Patients must demonstrate adequate organ function as defined below; all screening labs to be obtained =< 14 days prior to registration; (Note: screening labs will be repeated again on cycle 1 day 1 [C1D1] if they were performed outside of the =< 4 day window)
Adequate labs
Adequate labs
Adequate organ function as appropriate for the disease under study. All screening laboratory tests should be performed within 10 days of treatment initiation.
Have adequate organ function (all screening labs should be performed within 15 days prior to study treatment):
Demonstrate adequate organ function, all screening labs should be performed within 14 days prior to registration
iC9-CAR19 CELL INFUSION: Demonstrate adequate renal and hepatic function; all screening labs to be obtained within 24 hrs prior to cell infusion
Demonstrate adequate organ function; all screening laboratory tests should be performed within 7 days of treatment initiation
Demonstrate adequate organ function, all screening labs should be performed within 10 days of study drug administration
Foundation for the Accreditation of Cellular Therapy (FACT) labs and final test results available prior to infusion into the patient (copy of labs included in appendices); in the second donation from the donor, the FACT labs must be redrawn within 30 days of initiation of apheresis; positive serologies are not repeated as they remain positive for lifetime
Demonstrate adequate organ function, screening labs that include hematology and chemistry labs should be performed within 14 days of registration on the study
All screening labs should be performed within 14 days (+3 working days) of treatment initiation: hemoglobin >= 9 g/dL or >= 5.6 mmol/L;
Patients must have adequate labs within 7 days of treatment unless cytopenia is thought to be due to underlying disease
Have adequate organ function, with all screening labs performed within 7 days of treatment initiation.
Demonstrate adequate organ function, all screening labs should be performed within 14 days of treatment initiation
Demonstrate adequate organ function, all screening labs should be performed within 6 weeks of treatment initiation
Leukocytes >= 2,000/mcL (labs should be performed within 14 days of treatment initiation)
Have adequate organ function (all screening labs should be performed within 15 days prior to treatment initiation):
Use of hydroxyurea within 7 days prior to screening labs
Specific ranges/levels of Screening labs that are acceptable per protocol.
Satisfactory results of screening safety labs, serum testosterone test and drug test
VTE risk score >= 1, using labs drawn within 28 days of consent
Labs required for enrollment (prior to microinjection):
Demonstrate adequate organ function, all screening labs must be performed within 10 days of treatment initiation; labs must meet eligibility criteria within 4 days of cycle 1 day 1
Must be obtained within 14 days prior to registration for protocol therapy: Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Within 21 days of treatment initiation:\r\nSerum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Bilirubin =< 1.5 x ULN OR direct bilirubin of =< ULN for subjects with total bilirubin levels of > 1.5 x ULN obtained within 14 days prior to registration
Within 14 days of treatment initiation: Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN (up to 14 days before treatment initiation)
Total bilirubin =< 1.5 x ULN OR, for subjected with total bilirubin levels > 1.5 x ULN, a direct bilirubin =< ULN must be met within 28 days of C1D1
Within 14 days of treatment initiation:\r\nSerum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Within 10 days of treatment initiation: Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 10 days of treatment initiation
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 14 days of treatment initiation
COHORT 1: Serum total bilirubin =< 1.5 X ULN unless considered due to leukemic organ involvement, Gilbert’s or hemolysis, OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN within 14 days of treatment initiation
COHORT 2: Serum total bilirubin =< 1.5 X ULN unless considered due to leukemic organ involvement, Gilbert’s or hemolysis, OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN within 14 days of treatment initiation
SAFETY RUN-IN: Within 10 days of registration: Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
RANDOMIZED PHASE II CLINICAL TRIAL: Within 10 days of registration: Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Total bilirubin ? 1.5 x ULN or direct bilirubin ? ULN for subjects with total bilirubin > 1.5 x ULN
Within 10 (except as noted) days of planned treatment initiation: Serum bilirubin =< 1.5 x institutional ULN OR direct bilirubin =< ULN for patients with total bilirubin levels > 1.5 x ULN
Total bilirubin =< 1.5 x ULN OR direct bilirubin =< 1 x ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for patients with total bilirubin levels > 1.5 ULN.
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 10 days of treatment initiation
Within 14 days of treatment registration: Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 14 days of treatment initiation
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN within 14 days of treatment initiation
Serum total bilirubin =< 1.5 X ULN unless due to Gilbert’s disease, hemolysis or leukemic infiltration OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 14 days of D1 of treatment under LCCC1522
Serum total bilirubin =< 1.5 upper limit of normal (ULN) or, direct bilirubin =< ULN for participants with total bilirubin levels > 1.5 ULN (performed within 14 days of treatment initiation)
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN (performed within 28 days of treatment initiation)
Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =<1.5 X institutional ULN OR direct bilirubin =< institutional ULN for subjects with total bilirubin levels > 1.5 institutional ULN, performed within 28 days of study registration
Total bilirubin ? 1.5 × ULN or direct bilirubin ? ULN.
Performed within 10 business days of treatment initiation with the exception of beta- HCG (72 hours), if applicable: Serum total bilirubin =< 1.5 X ULN or direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN.
At time of registration and within 4 weeks prior to initiating on-protocol treatment: Total bilirubin =< 1.5 x ULN, OR direct bilirubin =< ULN for participants with total bilirubin levels >1.5 x ULN
Within 10 days prior to the start of study treatment: Total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for participants with total bilirubin levels > 1.5 x ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 28 days of treatment initiation
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, should be performed within 10 days of treatment initiation
STRATUM A: Total bilirubin =< ULN or if > ULN then direct bilirubin =< 1.5 x ULN
STRATUM B: Total bilirubin =< ULN; or if > ULN then direct bilirubin =< 1.5 x ULN
STRATUM C: Total bilirubin =< ULN; or if > ULN then direct bilirubin =< 1.5 x ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 10 days of treatment
Serum total bilirubin ? 1.5 X ULN OR direct bilirubin ? ULN for subjects with total bilirubin levels > 1.5 ULN within 21 days of treatment initiation
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN within 21 days of treatment initiation
Performed within 10 days of treatment initiation: serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Should be performed within 30 days of treatment initiation: serum total bilirubin ? 1.5 X ULN OR direct bilirubin ? ULN for subjects with total bilirubin levels > 1.5 ULN
Within 28 days of cycle 1 day 1: Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN (performed within 10 days of treatment initiation)
Within 5 days prior to the start of study treatment: Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN.
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin ? ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 14 days of treatment initiation
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 28 days of treatment initiation
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 x ULN
To be performed within 14 days of treatment initiation: serum total bilirubin ? 1.5 x ULN OR direct bilirubin ? ULN for subjects with total bilirubin levels > 1.5 ULN
Within 10 days of treatment initiation: Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN.
Within 10 days of treatment initiation: Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Within 14 days of treatment initiation: Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 10 days of treatment initiation
Performed within 10 days of treatment initiation: Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN.
Within 7 days of registration: Total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 x ULN
Obtained =< 14 days prior to registration: Serum total bilirubin =< 1.5 X upper limit of normal (ULN) or direct bilirubin =< (ULN) for subjects with total bilirubin levels > 1.5 ULN
Within 28 days prior to enrollment: Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin >= 1.5 ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for patients with total bilirubin levels > 1.5 ULN
Total bilirubin ? 1.5 × upper limit of normal (ULN) OR direct bilirubin ? ULN for subjects with total bilirubin levels > 1.5 x ULN
Within 10 days of treatment initiation: Serum total bilirubin ? 1.5 X ULN OR direct bilirubin ? ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin ? 1.5 X ULN OR direct bilirubin ? ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 x ULN or direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 x ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN (performed within 10 days of treatment initiation)
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 X upper limit of normal (ULN) OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 10 days of treatment initiation
Obtained =< 28 days prior to registration: Total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for patients with total bilirubin levels > 1.5 x ULN
Performed within 7 days of treatment initiation: Total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Performed within 14 days of treatment initiation: Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin >= 1.5 ULN
Total bilirubin ?1.5 times the ULN, or direct bilirubin <ULN for patients with total bilirubin levels >1.5xULN;
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 x ULN or =< 3 x ULN if patient has Gilberts disease OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 14 days of treatment initiation
Serum total bilirubin =< 1.5 x ULN, performed within 10 days of treatment initiation OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN; for subjects with Gilbert’s disease =< 3 mg/dL
Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Performed within 10 days of treatment initiation: Serum total bilirubin =< 2.0 x ULN (unless considered due to Gilbert’s disease or leukemia disease) or direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin >= 1.5 x ULN OR direct bilirubin >= ULN for patients with total bilirubin levels > 1.5 x ULN
Serum total bilirubin =< 1.5 x upper limit of normal (ULN) OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Within 28 days prior to registration for protocol therapy: Serum total bilirubin => 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Performed within 10 days of treatment initiation: Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN; unless due to Gilbert’s disease or hemolysis
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN within 14 days of treatment initiation
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Within 10 days of treatment initiation: Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Within 14 days of treatment initiation: Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 X institutional ULN OR direct bilirubin =< institutional ULN for subjects with total bilirubin levels > 1.5 institutional ULN, performed within 14 days of registration
Performed within 10 days of treatment initiation: Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 x ULN or direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 x ULN performed within 10 days of treatment initiation
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 X ULN or direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN (within 10-15 days of treatment initiation)
Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for patients with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN within 16 days of treatment initiation
Total bilirubin =< 2 mg/dL, or direct bilirubin =< ULN for those with total bilirubin > 2 x ULN performed within 7 days of treatment initiation
Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, during screening and on cycle 1, day 1
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN within 14 days of treatment initiation
Serum total bilirubin =< ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > ULN (performed within 10 days of treatment initiation)
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Within 10 days of treatment initiation: Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin: =< 1.5 X ULN OR direct bilirubin =< ULN for participants with total bilirubin levels > 1.5 ULN
Completed within 10 days of SBRT treatment initiation: Direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Total serum bilirubin =< 1.5 x upper limit of normal (ULN) OR direct bilirubin =< ULN if total bilirubin levels > 1.5 x ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 x ULN or direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN within 14 days of treatment initiation
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN within 14 days prior to registration
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 10 days of treatment initiation
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 X ULN or direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 X ULN (except for subjects with Gilbert Syndrome, who may have total bilirubin < 3.0 mg/dl) or direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 X ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Performed 28 days prior to study registration up to the first dose of study drug: serum total bilirubin =< 1.5 X ULN (except for subjects with Gilbert syndrome, who may have total bilirubin < 3.0 mg/dl) or direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 x ULN
Within 10 days of treatment initiation: Serum total bilirubin =< 1.5 X 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 ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 10 days of treatment initiation
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN (within 28 days of treatment initiation)
Performed within 14 days (+3 working days) of treatment initiation: Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Performed within 14 days of treatment initiation: Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Total bilirubin levels =< 1.5 x ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 X ULN (patients who do not meet this criteria must have a direct\r\nbilirubin =< 1.5 X ULN)
Direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Direct bilirubin ? ULN for subjects with total bilirubin levels > 1.5 x ULN
Performed within 28 days prior to study registration up to the first dose of study drug: Serum total bilirubin =< 1.5 X ULN or direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 X ULN or direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 10 days of treatment initiation
Performed within 10 days of treatment initiation; serum total bilirubin ? 1.5 X ULN or direct bilirubin ? ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for patients with total bilirubin level 1.5 ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for patients with total bilirubin levels > 1.5 x ULN
Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for patients with total bilirubin levels > 1.5 x ULN
Serum total bilirubin ? 1.5 X ULN OR direct bilirubin ? ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin ? 1.5 x ULN OR o Direct bilirubin ? ULN for subjects with total bilirubin >1.5 x ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 X upper limit of normal (ULN) or direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin ? 1.5 X ULN OR direct bilirubin ? ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
REGISTRATION TO TREATMENT (STEP 1): Serum total bilirubin =< 1.5 X ULN OR direct bilirubin \r\n=< ULN for subjects with total bilirubin levels > 1.5 X ULN, within 14 days prior to first dose of pembrolizumab
REGISTRATION TO TREATMENT (STEP 2): Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 X ULN, within 14 days prior to first dose of pembrolizumab
Total bilirubin ? 1.5 ULN OR direct bilirubin ? ULN if total bilirubin > 1.5 x ULN
Serum total bilirubin ? 1.5 X ULN within 7 days of treatment initiation\r\n* Direct bilirubin ? ULN for subjects with total bilirubin levels > 1.5 ULN within 7 days of treatment initiation
All screening labs should be performed within 14 days (+3 working days) of treatment initiation: serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN;
Serum total bilirubin ? 1.5 X ULN OR direct bilirubin ? ULN for patients with total bilirubin levels > 1.5 ULN
Within 10 days of treatment initiation: total bilirubin =< 1.5 x ULN (3 X ULN if a exists a history of Gilbert syndrome) or direct bilirubin >= ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 28 days of treatment initiation
Within 10 days of treatment initiation: Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 x upper limit of normal (ULN) OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 x ULN obtained =< 28 days prior to registration
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN (performed within 10 days of treatment initiation)
Direct bilirubin: =< ULN for patients with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 10 days of treatment initiation
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 X upper limit of normal (ULN) or direct bilirubin =< ULN for patients with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN; patients with Gilbert’s syndrome must have a total bilirubin < 3.0 mg/dL
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for participants with total bilirubin levels > 1.5 x ULN, specimens must be collected within 10 days prior to the start of study treatment
Within 30 days prior to treatment initiation: Serum total bilirubin =< 1.5 X institutional ULN OR direct bilirubin =< institutional ULN for subjects with total bilirubin levels > 1.5 institutional ULN
Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Total Bilirubin: ?1.5xULN OR Direct bilirubin ?ULN for subjects with total bilirubin levels >1.5xULN
Total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 X ULN or direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 x upper limit of normal (ULN) OR direct bilirubin =< ULN if total bilirubin levels > 1.5 x ULN (within 14 days prior to day 1 of protocol therapy)
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN (performed within 10 days of treatment initiation)
Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 10 days of treatment initiation
Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for participants with total bilirubin levels > 1.5 ULN (within 14 days of treatment initiation)
Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, should be performed within 28 days of treatment initiation, unless otherwise indicated
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Within 4 weeks of administration of study therapy: Serum total bilirubin =< 1.5 x ULN or direct bilirubin =< ULN for patients with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 28 days of treatment initiation
Bilirubin levels >= 1.5 institutional ULN
Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 x ULN
Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
total bilirubin ? 1.5 × upper limit of normal (ULN) OR direct bilirubin ? ULN for subjects with total bilirubin levels > 1.5 x ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 14 days prior to registration
Within 14 days of treatment initiation: Serum total bilirubin =< 1.5 X institutional ULN OR direct bilirubin =< institutional ULN for subjects with total bilirubin levels > 1.5 institutional ULN
Performed within 28 days of radiation therapy: Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 28 days of treatment initiation
Serum total bilirubin =< 1.5 x ULN (direct bilirubin =< ULN if total bilirubin [bili] > 1.5 x ULN)
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin >= 1.5 ULN
Serum total bilirubin =< 1.5 x upper limit of normal (ULN) OR direct bilirubin =< ULN for patients with total bilirubin levels > 1.5 x ULN (labs should be performed within 14 days of treatment initiation)
Total bilirubin levels < 1.5 X ULN
Serum total bilirubin =< 1.5 x ULN or direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 x ULN
Total bilirubin ? 1.5 × upper limit of normal (ULN) OR direct bilirubin ? ULN for subjects with total bilirubin levels > 1.5 x ULN
Serum total bilirubin =< 1.5 x ULN (1.5 mg/dL or 25.65 umol/L) OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN; except patients with Gilbert's disease (=< 3 x ULN)
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 X ULN or direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN within 7 days of treatment initiation
Performed within 10 days of treatment initiation: Serum total bilirubin =< 1.5 x upper limit of normal (ULN) OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Bilirubin and total bilirubin levels =< 1.5 x ULN
Total bilirubin ? 1.5 × ULN OR direct bilirubin ? 1 × ULN
Bilirubin levels < 1.5 x ULN
Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Performed within 10 days of treatment initiation: Total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for patients with total bilirubin levels > 1.5 x ULN
Serum total bilirubin =< 2 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 2 ULN (performed within 10 days of treatment initiation)
Total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 10 days of treatment initiation
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, obtained =< 30 days prior to registration
Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 10 days of treatment initiation
Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 10 days of protocol enrollment
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
Total serum bilirubin =< 1.5 x ULN
Total serum bilirubin ? 1.5 X ULN
Serum total bilirubin ? ULN
Serum total bilirubin =< 1.5 x ULN OR
Total serum bilirubin less than ULN.
Total serum bilirubin =< 1.5 x ULN
Serum total bilirubin =< 1.5 x ULN
Within 10 days prior to on-study date: Serum total bilirubin ? 1.5 X ULN OR
Within 10 days of treatment initiation: Serum total bilirubin =< 1.5 X ULN
Performed within 10 days of treatment initiation: Serum total bilirubin =< 1.5 X ULN
Total serum bilirubin =< 1.5 ULN
Total serum bilirubin =< 1.5 x ULN
Serum total bilirubin =< 1.5 x ULN
Serum total bilirubin =< 1.5 X ULN
Serum total bilirubin =< 2.0 X ULN (performed within 28 days of registration)
Completed within 10 days of SBRT treatment initiation: Serum total bilirubin =< 1.5 X ULN OR
Serum total bilirubin =< 1.5 X ULN
Total serum bilirubin ? 1.5 x ULN
Serum total bilirubin =< 1.5 X ULN OR
Serum total bilirubin =< 1.5 x ULN
Total serum bilirubin ? 1.5 × ULN.
Serum total bilirubin =< 1.5
Serum total bilirubin ? 1.5 x ULN
Total serum bilirubin =< 1.5 x ULN
Total serum bilirubin =< 1.5 x ULN
Patients must have a total serum bilirubin =< 1.5 x ULN (grade =< 1) and a serum creatinine =< grade 1
Serum total bilirubin: =< 1.5 X ULN OR
Total serum bilirubin of =< 1.5 x institutional ULN
Total serum bilirubin < 2.5 x ULN
Serum total bilirubin ? 1.5 x ULN
Total serum bilirubin ?1.5×ULN.
Total serum bilirubin ? 1.5 x ULN (CTCAE Grade ? 1);
Serum total bilirubin ? 1.5 x ULN (except in subjects with Gilbert's who may have serum bilirubin < 3.0 x ULN),
Total serum bilirubin <=1.5 * ULN
Serum total bilirubin =< 1.5 x ULN
Serum total bilirubin > 1.5 x ULN
Serum total bilirubin ? 1.5 X ULN
Within 14 days of study start: Serum total bilirubin =< 1.5 x ULN
Serum total bilirubin ? 1.5 x Institutional ULN
Total serum bilirubin within ULN
Total serum bilirubin =< 1.5 x ULN
Serum total bilirubin =< 1.5 x ULN
Serum total bilirubin ? 1.5 x ULN
Total serum bilirubin =< 2.0 x ULN
Total serum bilirubin =< 1.5 x ULN
Total serum bilirubin ? 1.5 x institutional ULN
Total serum bilirubin =< 2.0 x ULN
Serum total bilirubin < 1.5 x ULN
Serum total bilirubin =< 2.0
Serum total bilirubin =< 1.5 X ULN
Serum total bilirubin =< 1.5 x ULN
Total serum bilirubin =< 1.5 x ULN
Total serum bilirubin ? 1.5 x ULN
Serum total bilirubin < 1.5 x ULN
Serum total bilirubin ? 1.5 x the ULN.
Total serum bilirubin =< 2.0 x ULN
Serum total bilirubin =< 1.5 x ULN
Serum total bilirubin >1.5 x ULN
Total serum bilirubin < 1.5x institutional ULN
Total serum bilirubin < 1.5 x ULN
Total serum bilirubin <1.5 × ULN and
Serum total bilirubin ? 2.0 x ULN
Serum total bilirubin =< 3
Total serum bilirubin =< 1.5 x ULN