FDG-PET/CT Imaging as Early Predictor of DP

July 10, 2023 updated by: Abramson Cancer Center at Penn Medicine

A Pilot Study Using FDG-PET/CT Imaging as an Early Predictor of Disease Response in Lymphoma Subjects Receiving Redirected Autologous CART- 19 T-cell Immunotherapy

In this study the investigators would like to describe FDG-PET/CT responses in patients who are receiving CART-19 immunotherapy for Follicular Lymphoma (FL), Diffuse Large B-cell Lymphoma (DLBCL), and Mantle Cell Lymphoma (MCL) as part of UPCC #13413. Subjects will undergo two FDG-PET/CTs. One performed within 6 weeks of CART-19 infusion and a repeat scan at about 1 month after infusion.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this study the investigators described FDG-PET/CT responses in patients who were receiving CART-19 immunotherapy for Follicular Lymphoma (FL), Diffuse Large B-cell Lymphoma (DLBCL), and Mantle Cell Lymphoma (MCL) as part of UPCC #13413. Subjects underwent two FDG-PET/CTs. One performed within 6 weeks of CART-19 infusion and a repeat scan at about 1 month after infusion.

Study Type

Observational

Enrollment (Actual)

9

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Abramson Cancer Center of the University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects with DLBCL and FL treated on a phase I study with Autologous T cells

Description

Inclusion Criteria:

  • Subjects enrolled on the study UPCC 13413 Pilot Study Of Redirected Autologous T Cells Engineered To Contain Anti-Cd19 Attached To Tcr And 4-1bb Signaling Domains In Patients With Chemotherapy Resistant Or Refractory Cd19+ Lymphoma CART-19 autologous T-cell trial with relapsed or refractory DLBCL and FL. As this is a pilot study, we plan to enroll 4 subjects from the two disease types of interest.
  • Subjects ≥ 18 years of age
  • Subjects able to provide informed consent and agree to comply with study procedures

Exclusion Criteria:

  • Subjects who are pregnant or lactating.
  • Subjects will be co-enrolled in this study and UPCC 13413 and therefore must comply with the UPCC 13413 Pilot Study Of Redirected Autologous T Cells Engineered To Contain Anti-Cd19 Attached To Tcr And 4-1bb Signaling Domains In Patients With Chemotherapy Resistant Or Refractory Cd19+ Lymphoma requirements pertaining to pregnancy, lactation, conception and contraception use throughout their participation in both studies.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Diffuse Large B-cell Lymphoma
There is no intervention. Will undergo baseline FDG-PET/CT to be performed within 6 weeks of infusion of CART-19 autologous T-cell therapy in a different study and then undergo repeat FDG-PET/CT at approximately 1 month after infusion. Infusion of CART-19 autologous T-cell therapy is not part of this study.
Other: There is no intervention
Subjects undergo FDG-PET CT scans in order to determine lesional FDG intake and changes in lesional FDG uptake.
Follicular Lymphoma
There is no intervention. Will undergo baseline FDG-PET/CT to be performed within 6 weeks of infusion of CART-19 autologous T-cell therapy in a different study and then undergo repeat FDG-PET/CT at approximately 1 month after infusion. Infusion of CART-19 autologous T-cell therapy is not part of this study.
Other: There is no intervention
Subjects undergo FDG-PET CT scans in order to determine lesional FDG intake and changes in lesional FDG uptake.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global objective tumor response measured from serial PET/CT scans
Time Frame: 1 month
global objective tumor response measured from serial PET/CT scans as the change (absolute and relative (%)) in total metabolically active tumor volume (i.e., the total volume (in cc) of FDG-avid tumor throughout the body) between pre-treatment and post-treatment PET/CT scans.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abramson Cancer Center at Penn Medicine

Investigators

  • Principal Investigator: Jakub Svoboda, MD, Abramson Cancer Center at Penn Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

June 16, 2015

First Submitted That Met QC Criteria

June 18, 2015

First Posted (Estimated)

June 19, 2015

Study Record Updates

Last Update Posted (Actual)

July 11, 2023

Last Update Submitted That Met QC Criteria

July 10, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UPCC 12914

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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