FDG-PET/CT Imaging as Early Predictor of DP
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
1 other identifier
observational
9
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2014
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 16, 2015
CompletedFirst Posted
Study publicly available on registry
June 19, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedJuly 11, 2023
July 1, 2023
1.5 years
June 16, 2015
July 10, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Global objective tumor response measured from serial PET/CT scans
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
Study Arms (2)
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.
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.
Interventions
Subjects undergo FDG-PET CT scans in order to determine lesional FDG intake and changes in lesional FDG uptake.
Eligibility Criteria
Subjects with DLBCL and FL treated on a phase I study with Autologous T cells
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jakub Svoboda, MD
Abramson Cancer Center at Penn Medicine
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2015
First Posted
June 19, 2015
Study Start
August 1, 2014
Primary Completion
February 1, 2016
Study Completion
August 1, 2018
Last Updated
July 11, 2023
Record last verified: 2023-07