FDG-PET/CT Imaging as Early Predictor of DP
This trial is active, not recruiting.
|Treatments||cart-19 autologous t-cells, fdg-pet/ct|
|Sponsor||University of Pennsylvania|
|Start date||August 2014|
|End date||February 2016|
|Trial size||9 participants|
|Trial identifier||NCT02476734, UPCC 12914|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
4 subjects with DLBCL
4 subjects with FL
NUmber of Adverse Events
time frame: 2 years
Male or female participants at least 18 years old.
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.
|Official title||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|
|Principal investigator||Jakub Svoboda, MD|
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