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

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.

Stanford is currently accepting patients for this trial.

Stanford Investigator(s):

Intervention(s):

  • drug: [ 18F]F-AraG PET

Eligibility


Inclusion 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

Exclusion Criteria:

   - 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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Maria Iglesias
I'm interested

Our research team includes physicians, residents, medical students, research assistants, and volunteers. Our research topics include medical imaging, device validation,  mobile application development, and pharmaceutical trials.  

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