If the lab abnormality is thought to be due to the lymphoma the patient is eligible and dose adjustments should be made
Measurable disease confirmed by central lab at Screening, defined by at least 1 of the following:
Serum bilirubin < 1.5 x the ULN for the reference lab;
Lab values must also be verified, meeting eligibility criteria, within 14 days prior to starting treatment. If treatment is planned > 14 days after lab values were obtained for registration, labs must be repeated
Acceptable lab testing results
acceptable lab values prior to randomization
Lab results per the following within 4 weeks prior to study registration:
Appropriate renal, liver, and hematologic lab values
Patients must have the following lab values obtained < 4 weeks prior to starting treatment:
Normal serum creatinine based on age/gender as defined by Seattle Children's Hospital (SCH) chemistry lab
Serum creatinine performed within 4 weeks prior to study entry must be less than or equal to 1.5 x ULN for the lab.
Baseline laboratories (repeat lab tests are permitted to evaluate eligibility during the Screening Period. Lab results must be within protocol range prior to study treatment.)
Screening heart function lab test
Positive antinuclear antibody (ANA) lab result
Pretreatment lab values must be performed within 14 days of patient registration unless otherwise specified; other baseline studies must be performed within 30 days of registration
Adequate lab values
Testing for MSI Status (by an accredited lab)
Patients must have marrow function and organ function as defined below\r\n* Note: to remain on treatment, any abnormal lab values allowed by the PI must remain stable or improve during treatment; similar off treatment rules will be applied to all patients, except the following: the grade of any abnormal laboratory (lab) value allowed by the protocol principal investigator (P.I.) at enrollment will be considered the patient’s baseline for potentially resuming therapy after modification/holding of therapy when off treatment criteria are applied
Adequate organ function as follows: Hematologic system: Absolute neutrophil count (ANC), Lab values - >=1.5 X 10^9/L; Hematologic system: Hemoglobin, Lab values - >=9.5 grams/deciliter (g/dL) (subjects that required transfusion or growth factor need to demonstrate stable haemoglobin for 7 days of 9.5 g/ g/dL); Hematologic system: Platelets, Lab values - >=100 X 10^9/Liter [L] ); Hematologic system: Prothrombin time /International normalized ratio and partial thromboplastin time, Lab values - <=1.5 X upper limit of normal (ULN). Renal system: Creatinine, lab values - <=1.5 X ULN; or Renal system: Calculated creatinine clearance [calculated by Cockcroft Gault formula], lab values - >=50 milliliter (mL)/minute (min); or Renal system: 24-hour urine creatinine clearance>=50 mL/min; Hepatic system: total Bilirubin <=1.5 X ULN (isolated bilirubin >1.5 X ULN is acceptable if bilirubin is fractionated and direct bilirubin <35% or subject has a diagnosis of Gilbert's syndrome), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >=2.5 x ULN. Cardiac system: Ejection fraction, lab values - >=lower limit of normal (LLN) by Echocardiogram (ECHO) (minimum of 50%); Cardiac system: Troponin ( T), lab values - <=ULN; Cardiac system: Potassium, lab values - >=LLN and <=ULN; Cardiac system: Magnesium, lab values - >=LLN. Thyroid system: thyroid stimulating hormone, lab values >=LLN and <=to ULN. Reproductive /endocrine system: testosterone <50 nanogram (ng)/dL (only for subject with CRPC)
Lipase performed within 28 days of randomization must be less than or equal to 1.5 x ULN for the lab.
Serum creatinine performed within 28 days of randomization must be less than or equal to 1.5 x ULN for the lab.
Not consenting to participate in LAB00-099
Out of range lab values as defined in protocol
Patients will have the option to enroll on blood collection protocol, LAB09-0983, for serial collections of blood before, during intervals of treatment, and at follow up visits; enrolling on the LAB09-0983 protocol is not required to enroll on the 2014-0722 study
Two (2) Screening PCRs have been completed and both results are < 0.01% (>MR4 i.e > 4 log reduction) by central lab
PD-L1+ on immunohistochemistry testing performed by central lab
Prior therapy and screening lab criteria must be met
Serum creatinine performed within 4 weeks prior to study entry must be less than or equal to 1.5 x ULN for the lab.
Bicarbonate within the normal range of the hospital lab (24-32 mmol/L)
Creatinine within normal range for age (per institutional defined lab value ranges)
Subjects must have the following lab values:
Serum creatinine =< 1.5 x ULN for the lab
Subjects must have confirmed EGFR amplification by central lab
Lab values:
Lab values:
Lab values:
Lab values:
Patients must have LVEF >= 50% by 2-dimensional (D) echocardiogram within 28 days prior to registration; the echocardiogram must be obtained from a S1501 validated ECHO laboratory (lab) and submitted for central review by the S1501 ECHO core lab; ECHO should not be submitted for central read until patient has been otherwise deemed eligible
Protein levels within normal limits (lab results must be within 45 days prior enrollment)
Normal chemistries (lab results must be within 45 days prior enrollment)
Pretreatment lab values must be performed within 14 days of treatment initiation, and other baseline studies performed within 30 days prior to registration
Hemoglobin (Hgb) within normal limits for institution/lab
Other lab values that in the opinion of the primary surgeon would prevent surgical resection
Lab values that in the opinion of the primary surgeon would prevent surgical resection
Recent lab tests showing elevated serum creatinine (>= 1.5 mg/dL)
Lab values that in the opinion of the primary surgeon would prevent surgical resection
Lab values that in the opinion of the primary surgeon would prevent surgical resection
Lab values that in the opinion of the primary surgeon would prevent surgical resection
Renal lab values: Creatinine > 1.5 ULN
Patient in MR4.5 at prescreening at Novartis designated lab