FDG-PET/CT Imaging as Early Predictor of DP

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Lymphoma

Intervention / Treatment
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* Other: There is no intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diffuse Large B-cell Lymphoma<br>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<br>* Subjects undergo FDG-PET CT scans in order to determine lesional FDG intake and changes in lesional FDG uptake.<br>|
| Follicular Lymphoma<br>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<br>* Subjects undergo FDG-PET CT scans in order to determine lesional FDG intake and changes in lesional FDG uptake.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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REDIRECTED AUTOLOGOUS CART- 19 T-CELL IMMUNOTHERAPY