Non Hodgkin Lymphoma Clinical Trial

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

Summary

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.

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Full Description

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.

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Eligibility Criteria

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:

Creatinine clearance (as estimated by Cockcroft Gault) ≥ 60 mL/min or Cr < 1.6 mg/dL
Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5x upper limit of normal (ULN)
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.

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

6

Study ID:

NCT05096234

Recruitment Status:

Recruiting

Sponsor:

Stanford University

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There is 1 Location for this study

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Stanford University, School of Medicine
Stanford California, 94305, United States More Info
Maria Iglesias
Contact
[email protected]
David Miklos
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

6

Study ID:

NCT05096234

Recruitment Status:

Recruiting

Sponsor:


Stanford University

How clear is this clinincal trial information?

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