18F-F-AraG PET Imaging for Lymphoma

Phase 2

Recruiting

Led By David Miklos, MD, PhD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically confirmed aggressive B cell NHL including specific types defined by WHO 2008

Scheduled to receive CAR T cell therapy with axicabtagene ciloleucel as part of anticancer therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up ≥ 3 months

Awards & highlights

Study Summary

This trial tests a new type of cancer treatment using CAR T cells to treat aggressive B-cell lymphoma.

Who is the study for?

Adults over 18 with aggressive B-cell non-Hodgkin's lymphoma eligible for CAR T cell therapy can join. They must have a type of tumor visible on PET scans, not located in sensitive areas like the head or abdomen, and be able to undergo a biopsy. Pregnant women and those with significant GI tract involvement by cancer cannot participate.Check my eligibility

What is being tested?

The trial is testing how well [18F]F-AraG PET imaging works in evaluating the body's immune response to CAR T cell therapy in patients with aggressive B-cell lymphoma. It aims to see if this imaging method can effectively monitor treatment progress.See study design

What are the potential side effects?

While the document doesn't specify side effects related to [18F]F-AraG PET imaging, typical risks may include exposure to radiation and discomfort from the injection site. The procedure is generally considered low-risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My diagnosis is aggressive B cell non-Hodgkin lymphoma.

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I am scheduled for CAR T cell therapy with axicabtagene ciloleucel.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ ≥ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~≥ 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and ≥ 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

measure

Other outcome measures

First exploratory outcome measure

Second exploratory outcome measure

Trial Design

1Treatment groups

Experimental Treatment

Group I: [18F]F-AraG PETExperimental Treatment1 Intervention

Subjects will undergo PET imaging at the following time points: Baseline, prior to lymphodepleting chemotherapy: [18F]F-AraGPET/CT, followed the next day by FDG-PET/CT At peak CAR expansion: Day 4 (± 2 days) post-CAR infusion: [18F]F-AraG PET At Day +28 (± 4 days) post-CAR infusion: FDG-PET/CT Subjects will have a paired biopsy after each imaging time point, if possible. Subjects will be followed for safety of [18F]F-AraG for 30 days after last dose

0 / 3Eligibility criteria met