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