bilirubin > ULN but =< 1.5 x ULN and any AST* Group C (moderate hepatic dysfunction)** Bilirubin > 1.5 x ULN to =< 3 x ULN and any AST* Group D (severe hepatic dysfunction) ** Bilirubin > 3 x ULN and up to investigators discretion and any AST* Patients with active hemolysis should be excluded; no distinction will be made between liver dysfunction due to metastases and liver dysfunction due to other causes; registration laboratory investigations will be used to assign a patient to a hepatic function group; liver function tests should be repeated within 24 hours prior to starting initial therapy and may result in the patients' group assignment being altered if different to registration test results
Bilirubin =< 1.5 x ULN
Total bilirubin =< 1.5 x ULN for age AND
Total bilirubin=< 1.5 x upper limit of normal (ULN) (if, however, the participant has Gilberts 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 =< 2.0, within 30 days prior to enrollment
Direct or total bilirubin < 1.5 x ULN (unless related to Gilberts or Meulengrachts syndrome); the values must be obtained within 48 hours prior to randomization
Patients with abnormal hepatic function will be eligible and will be grouped according to criteria summarized below:* Group A: Normal hepatic function** Bilirubin =< ULN** Aspartate aminotransferase (AST) =< ULN* Group B: Mild hepatic dysfunction** B1: bilirubin =< ULN and AST > ULN** B2: ULN < bilirubin =< 1.5 x ULN and any AST* Group C: Moderate hepatic dysfunction** 1.5 x ULN < bilirubin =< 3 x ULN and any AST* Group D: Severe hepatic dysfunction** 3 x ULN < bilirubin =< 10 x ULN and any AST; hepatic function tests should be repeated within 24 hours prior to starting initial therapy and may result in patients group assignment being altered if different to registration test results
Bilirubin =< 1.5 x ULN within 14 days prior to study registration; unless patient has Gilberts disease
Total bilirubin =< ULN (institutional upper limit of normal) except elevated total bilirubin < 1.5 x ULN due to Gilberts disease or similar syndrome involving slow conjugation of bilirubin, measured within 28 days prior to randomization
Bilirubin =< 1.5 x ULN; for subjects with liver metastases =< 3 x ULN is allowed
Total serum bilirubin =< 1.5 x ULN
Total bilirubin =< 1.5 x ULN except subjects with normal direct bilirubin or those with known Gilberts syndrome, obtained within 4 weeks prior to randomization
Serum total bilirubin =< 1.5 X upper limit of normal (ULN) or direct bilirubin =< ULN for patients with total bilirubin levels > 1.5 ULN
Total bilirubin =< 1.5 x upper limit of normal (ULN); for subjects with known Gilberts disease or similar syndrome with slow conjugation of bilirubin, total bilirubin =< 3.0 mg/dL
Total bilirubin =< 1.5 x ULN except subjects with normal direct bilirubin or those with known Gilberts syndrome
Total bilirubin < 1.5 x ULN
Within 6 weeks prior to randomization: Total bilirubin must be =< upper limit of normal (ULN) for the laboratory (lab) unless the patient has a bilirubin elevation > ULN to 1.5 x ULN due to Gilberts disease or similar syndrome involving slow conjugation of bilirubin
Total bilirubin =< 1.5 x upper limit of normal (ULN) in absence of Gilbert disease (total bilirubin =< 3 x ULN with Gilbert); also, if hyperbilirubinemia is clearly attributed to liver metastases total bilirubin =< 3 x ULN is permitted
Re-registration: total bilirubin =< 1.5 x ULN in absence of Gilbert disease (total bilirubin =< 3 x ULN with Gilbert); if hyperbilirubinemia is clearly attributed to liver metastases, total bilirubin =< 3 x ULN is permitted
PARTICIPANTS NOT ON THE HODGKIN LYMPHOMA EXPANSION COHORT: Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) =< 3 x ULN for subjects with Gilberts disease or with atazanavir- or indinavir-induced unconjugated hyperbilirubinemia without aspartate aminotransferase (AST) or alanine aminotransferase (ALT) elevation and must have a total bilirubin less than 3.0 mg/dL, within 2 weeks prior to enrollment
PARTICIPANTS ON THE HODGKIN LYMPHOMA EXPANSION COHORT: Total bilirubin: =<1.5 institutional upper limit of normal (ULN), or =< 3 x ULN for participants with Gilberts 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 ULN
Total bilirubin =< 1.5 x the institutional ULN
Total bilirubin =< 1.5 x ULN (patients with Gilberts syndrome may have serum bilirubin > 1.5 x ULN)
Total bilirubin =< 1.5 x ULN unless Gilberts syndrome of disease infiltration of the liver is present
If no known liver metastases: total bilirubin < 1.5 x institutional upper limit of normal (ULN); if known liver metastases, then: total bilirubin < 2.5 x ULN
Total serum bilirubin =< 1.5 x ULN (in patients with known Gilbert syndrome, a total bilirubin =< 3.0 x ULN, with direct bilirubin =< 1.5 x ULN)
Total bilirubin 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 Gilberts disease or similar syndrome involving slow conjugation of bilirubin within 28 days before randomization
Bilirubin =< 1.5 x ULN (=< 3 x ULN for patients with Gilbert syndrome)
Total bilirubin =< 1.5 x ULN (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 x ULN), within 4 weeks of randomization
Serum total bilirubin: =< 1.5 X ULN OR
Direct bilirubin: =< ULN for patients with total bilirubin levels > 1.5 ULN
Total bilirubin =< 1.5 x ULN within 14 days prior to registration.
Within 14 days prior to registration: Total Bilirubin =< 1.5 x ULN (patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled)
Total bilirubin =< 1.5 x local institutional upper limit of normal (ULN)* If elevated total bilirubin is due Gilberts disease or disease-related hemolysis then total bilirubin =< 3.0 x local institutional ULN
Total bilirubin > 1.5 times ULN if no liver metastases or > 3 times ULN in the presence of documented Gilberts syndrome (unconjugated hyperbilirubinemia) or liver metastases
Total bilirubin:* If no known liver metastases: total bilirubin < 1.5 x institutional upper limit of normal (ULN)* If known liver metastases, then: total bilirubin < 2.5 x ULN