FDG-PET/CT Imaging as Early Predictor of DP

Completed

• Conditions: Lymphoma
• Interventions: Other: There is no intervention

• Registration Number: NCT02476734
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

Brief Summary

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.

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 Timeline

• Study Start: 2014-08
• Study First Submitted: 2015-06-16
• Study First Submitted QC: 2015-06-18
• Study First Posted: 2015-06-19
• Primary Completion: 2016-02
• Study Completion: 2018-08
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-10
• Last Update Posted: 2023-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diffuse Large B-cell Lymphoma	There is no intervention	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.
Follicular Lymphoma	There is no intervention	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.

Primary Outcome Measures

Name	Time	Method
Global objective tumor response measured from serial PET/CT scans	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.

Trial Locations

Locations (1)

Abramson Cancer Center of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States