18F-F-AraG PET Imaging to Evaluate Immunological Response to CAR T Cell Therapy in Lymphoma
Trial ID or NCT#
Status
Purpose
This is a pilot study in adult subjects with aggressive B-cell lymphoma who will receive commercial or research CAR T cell therapy as anticancer treatment.
Official Title
Pilot Study of [18F]F-AraG PET Imaging to Evaluate Immunological Response to Chimeric Antigen Receptor (CAR) T Cell Therapy in Lymphoma
Eligibility Criteria
- * 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
- * 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.
Investigator(s)
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Contact
Maria Iglesias
View on ClinicalTrials.gov