Total bilirubin within normal institutional limits
total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits within 14 days of registration
Total bilirubin within normal institutional limits
Total bilirubin within normal laboratory limits
Total bilirubin within normal institutional limits
Total bilirubin =< upper normal institutional limits
Total bilirubin within normal institutional limits
Total serum bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Within 2 weeks prior to initiation of study treatment: Total bilirubin within normal institutional limits
Bilirubin must be within or below normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within 1.5 times normal institutional limits
COHORT I: Total bilirubin within normal institutional limits
Total bilirubin within normal limits;
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits unless due to Gilbert’s disease
Total bilirubin must be within normal limits.
Total bilirubin within normal institutional limits
Bilirubin =< 1.5 x institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within 1.5 x normal institutional limits
Total Bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits 14 days or fewer from registration
Total bilirubin =< 1.5 X institutional upper limits of normal; total bilirubin > 1.5 X above institutional upper limits of normal will be allowed if direct bilirubin is within normal limits or if patients has a documented history of Gilbert’s disease
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within 1.5 x normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin =< 2.5 X institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits (unless Gilbert’s disease with elevated indirect bilirubin only)
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits, determined within 14 days of registration
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin < 1.5 x the upper limits of institutional normal
Total bilirubin =< 1.5 X normal institutional limits (within 2 weeks prior to radiotherapy)
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits (except for participants with Gilbert’s disease)
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal limits
total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin < 1.5 x the upper limits of institutional normal
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
DOSE ESCALATION COHORT: Total bilirubin within normal institutional limits
DOSE EXPANSION COHORT: Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin =< 2 X normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total serum bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal limits
Total bilirubin within normal limits
Total bilirubin within normal institutional limits
Total bilirubin =< normal institutional limits
Total bilirubin within normal institutional limits
Bilirubin within institutional normal limits
Total bilirubin within institutional normal limits (or < 2.5 X the ULN for patients with Gilbert’s disease)
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Obtained within 30 days of registration: Total bilirubin within normal institutional limits (may be elevated if direct bilirubin normal)
Total bilirubin within normal institutional limits within 4 weeks of pre-registration
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin must be within 1.5 X the normal institutional limits; if total bilirubin is outside the normal institutional limits, assess direct bilirubin
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits (unless known Gilbert’s syndrome)
Total bilirubin within normal institutional limits
Bilirubin within the institutional limits of normal
PHASE I: Total bilirubin within normal institutional limits
PHASE II: Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Bilirubin =< 1.5 X institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within institutional normal limits
Total bilirubin within institutional normal limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin < 1.5 x normal institutional limits
Total bilirubin =< institutional upper limits of normal
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin =< 1.5 x normal institutional limits
Total bilirubin =< 1.5 x normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin =< 1.5 X normal institutional limits
EXPANSION COHORT ONLY: Total bilirubin =< 1.5 X normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin\r\n* For patients on FOLFIRI, within normal limits\r\n* For patients on FOLFOX, =< 3 X normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Bilirubin within normal institutional limits within 14 days prior to registration
Total bilirubin within normal limits
Total bilirubin within normal limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal limits
Total bilirubin within normal institutional limits
Total bilirubin must be within 1.5 X the normal institutional limits; if total bilirubin is outside the normal institutional limits, assess direct bilirubin; the direct bilirubin must be within normal parameters
Total bilirubin within normal limits
Total bilirubin within normal institutional limits
Total serum bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin =< 1.5 x institutional upper limits of normal
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Serum total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
SURGICAL ARM: total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
Total bilirubin within normal institutional limits
total bilirubin within normal institutional limits
total bilirubin within normal institutional limits
total bilirubin within normal institutional limits (except in cases of malignant biliary obstruction)
Direct bilirubin ? 1.5 × ULN (may be assumed if total bilirubin is below ULN)
Within 14 days of treatment initiation: Serum total bilirubin =< upper limit of normal (ULN) OR direct bilirubin =< ULN for patients with total bilirubin levels > ULN; (except patients with Gilbert’s syndrome, who must have a total bilirubin less than 3.0 mg/dL)
Total bilirubin =< 1.5 x ULN except subjects with normal direct bilirubin or those with known Gilbert’s syndrome, obtained within 4 weeks prior to randomization
If total bilirubin is > upper limit of normal (ULN) (NOTE: in subjects with Gilbert’s syndrome, if total bilirubin is \r\n> ULN, measure direct and indirect bilirubin and if direct bilirubin is within normal range, subject may be eligible) or
Serum total bilirubin =< 1.5 x upper limit of normal (ULN) (Note: in subjects with Gilbert’s syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is =< 1.5 x ULN, subject is eligible) within 90 days prior to Step 1 registration
Obtained within 14 days prior to treatment start: Total serum bilirubin =< 1.5 x ULN; or total bilirubin (TBILI) =< 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert’s syndrome
Total bilirubin =< 3.0 x ULN; if patient has known Gilbert’s syndrome direct bilirubin =< 1.5 x ULN
Total bilirubin < 1.5 x upper limit of normal (ULN); or total bilirubin =< 3.0 x ULN or direct bilirubin =< 1.5 x ULN in patients with well-documented Gilbert’s syndrome
Total bilirubin and direct bilirubin =< ULN
Total bilirubin =< 2.0 x upper limit of normal (ULN) or direct bilirubin =< 1.5 x ULN in patients with well-documented Gilbert’s syndrome
Total bilirubin < ULN; or total bilirubin =< 3.0 x ULN or direct bilirubin =< 1.5 x ULN in patients with well-documented Gilbert’s syndrome
Total bilirubin =< 1.5 x upper limit of normal (ULN) or if total bilirubin is > 1.5 x ULN, the direct bilirubin must be normal obtained =< 14 days prior to registration
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)\r\n* Note: Patients with Gilbert’s syndrome with a total bilirubin =< 2.0 times ULN and direct bilirubin within normal limits are permitted
Total bilirubin < ULN; or total bilirubin =< 3.0 x ULN or direct bilirubin =< 1.5 x ULN in patients with well-documented Gilbert’s syndrome
Total bilirubin =< upper limit of normal performed within 30 days prior to the date of registration (ULN, Note: In subjects with Gilbert’s syndrome, if total bilirubin is > ULN, measure direct and indirect bilirubin and if direct bilirubin is =< ULN, subject may be eligible)
Total bilirubin < ULN; or total bilirubin =< 3.0 x ULN or direct bilirubin =< 1.5 x ULN in patients with well-documented Gilbert’s syndrome
Total bilirubin within normal institutional limits (WLN) or =< 1.5 x upper limit of normal (ULN) in patients with liver metastases; or total bilirubin =< 3 x ULN with direct bilirubin WLN in patients with well documented Gilbert’s syndrome
Total bilirubin =< 1.5 x upper limit of normal (ULN), except for patients with Gilbert’s syndrome, who may only be included if total bilirubin =< 3.0 x ULN or direct bilirubin =< 1.5 x ULN, at the screening visit
Total serum bilirubin =< 1.5 x upper limit of normal (ULN) (< 3 x ULN in patients with documented/suspected Gilbert’s disease with concomitant direct bilirubin =< 1.5 x ULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN) or if total bilirubin is > 1.5 x ULN, the direct bilirubin must be =< ULN =< 28 days prior to registration
Hepatic: Total bilirubin =< upper limit of normal (ULN) for age, or if total bilirubin is > ULN, direct bilirubin is =< 1.4 mg/dL
Total bilirubin =< 1.5 x ULN (unless Gilbert’s syndrome or disease infiltration of the liver is present, who may be included if total bilirubin =< 3.0 x ULN or direct bilirubin =< 1.5 x ULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN) unless due to Gilbert’s syndrome, in which case the direct bilirubin must be =< 1.5 X ULN, obtained =< 14 days prior to registration
Obtained =< 14 days prior to registration: Total bilirubin =< 1.5 x upper limit of normal (ULN) or direct bilirubin =< ULN
Within 28 days prior to treatment start: Total bilirubin =< 1.5 x upper limit of normal (ULN) (Note: In subjects with Gilbert’s syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is =< 1.5 x ULN, subject may be eligible)
Serum total bilirubin =< 1.5 x institutional ULN (except subjects with Gilbert’s syndrome, who must have normal direct bilirubin)
Serum bilirubin < 1.5 x upper limit of normal (ULN); Note: In subjects with Gilbert’s syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is =< 1.5 x ULN, subject may be eligible
Serum total bilirubin =< 1.5 times upper limit of normal (ULN) OR direct bilirubin =< ULN for subjects with total bilirubin >= 1.5 x ULN
Total bilirubin > ULN (NOTE: in subjects with Gilbert’s syndrome, if total bilirubin is > ULN, measure direct and indirect bilirubin and if direct bilirubin is within normal range, subject may be eligible) or
Serum bilirubin ? 1.5 x institutional ULN (in subjects with Gilbert’s syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin and patient is eligible if direct bilirubin ? 1.5 x ULN)
Obtained =< 14 days prior to registration: Total bilirubin =< 1.5 x upper limit of normal (ULN) (in patients with well-documented Gilbert’s syndrome and the total bilirubin is grade 1, then direct bilirubin value must be =< 1.0 mg/dL)
Direct (conjugated) bilirubin ?2 x ULN
Total serum bilirubin =< 1.5 x ULN (=< 3 x ULN or direct bilirubin =< 1.5 x ULN if known Gilbert’s syndrome)
Total bilirubin < 1.5 X institutional upper limit of normal OR direct bilirubin =< ULN for patients with total bilirubin > 1.5 ULN
Obtained =< 14 days prior to registration: Total bilirubin =< 1.5 x the upper limit of the normal range (ULN) or if total bilirubin is > 1.5 x ULN, the direct bilirubin must be =< 2.0 mg/dL
Total bilirubin: =< 3 x upper limit of normal (ULN) for age OR direct bilirubin =< 2 mg/dl
Total bilirubin =< 1.5 x upper limit of normal (ULN), except for patients with Gilbert’s syndrome who may be included if total bilirubin =< 3.0 x ULN or direct bilirubin =< 1.5 x ULN
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) OR direct bilirubin =< ULN with total bilirubin > 1.5 x ULN
Serum total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (for patients with a diagnosis of Gilbert’s syndrome, direct bilirubin =< 1.5 x ULN)
Determined within 3 weeks of treatment initiation: Serum bilirubin =< 1.5 x upper limit of normal (ULN) OR direct bilirubin =< ULN for a subject with total bilirubin level > 1.5 x ULN
Total bilirubin: =< 1.5 X ULN (isolated bilirubin > 1.5 X ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%)
Total bilirubin =< 1.5 X upper limit of normal (ULN); if total bilirubin > 1.5 X ULN then direct bilirubin =< ULN (obtained =< 14 days prior to registration)
Total serum bilirubin =< upper limit of normal (ULN); or total bilirubin =< 3.0 x ULN with direct bilirubin within normal range in patients with documented Gilbert’s syndrome
Direct bilirubin ? 2.0 × the upper limit of laboratory normal (ULN). (NOTE: direct bilirubin will only be determined if total bilirubin is ? 2.0 × ULN)
Total bilirubin =< 1.5 x ULN; (in patients with well documented Gilbert’s syndrome, total bilirubin =< 3 x ULN with direct bilirubin within normal range)
Total bilirubin < institutional upper limit of normal (ULN), except for subjects with documented Gilbert’s syndrome, for which =< 3.0 x ULN or direct bilirubin =< 1.5 x ULN
Total bilirubin =< 1.5 X upper limit of normal (ULN) (or total bilirubin =< 3.0 X ULN with direct bilirubin =< 1.5 X ULN in patients with well-documented Gilbert’s syndrome) obtained =< 14 days prior to registration
Total bilirubin =< 1.5 x ULN; subjects with Gilbert’s syndrome should have direct bilirubin within normal institutional limits
Total serum bilirubin =< 1.5 x ULN; for patients with well documented Gilbert’s syndrome, total bilirubin =< 3 x ULN with direct bilirubin within normal range
Serum total bilirubin =< 1.5 × upper limit of normal (ULN) (Note: In subjects with Gilbert’s syndrome, if total bilirubin is > 1.5 × ULN, measure direct and indirect bilirubin and if direct bilirubin is =< 1.5 × ULN, subject may be eligible)
Total serum bilirubin =< 1.5 x ULN; or total bilirubin =< 3 x ULN with direct bilirubin within normal range in patients with well documented Gilbert’s syndrome
Obtained =< 14 days prior to randomization: Total bilirubin =< upper limit of normal (ULN)\r\n* NOTE: If total bilirubin is out of range then direct bilirubin must be =< ULN
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >= 2.5 x ULN; Note: in subjects with Gilbert’s syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is =< 1.5 x ULN, subject may be eligible
Serum bilirubin =< 1.5 x upper limit of normal (ULN); for patients with Gilbert’s disease, serum bilirubin up to =< 3 x ULN is allowed provided normal direct bilirubin
PART 2 GROUP 1 INCLUSION CRITERIA: Total serum bilirubin (sum of conjugated + unconjugated) =< 1.5x upper limit of normal (ULN), except for subjects with Gilbert’s Syndrome who may be included if total bilirubin is =< 3.0 x ULN and direct bilirubin is =< 1.5 x ULN
PART 2 GROUP 2A INCLUSION CRITERIA: Total serum bilirubin (sum of conjugated + unconjugated) =< 1.5x ULN, except for subjects with Gilbert’s Syndrome who may be included if total bilirubin is =< 3.0 x ULN and direct bilirubin is =< 1.5 x ULN
PART 2 GROUP 3 INCLUSION CRITERIA: Total serum bilirubin (sum of conjugated + unconjugated) =< 1.5x ULN, except for subjects with Gilbert’s Syndrome who may be included if total bilirubin is =< 3.0 x ULN and direct bilirubin is =< 1.5 x ULN
Total serum bilirubin levels < 1.5 x ULN (note: in subjects with Gilbert’s syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is =< 1.5 x ULN, subject may be eligible)
Total bilirubin =< 1.5 x ULN, except for patients with Gilbert’s syndrome who may be included if total bilirubin =< 3.0 x ULN and direct bilirubin =< 1.5 x ULN
Total bilirubin =< 1.5 x upper limit of normal (ULN) or =< 3 x ULN for patients with Gilbert’s disease (in patients [pts] with elevated total bilirubin due to increased indirect bilirubin, pts with direct bilirubin =< 1.5 x ULN are eligible)
Total bilirubin =< 1.5 x upper limit of normal (ULN), except for patients with Gilbert’s syndrome or documented hepatic involvement with lymphoma who may be included if bilirubin =< 3.0 x ULN or direct bilirubin =< 1.5 x ULN
Serum total bilirubin =< 1.5 x upper limit of normal (ULN) (note: in subjects with Gilbert’s syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is =< 1.5 x ULN, subject may be eligible)
Total bilirubin > 2 X upper limit of normal (ULN) , or direct bilirubin > 2.0 mg/dL (except patients with Gilbert’s syndrome, then total bilirubin greater than 2 X ULN allowed in the absence of other hepatic signs or symptoms)
Total bilirubin =< 1.5 x ULN; subjects with Gilbert’s syndrome should have direct bilirubin within normal institutional limits
Total bilirubin < ULN; or total bilirubin =< 3.0 x ULN or direct bilirubin =< 1.5 x ULN in patients with well documented Gilbert’s syndrome
Total bilirubin within 1.5 x institutional level of normal or direct bilirubin =< upper limit of normal (ULN) for patient with total bilirubin levels > 1.5 ULN
CAPMATINIB INCLUSION CRITERIA: Total bilirubin =< 1.5 x upper limit of normal (ULN); patients with Gilbert’s syndrome may be included if total bilirubin =< 3 x ULN or direct bilirubin =< 1.5 x ULN
CERITINIB INCLUSION CRITERIA: Total bilirubin =< 1.5 x upper limit of normal (ULN); patients with Gilbert’s syndrome may be included if total bilirubin =< 3 x ULN and direct bilirubin =< 1.5 x ULN
REGORAFENIB INCLUSION CRITERIA: Total bilirubin =< 1.5 x upper limit of normal (ULN); patients with Gilbert’s syndrome may be included if total bilirubin =< 3 x ULN or direct bilirubin =< 1.5 x ULN
ENTRECTINIB INCLUSION CRITERIA: Total bilirubin =< 1.5 x upper limit of normal (ULN); patients with Gilbert’s syndrome may be included if total bilirubin =< 3 x ULN or direct bilirubin =< 1.5 x ULN
Total bilirubin =< 1.5 x upper limit of normal (ULN), except for patients with Gilbert’s syndrome who may be included if total bilirubin =< 3.0 x ULN or direct bilirubin =< 1.5 x ULN
Total bilirubin ? 1.5 x ULN for age, direct bilirubin ? ULN for age
Within 3 months of registration: Bilirubin =< 1.5 x upper limit of normal (ULN); in subjects with Gilbert’s syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin; if direct bilirubin is =< 1.5 x ULN, subject may be eligible
Direct bilirubin > 2 x ULN
Total bilirubin =< 1.5 x ULN for the laboratory\r\n* Exception: if a patient has documented Gilbert’s syndrome and a total bilirubin is > 1.5 x ULN, the total bilirubin requirement may be waived provided the direct bilirubin is within normal limits (WNL) for the laboratory
Total bilirubin =< 1.5 x upper limit of normal (ULN); for patients with Gilbert’s disease, total bilirubin up to =< 3 x ULN is allowed provided normal direct bilirubin
Must be met within 28 days of C1D1: Total bilirubin =< 1.5 x upper limit of normal (ULN) (unless evidence of Gilbert’s syndrome, in which case, direct bilirubin must be =< 1.0 x ULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN), except for patients with Gilbert’s syndrome who may be included if total bilirubin =< 3.0 x ULN or direct bilirubin =< 1.5 x ULN
Total bilirubin =< 1.5 x ULN (isolated bilirubin > 1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%)
Total bilirubin =< 1.5 x ULN (patient with diagnosed Gilbert’s syndrome and normal direct bilirubin will be allowed)
Total bilirubin =< 1.5 x upper limit of normal (ULN) or direct bilirubin =< ULN
Serum total bilirubin =< 1.5 x institutional ULN (Note: In subjects with Gilbert’s syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is =< 1.5 x ULN, subject may be eligible)
Total bilirubin =< 2 x upper limit of normal (ULN) (if > 2 x ULN direct bilirubin is required and should be =< 1.5 x ULN), obtained =< 14 days prior to registration
Total bilirubin (<=) 2* ULN or direct bilirubin level (<=) 2.0* ULN
Alanine transaminase ALT >3x upper limit of normal (ULN) AND bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
Within 14 days prior to registration: Total serum bilirubin level =< 1.5 x ULN; direct bilirubin =< ULN for subjects with total bilirubin > 1.5 x ULN (patients with isolated indirect bilirubin elevations and a history of Gilbert’s syndrome are eligible)
Serum bilirubin within normal limits (WNL) or =< 1.5 x ULN in patients with liver metastases; or total bilirubin =< 3.0 x ULN with direct bilirubin WNL in patients with well documented Gilbert’s syndrome
Within 14 days prior to randomization: Total bilirubin must be =< 1.5 x upper limit of normal (ULN) for the lab or direct bilirubin =< ULN for patients with bilirubin levels > 1.5 x ULN
Within 14 days of study drug(s) initiation: Serum bilirubin within normal limits (WNL) or =< 1.5 x ULN in patients with liver metastases; or total bilirubin =< 3.0 x ULN with direct bilirubin WNL in patients with well documented Gilbert’s syndrome.
For high risk and very high risk CLL-IPI (Arms A and B) only; obtained ? 30 days prior to randomization: Total bilirubin ? 1.5 x upper limit of normal (ULN) (or total bilirubin ? 3.0 x ULN with direct bilirubin ? 1.5 x ULN in patients with well-documented Gilbert’s syndrome)
Obtained ? 14 days prior to registration: total bilirubin ? 1.5 x upper limit of normal (ULN) unless due to Gilbert’s syndrome, in which case the direct bilirubin must be ? 1.5 x ULN
Total serum bilirubin ? 1.5 x ULN; in subjects with known or suspected Gilbert’s syndrome, if total bilirubin is > 1.5 x ULN, direct bilirubin is ? 1.5 x ULN
Bilirubin =< ULN, if total bilirubin is > ULN, measure direct/indirect bilirubin to evaluate for Gilbert’s Syndrome (if direct bilirubin is within normal range, subject may be eligible)
Total bilirubin < institutional upper limit of normal (ULN), except for subjects with documented Gilbert’s syndrome, for which =< 3.0 x ULN or direct bilirubin =< 1.5 x ULN
Total bilirubin =< 1.5 X upper limit of normal (ULN) or if total bilirubin is > 1.5 X ULN, the direct bilirubin =< ULN
Total bilirubin =< 1.5 x ULN (institutional upper limit of normal) (patients with Gilbert’s syndrome may have direct bilirubin > 2.5 x ULN)
Within 28 days of study registration: Bilirubin =< 1.5 times the upper institutional limits of normal (ULN); patients with a history of Gilbert's syndrome may be enrolled if the total bilirubin is < 3 mg/dL with a predominance of indirect bilirubin; if the total bilirubin is > 1.5 x the institutional ULN, direct and indirect bilirubin will be measured and if direct bilirubin is =< 1.5 x the institutional ULN, the patient will be eligible to participate
Total serum bilirubin =< 1.5 times upper limit of normal (ULN) (=< grade 1); if total bilirubin is 2 to 3 mg/dL, but direct bilirubin is normal, then the patient will be considered eligible
Total bilirubin =< 1.5 x ULN except subjects with normal direct bilirubin or those with known Gilbert’s syndrome
Serum total bilirubin =< 1.5 x institutional ULN (=< 3 x institutional ULN for Gilbert’s syndrome) OR direct bilirubin =< institutional ULN for subjects with total bilirubin levels > 1.5 institutional ULN
Total bilirubin =< 1.5 x upper limit of normal (ULN) or if total bilirubin is > 1.5 x ULN the direct bilirubin must be =< 1.5 x ULN (=< 0.45 mg/dL)
Total bilirubin =< upper limit of normal (ULN) (except for patients with Gilbert’s syndrome who may only be included if the total bilirubin is =< 3.0 x institutional ULN or direct bilirubin =< 1.5 x ULN)
Total bilirubin =< ULN; or total bilirubin =< 3.0 x ULN or direct bilirubin in patients with well-documented Gilbert’s syndrome
Total bilirubin =< upper limit of normal (ULN) for age, or if total bilirubin is > ULN, direct bilirubin is =< 1.4 mg/dL, and
Total bilirubin =< ULN; or total bilirubin =< 3.0 x ULN with direct bilirubin =< 1.5 ULN n patients with well documented Gilbert’s syndrome
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (isolated bilirubin > 1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%)
Direct bilirubin =< 1.5 X upper limit of normal (ULN) (subjects with Gilbert’s syndrome and elevations of indirect bilirubin only are eligible)
Total bilirubin < 1.5 X upper limit of normal (ULN); or < 3 x institutional ULN for Gilbert’s syndrome or HIV protease inhibitors; or < 5 x ULN and direct bilirubin < 0.7 mg/dL for patients on atazanavir containing HIV regimen
Total bilirubin: serum bilirubin within normal limits (WNL) or =< 1.5 x ULN in patients with liver metastases; or total bilirubin =< 3.0 x ULN with direct bilirubin WNL in patients with documented Gilbert’s syndrome
Total bilirubin =< 1 x upper limit of normal (ULN); or total bilirubin =< 3.0 x ULN with direct bilirubin =< 1.5 x ULN in patients with well-documented Gilbert’s syndrome, obtained =< 21 days prior to registration
MF PATIENTS: Direct bilirubin =< 1.5 x ULN
Total bilirubin =< 1.5 x upper limit of normal (ULN) or if total bilirubin is > 1.5 x ULN, the direct bilirubin must be normal
Total bilirubin < 1.5 x upper limit of normal (ULN) or normal direct bilirubin if the patient has Gilberts
Direct bilirubin (bili) < 3 x ULN
Direct bilirubin ? 2.0 x ULN
Serum direct bilirubin =< 1.5 x ULN; if considered related to ASM/MCL =< 3 x ULN
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN), or direct bilirubin =< ULN in patients with Gilbert’s syndrome
Total bilirubin < ULN; or total bilirubin =< 3.0 x ULN or direct bilirubin =< 1.5 x ULN in patients with well-documented Gilbert’s syndrome.
Within 72 h of initiating study treatment: Bilirubin =< 1.5 x upper limit of normal (ULN) or direct bilirubin =< ULN for subject with total bilirubin > 1.5 x ULN
Total serum bilirubin =< ULN (or =< 1.5 x ULN if documented hepatic involvement; or total bilirubin =< 3 x ULN with direct bilirubin =< 1.5 ULN in patients with documented Gilbert’s syndrome)
Total bilirubin =< 2 x upper limit of normal (ULN) or if total bilirubin is > 2 x ULN, the direct bilirubin must be normal
Hepatic total bilirubin =< 1.5 X ULN (isolated bilirubin > 1.5 X ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%)
Serum bilirubin =< 1.5 x upper limit of normal (ULN); for patients with Gilbert’s disease, serum bilirubin up to =< 3 x ULN is allowed provided normal direct bilirubin
The direct bilirubin must be within normal parameters
Total bilirubin =< 1.5 x upper limit of normal (ULN); if patient has known Gilbert’s syndrome, direct bilirubin =< 2.0 x ULN obtained =< 14 days prior to registration
Total bilirubin =< 1.5mg/dL (in patients with known Gilbert’s syndrome direct bilirubin =< 1.5 x upper limit of normal [ULN] will be used as organ function criteria, instead of total bilirubin)
Direct bilirubin ? 2.0 x ULN
Total bilirubin within normal institutional limits (isolated bilirubin > 1.5 × institutional ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%)
Serum total and direct bilirubin =< 1.5 x upper limit of normal (ULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN) or if total bilirubin is > 1.5 x ULN the direct bilirubin must be normal
Bilirubin =< 1.5 times ULN (if total bilirubin elevated, but direct is within normal limits [WNL], patient is eligible)
Serum total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (isolated total bilirubin > 1.5 institutional ULN is acceptable if bilirubin is fractionated and direct bilirubin is < 35%)
Total bilirubin ? 1.5x ULN for age. If the total bilirubin is elevated, patient will still be eligible if the conjugated (direct) serum bilirubin ? ULN for age.
Total bilirubin =< 1.5 x upper limit of normal (ULN) or if total bilirubin is > 1.5 x ULN, the direct bilirubin must be normal
Direct bilirubin ? 2.0 x ULN
Direct bilirubin =< 1.5 x the upper limit of normal (ULN); for subjects with known Gilbert’s disease, direct bilirubin =< 3.0 mg/dL
Total bilirubin =< upper limit of normal (ULN) for age, or if total bilirubin is > ULN, direct bilirubin is =< 1.5 mg/dL
Total bilirubin =< upper limit of normal (ULN) for age, or if total bilirubin is > ULN, direct bilirubin is =< 1.4 mg/dl and
Total bilirubin =< 1.5 × upper limit of normal (ULN), except in patients with previously documented Gilbert’s syndrome, in which case the direct bilirubin should be less than or equal to the ULN
Total bilirubin =< 1.5 mg/dL; in patients with known Gilbert’s syndrome, direct bilirubin =< 1.5 x upper limit of normal (ULN) will be used as organ function criteria, instead of total bilirubin
Total bilirubin =< 2 X ULN unless related to antiretroviral use (e.g., atazanavir and indinavir), then the direct bilirubin must be =< 2 X ULN
Total bilirubin =< 1.5 x upper limit of normal (ULN), or if total bilirubin is > 1.5 ULN, the direct bilirubin must be normal
Total bilirubin < 1.5 x upper limit of normal (ULN), If patient has known Gilbert’s syndrome, direct bilirubin < 2.0 x ULN
Serum bilirubin =< 1.5 x upper limit of normal (ULN); for patients with Gilbert’s disease, serum bilirubin up to =< 3 x ULN is allowed provided normal direct bilirubin
Total bilirubin =< 1.5 x ULN, except for patients with Gilbert’s syndrome who may be included if total bilirubin =< 3.0 x ULN OR direct bilirubin =< 1.5 x ULN
Total bilirubin =< 1.5 x upper limit of normal (ULN) or if total bilirubin is > 1.5 x ULN, the direct bilirubin =< ULN
Serum total bilirubin =< 1.5 x upper limit of normal (ULN) (except in subjects with Gilbert’s syndrome who have a total bilirubin > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is =< 1.5 x ULN, subject may be eligible)
Serum bilirubin < institutional ULN (in patients with Gilbert’s disease, direct bilirubin < institutional ULN)
Direct serum bilirubin ? 1.5 x ULN
Total bilirubin < ULN; or total bilirubin =< 3.0 x ULN or direct bilirubin =< 1.5 x ULN in patients with well- documented Gilbert’s syndrome
Total bilirubin within 1.5 x institutional level of normal or direct bilirubin =< upper limit of normal (ULN) for patient with total bilirubin levels > 1.5 ULN)
Total bilirubin =< 2 x institutional upper limit of normal (ULN); if total bilirubin is > 2 x ULN, the direct bilirubin must be normal
Total serum bilirubin < 1.5 x ULN or total bilirubin =< 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert’s syndrome or hemolysis or who required regular blood transfusions
Serum total bilirubin =< 1.5 X upper limit of normal (ULN) (=< 3 X ULN if Gilbert’s syndrome) OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 X upper limit of normal (ULN) (=< 3 X ULN if Gilbert’s syndrome) OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Total bilirubin must be < 1.5 x the upper limit of normal, unless the elevation of bilirubin is thought to be secondary to Gilbert’s syndrome or combined antiretroviral therapy (cART); if, however, the elevated bilirubin is felt to be secondary to antiretroviral therapy, the total bilirubin must be =< 3.5 mg/dL, provided that the direct bilirubin is normal and the aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x the upper limit of normal; also, if the elevated bilirubin is thought to be secondary to cHL the same criteria for hyperbilirubinemia should be applied; however 1 prior cycle of cyclophosphamide is permitted in attempt to make the participant eligible; patients should not be excluded from study participation unless dosing cannot be safely established
Direct bilirubin =< 3 x upper limit of normal (ULN), unless suspected leukemic involvement of the liver
Total bilirubin =< 1.5 times the institutional upper limit of normal (ULN), unless elevated secondary to lymphomatous involvement of liver or biliary system, or due to other HIV medications (e.g., indinavir, tenofovir, or atazanavir); if secondary to lymphomatous involvement, an initial upper limit of total bilirubin 5 mg/dL (85.5 uM/L) should be utilized - for direct bilirubin > 1.2 mg/dL (20.5 uM/L)
Total bilirubin =< 1.5 x upper limit of normal (ULN) (unless hepatic dysfunction is caused by cGVHD)
Evidence of significant renal, hepatic, hematologic, or immunologic disease determined by any one of the following: Estimated creatinine clearance <30 mL/min; ALT or AST level greater than 10-fold the upper limit of normal or total bilirubin greater than 3-fold the upper limit of normal; Manifestations of end-stage liver disease, such as ascites or hepatic encephalopathy; Thrombocytopenia; or CD4+ T cell count below 200 cells per ?L
Total bilirubin =< 2 x institutional upper limit of normal (IULN) except for Gilbert’s disease or when in the opinion of treating physician elevated levels are due to direct involvement of leukemia (e.g., hepatic infiltration or biliary obstruction due to leukemia)
Total bilirubin =< 1.5 x institutional upper limit of normal, unless related to leukemic infiltration or hemolysis
Impaired liver function defined as a total bilirubin > 1.5 x normal range and AST or ALT > 2.5 x normal range unless secondary to Gilbert’s disease, hemolysis or leukemic involvement of the liver
Bilirubin =< 2 unless consistent with Gilbert’s (total/direct > 5)
Direct bilirubin =< 2 x upper limit of normal (ULN) unless deemed to be related to underlying leukemia.
Bilirubin ? 3.0 x ULN, unless due to Gilbert’s syndrome (unless considered due to leukemic organ involvement)
Adequate hepatic function including total bilirubin < 2 x upper limit of normal (ULN) unless increase is due to Gilbert’s disease or leukemic involvement
Total bilirubin < 1.5x upper limit of normal (ULN) unless increase is due to Gilbert’s disease or leukemic involvement
Bilirubin < 1.5 x upper limit of normal (ULN) unless believed due to leukemic infiltration
Unless considered to be due to leukemic organ involvement.
Have AST, ALT, GGT, and AP that are ?2.5*upper limit of normal (ULN) and normal bilirubin (total and direct) regardless of liver involvement.
Low likelihood of being eligible for reduced intensity conditioning HCT based on known information\r\n* Cardiac ejection fraction < 40% or symptomatic coronary artery disease or uncontrolled arrhythmia\r\n* Diffusing capacity of the lungs for carbon monoxide (DLCOc) < 40% or forced expiratory volume in 1 second (FEV1) < 50%\r\n* Estimated glomerular filtration rate (GFR) < 40 ml/min\r\n* Need for supplemental oxygen\r\n* Direct bilirubin or alanine aminotransferase (ALT) > 2 x upper limit of normal, unless these abnormalities are thought to be related to Gilbert’s disease or leukemic infiltration of hepatic parenchyma
Direct bilirubin or ALT > 2 x upper limit of normal, unless these abnormalities are thought to be related to Gilbert’s disease or leukemic infiltration of hepatic parenchyma
Serum bilirubin =< 2 x upper limit of normal, unless proven to be due to disease involvement
The patient has a history of liver disease (excluding Gilbert’s disease and non-active hepatitis C) and/or elevation of transaminases or bilirubin above the normal limit
Direct bilirubin < 1.6 (unless related to Gilbert’s disease or medications)
Patients with creatinine > 2.5 times upper limit of normal unless felt to be related the underlying leukemia by the treating physician or hemolysis or Gilbert's disease
Patients with total bilirubin >= 2.0 times upper limit of normal unless felt to be related the underlying leukemia by the treating physician or hemolysis or Gilbert's disease
Bilirubin =< 2 unless consistent with Gilbert’s (total/direct > 5)
Transaminases less than or equal 3 x upper limit of normal unless related to the disease
Total bilirubin > 3 x ULN unless isolated hyperbilirubinemia is directly related to the acute infection or due to known Gilbert disease; manifestations of end-stage liver disease, such as ascites or hepatic encephalopathy
Total bilirubin =< 1.5 x upper limit of normal unless clearly related to Gilbert’s disease, hemolysis or leukemic infiltrate
Total bilirubin within normal institutional limits (unless isolated indirect hyperbilirubinemia due to Gilbert’s disease)
Total bilirubin =< 1.5 institutional upper limit of normal (ULN), unless elevated secondary to lymphomatous involvement of liver or biliary system, or due to other HIV medications (e.g., indinavir, tenofovir, or atazanavir); for direct bilirubin > 1.2 due to hepatic involvement by tumor for the initial dose of EPOCH drug adjustment
Bilirubin =< 2.0 x the institutional normal upper limit unless secondary to bile duct obstruction by tumor
Total bilirubin =< 2 x institutional upper limit of normal (IULN) except when, in the opinion of the treating physician, is due to direct involvement of lymphoma (e.g., hepatic infiltration or biliary obstruction due to lymphoma) or Gilbert’s disease
Total bilirubin =< 2 x IULN except when in the opinion of treating physician is due to direct involvement of leukemia (e.g. hepatic infiltration or biliary obstruction due to leukemia) or Gilbert’s disease
Total bilirubin < 1.5 times institutional upper normal limit (unless due to disease involvement of liver, hemolysis or a known history of Gilbert’s disease)
Serum total bilirubin ?1.5 × upper limit of normal (ULN), unless considered due to Gilbert's disease, a gene mutation in UGT1A1, or leukemic organ involvement, following approval by the Medical Monitor;
Direct bilirubin =< 1.5 upper limit of normal (ULN) age unless elevation thought to be due or hepatic infiltration by the hematologic malignancy
Adequate liver function, as evidenced by total serum bilirubin =< 1.5 times the upper limit of normal (patients with Gilbert’s disease are eligible, provided intermittent indirect hyperbilirubinemia)
LVEF by ECHO or MUGA within institutional normal limits unless thought to be disease related; DLCO >= 60% with no symptomatic pulmonary disease unless thought to be disease related
Patients must have a direct bilirubin < 1.5 x upper limit of normal (ULN) for age or normal; these criteria may be waived for patients with known or suspected liver involvement by leukemia following review and approval by the study chair or vice chair
If organ function abnormalities are considered due to leukemic infiltration, total bilirubin must be =< 2 x ULN
Total bilirubin =< 1.5 x upper limit of normal (ULN) unless elevation is deemed due to leukemia infiltration; in these patients, dose modification may be required based on standard guidelines
Total bilirubin =< 1.5 x ULN unless bilirubin rise is considered to be the result of leukemic involvement by the PI
Total bilirubin =< 3 times the upper limit of normal unless hepatic dysfunction is related to liver involvement with disease
Direct bilirubin =< 2.0 x upper limit of normal (ULN) (unless considered due to leukemia involvement)
POST-TRANSPLANT ELIGIBILITY CRITERIA:\r\n* In complete remission (CR) (including incomplete blood count recovery [CRi] and marrow CR) on bone marrow biopsy for response assessment after HCT (typically day +30)\r\n* Patient is within 30-100 days after HCT\r\n* Absolute neutrophil count (ANC) >= 1000/uL, platelet count >= 20,000/uL\r\n* ECOG performance status 0-2\r\n* Adequate major organ function, as defined by AST and ALT =< 2 x upper limit of normal\r\n* Total serum bilirubin < 2 x upper limit of normal (unless due to hemolysis or Gilbert’s syndrome, then no upper limit)\r\n* Creatinine =< 2 x upper limit of normal unless there is known chronic kidney disease (CKD) (creatinine must be at baseline for subjects with CKD)\r\n* In agreement to use an effective barrier method of birth control to avoid pregnancy during the study and for a minimum of 30 days after study treatment, for all male and female patients who are fertile
POST-TRANSPLANT EXCLUSION CRITERIA:\r\n* Active grade II-IV acute graft versus host disease (GVHD)\r\n* Uncontrolled, life-threatening infection that is not responding to antimicrobial therapy\r\n* Serum creatinine > 2 x upper limit of normal unless there is known CKD (creatinine must be at baseline for subjects with CKD)\r\n* AST or ALT > 2 x upper limit of normal\r\n* Total bilirubin > 2 x upper limit of normal\r\n* History of psychiatric disorder which may compromise compliance with the protocol or which does not allow for appropriate informed consent\r\n* Pregnancy\r\n* Concurrent use of any other investigational agents on a clinical trial\r\n* Known hypersensitivity to 5-azacytidine\r\n** Prior treatment with 5-azacytidine is allowed
Total bilirubin > 2 times upper normal limit (unless due to tumor involvement of liver or a known history of Gilbert’s disease)
Total bilirubin < 1.5 x within normal institutional limits (unless due to lymphoma involvement of liver or a known history of Gilbert’s disease)
Liver function tests less than 2 x upper limit of normal range (unless related to medications or Gilbert’s disease)
ALT or AST ? twice the upper limit of normal (ULN), unless considered due to organ leukemic involvement;
Total bilirubin < 1.5 x upper limit of reference range (ULRR), unless the patient meets the criteria for Gilbert’s syndrome
Total bilirubin within normal institutional limits; higher values (=< 3 x institutional upper limit of normal [ULN]) are acceptable in participants with: 1. known or suspected cholangitis associated with Crohn’s disease, or 2, known or suspected inborn errors of metabolism that lead to increased bilirubin
Total or conjugated (direct) bilirubin =< 2.5 X ULN within 45 days prior to entry, with the exception of isolated hyperbilirubinemia that is considered due to atazanavir
Serum amylase =< 1.5 x ULN
Serum amylase =< 1.5 ULN
Amylase: 1.5 x ULN. Subjects with amylase >1.5 x ULN may enrol if there are neither clinical or radiographic signs of pancreatitis
Serum pancreatic amylase < 1.5 x ULN
Serum amylase =< 1.5 x institutional upper limit of normal
Asymptomatic serum amylase =< 2 x ULN; patients with > ULN but =< 2 x ULN serum amylase at study start must be confirmed to have no signs and/or symptoms suggestion pancreatitis or pancreatic injury (e.g. elevated pancreatic [P]-amylase, abnormal imaging findings of pancreas, etc.)
Amylase =< 1 x ULN.
Baseline amylase above the upper limit of normal
Serum amylase =< 1.5 X institutional ULN
Serum amylase =< 2 x ULN
Serum amylase =< ULN
Serum amylase =< 2 x ULN
CAPMATINIB INCLUSION CRITERIA: Serum amylase =< grade 2 and asymptomatic; patients with grade 1 or 2 serum amylase at the beginning of the study must be confirmed to have no signs and/or symptoms suggesting pancreatitis or pancreatic injury (e.g., elevated P-amylase, abnormal imaging findings of pancreas, etc.)
Serum amylase =< 2 x ULN
Amylase =< 2 X ULN
For patients being screened for Group 2, asymptomatic serum amylase > CTCAE Grade 2 (1.5-2.0 x ULN). Patients with Grade 1 or Grade 2 serum amylase at the beginning of the study must be confirmed to have no signs or symptoms suggesting pancreatitis or pancreatic injury (e.g., elevated P-amylase, abnormal imaging findings of pancreas, etc.)
Serum amylase =< 2 x ULN
Serum amylase =< 2 x ULN
Serum amylase =< ULN
Serum amylase =< 1.5 x institutional upper limit of normal
Amylase =< 2 x upper limit of normal
Asymptomatic serum amylase grade > 2 (1.5-2.0 x ULN). Patients with grade 1 or grade 2 serum amylase at the beginning of the study must be confirmed to have no signs or symptoms suggesting pancreatitis or pancreatic injury (e.g., elevated P-amylase, abnormal imaging findings of pancreas, etc.)
Serum amylase =< ULN
Amylase < ULN
Amylase =< 1.5 x the ULN
Within 14 days prior to registration: Serum amylase =< 1.5 x institution’s ULN
Amylase > 1.5 ULN; participants with amylase > 1.5 ULN may enroll if there are neither clinical nor radiographic signs of a pancreatitis
Fasting serum amylase =< 2 x institutional ULN
Serum amylase =< upper limit of normal
Amylase =< 1.5 x ULN
Serum amylase =< ULN
Serum amylase =< ULN
Serum amylase =< ULN
Amylase =< 1.5 x the ULN
Serum amylase =< upper limit of normal
PART B: Serum amylase =< 1.5 X ULN
Normal serum amylase =< (ULN) OR normal
Obtained =< 7 days prior to registration: Serum amylase =< 1.5 x upper limit of normal (ULN)
Serum amylase =< 1.5 x ULN
Have Amylase =< 2.5x ULN
Amylase < 1.5 times ULN
Amylase levels < 1.5 X ULN
Serum amylase =< ULN
Amylase =< 1.5 x the ULN
Asymptomatic serum amylase > grade 2
Serum amylase =< 2 x ULN
Serum amylase =< upper limit of normal (ULN) (if > ULN, confirm pancreatic amylase < 1 .1ukat/L and serum lipase < ULN)
Amylase =< 1.5 x ULN
Serum amylase =< ULN
Amylase =< 2 × upper limits of normal
Amylase =< 1.5 x ULN
Serum amylase =< 2 x ULN
Total bilirubin =< 1.5 times upper limit of normal (ULN)
Total bilirubin =< 2 mg/dL or =< 1.5 times upper limit of normal (ULN)
Total bilirubin =< 1.5 times institutional upper limit of normal (ULN)
Total bilirubin < 1 times the upper limit of normal
Total bilirubin =< 2.5 times upper limit of normal AND
total bilirubin ? 3 times the upper limit of normal (ULN)
Serum total bilirubin =< 2.0 times the upper limit of normal
Total bilirubin =< 1.5 times the institutional upper limit of normal (ULN) OR direct bilirubin =< the normal in subjects with total bilirubin > 1.5 times the ULN
Total bilirubin =< 1.5 times upper limit of normal (ULN)
Total bilirubin < 1.5 times upper limit of normal for age and documented within 14 days prior to registration and within 14 days prior to the start of treatment
Documented within 14 days of registration: Total bilirubin < 1.5 times upper limit of normal for age
Total bilirubin =< 1.5 times upper limit of normal\r\n* If transaminase elevation and/or bilirubin elevation is attributed to the presence of liver metastases, a total bilirubin =< 2.5 times the upper limit of normal and an aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 times the upper limit of normal are permissible; patients with an elevated bilirubin level that is attributed to an inherited disorder, such as Gilbert’s disease, may be enrolled at the discretion of the principal investigator
Total bilirubin >1.5 times upper limit of normal (ULN)
Total bilirubin < 1.5 times upper limit of institutional normal
PHASE I: Total bilirubin =< 1.5 times upper limit of normal (ULN)
PHASE IB: Total bilirubin =< 1.5 times upper limit of normal (ULN)
Total bilirubin =< 1.5 times institutional upper limit of normal (ULN)
INCLUSION CRITERIA FOR STRATUM C: Total bilirubin =< 1.5 times institutional upper limit of normal (ULN)
Total bilirubin =< 1.5 times upper limit of institutional normal (ULN) for age
Total bilirubin =< 2.5 times upper limit of normal
total bilirubin ? 2 times the upper limit of normal (ULN)
Total bilirubin (TBL) > 2.5 times the upper limit of normal at the screening visit
Total bilirubin < 3.0 times the institutional upper limit of normal (ULN)
Total bilirubin < 2.0 times the institutional upper limit of normal (ULN)
Total bilirubin =< 1.5 times the upper limit of the reference range
Total serum bilirubin =< 1.5 times upper limit of normal (ULN).
Total bilirubin =< 1.5 times upper limit of normal (ULN).
Total bilirubin less than 2 mg/dL or 1.5 times upper limit of normal (ULN)
Total bilirubin =< 1.5 times the institutional upper limit of normal.
Total bilirubin =< 1.5 times the upper limit of normal (ULN)
Total bilirubin =< 1.5 times upper limit of normal (x ULN).
Within two weeks prior to enrollment: Total bilirubin =< 1.5 times the upper limit of normal
Total bilirubin < 1.5 times upper limit of normal for age, within 14 days of registration and within 7 days of the start of treatment
Total bilirubin (Tbili) > 1.5 times the upper limit of normal at the screening visit
Total bilirubin =< 1.5 times upper limit of normal (ULN)
Total bilirubin > 2 times the upper limit of normal OR in patients with Gilbert’s syndrome, a total bilirubin > 3.0
Total bilirubin ? 3 times the upper limit of normal (ULN)
Total bilirubin =< 1.5 times the upper limit of the institutional normal values
Total bilirubin greater than 2.5 times the upper limit of normal
Total serum bilirubin =< 1.5 times upper limit of normal (ULN)
Total bilirubin =< 1.5 times upper limit of (institutional/central) normal (patients with Gilbert’s syndrome total bilirubin must be =< 4 times institutional upper limit of normal)
Total bilirubin =< 1.5 times upper limit of normal (ULN)
Bilirubin (total) > 1.5 times the upper limit of normal
Completed within 60 days of surgery: Total bilirubin < 1.5 times the upper limit of institutional normal value
Total bilirubin =< 2 mg/dL; serum transaminases less than two times the institutional upper limit of normal (< 2 x upper limit of normal [ULN])
Serum total bilirubin > 1.5 times the upper limit of normal (ULN);
Total bilirubin =< 1.5 times upper limit of normal (ULN)
Total bilirubin of =< 1.5 times upper limit of normal (exception is made for patients with Gilbert’s syndrome who may be considered eligible if total bilirubin is < 3 times upper limit of normal)
Total serum bilirubin =< 1.5 times the upper limit of normal
EXCLUSION CRITERIA FOR ADDITIONAL PTCy-MILs INFUSION AT RELAPSE: Total bilirubin > 3 times the upper limit of normal (ULN)
Within 21 days prior to course 1 day 1 (C1D1): Total bilirubin < 2 times the upper limit of normal (ULN)
Total bilirubin =< 1.5 times the institutional upper limit of normal
Total bilirubin =< 1.5 times the upper limit of normal (ULN) (to be performed within 7 days prior to start of study treatment)
Total bilirubin < 2.0 times the institutional upper limit of normal (ULN)
Total bilirubin =< 3 times the upper limit of normal if patient had recent biliary stenting and a falling trend in bilirubin is demonstrated such that capecitabine treatment is deemed feasible per the treating medical oncologist, total bilirubin =< 1.5 times the upper limit of normal if no biliary stenting was done
Total bilirubin < 1.5 times upper limit of normal
Total bilirubin =< 2 times the upper limit of normal (ULN)
Total bilirubin < 1.5 times upper limit of normal
Total bilirubin =< 1.5 times the upper limit of normal (ULN)
Total bilirubin < 2.0 times the institutional upper limit of normal (ULN)
Total bilirubin =< 1.5 times institutional upper limit of normal (ULN)
Total bilirubin =< 1.5 times upper limit of normal for age
Total bilirubin =< 1.5 times upper limit of normal range
Total bilirubin =< 2 times the upper limit of normal (ULN) (except patients with Gilbert’s syndrome who must have a total bilirubin of < 3 times ULN)
Total bilirubin =< 1.5 times upper limit of normal (ULN) within 28 days prior to registration.
Total bilirubin < 1.5 times upper limit of normal
Serum total bilirubin and liver enzymes are 2 times the upper limit of normal
Total bilirubin =< 1.5 times upper limit of normal (ULN)
Total bilirubin =< 1.5 times upper limit of normal (ULN)
Total bilirubin =< 1.5 times upper limit of normal (ULN)
Total bilirubin =< 1.5 times institutional upper limit of normal (ULN)
Total bilirubin =< 1.5 times upper limit of normal (ULN)
Total bilirubin level >= 1.5 times the upper limit of normal (ULN) (except patients with Gilbert syndrome, who are excluded if total bilirubin >= 3 times ULN), or
Total bilirubin =< 1.5 times upper limit of normal (ULN) for age
Total bilirubin within =< 1.5 times the upper limit of normal (ULN) institutional limits
Total bilirubin < 1.5 times upper limit of institutional normal
Total bilirubin =< 1.5 times upper limit of normal (ULN)
Total bilirubin =< 1.5 times the upper limit of normal (ULN)
Total bilirubin < 2 times the upper limit of normal (ULN) (except patients with Gilbert’s syndrome who must have a total bilirubin of < 3 times ULN)
Total serum bilirubin of less than 3 times the upper limit of normal
Total bilirubin =< 2 mg/dL or =< 1.5 times upper limit of normal (ULN)
Total bilirubin =< 1.5 times institutional upper limit of normal (ULN)
PHASE II: Total bilirubin =< 1.5 times institutional upper limit of normal (ULN)
Total bilirubin < 1.5 times the institutional upper limit of normal (ULN); subjects with Gilbert’s syndrome and total bilirubin >= 1.5 times the upper limit of normal are eligible to participate
Total serum/plasma bilirubin ?1.5 times the upper limit of normal (ULN).
Total bilirubin ? 1.5 times the upper limit of normal;
Total bilirubin ? 3 times upper limit of normal (ULN) for age
Total bilirubin =< 1.25 times upper limit of normal
Total bilirubin =< 1.5 times the upper limit of normal
Total bilirubin =< 2.5 times upper limit of normal; AND
Total bilirubin > 3 times the upper limit of normal
Total bilirubin within 1.5 times the institutional upper limit of normal (ULN)
Total bilirubin =< 1.5 times institutional upper limit of normal (ULN)
Total bilirubin =< 1.5 times the upper limit of normal (ULN) unless due to Gilbert’s disease or hemolysis, then =< 3.0 times ULN
Total bilirubin > 3 times the upper limit of normal
Total bilirubin < 2 times the upper limit of normal (ULN) (except patients with Gilbert’s syndrome who must have a total bilirubin of < 3 times ULN)
Bilirubin < 2 times the upper limit of normal (ULN) (except patients with Gilbert’s syndrome who must have a total bilirubin of < 3 times ULN)
Total bilirubin < 1.5 times the upper limit of normal (x ULN) for the institution
Bilirubin < 2 times the upper limit of normal (ULN) (except patients with Gilbert’s syndrome who must have a total bilirubin of < 3 times ULN)
Serum total bilirubin =< 2 times the upper limit of normal
Total bilirubin =< 1.5 times ULN (upper limit of normal)
Total bilirubin > 2.5 times the upper limit of normal
Total bilirubin =< 1. 5 times the institutional upper limit of normal
Total bilirubin =< 1.5 times the upper limit of normal (ULN)
Total bilirubin > 1.5 times upper normal limit (unless due to chronic GVHD)
Total bilirubin < 2.0 times the institutional upper limit of normal (ULN)
Total bilirubin =< 2 times upper limit of normal
Total bilirubin =< 1.5 times the upper limit of normal within two weeks prior to enrollment
Total bilirubin within 1.5 times the upper limit of normal institutional limits
Total bilirubin < 2.0 times the institutional Upper Limit of Normal (ULN)
Total and direct bilirubin < 1.5 times upper limit of laboratory normal
Total bilirubin < 1.5 times upper limit of normal (ULN), except patients with Gilbert's syndrome who must have total bilirubin of < 3 times ULN
Total bilirubin ?2 times the upper limit of normal (× ULN)
Total bilirubin ? 1.5 times the upper limit of normal (ULN)
Total bilirubin =< 1.5 times the upper limit of normal (ULN)
Total bilirubin =< 1.5 times the upper limit of normal (ULN)
Total bilirubin </=1.5 times the upper limit of normal (ULN)
Total bilirubin =< 1.5 times the institutional upper limit of normal
Patients must have adequate hepatic function with a total bilirubin =< 1.5 times upper limit normal (ULN) within one week prior to treatment
RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Total bilirubin =< 1.5 times institutional upper limit of normal (ULN)
NON-PROGRESSED DIPG (STRATUM 2): Total bilirubin =< 1.5 times institutional upper limit of normal (ULN)
Total bilirubin < 2 times the upper limit of normal (ULN) (except patients with Gilbert’s syndrome who must have a total bilirubin of < 3 times ULN)
Total bilirubin </=1.5 times the upper limit of normal (ULN)
Inadequate liver function as indicated by total bilirubin >= 1.5 times the upper limit of normal
Total bilirubin less than 1.5 times upper limit of normal (ULN), or less than 3 times ULN at study entry in a patient with documented Gilbert’s disease
Total bilirubin =< 1.5 times institutional upper limit of normal (ULN)
Total bilirubin ? 3 times the upper limit of normal (ULN)
Total bilirubin =< 1.5 times upper limit of normal (ULN)
Total bilirubin =< 1.5 times the upper limit of normal for age
Total bilirubin =< 1.5 times upper limit of normal (ULN) for age
Total bilirubin >= 1.5 times upper limit of normal (ULN)
Total bilirubin < 2 times the upper limit of normal
Total bilirubin =< 1.5 times upper limit of normal
Total bilirubin < 2 times the upper limit of normal (ULN) (except patients with Gilbert’s syndrome who must have a total bilirubin of < 3 times ULN)
Total bilirubin ? 2.5 times upper limit of normal (ULN);
Total bilirubin =< 1.5 times upper limit of normal (ULN) OR direct bilirubin normal (per institute standards)
Total serum bilirubin < 2 times upper limit of normal
Total bilirubin greater than 2 times upper limit of normal
Total bilirubin must be < 2.0 times the upper limit of the institutional normal range; test results must be no more than 3 months old
Total bilirubin must be < 1.5 times the upper limit of normal
Minocycline trial only: screening results for total bilirubin must be < 2 times the upper limit of normal
Patient with total bilirubin three times the upper limit of normal
Total bilirubin must be < 1.5 times the upper limit of normal, as evidenced in laboratory values =< 3 months old
Total bilirubin level =< 1.5 times upper limit of normal (ULN)
Total bilirubin within 1.5 times the institution’s upper limit of normal (ULN)
SUB-STUDY I: Total bilirubin > 3 times the upper limit of normal
SUB-STUDY II: Total bilirubin > 3 times the upper limit of normal
SUB-STUDY III: Total bilirubin > 3 times the upper limit of normal
Total bilirubin > 2 times the upper limit of normal
Total bilirubin > 2 times the upper limit of normal
Total bilirubin > 3 times the upper limit of normal
Bilirubin (total) less than 4.0 times below or above the upper or lower limit range
Total bilirubin less than 4.0 times below or above the upper or lower limit range
Total bilirubin > 2 times the upper limit of normal
Total bilirubin ?1.5 times the upper limit of normal (ULN)
Total bilirubin ? 1.5 times the upper limit of normal (ULN). For intrahepatic cholangiocarcinoma (IHCC) patients only, total bilirubin ? 2.5 times ULN is acceptable
Blood urea nitrogen (BUN) =< 30 mg/dl
Serum creatinine =< 1.5 X institutional upper limit of normal\r\n* Creatinine (Cr) < 2, blood urea nitrogen (BUN) < 100 mg/dL
Blood urea nitrogen (BUN) =< 1.5 x upper limit of normal range
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.
Blood urea nitrogen (BUN): 10-20 MG/DL
Blood urea nitrogen (BUN) =< 30 mg/dl within 14 days prior to Step 2 registration and
BUN >30 and a creatinine >2.
Blood urea nitrogen (BUN) =< 30 mg/dl
Blood urea nitrogen (BUN) =< 1.5 times institutional normal
Blood urea nitrogen (BUN) < 30 mg/dL
Blood urea nitrogen (BUN) < 30 mg/dL
Within 2 weeks of enrollment: Blood urea nitrogen (BUN) =< 25 mg/dl
Blood urea nitrogen (BUN) < 25
Within 14 days prior to registration: Blood urea nitrogen (BUN) and creatinine (Cr) < 2 x ULN
Blood urea nitrogen (BUN) =< 30 mg/dl
Blood urea nitrogen (BUN) < 2 x ULN
Blood urea nitrogen (BUN) =< 1.5 x ULN
Blood urea nitrogen (BUN) less than 2 x upper limit of normal
Blood urea nitrogen (BUN) =< 40 mg/dL.
Blood urea nitrogen < 2 X ULN
Blood urea nitrogen (BUN) =< 1.5 times normal
Blood urea nitrogen (BUN) 8-26 mg/dL
Blood Urea Nitrogen (BUN) < 30 mg/dL
Blood urea nitrogen (BUN) < 25 mg/dL
Blood urea nitrogen (BUN) =< 40 mg/dl
Serum electrolytes including sodium, potassium, blood urea nitrogen (BUN), creatinine, glucose, magnesium, phosphate, and calcium within 10 days prior to registration
Patients must have blood urea nitrogen (BUN), alkaline phosphatase, sodium, potassium, calcium, glucose, chloride, and bicarbonate levels obtained within 14 days prior to registration
Blood urea nitrogen (BUN) =< 30 mg/dl
Have blood urea nitrogen and serum creatinine (BUN/Cr) without clinically significant abnormalities after review by the study physicians
Blood urea nitrogen (BUN) < 1.5 times ULN
Blood urea nitrogen (BUN) =< 30 mg/dl within 21 days prior to study registration
blood urea nitrogen (BUN) < 30 mg/dL
Blood urea nitrogen (BUN) =< 35 mg/dl
Within 14 days prior to registration: Blood urea nitrogen (BUN) =< 1.5 x upper limit of normal range
Blood urea nitrogen (BUN) =< 30 mg/dL
Blood urea nitrogen (BUN) < 1.5 times upper limit of laboratory normal
Blood urea nitrogen (BUN) =< 1.5 times normal
Blood urea nitrogen (BUN) < 2.5 times the upper limit of normal
Normal organ function tests including blood urea nitrogen (BUN)
Blood urea nitrogen (BUN) > 25mg%
Blood urea nitrogen (BUN) =< 30 mg/dl
Blood urea nitrogen measurement (BUN) < 30 mg/dL
Blood urea nitrogen (BUN) < 30mg/dl
Laboratory tests (transaminases [alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP)], blood urea nitrogen [BUN] and creatinine not greater than twice normal) and normal electrocardiogram (ECG)
Blood urea nitrogen (BUN) within 1.5 times the institutional upper limit of normal (ULN) (e.g., if the ULN is 20 mg/dL, then BUN up to 30 mg/dL is permitted)
Serum renal functional parameters, blood urea nitrogen (BUN) and creatinine within normal limits
Blood urea nitrogen < 2 x upper limit of normal (ULN)
Blood urea nitrogen (BUN) =< 40 mg/dL
Blood urea nitrogen (BUN) within institutional limits of normal or judged to be not clinically significant by the investigator
Blood urea nitrogen < 2 x ULN
Blood urea nitrogen (BUN) =< 1.5 x institutional upper limit of normal
Blood urea nitrogen (BUN) within 2 x ULN
Have BUN/Cr (Blood urea nitrogen and serum creatinine) without clinically significant abnormalities after review by the study physicians
Poor kidney function defined as a known renal disease or elevated blood urea nitrogen (BUN) and creatine
Urea nitrogen less than 4.0 times below or above the upper or lower limit range
Blood urea nitrogen (BUN) less than 4.0 times below or above the upper or lower limit range
Blood urea nitrogen (BUN) less than 4.0 times below or above the upper or lower limit range
Greater than 1.5 x the ULN for blood urea nitrogen (BUN)
Within 28 days prior to registration: Total bilirubin =< 2.0 x institutional upper limit of normal (IULN) or for documented/suspected Gilbert’s disease, total bilirubin =< 3.0 x IULN
Serum bilirubin =< institutional upper limit of normal (IULN) within 28 days prior to sub-study registration; for patients with liver metastases, bilirubin must be =< 5 x IULN
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) (or =< 2.5 x upper limit of normal [ULN] with Gilbert’s syndrome)
Total bilirubin =< 2.5 x institutional upper limit of normal (IULN) (except patients with Gilbert’s syndrome) within 28 days prior to registration
Patients must have AST and ALT =< 2.5 x institutional upper limit of normal (IULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) (except Gilbert’s syndrome, who must have a total bilirubin < 3.0 mg/dL), obtained within 28 days prior to step 2 registration
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) (=< 5 x IULN if secondary to lymphoma, Gilbert’s syndrome, or medication related [e.g., indinavir, tenofovir, atazanavir]) within 28 days prior to registration
Obtained within 28 days prior to registration: Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) (or =< 3.0 x IULN with Gilbert's syndrome)
AST and ALT =< 3.0 x institutional upper limit of normal (IULN) within 14 days prior to registration
Registration Step 3 – Maintenance: Patients must have total bilirubin < 2.0 x institutional upper limit of normal (IULN) within 14 days prior to registration
Within 10 days of treatment initiation: Institutional normalized ratio (INR) =< 1.5 X institutional upper limit of normal (IULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (IULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)
Total bilirubin =< institutional upper limit of normal (IULN) or total bilirubin =< 3.0 x IULN with direct bilirubin within normal range in patients with documented Gilbert’s syndrome
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN); no prior history of Gilbert’s syndrome
Total bilirubin =< 1.5 institutional upper limit of normal (IULN)
Total bilirubin ? 1.5 x institutional upper limit of normal (IULN)
Total bilirubin =< 2 x institutional upper limit of normal (IULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) (except Gilbert’s syndrome, who must have a total bilirubin < 3.0 mg/dL)
Total bilirubin ? institutional upper limit of normal (IULN); patients with Gilbert’s syndrome may enroll if direct bilirubin ? 1.5 x IULN
Total bilirubin =< 2 X institutional upper limit of normal (IULN)
Total bilirubin ? 1.5 x institutional upper limit of normal (IULN) (unless due to diagnosis of Gilbert’s syndrome)
Total bilirubin =< 2.0 x institutional upper limit of normal (IULN)
Total bilirubin =< institutional upper limit of normal (IULN)
Total bilirubin =< institutional upper limit of normal (IULN)
Bilirubin levels > 1.5 institutional upper limit of normal (IULN)
Serum bilirubin < 1.5 x institutional upper limit of normal (IULN) (except for patients with known Gilbert’s disease)
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)
Total bilirubin < 1.5 x institutional upper limit of normal (IULN)
Total bilirubin less than 1.5 X institutional upper limit of normal (IULN) except in patients with Gilbert’s syndrome who must have a total bilirubin less than 2.5 X IULN
Total bilirubin =< international upper limit of normal (IULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)
ARM B COHORT 2: Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)
Serum creatinine =< 1.5 x institutional upper limit of normal (IULN)
Patient must have adequate hepatic function as defined by total bilirubin < 2.5 x IULN (institutional upper limit of normal)
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)
Total bilirubin =<1.5 x institutional upper limit of normal (IULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) (except participants with Gilbert’s Syndrome who must have normal direct bilirubin)
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)
Serum bilirubin =< institutional upper limit of normal (IULN); for patients with liver metastases, bilirubin must be =< 5 x IULN obtained within 28 days prior to Step 2 re-registration
Serum bilirubin =< institutional upper limit of normal (IULN); for patients with liver metastases, bilirubin must be =< 5 x IULN within 28 days prior to Step 2 re-registration
Serum bilirubin =< institutional upper limit of normal (IULN); for patients with liver metastases, bilirubin must be =< 5 x IULN within 28 days prior to step 2 re-registration
Within 14 days of subject registration: Total bilirubin within normal range or =< 1.5 X institutional upper limit of normal (IULN) if liver metastases are present or total bilirubin =< 3.0 X IULN with direct bilirubin within normal range in subjects with well-documented Gilbert’s syndrome, which is defined as presence of unconjugated hyperbilirubinemia with normal results from complete blood count (CBC) (including normal reticulocyte count and blood smear), normal liver function test results and absence of other contributing disease processes at the time of diagnosis
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)
Obtained within 28 days prior to registration: Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)
Creatinine < 1.5 x institutional upper limit of normal (IULN)
Total bilirubin =< 2 x institutional upper limit of normal (IULN) (unless due to Gilbert syndrome) within 42 days prior to registration
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) (except Gilbert’s syndrome, who must have a total bilirubin < 3.0 mg/dL) be obtained within 42 days prior to registration
CLINICAL/LABORATORY CRITERIA: Total bilirubin =< 1.5 x institutional upper limit of normal (IULN); these results must be obtained within 28 days prior to registration
Performed within 14 days of patient registration: Total bilirubin within normal range or =< 1.5 x institutional upper limit of normal (IULN) if liver metastases are present or total bilirubin =< 3.0 x IULN with direct bilirubin within normal range in patients with well documented Gilbert’s syndrome, which is defined as presence of several episodes of unconjugated hyperbilirubinemia with normal results from complete blood count (CBC) (including normal reticulocyte count and blood smear), normal liver function test results, and absence of other contributing disease processes at the time of diagnosis
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) except in the case of patients with Gilbert’s disease
Total bilirubin within institutional upper limit of normal (IULN)
Serum bilirubin =< institutional upper limit of normal (IULN) within 28 days prior to RE-TREATMENT registration; for patients with liver metastases, bilirubin must be =< 5 x IULN
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)
Within 14 days prior to registration: Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)
Total bilirubin =< institutional upper limit of normal (IULN)
Serum bilirubin =< 1.5 x institutional upper limit of normal (IULN) OR serum bilirubin =< 3.0 x IULN for patients with Gilbert’s disease or documented hepatic involvement with non-Hodgkin lymphoma (NHL)
Within 14 days prior to registration: Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)
Serum bilirubin =< 1.5 x institutional upper limit of normal (IULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)
Direct bilirubin =< 1.5 x institutional upper limit of normal (IULN)
Serum bilirubin =< institutional upper limit of normal (IULN)
Total serum bilirubin =< 2.0 x institutional upper limit of normal (IULN)
Total bilirubin =< 2.0 x institutional upper limit of normal (IULN)
Total bilirubin =< 1.5 × the institutional upper limit of the normal range (IULN)
Total bilirubin up to 1.5 X institutional upper limits of normal (IULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) (or =< 2.5 x ULN for patients with Gilbert’s syndrome)
Total bilirubin =< 1.5 institutional upper limit of normal (IULN)
Total bilirubin =< 1.5 institutional upper limit of normal (IULN)
Total bilirubin =< 2.0 x institutional upper limit of normal (IULN)
Serum bilirubin =< 2 X institutional upper limit of normal (IULN)
Total bilirubin =< 2.0 x institutional upper limit of normal (IULN)
Total bilirubin =< 2.0 x institutional upper limit of normal (IULN)
Bilirubin =< 1.5 x institutional upper limit of normal (IULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)
Serum bilirubin < 3.0 x institutional upper limit of normal (IULN)
Direct bilirubin =< 1.5 x institutional upper limit of normal (IULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) except patients with documented Gilbert’s syndrome within 28 days prior to registration
Total bilirubin =< 2.0 x institutional upper limit of normal (IULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)
Transaminases =< 2.5 x institutional upper limit of normal (IULN)
Transaminases =< 2.5 x institutional upper limit of normal (IULN)
Total bilirubin =< 1.5 x the institutional upper limit of normal (IULN) for age
Serum creatinine =< institutional upper limit of normal (IULN)
Patients must have lactate dehydrogenase (LDH) obtained within 28 days prior to registration in order to obtain baseline stratification information
Serum lactate dehydrogenase (LDH) < 10 X ULN (patients with LDH > 10 X ULN are felt to have aggressive disease and should be considered for BRAF inhibitor therapy off protocol), obtained within 4 weeks prior to randomization
Patients must have the following components of Follicular Lymphoma International Prognostic Index (FLIPI) available from diagnosis, and collected again at time of registration:\r\n* Age\r\n* Lactate dehydrogenase (LDH)\r\n* Number of nodal groups involved\r\n* Serum or plasma hemoglobin \r\n* Ann Arbor stage\r\nAdditionally, patients must have beta-2-microglobulin collected at time of registration
Patients must have lactate dehydrogenase (LDH) performed within 28 days prior to registration
Within 10 (except as noted) days of planned treatment initiation: Lactate dehydrogenase (LDH) =< 1.5 x institutional ULN (may be within 28 days)
Baseline labs as within standard of care (complete blood count [CBC], comprehensive metabolic panel [CMP], lactate dehydrogenase [LDH], erythrocyte sedimentation rate [ESR], etc) are required within 14 days of enrollment
Lactate dehydrogenase (LDH) =< 1.5 x ULN
Patients with symptomatic leukemic meningitis, bony or gastrointestinal (GI) tract involvement, serum calcium or lactate dehydrogenase (LDH) > 1.5 X the upper limit of normal will be excluded; however, patients that have both ATL and another HTLV-1 associated disease such as tropical spastic paraparesis (HTLV-I-associated myelopathy [HAM]/tropical spastic paraparesis [TSP]) will be included
Subjects must have serum lactate dehydrogenase (LDH) > institutional upper limit of normal (ULN) at time of study enrollment
LDH < 2 times ULN for each institution.
Serum lactate dehydrogenase (LDH) level =< 1.5 upper limit of normal (ULN) within 28 days prior to enrollment
Serum lactate dehydrogenase (LDH) levels < 1.5 × ULN
LDH ?2.5 times the ULN.
Serum lactate dehydrogenase (LDH) not greater than 1.5 times the upper limit of the local laboratory assay within 14 days of RPLND
LDH < 2 x ULN
Normal serum lactate dehydrogenase (LDH)
Lactate dehydrogenase (LDH) - no clinically significant findings
Serum lactate dehydrogenase (LDH) > 1.5 x institutional ULN
At least one risk factor predicting higher likelihood of bone marrow sample yield: elevated alkaline phosphatase, low hemoglobin, or elevated lactate dehydrogenase (LDH)
Melanoma patients with an LDH ? 3 x ULN.
Serum lactate dehydrogenase (LDH) =< 10 X ULN
Lactate dehydrogenase (LDH) < 5 × upper limits of normal\r\n* (NOTE: these criteria will select against patients with bulky disease and will select for patients with less disease and earlier disease)
Patient with group classification A disease, or group classification B stage I or II disease with normal lactate dehydrogenase (LDH) level AND tumor mass less than 7 cm; NOTE: Patients who would be excluded from treatment on this protocol strictly for laboratory or performance status abnormalities can be included at the principal investigator’s discretion after consultation with the members of the Texas Children's Hospital (TXCH) Lymphoma Team
Current or prior features of acute (corrected calcium [Ca]++ > 2.73 or lactate dehydrogenase [LDH] > 2-fold above ULN) or chronic (LDH 1.5-2-fold above ULN or absolute lymphocyte count > 4 x 10^9/L with T-cells > 3.5 x 10^9/L) ATL; patients with smoldering ATL (no acute or chronic features) and symptomatic ATL skin lesions are also eligible
The following tests must be performed within 42 days prior to registration either for diagnosis/staging or to obtain baseline values:\r\n* White blood cells (WBC)\r\n* Hemoglobin\r\n* Lactate dehydrogenase (LDH)\r\n* Hepatitis B-surface antigen (Ag) and anti-core antibody (Ab)
Patients must have lactate dehydrogenase (LDH) performed within 42 days prior to registration
Subject must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and must have a serum lactate dehydrogenase (LDH) ? 1.0 X upper limit of normal and adequate hematologic, hepatic, renal, and coagulation organ function- Other criteria may apply
LDH level ? 1.5 × ULN at screening
LDH level ? 1.5 × ULN at screening.
Within 4 weeks of administration of study therapy: Lactate dehydrogenase (LDH) < 4 x upper limit of normal (ULN)
Patients with melanoma must have a serum lactate dehydrogenase (LDH) test performed within 28 days prior to registration
Stage III with elevated LDH level (\B-high\), [LDH > twice the institutional upper limit of the adult normal values (> Nx2)] or any stage IV or B-AL.
Meets criteria for poor-risk defined as 3 or more of the following: ECOG performance status 2, anemia (hemoglobin lower than reference range), elevated serum lactate dehydrogenase (LDH) > 1.5 x upper limit of normal (ULN), hypercalcemia (corrected serum calcium level > upper limit of normal), time from initial RCC diagnosis to registration on this trial < 1 year, and > 1 metastatic organ sites
Lactate dehydrogenase (LDH) within normal limits (WNL)
Elevated lactate dehydrogenase (any elevation above normal range)
Sufficient data to calculate the International Prognostic Index (IPI) score at baseline:\r\n* Age\r\n* Stage of disease\r\n* Lactate dehydrogenase (LDH)\r\n* ECOG performance status\r\n* Number of extranodal sites
increase in serum Lactase Dehydrogenase (LDH)
Subject has a known elevation in serum lactate at screening ? 2x institutional ULN
LDH < 1.50 X institutional upper limit of normal
Lactate dehydrogenase (LDH) ? 2 times the upper limit of normal (ULN).
Lactate dehydrogenase (LDH): there is no restriction
Patients must have lactate dehydrogenase (LDH) obtained prior to registration
Lactate dehydrogenase < 2 x ULN
Lactate dehydrogenase (LDH) less than 4.0 times below or above the upper or lower limit range
Lactate dehydrogenase (LDH) less than 4.0 times below or above the upper or lower limit range
LDH ?2.0 times the ULN range of each institution
Elevated LDH levels are permissible if transaminases are =< IULN
Platelets >= 100 x 10^3/mm^3 (or >= lower limit of institutional normal value)
Potassium >= lower limit of normal (LLN) range for the institution
Corrected calcium level >= lower limit of the institutional normal range
Potassium >= 3.3 mmol/L or at/above the lower limit of normal for the performing laboratory
Platelets >= institutional lower limit
LVEF below institutional lower level of normal (LLN) or below 50%, whichever is lower
Potassium above the institutional lower limit of normal (supplementation to meet this is allowed)
Mg ? lower limit of normal
Thyrotropin/25-hydroxyvitamin D levels < lower limit of normal
Platelets >= institutional lower limit of normal
LVEF at or above institutional lower limits of normal (>= 50%), or at least 5% above lower limits of normal if prior anthracycline exposure (by echocardiogram or nuclear scan within 12 weeks of registration)
Serum potassium >= lower limit of normal (LLN)
Hemoglobin within 10% of upper and lower limit of normal range of test (gender based)
Platelet within 10% of upper and lower limit of normal range of test
DONOR: Hemoglobin within 10% of upper and lower limit of normal range of test (gender based for hemoglobin)
DONOR: WBC within 10% of upper and lower limit of normal range of test (gender based for hemoglobin)
DONOR: Platelet within 10% of upper and lower limit of normal range of test (gender based for hemoglobin)
Serum potassium >= institutional lower limit of normal (ILLN)
Potassium >= lower limit of normal
Baseline albumin greater than or equal to Lower Limit of Normal
Serum potassium >= lower limit of normal (LLN)
Anemia: normochromic, normocytic with a hemoglobin value of > 2g/100 ml below the lower limit of normal or a hemoglobin value < 10g/100 ml
Potassium >= lower limit of normal (LLN) range for the institution =< 14 days prior to registration\r\n* NOTE: Supplementation may be given before the first dose of study medication
DONORS: Hemoglobin within 10% of upper and lower limit of normal range of test (gender based for hemoglobin)
DONORS: White blood cells (WBC) within 10% of upper and lower limit of normal range of test (gender based for hemoglobin)
DONORS: Platelets within 10% of upper and lower limit of normal range of test (gender based for hemoglobin)
Sodium >= the institutional lower limit of normal
Potassium >= lower limit of normal
Potassium above lower limit normal range for the institution; supplementation may be given before the first dose of study medication
Sodium above lower limit normal range for the institution; supplementation may be given before the first dose of study medication
Ejection fraction < 50% or below the lower limit of the institutional normal range, whichever is lower
Leukocytes no lower limit
(A) Anemia (hemoglobin <10 g/dl or >2 g /dL below the lower limit of laboratory normal)
Patients must have adequate organ and marrow function as defined below: NOTE: Institutional/laboratory upper limit of normal = ULN Institutional/laboratory lower limit of normal = LLN
Serum potassium >= the institutional lower limit of normal (supplementation of electrolytes prior to screening is allowed)
Serum potassium ? Institutional lower limit of normal (LLN)
Absence of anemia attributed to the plasma cell disorder*: hemoglobin > 10 g/dl or not more than 2 g/dL below the lower limit of normal\r\n* To be determined based on clinical and laboratory assessment by the primary oncologist
Anemia: hemoglobin value of > 20 g/L below the lower limit of normal, or a hemoglobin value < 100 g/L
Baseline testosterone >= lower limit of normal
Phosphorus at or above lower limit of normal (correction with supplements is fine as long as the resultant level is at or above the lower limit of normal)
Serum potassium >= lower limit of normal (LLN)
Serum potassium >= lower limit of normal (LLN)
Hemoglobin (Hb) > 9 g/dL or values >= lower limit of normal (LLN) for site-specific lab
Sodium >= lower limit of normal (LLN) after correction of hyperglycemia
RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Potassium >= lower limit of normal (LLN)
Serum potassium >= lower limit of normal (LLN)
Serum creatinine >1.5 x ULN or calculated or directly measured CrCl < 50% lower limit of normal
LVEF above the institution's lower limit of normal
Serum potassium >= lower limit of normal (LLN)
Serum potassium >= lower limit of normal (LLN)
Serum potassium greater than the lower limit of normal (LLN) and < 5.5 mmol/L
Ejection fraction < 50% or below the lower limit of the institutional normal range, whichever is lower
Baseline LVEF ? 50% and not lower than the institutional lower limit of normal;
LVEF that is ?50% (or ? institutional lower limit of normal);
Thrombosis of lower extremities in the last week
Platelets >= the lower institutional limits
Hemoglobin greater than 90% of the lower limit of institutional normal
Amylase less than 4.0 times below or above the upper or lower limit range
Albumin less than 4.0 times below or above the upper or lower limit range
Sodium less than 4.0 times below or above the upper or lower limit range
Potassium less than 4.0 times below or above the upper or lower limit range
Chloride less than 4.0 times below or above the upper or lower limit range
Bicarbonate (HCO3) less than 4.0 times below or above the upper or lower limit range
Calcium less than 4.0 times below or above the upper or lower limit range
Creatinine less than 4.0 times below or above the upper or lower limit range
Glucose less than 4.0 times below or above the upper or lower limit range
Prothrombin time less than 4.0 times below or above the upper or lower limit range
Serum electrolytes less than 4.0 times below or above the upper or lower limit range
Creatinine less than 4.0 times below or above the upper or lower limit range
Urinalysis less than 4.0 times below or above the upper or lower limit range; urinalysis abnormalities will not preclude the patient from being enrolled and studied
Absolute neutrophil count (ANC) >= 4.0 X upper limit of normal (ULN) or lower limit of normal (LLN)
Serum potassium between the institution’s lower limit of normal and 5.5
LVEF < 45% or below the institutional lower limit of the normal range (whichever is higher)
Ineligible for high dose cisplatin therapy; the reason for ineligibility must be defined; acceptable reasons for ineligibility include the following:\r\n* Abnormal renal function (glomerular filtration rate [GFR] < lower limit of institutional normal (< lower limit of institutional normal [LLN])\r\n* Abnormal hearing (patient or audiology defined)\r\n* Pre-existing tinnitus\r\n* Neuropathy (bilateral paresthesias or loss of deep tendon reflexes in upper and/or lower extremities)\r\n* Diabetes mellitus\r\n* Oncologist-certification that patient would not be considered eligible for high dose cisplatin when given as standard of care (for example, due to age or another medical problem); reason should be documented\r\n* Patient refusal for high dose cisplatin
Serum bilirubin levels ?2 x ULN
Serum bilirubin =< 1.5 x institutional ULN
Serum bilirubin =< 2 x ULN
Serum bilirubin =< 1.5 x ULN
Serum bilirubin =< 1.0 x ULN
Serum bilirubin < 2 x ULN
Serum bilirubin =< 1.5 x ULN
Serum bilirubin ?1.5 × ULN (Grade ? 1).
Serum bilirubin =< 1.0 x ULN
Serum bilirubin =< 1.0 x ULN
Serum bilirubin > 1.5 x ULN; patients with known Gilbert’s disease who have a serum bilirubin level =< 3 x ULN may be enrolled
Serum bilirubin =< 1.5 x ULN
Serum bilirubin < 1.5 x ULN
Serum bilirubin =< 1.5 x institutional ULN
Serum bilirubin < 1.5 x ULN
Serum bilirubin < 3 x ULN
Serum bilirubin =< 1.5 x ULN
Serum bilirubin =< 1.5 x ULN
Serum bilirubin =< 2.0 x ULN
Serum bilirubin less than or equal to 1.5 x ULN
Serum bilirubin =< 2 x ULN
Serum bilirubin =< 1.0 x ULN
Serum bilirubin =< 1.5 x ULN
Serum bilirubin =< 2 x ULN or considered not clinically significant
Within 14 days prior to registration: Serum bilirubin =< 1.5 x institution’s ULN
Pretreatment serum bilirubin =< 2.5 x institutional ULN or
Serum bilirubin =< 1.5 x ULN
Serum bilirubin =< 2 x ULN
Serum bilirubin =< 2.5 x ULN
Serum bilirubin =< 1.5 x ULN
Serum bilirubin =< 1.5 x institutional ULN
Serum bilirubin =< 1.5 x ULN
Serum bilirubin =< 2.5 x ULN
Serum bilirubin =< 1.5 x ULN and
Serum bilirubin =< 1.5 x ULN
Serum bilirubin =< 1.5 X ULN
Serum bilirubin =< 1.5 x ULN
Serum bilirubin =< 1.5 x ULN
Serum bilirubin =< 1.5 x ULN
Serum bilirubin < 1.5 x ULN
Serum bilirubin <2x ULN
Serum bilirubin < 1.5 x ULN
Serum bilirubin =< ULN
Serum bilirubin =< 1.5 x ULN
Serum bilirubin < 1.5 x ULN
Serum bilirubin < 2 x ULN
Serum bilirubin =< 1.5 x ULN
Serum bilirubin =< 1.5 x ULN
Serum bilirubin =< 1.5 x ULN
Serum bilirubin =< 2.0 x ULN with the following exception: patients with known Gilbert’s disease should have a serum bilirubin =< 3 x ULN (obtained within 28 days prior to the first study treatment)
Serum bilirubin ? 1.5 x ULN.
Serum bilirubin =< institution ULN (except for subjects with Gilbert’s Disease who are eligible despite elevated serum bilirubin level)
Serum bilirubin =< 1.5 x institutional ULN
Bilirubin =< 1.5 times normal 14 days prior to study entry
Bilirubin < 1.5 times institutional upper limit of normal, within 21 days prior to study entry
Bilirubin =< 1.5 times the upper limit of normal (x ULN).
Bilirubin 1.5 times upper limit of normal
Bilirubin < 1.5 times the upper limit of normal (ULN)
Bilirubin less than 3 times the upper limit of normal
INCLUSION - TREATMENT: Bilirubin less than 3 times the upper limit of normal
Bilirubin < 2.5 times institutional upper limit of normal (ULN)
TREATMENT INCLUSION: Bilirubin 1.5 times or less than the upper limit of normal
Bilirubin ? 1.5 times the upper limit of normal (ULN),
Bilirubin ? 2 times the upper limit of normal
Bilirubin greater than 1.5 times the upper limit of normal (ULN)
Serum bilirubin =< 1.5 times upper-limit of normal (ULN) (measured within 28 days of registration)
Bilirubin =< 1.5 times upper limit of normal for age
Serum bilirubin =< 1.5 times upper limit of normal (prior to biopsy)
Bilirubin < 1.5 times the upper limit of normal (ULN)
STUDY TREATMENT: Serum bilirubin value less than 1.5 times the upper limit of the normal range
Bilirubin =< 1.5 times the upper limit of normal (ULN)
Bilirubin > 1.5 times the upper limit of the normal range (ULN)
Bilirubin =< 3 times upper limit of normal (CTCAE grade 2 baseline)
Serum bilirubin =< 3 times the upper limit of normal (ULN) (within 14 days prior to registration)
Bilirubin =< 3 times the upper limit of normal for age
PRIOR TO CELL PROCUREMENT: Bilirubin ? 1.5 times the upper limit of normal (ULN)
PRIOR TO INFUSION OF ATLCAR.CD30 CELLS: Bilirubin ? 1.5 times the upper limit of normal (ULN)
Bilirubin ? 2 times upper limit of normal
Bilirubin =< 1.5 times upper limit of normal (ULN)
bilirubin less than or equal 1.5 times the upper limit of normal (ULN).
Bilirubin =< 1.5 times the upper limit of normal (ULN); this value must be obtained within two weeks before protocol entry
Bilirubin < 2.5 times institutional upper limit of normal (ULN)
Bilirubin =< 1.5 times upper limit of normal
Bilirubin less than 3 times the upper limit of normal
Bilirubin =< 3 times the upper limit of normal for age
Bilirubin =< 1.5 times the upper limit of the normal range (ULN)
Bilirubin =< 1.5 times the upper limit of normal (ULN); this value must be obtained within four weeks before protocol entry
Bilirubin 1.5 times or less than the upper limit of normal
Bilirubin < 4 times the upper limit of institutional normal
Bilirubin < 3 times the upper limit of institutional normal
Bilirubin < 1.5 times upper limit of normal
Serum bilirubin < 1.5 times the institutional upper limit of normal
Bilirubin less than 3 times the upper limit of normal
Bilirubin =< 1.5 times upper limit of normal
Bilirubin less than 3 times the upper limit of normal
Bilirubin =< 1.5 times upper limit of normal (ULN)
Bilirubin ? 1.5 times upper limit of normal (CTCAE Grade 2 baseline)
Bilirubin =< 1.5 times upper limit of normal
Bilirubin =< 1.5 times the institutional limit of normal
Bilirubin <= 1.5 times the upper limit of normal (ULN).
Bilirubin 1.5 times or less than the upper limit of normal
Bilirubin < 1.5 times the upper limit of normal (ULN)
Bilirubin =< 1.5 times upper limit of normal
Bilirubin =< 1.5 times upper limit of normal
Serum bilirubin =< 1.5 times upper-limit of normal (ULN)
Bilirubin =< 1.5 times (x) the institutional upper limit of normal (ULN)
Bilirubin < 1.5 times the upper limit of normal (ULN)
Bilirubin < 2 times the upper limit of normal
Bilirubin less than 6 times the upper limit of normal
Bilirubin < 2 times the upper limit of normal
Bilirubin =< 2.0 times normal
Bilirubin =< 1.5 times the upper limit of normal (ULN) for the institution
Bilirubin < 1.5 times the upper limit of normal
Bilirubin =< 3 times the upper limit of normal for age
Bilirubin =< 3 times the upper limit of normal for age
Bilirubin > 1.5 times the upper limit of the normal range (ULN).
Bilirubin < 1.5 times upper limit of normal (ULN)
Bilirubin < 1.5 times upper limit of normal
Serum bilirubin < 1.5 times the Upper Limit of Nor-mal (ULN).
Serum bilirubin < 1.5 times the Upper Limit of Nor-mal (ULN).
Bilirubin < 1.5 times upper limit of normal (ULN) for age
Bilirubin =< 1.5 times the upper limit of normal
Obtained within 14 days prior to initiation of treatment: Serum bilirubin < 1.5 times the upper limit of normal (ULN)
Serum bilirubin < 1.5 times upper limit of normal
Serum bilirubin </= 3 times upper limit of normal (x ULN)
Serum bilirubin =< 1.5 times the upper limit of normal; or total bilirubin =< 3 times the upper limit of normal with direct bilirubin within the normal range in patients with well documented Gilbert syndrome
Baseline direct bilirubin lower than three times the upper limit of normal
Bilirubin < 1.5 times upper limit of normal
Bilirubin =< 1.5 times the upper limit of normal (ULN)
Required prior to infusion of ATLCAR.CD30 cells: Bilirubin =< 1.5 times the upper limit of normal (ULN)
Bilirubin <4.0 mg/dl, SGOT ? 1.5 times the upper limit of normal