Saves the questions and what to expect into your notes, next to the visit they belong to.
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Lead
Stanford University
With
CellSight Technologies, Inc.
Primary Objectives:
\* Explore the relationship of change in \[18F\]F-AraG PET signal following CAR T cell treatment with changes in T cell infiltration in tumor biopsies.
Exploratory Analyses:
* Explore the relationship of change in \[18F\]F-AraG PET signal in tumor lesions following CAR T cell treatment with clinical benefit rate (defined as Complete Response (CR) + Partial Response (PR) + stable disease (SD) ≥ 3 months) using RECISTv1.1 criteria
* Correlate the change in \[18F\]F-AraG PET signal in tumor lesions following CAR T cell therapy with maximum grade of Cytokine Release Syndrome (CRS) and neurotoxicity experienced.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Age ≥ 18 years old
Histologically confirmed aggressive B cell NHL including the following types defined by WHO 2008:
* DLBCL not otherwise specified; T cell/histiocyte rich large B cell lymphoma; DLBCL associated with chronic inflammation; Epstein Barr virus (EBV)+ DLBCL of the elderly; OR
* primary mediastinal (thymic) large B cell lymphoma
* transformation of follicular lymphoma, marginal zone lymphoma or chronic lymphocytic leukemia to DLBCL will also be included
Measurable disease by PET imaging (as defined by Cheson (2014)), that meets all the following criteria:
* At least one measureable lesion away from head \& neck, liver, kidneys, GI tract and bladder
* At least one biopsy-accessible lesion or lymph node.
Express willingness to undergo low risk FNA or core biopsy of subcutaneous accessible lesion or lymph node.
Scheduled to receive commercial or research CAR T cell therapy with axicabtagene ciloleucel (Yescarta ®) as part of anticancer therapy.
Adequate renal and hepatic function, defined as:
1. Creatinine clearance (as estimated by Cockcroft Gault) ≥ 60 mL/min or Cr \< 1.6 mg/dL
2. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5x upper limit of normal (ULN)
3. Total bilirubin ≤ 1.5 mg/dL, except in cases of Gilbert's syndrome
Able to give informed consent. Subjects unable to give informed consent will not be eligible for this study
You may not be if
Women who are pregnant or breastfeeding.
Subjects with significant GI disease involvement by PET imaging
In the investigator's judgment, have any medical condition likely to interfere with assessment of safety or efficacy, be unable to tolerate additional radiation, or be unlikely to complete all protocol-required visits and procedures.
Clareo Health | 18F-F-AraG PET Imaging to Evaluate Immunological Response to CAR T Cell Therapy in Lymphoma
