[c09aa8]: / clusters / ordered9kclusters / clust_421.txt

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Procurement: Patients with life expectancy >= 6 months
Procurement: Patients with active human immunodeficiency virus (HIV) infection (can be pending at this time)
>= 3 weeks from protocol tissue procurement since treatment (surgery, chemo-, radiation-, hormone- therapy, check point blockade [e.g., anti-CTLA-4, PD-1, PDL-1]); (windows are in relation to the date of the protocol tissue procurement)
PROCUREMENT: Patient able to give informed consent
PROCUREMENT: Patients with active human immunodeficiency virus (HIV) positive at time of procurement (can be pending at the time of blood draw)
INCLUSION CRITERIA FOR BLOOD PROCUREMENT:
EXCLUSION CRITERIA FOR BLOOD PROCUREMENT:
PROCUREMENT INCLUSION CRITERIA: Patients with life expectancy ? 12 weeks
PROCUREMENT INCLUSION CRITERIA: Hemoglobin (Hgb) > 8.0 (transfusions allowed)
PROCUREMENT EXCLUSION CRITERIA: Patients with severe intercurrent infection
PROCUREMENT EXCLUSION CRITERIA: Patients with active human immunodeficiency virus (HIV) infection at time of procurement
INCLUSION - PROCUREMENT: If pheresis required to collect blood:\r\n* Creatinine <1.5 × upper limit normal
INCLUSION - PROCUREMENT: EBV positive tumor (can be pending)
INCLUSION - PROCUREMENT: Weighs at least 12 kg
PROCUREMENT INCLUSION: Diagnosis of relapsed/refractory HL or NHL
PROCUREMENT INCLUSION CRITERIA: Patients with life expectancy ? 6 weeks
PROCUREMENT INCLUSION CRITERIA: Hemoglobin (Hgb) > 8.0 (transfusions allowed)
PROCUREMENT EXCLUSION CRITERIA: Patients with severe intercurrent infection
PROCUREMENT EXCLUSION CRITERIA: Patients with active human immunodeficiency virus (HIV) infection at time of procurement (can be pending at the time of blood draw)
PROCUREMENT EXCLUSION CRITERIA: Patients in remission who are enrolled on another study where time to progression or disease free survival is a primary endpoint
PROCUREMENT CRITERIA
CELL PROCUREMENT: Life expectancy >= 12 weeks
CELL PROCUREMENT: Bilirubin =< 1.5 x upper limit of normal (ULN), unless attributed to Gilbert’s syndrome, obtained within 72 hrs prior to procurement
CELL PROCUREMENT: Aspartate aminotransferase (AST) =< 3.0 x ULN, obtained within 72 hrs prior to procurement
CELL PROCUREMENT: Alanine aminotransferase (ALT) =< 3.0 x ULN, obtained within 72 hrs prior to procurement
CELL PROCUREMENT: Subjects currently receiving “maintenance” doses of chemotherapy are eligible and the need for intrathecal prophylaxis prior to procurement is left to the discretion of the investigator; maintenance doses of chemotherapy are defined as methotrexate =< 30 mg/m^2/week, mercaptopurine =< 100 mg/m^2/day and vincristine =< 2 mg/28 days; corticosteroid-containing maintenance therapy is permitted only if corticosteroids are administered > 14 days prior to procurement; (Note: corticosteroid use with doses at the discretion of the treating physician are allowed after procurement up to the beginning of lymphodepletion; corticosteroid use is contraindicated following iC9-CAR19 infusion unless medically necessary e.g., to treat CRS)
CELL PROCUREMENT: Received anti-CD19 antibody-based therapy OR cytotoxic chemotherapy not described as maintenance therapy within 2 weeks of procurement
PRIOR TO CELL PROCUREMENT: Serum creatinine ? 1.5 times ULN
PRIOR TO CELL PROCUREMENT: Negative serum pregnancy test in females within 72 hours prior to procurement or documentation that the subject is post-menopausal or premenarchal
PRIOR TO CELL PROCUREMENT: Pregnant or lactating
AT THE TIME OF PROCUREMENT: Recurrent or refractory GBM
AT THE TIME OF PROCUREMENT: Subjects having a tumor resection
AT THE TIME OF PROCUREMENT: Karnofsky score of ? 60
PROCUREMENT: Karnofsky score ? 50%
PROCUREMENT: Diagnosis of myeloma after receiving at least one treatment regimen
PROCUREMENT: Patient able to give informed consent
PROCUREMENT: Patients with severe active infection
PROCUREMENT: Patients with active human immunodeficiency virus (HIV) infection at time of procurement (can be pending at the time of blood draw)
INCLUSION CRITERIA AT TIME OF PROCUREMENT:
EXCLUSION CRITERIA AT TIME OF PROCUREMENT:
PROCUREMENT INCLUSION CRITERIA:
PROCUREMENT EXCLUSION CRITERIA:
PROCUREMENT ELIGIBILITY:
PROCUREMENT ELIGIBILITY:
AT TIME OF PROCUREMENT:
AT TIME OF PROCUREMENT:
PROCUREMENT INCLUSION CRITERIA:
PROCUREMENT EXCLUSION CRITERIA:
AT THE TIME OF PROCUREMENT: Nasopharyngeal carcinoma in first or subsequent relapse or with primary refractory disease
AT THE TIME OF PROCUREMENT: EBV positive tumor
Patients must have an accessible metastatic lesion for pretreatment core biopsy procurement.
ELIGIBILITY FOR BLAST COLLECTION (PROCUREMENT)
Procurement consent signed and faxed to Research Coordinator