[c09aa8]: / clusters / 9knumclustersv2 / clust_1297.txt

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Patients must demonstrate adequate organ function as defined below; all screening labs to be obtained =< days prior to registration; (Note: screening labs will be repeated again on cycle day [CD] if they were performed outside of the =< day window)
Adequate labs
Adequate labs
Have adequate organ function (all screening labs should be performed within days prior to study treatment):
Demonstrate adequate organ function, all screening labs should be performed within days prior to registration
iC-CAR CELL INFUSION: Demonstrate adequate renal and hepatic function; all screening labs to be obtained within hrs prior to cell infusion
Demonstrate adequate organ function, all screening labs should be performed within 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 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 days of registration on the study
Patients must have adequate labs within days of treatment unless cytopenia is thought to be due to underlying disease
Has adequate organ function as defined by protocol defined labs.
Have adequate organ function, with all screening labs performed within days of treatment initiation.
Demonstrate adequate organ function, all screening labs should be performed within days of treatment initiation
Demonstrate adequate organ function, all screening labs should be performed within weeks of treatment initiation
Leukocytes >= ,/mcL (labs should be performed within days of treatment initiation)
Unable to draw labs for HDMTX serum concentration
DONOR: Donors must not have any medical condition which would make apheresis more than a minimal risk, and should have the following:\r\n* Family members will be considered for donation if they do not have a history of known cardiac problem and do not have abnormal cardiac findings by physical examination; those with a history of cardiac problems or abnormal cardiac findings by physical examination should undergo a stress evaluation or be evaluated by a cardiologist and deemed eligible to donate\r\n* Bilirubin and hepatic transaminases =< . x upper limit or normal (ULN)\r\n* Adequate hematologic parameters including a hematocrit > % for males and % for females, white blood cell count of >= ,, and platelets >= ,\r\n* Foundation for the Accreditation of Cellular Therapy (FACT) laboratories (labs) must be drawn within days of collection and final test results available prior to infusion into the patient; in the case of multiple donations from the donor, the FACT labs must be redrawn within days of each initiation of apheresis (positive serologies are not repeated as they remain positive for lifetime but all other donor labs are performed)
Have adequate organ function (all screening labs should be performed within days prior to treatment initiation):
Use of hydroxyurea within days prior to screening labs
Growth factors within days prior to screening labs
Specific ranges/levels of Screening labs that are acceptable per protocol.
Baseline laboratories (repeat labs can be evaluated at baseline to establish eligibility):
Satisfactory results of screening safety labs, serum testosterone test and drug test
Severe active anemia (a hemoglobin < documented by labs drawn within months of first study treatment)
Subjects who exhibit signs of infection or a significant change from baseline test measurements via safety labs will be informed
VTE risk score >= , using labs drawn within days of consent
Satisfactory results of screening safety labs, urine pregnancy test and drug test
Labs required for enrollment (prior to microinjection):
Demonstrate adequate organ function, all screening labs must be performed within days of treatment initiation; labs must meet eligibility criteria within days of cycle day