18F-F-AraG PET Imaging to Evaluate Immunological Response to CAR T Cell Therapy in Lymphoma

Trial ID or NCT#



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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

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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
Exclusion Criteria:
  1. - 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.


David Miklos
David Miklos
Blood and marrow transplant specialist, Blood and marrow transplant specialist, Hematologist, Medical oncologist
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Contact us to find out if this trial is right for you.


Maria Iglesias